Peeji a na-enye ndepụta nke analogues Insugen-30/70 (Bifazik) site na mejupụtara na ngosipụta maka ojiji. Ndepụta analogues dị ọnụ ala, ị nwekwara ike ịtụle ọnụ ahịa dị na ụlọ ahịa ọgwụ.

• Analogue dị ọnụ ala nke Insugen-30/70 (Bifazik):Humalog Mix
• Analog analog nke insugen-30/70 (Bifazik):Humalog Mix
• Nhazi ATX: Insulin (mmadụ)
• Ngwaọrụ mejupụtara / ihe mejupụtara: insulin mmadu
  

Mgbe ị na-agbakọ ọnụ ego ahụ ọnụ ala analogues Insugen-30/70 (Bifazik) agbakwunyere ụgwọ opekata mpe enwere na ndepụta ọnụahịa nke ndị ahịa ọgwụ nyere

Nyere ndepụta ọgwụ analogues dabere na ndekọ ọnụ ọgụgụ nke ọgwụ a kacha chọọ

Analogs na ihe mejupụtara ma gosipụta maka ojiji

Ndepụta dị n'elu analogues ọgwụ, nke na-egosi nọchiri Insugen-30/70 (Bifazik), bụ nke kachasị mma n'ihi na ha nwere otu ihe mejupụtara nke ihe ndị na-arụ ọrụ ma na-emekọ ihe dabere na ngosipụta maka ojiji

Analogs site na ngosipụta na usoro eji

Ngwakọta dị iche iche, nwere ike yikọ ọnụ na njiri na usoro nke ngwa

Etu esi achọta analog dị ọnụ ala nke ọgwụ na-akwụ ụgwọ?

Iji chọta analog na-enweghị ego ọfụma n’egwuregwu, mkpụrụ ọgụgụ ma ọ bụ ntụgharị, nke mbụ anyị na-atụ aro ị attentiona ntị na ihe mejupụtara ahụ, ya bụ otu ihe ahụ na njiri mara maka ojiji. Otu ihe eji eme ọgwụ eme ihe ga-egosi na ọgwụ ahụ kwekọrọ na ọgwụ ahụ, ọgwụ kwekọrọ ma ọ bụ ọgwụ ọzọ. Agbanyeghị, echefula maka ihe ndị na - adịghị ike nke ọgwụ ndị yiri ya, nke nwere ike imetụta nchekwa na ịdị irè. Echefula banyere ntuziaka nke ndị dọkịta, ọgwụ ịchọrọ onwe gị nwere ike imerụ ahụ ike gị, yabụ gbaa dọkịta gị mgbe niile tupu ị beforeụ ọgwụ ọ bụla.

Nkọwapụta ọgwụ ọjọọ

Insulin degludec + Insulin na mbinye ya (Insulin degludec + Insulin aspart *) - Inslọ ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill preparation bu nkwadebe ejikọtara nke nwere insulin insulin nke mmadụ na - eme (insulin degludec) yana ngwa ngwa na - arụ ọrụ nke insulin mmadụ (insulin aspart) mepụtara site na teknụzụ ndị na - agbagha ọgwụ. A na - ejikwa DNA na - enwe nsogbu Saccharomyces cerevisiae.

Insulin degludec na insulin gbadoro ụkwụ n'ụzọ a kapịrị ọnụ jikọtara ọnụ na nnabata nke insulin na-emekọ ihe ma soro ya meekọrịta ihe, na-achọpụta mmetụta ọgwụ ọgwụ yiri nke insulin na-arụ ọrụ mmadụ. Mmetụta hypoglycemic nke insulin bụ n'ihi ịba ụba nke glucose site na anụ ahụ mgbe ha jikọsịrị insulin na akwara na ndị na-anabata abụba na-adị, ma na-agbada n'otu oge ọnụego glucose na-emepụta site na imeju.

Mmetụta ọgwụ ọgwụ nke mmiri ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® dị iche iche na profaịlụ ọgwụ niile gosipụtara profaịlụ nke ihe ndị mejupụtara ya: insulin na-agba ọsọ dị elu na insulin degludec nke mgbakwunye ogologo oge.

Akụkụ basal nke ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ®, nke nwere oke ihe dị ogologo (insulin degludec), mgbe ntinye ọgwụ subcutaneous soluble multihexamers na subcutaneous depot, nke na-enwe usoro na-aga n'ihu nke insulin degludec banye na mmegharị. profaịlụ dị larịị nke arụmọrụ yana ike hypoglycemic mmetụta nke ọgwụ. A na - echekwa nsonaazụ a na insulin aspart ma ọ naghị emetụta ọnụego nnabata nke ndị nwere insulin as-eme ngwa ngwa.

Ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® amalite ime ihe ngwa ngwa, na-enye prandial mkpa insulin obere oge mgbe ịgbasịrị, ebe akụkụ basal nwere profaịlụ dị larịị, kwụsiri ike ma bụrụ nke na-enye ọtụ aka. na insulin. Ogologo oge ị actionụ ọgwụ otu insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® karịrị awa 24.

E gosipụtawo mmekọrịta dị n'etiti ịbawanye ụba nke insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfnill ® yana oke hypoglycemic mmetụta ya. A na-enweta ntinye uche nke ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® ka emerechara ụbọchị 2-3 nke ọgwụ a.

Enweghị ọdịiche dị iche iche na ọgwụ ọgwụ nke insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® na ndị agadi na ndị ọrịa nwere nsogbu na ndị ọrịa obere.

Arụmọrụ arụmọrụ yana nchekwa

Conductedgwọ ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) internationalgwọ maka usoro mgbaru ọsọ maka mgbaru ọsọ 26 ma ọ bụ 52 metụtara ndị ọrịa 1360 nwere ọrịa mellitus (362 ndị nwere ọrịa shuga mellitus) 1dị 1 na ndị ọrịa 998 nwere ọrịa shuga 2). Emere ọmụmụ heliko abụọ na otu nchịkwa nke insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) combination yana ọgwụ hypoglycemic ọgwụ (PHGP) na otu ọgwụ insulin glargine na PHGP na ndị ọrịa nwere ụdị ọrịa shuga 2 nke ọrịa mellitus. Nlekọta nke insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® ugboro abụọ kwa ụbọchị yana PHGP ka e jiri ya na nchịkwa insulin aspart 30 nke ugboro abụọ n’ụbọchị yana PHGP n’ọmụmụ ihe abụọ n’ime ndị ọrịa nwere ụdị shuga 2. . Nlekọta nke ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® otu ugboro kwa ụbọchị yana insulin aspart e jiri ya na njikwa insulin wepụta otu ugboro ma ọ bụ abụọ kwa ụbọchị yana insulin na-eke ndị ọrịa nwere ụdị 1 ọrịa shuga. .

Enweputara na enweghi ike nke ihe nlere gosiputara na insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) n'ihe banyere mbelata na HbA_1c n'ihe omumu nile na usoro ọgwụgwọ nke ndi oria ka ha mezuo.

N'ime ndị ọrịa nwere ụdị shuga nke 2 na-enwetabeghị ọgwụ insulin na ndị ọrịa nwetasịrị ọgwụ insulin, insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) combination na PHGP na-enye njikwa glycemic yiri nke ahụ karịa insulin. Glargin. Insulin degludec + Insulin aspart * (Insulin degludec + insulin aspart *) ® na - enye prandial glycemic akara ka ọ dị n ’insulin glargine na - enwekarị ogo hycggcecemia (nke akọwapụtara dị ka akụkụ nke hypoglycemia nke mere n'etiti awa 0 na awa 6), na nsonaazụ gosipụtara na --ele ntinye glucose plasma nke erughi 3.1 mmol / l ma obu ihe akaebe na onye ọrịa choro enyemaka nke ndi ozo).

Nlekọta ọgwụ ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® ugboro abụọ kwa ụbọchị na-enye njikwa glycemic (HbA)_1c) ka atụnyere biphasic insulin aspart 30, nke a na-ahụkwa ugboro abụọ n'ụbọchị. Ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® na - enye ezigbo ngbanwe dị mma iji belata oke glucose na plasma na - ebu ọnụ. Mgbe ị na-eji insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ®, ebumnuche plasma glucose nke 5 mmol / L na-enweta ngwa ngwa na ndị ọrịa ma e jiri ya tụnyere ndị ọrịa mesoro insulin bi insulin. (Insulin degludec + Insulin aspart *) ® na - ebutekarị hypoglycemia (gụnyere abalị). N'ime ndị ọrịa nwere ụdị shuga 1, ịgwọ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® otu ugboro n'ụbọchị yana insulin aspart tupu nri ndị ọzọ egosipụtara njikwa glycemic (HbA)_1c (glucose plasma glucose) na -arụ ọrịa shuga na-adịghị ala ala ma e jiri ya tụnyere ngọngọ nke bolus nke insulin dstemir na insulin na-eri nri kwa ụbọchị.

Dabere na nyocha nke meta nke izu abụọ mepere emepe 26 nke a na-eme atụmatụ dịka “ịgwọ maka ebumnuche” nke metụtara ndị ọrịa nwere ọrịa shuga 2, ọgwụ insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ®, nyere ya ugboro abụọ. kwa ụbọchị, gosipụtara ọnọdụ dị ala nke hypoglycemia nwapụtara n'ozuzu ya na oke nke hypoglycemia nke enwetara na-akpata ya ma e jiri ya tụnyere insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ased gbadara. ọ nwere oghere glucose plasma na-ebu ọnụ nke nwere obere ọrịa hypoglycemia ma n'oge ọmụmụ ihe yana n'oge mmezi nke dose site na izu iri na isii (Isiokwu 1)

Tebụl 1. Nsonaazụ nyocha-meta nke data n’akụrụngwa hypoglycemia mgbe etinyere ya ugboro abụọ n’ụbọchị n’oge ọmụmụ ihe ahụ na n’oge mmezi nke dose site n’izu iri na isii.

Enweghi ọgwụ mgbochi dị ka ọgwụ na insulin ka ọ gwọchara insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) an ruo ogologo oge.

Njirimara nke ọgwụ insulin degludec + Insulin aspart

Achịkọta ọgwụ mejupụtara analog nke insulin nke mmadụ nwere oke ihe (insulin degludec) yana ngwa ngwa soluble nke insulin mmadụ (insulin aspart) mepụtara site na teknụzụ ihe omimi nke DNA site na iji eriri. Saccharomyces cerevisiae.

Njikọ insulin analorọ mmadụ nwere insulin 70% na-arụ ọrụ ogologo oge (insulin degludec) na 30% insulin na-arụ ọrụ ọsọ ọsọ (insulin aspart).

Insulin Degludec dị iche na insulin mmadụ n’enweghi amino acid nke threonine nọ n'ọnọdụ B30 na ọnụnọ nke ihe mejupụtara ya bụ glutamic acid na C16 fatty acid, nke teknụzụ DNA na-emegharị site n'iji ụdị emegharị. Saccharomyces cerevisiae. Degludec insulin nwere aru di egwu nke 6103.97.

Insulin aspart bụ insulin mmadụ, ewezuga nnọchi nke amino acid nọ n'ọnọdụ B28 yana acid aspartic, nke teknụzụ DNA na-ejikọ site n'iji ụdị njegharị. Saccharomyces cerevisiae, kilogram di ndu 5825.8.

Insulin Aspart, Bifazik na Degludek: ọnụahịa na ntuziaka

Ọrịa shuga mellitus bụ ọrịa nkịtị nke chọrọ ọgwụgwọ oge niile. Ya mere, n'ụdị ọrịa mbụ na ụdị ọrịa nke abụọ nke ọrịa, ndị ọrịa chọrọ insulin insulin, nke na-enyere aka ịme glucose, na-agbanwe ya ike.

Ọtụtụ mgbe, na-arịa ọrịa shuga, a na-eji insulin Aspart eme ihe. Nke a bụ ọgwụ ultrashort.

Ngwá ọrụ bụ ntụnyere nke insulin mmadụ, nke enwetara site na teknụzụ DNA eleghachi anya azụ site na iji ụdị Saccharomyces cerevisiae, ebe eji dochie ntụpọ B28 (amino acid) na aspartic acid. Igwe ihe motu di bu 5825.8.

Ngwakọta, ụdị ntọhapụ na mmetụta ọgwụ

Biphasic insulin na - agwakọta protinine sofulal dị na ọgwụ ahụ na 30st 70%.

Nke a bụ nkwusioru maka sc አስተዳደር, inwe agba ọcha. 1 milliliter nwere 100 nkeji, na otu ED kwekọrọ na 35 mcg nke insulin insulin anhydrous.

Ihe anaulin insulin na-eme ka ihe di n’ime ya ike buru ibu, ya na onye na-anabata ya, membrane sel nke cytoplasmic. Nke ikpeazụ a na - arụ ọrụ njikọ nke glycogen synthetase, pyruvate kinase na enzymes hexokinase.

Mbelata shuga na-ebilite mgbe ọ na-abawanye n'ụgbọ njem intracellular yana mmelite anụ ahụ dị elu nke glucose. A na - enweta hypoglycemia site na ibelata oge maka ịhapụ glucose site na imeju, glycogenogenesis na mmegharị nke lipogenesis.

A na - enweta ọgwụ insulin Biphsic site na ntule biotechnology mgbe ejiri aspartic acid dochie moleculolo nke promonụ. Insdị insulins ndị dị na biphasic nwere mmetụta yiri nke ahụ na haemoglobin glycosylated, dịkwa insulin nke mmadụ.

Mkpụrụ ọgwụ abụọ ahụ na-arụkwa ọrụ n ’ọwụwa. Agbanyeghị, ọgwụ insulin na-eme ngwa ngwa karịa homonụ mmadụ na-arịa. Cryzọ protine nke na-eme ka ihe dị mma na-enwe oge ọrụ.

A na-enweta ihe omume mgbe sc sc nke ndị nnọchite ahụ mechara nkeji iri na ise. Ntinye uche kachasị dị n ’ọgwụ ahụ na - apụta awa 1-4 ka ịgba ntụtụ ahụ gasịrị. Ogologo oge nke mmetụta ahụ ruru awa 24.

Na serma Cmax, insulin bu 50% karia mgbe i jiri insulin nke mmadu mee ihe. Ọzọkwa, nkezi oge iji rute Cmax erughị ọkara.

T1 / 2 - ruo awa 9, ọ na-egosi ngwa ngwa iwere nke obere ihe mgbochi protamine. A na - ahụta ọkwa insulin kwa ụbọchị 15 ruo 18 ka ọ gbasasịrị.

Mana na oria oria abuo, iheoma Cmax putara bu ihe dika iri iteghete. Ọ na - eme ka ọkwa ya erughị 14 na karịa 0 mgbe nchịkwa sc gasịrị. Agaghị agụpụta mpaghara nchịkwa metụtara saịtị ịmịkọrọ.

Ọgwụ Farmacology

Usoro nke ime ihe. Insulin degludec na insulin steeti na-ejikọ kpọmkwem na onye na - anabata insulin ụmụ mmadụ ma na - emekọrịta ya, na - achọpụta mmetụta ọgwụ ọgwụ ya na mmetụta nke insulin mmadụ. Mmetụta hypoglycemic nke insulin bụ n'ihi ịba ụba nke glucose site na anụ ahụ mgbe ha jikọsịrị insulin na akwara na ndị na-anabata abụba na otu mbelata ọnụego glucose na-emepụta site na imeju.

Mmetụta ọgwụ ọgwụ nke ihe mejupụtara insulin degludec + insulin aspart dị iche iche, profaịlụ nke ọgwụ niile na-egosi profaịlụ nke omume nke otu onye: insulin na-agba ngwa ngwa na insulin degludec nke oge dị oke.

Ihe ndi ozo nke insulin degludec + insulin aspart, nke nwere otutu ihe di ogologo (insulin degludec), mgbe ntinyechara, na –eziputa otutu mmiri na - abanye na insulin degludec na - ebugharị, na - enye profaịlụ dị larịị nke arụmọrụ yana ike hypoglycemic mmetụta. A na - echekwa nsonaazụ a na insulin aspart ma ọ naghị emetụta ọnụego nnabata nke ndị nwere insulin as-eme ngwa ngwa.

Njikọ insulin degludec + insulin aspart amalite ime ihe ngwa ngwa, na-enye mkpa prandial maka insulin obere oge mgbe ịgbasịrị, ebe akụkụ basal nwere ọkwa dị larịị, nke kwụsiri ike ma bụrụ nke na-eme ka insulin nwee ike. Ogologo oge oge ị aụ ọgwụ were mejupụta insulin degludec + insulin karịa 24 awa.

Mmekọrịta dị n'etiti mmụba nke dose nke njikọta insulin degludec + insulin aspart na mmetụta ya na hypoglycemic hypeglycemic kachasị, C_ss mezuru mgbe ụbọchị 2-3 gachara.

Enweghị ọdịiche dị iche iche na ọgwụ ọgwụ nke njikọta insulin degludec + insulin na ndị ọrịa agadi na ndị ọrịa obere.

Arụmọrụ arụmọrụ yana nchekwa

Emere usoro ọgwụgwọ ọrịa elele na - emepe emepe insulin degludec + insulin na usoro ọgwụgwọ ụwa maka izu iri abụọ na isii ma ọ bụ 52 na ndị ọrịa 1360 nwere ọrịa shuga (362 ndị nwere ụdị shuga 1 na ndị ọrịa 998 nwere ụdị 2 nke ọrịa shuga) ) Emere ihe omumu ihe omumu abuo nke otu ihe banyere insulin degludec + insulin aspart with aral hypoglycemic ọgwụ (PHGP) na otu ochichi nke insulin glargine na PHGP na ndi oria nwere oria 2.Mejikọtara ochichi nke insulin degludec + insulin aspart 2 ugboro n'ụbọchị. e jiri PHGP tụnyere nlekọta nke insulin na-akpata insulin aspart 30 ugboro abụọ kwa ụbọchị yana PHGP n'ọmụmụ ihe abụọ n'ime ndị ọrịa nwere ụdị ọrịa shuga nke 2. E jikọtara insulin na-agọnarị otu ugboro kwa ụbọchị yana insulin aspart na njikwa insulin detemir 1 ma ọ bụ ugboro 2 kwa ụbọchị yana insulin aspart na ndị nwere ụdị ọrịa shuga mellitus nke 1.

Enweghi ike ịba uru karịa ọgwụ ntụnyere maka njikọta insulin degludec + insulin na-emetụta mbelata HbA_1c n'ihe omumu nile na usoro ọgwụgwọ nke ndi oria ka ha mezuo.

N'ime ndị ọrịa nwere ụdị shuga nke 2 na-enwetabeghị ọgwụ insulin na ndị ọrịa nwetasịrị ọgwụ insulin, njikọta nke insulin degludec + insulin aspart na PHGP na-enye njikwa glycemic yiri nke ahụ na insulin glargine. Nchikota insulin degludec + insulin aspart na-enye njikwa glycemic prandial ka mma karịa insulin glargine na obere hypoglycemia dị ala (nke akọwapụtara dị ka usoro nke hypoglycemia nke dị n'agbata elekere 0 na 6 nke ụtụtụ), na-egosi site na ị na-atụkọ ihe glucose plasma nke erughị 3.1 mmol / l ma ọ bụ mkpa maka enyemaka nke ndị ọzọ).

Ntinye nke ngwakọta nke insulin degludec + insulin aspart 2 ugboro n'ụbọchị na-enye njikwa glycemic yiri (HbA)_1c) atụnyere biphasic insulin aspart 30, nke a na-ahụkwa ya ugboro 2 n'ụbọchị. Nchikota nke insulin degludec + insulin aspart na-enye ihe oma kachasị mma iji belata glucose plasma na-ebu ọnụ. Mgbe ị na-ejikọkọta insulin degludec + insulin aspart, a na-enweta ọkwa glucose plasma nke 5 mmol / L ngwa ngwa na ndị ọrịa ma e jiri ya tụnyere ndị ọrịa e mesoro insulin na-eme ka ọnụọgụ 30. na-ejikọ insulin degludec + insulin aspart na-akpata hypoglycemia (gụnyere abalị) . N'ime ndị ọrịa nwere ụdị ọrịa shuga mellitus nke 1, ọgwụgwọ yana ngwakọta nke insulin degludec + insulin aspart 1 oge kwa ụbọchị yana njikọ insulin aspart gosipụtara njikwa glycemic yiri ya tupu nri ndị ọzọ (HbA_1c (glucose plasma glucose) na -arụ ọrịa shuga na-adịghị ala ala ma e jiri ya tụnyere usoro ntụpọ nke insulin na-apụ na insulin na-eri nri kwa ụbọchị.

Dabere na meta-analysis nke izu abụọ 26 mepere emepe emebere dịka “ọgwụgwọ maka ebumnuche” nke metụtara ndị ọrịa nwere ọrịa shuga 2, njikọta nke insulin degludec + insulin aspart, nke a na-ahụ maka ugboro 2 n'ụbọchị, gosipụtara ntakịrị ọnọdụ nke ngosipụta enwetara. Nnyocha hypoglycemia n'ozuzu ya na usoro nke hypoglycemia nke ehihie na-enyocha insulin na-akpata insulin degludec + insulin na-ebelata ngwakọta glucose plasma. ọbara na-ebu ọnụ nke nwere obere ọrịa hypoglycemia ma n'oge ọmụmụ na n'oge mmezi nke dose site na izu iri na isii. Oge ikeputara (95% CI) nke ngụkọta hypoglycemia nke insulin degludec + insulin aspart (ugboro abụọ n'ụbọchị) / biphasic insulin aspart 30 (ugboro 2 n'ụbọchị) n'oge ọmụmụ bụ 0.81 (0.67, 0.98 ), n'oge mmezi nke dose - 0.69 (0.55, 0.87), otu oge nke hypoglycemia abalị enen - 0.43 (0.31, 0.59) n'oge ọmụmụ na 0.38 (0.25, 0.58) n'oge mmezi nke dose.

Enweghi ọgwụ mgbochi dị iche iche na insulin ka ọ gwọchara ọgwụ insulin degludec + insulin ruo ogologo oge.

Orkpachara anya Mgbe ogwu ogbugba gasịrị, usoro nke insullọ insulin multihexamers na-arụ ọrụ nke ukwuu, na-emepụta oghere insulin n'ime anụ ahụ na - adịwanye njọ ma ghara igbochi mwepụta ngwa ngwa nke ndị ahịa insulin na-asọba n'ọbara. Multihexamers ji nwayọọ nwayọọ kewapụ, na-ewepụta ndị nwere insulin degludec, n'ihi nke ọ na-eji nwayọ abanye n'ọbara. C_ss ihe mejuputara insulin degludec) na plasma ọbara bu ubochi 2-3 ka ewebata nchikota nke insulin degludec + insulin aspart.

A na - echekwa ihe ama ama nke ngwa ngwa insulin aspart na ngwakọta nke insulin degludec + insulin aspart. Profaịlụ nke ọgwụ insulin na-apụta dị ka nkeji iri na anọ mgbe ogwu ogbugba gasịrị, C_max hụrụ mgbe 72 nkeji

Orkpachara anya Ntinye uche - oge ịdabere na profaịlụ mgbe otu sc nke 0.4, 0.6, na 0.8 U / kg jikọtara insulin degludec + insulin na ndị ọrịa nwere ụdị ọrịa shuga 1 nke ọrịa mellitus na ụdị ọrịa shuga 2 gosipụtara mmụba na mkpughe na ịba ụba nke ihe ndi mejuputara.

Insulin aspart gosipụtara mmụba dị ukwuu na C_max na nwantakịrị ihe ịrị elu na-abawanye n'ihe mgbakwunye na AUC_0–12 mgbe otu sc sc nke njikọta insulin degludec + insulin na-anabata ndị ọrịa nwere ụdị ọrịa shuga 1 nke ụdị mellitus type 2.

Insulin degludec gosipụtara mmụba nha nke C_max na AUC_0–120 nwere otu sc nchịkwa nke ngwakọta insulin degludec + insulin na-anabata ndị ọrịa nwere ụdị ọrịa shuga 1 nke ọrịa mellitus na ụdị ọrịa shuga 2.

Mmalite nke nsonaazụ maka ngwakọta ngwakọta - insulin aspart - nke enyere 14 min ogwu ogbugba, C_max - Nkeji 72 Ọbara C_ss ihe mejuputara - insulin degludec - emere site na Daysbọchị 3-4 mgbe nchịkwa nke njikọta nke insulin degludec + insulin aspart.

Nkesa. Mmechi nke insulin degludec maka serum albumin kwekọrọ n'ike ikike nke protein plasma (> 99%) na plasma ọbara mmadụ. Na insulin aspart, ikike ijikọ protein protein Plasma dị ala (T_1/2 Nchikota insulin degludec + insulin na-abanye mgbe a gwọchara ya wee kpebie n ’usoro n’onwe ya n’anụ arụ. Ndi_1/2 Insulin Degludec dị ihe dị ka awa 25 ma ọ bụrụ na ọ kwụsịrị onwe ya.

Linearity. Nsonaazụ nke ngwakọta nke insulin degludec + insulin aspart bụ nke kwekọrọ na nchịkwa nchịkwa nke ihe ndị dị na basal (insulin degludec) yana prandial mejupụtara (ụdị insulin aspart) n'ụdị 1 na ụdị ọrịa shuga 2 nke ọrịa mellitus.

Ndị otu ọrịa pụrụ iche

Enweghị ọdịiche dị na Njirimara ọgwụ nke nchịkọta nke insulin degludec + insulin na-adabere na okike ndị ọrịa.

Ndị agadi, ndị ọrịa nwere agbụrụ dị iche iche, ndị ọrịa nwere nsogbu gbasara akụrụngwa ma ọ bụ ọrụ hepatic. Enweghị ọdịiche dị ukwuu n'ụlọ ọgwụ dị n'etiti ọgwụ ọgwụ nke njikọta insulin degludec + insulin n'etiti ndị agadi na ndị ọrịa na-eto eto, n'etiti ndị ọrịa nke agbụrụ dị iche iche, n'etiti ndị ọrịa nwere ezumike mkpị na akwara na-agwọ ọrịa na ndị ọrịa nwere ahụ ike.

Geriatriiki A gụrụ ọgwụ pharmacokinetic na ọgwụ nke nchikota insulin degludec + insulin aspart n'ime ụmụ agbọghọ iri na atọ (18 ruo afọ 35) na ndị ọrịa 15 mejupụtara (≥65 afọ) nwere ụdị ọrịa shuga 1 nke mellitus mgbe ụdị mkpụrụ ọgwụ abụọ nke 0,5 U / kg: otu bụ ngwakọta insulin degludec + insulin aspart na otu bụ insulin deghari abụọ. Mkpokọta insulin aspart na insulin degludec + insulin aspart (dabere na AUC_0–12 n'ime ndị ọrịa emeela agadi, ọ mụbara karịa ndị okenye. Mkpokọta insulin degludec jikọtara insulin degludec + insulin aspart (dabere na AUC_0–120 insulin degludec) na nzaghachi nke pharmacodynamic na njikọta insulin degludec + insulin aspart (dabere na AUC_0–24 insulin degludec) dị otu ndị ahụ na-eto eto na ndị agadi nwere ọrịa shuga nke 1, ọ bụ ezie na mgbanwe ọdịiche dị n'etiti ndị ọrịa agadi dị elu.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Ngwongwo ọgwụ nke ngwakọta nke insulin degludec + insulin na-agbanye n'ọmụmụ na ụmụaka (6-1 afọ) na ndị nọ n'afọ iri na abụọ (afọ 12-18) na ụdị ọrịa shuga 1 bụ ọrịa mellitus yiri ndị ahụ okenye ọrịa nwere otu ọgwụ.

Nchịkọta mkpokọta na C_max insulin aspart di elu na umuaka karia ndi okenye, ya na ndi umuaka na ndi okenye.

Ngwongwo ọgwụ nke degludec insulin n'ime umuaka na umuaka nwere oria nke 1 dika nke ndi okenye. N ’ime ihe banyere otu ogwu onyonyo nke degludec insulin n’ime ndi ọrịa nwere oria 1 nke ọrịa mamellitus, egosiputara na ngụkọta mmetụta nke ọgwụ n’ahụ ụmụaka na ndị ntorobịa dị elu karịa na ndị ọrịa okenye.

Paul A na-enyocha mmetụta nke mmekọahụ na pharmacokinetics nke ihe ndị dị n'otu nke njikọta insulin degludec + insulin aspart na nyocha nke ọmụmụ ọgwụ dị iche iche na ọmụmụ ọgwụ. Na mkpokọta, enweghị ọdịiche pụtara ìhè dị na akụrụngwa nke insulin degludec ma ọ bụ insulin nke dị n'etiti ụmụ nwanyị na ụmụ nwoke.

Ibu ibu A na-atụle nsonaazụ nke ahụ mmadụ (BMI) na pharmacokinetics nke otu ihe dị iche iche nke njikọta insulin degludec + insulin aspart na nyocha nke ọmụmụ-pharmacokinetic na ọmụmụ ọgwụ. N'ime ndị ọrịa nwere ụdị ọrịa shuga 1 nke ọrịa mellitus, ọ nweghị mmekọrịta dị n'etiti ikpughe insulin degludec na BMI. N'ime ndị ọrịa nwere ụdị ọrịa shuga 1 na ụdị nke 2, a kpughere ọchịchọ nke mbelata insulin na-ebelata insulin degludec na mmụba na BMI. Maka insulin aspart, enweghị mkpakọrịta n'etiti BMI na ikpughe n'etiti ndị ọrịa nwere ọrịa shuga 1 ma ọ bụ ụdị 2.

Agbụrụ na agbụrụ. Amụrụ ihe agbụrụ na agbụrụ na ụlọ ọrụ ọgwụ nke njikọta insulin degludec + insulin aspart amụbeghị. A gụrụ ihe ndị dị na ngwakọta ahụ, insulin degludec, na ọmụmụ pharmacokinetic na ọmụmụ ọgwụ na Afrịka America nke Hispanic ma ọ bụ Latino (n = 18), ndị na-acha ọcha sitere na agbụrụ Hispanic ma ọ bụ Latino (n = 22), na ndị na-acha ọcha sitere na agbụrụ Hispanic ma ọ bụ Latino (n = 23) ụdị shuga mellitus nke 2. Ọ nweghị ọdịiche dị mkpa ndekọ ọnụ ọgụgụ dị n'etiti agbụrụ na agbụrụ ọmụmụ a mụrụ.

Ime Nyocha uto ime ime na pharmacokinetics na pharmacodynamics nke njikọta insulin degludec + insulin aspart amụbeghị (lee. “Ewere ya ime na lactation”).

Ọdịda ya. Amụọ ihe uto nke akụrụngwa na ọgwụ ọgwụ nke njikọ nke insulin degludec + insulin aspart amụbeghị. A na - amụrụ ihe ndị mejupụtara ya - insulin degludec (na ntinye nke otu sc sc nke 0.4 U / n'arọ) - a mụrụ n'ọmụmụ ọgwụ pharmacokinetic na mmadụ 32 (n = 4-8 / otu) na arụ ọrụ nkịtị ma ọ bụ arụ ọrụ ezumike arụmọrụ . Ekpebiri dysfunction ntaramahụhụ dabere na Cl creatinine: min90 ml / min (nkịtị), 60–89 ml / min (dị nro), 30–59 ml / min (agafeghị oke) na s / c nke 0.08 U / n'arọ Enyochale insulin aspart (ihe na-eme ngwa ngwa nke njikọta insulin degludec + insulin aspart) na nyocha n’ime ndị mmadụ nwere ọrụ mkpo nkịtị, dị nwayọ, agafeghị oke ma ọ bụ nke siri ike (mana ọ chọghị ka akwara hemodialysis) ghara ịrụ ọrụ ezumike. N ’ọmụmụ a, enweghị mmetụta pụtara ìhè na ikike ikpochapụ ihe na AUC na C_max insulin kewapụrụ.

Imeju imeju. Agụbeghị mmetụta uto imeju na pharmacokinetics nke njikọ insulin degludec + insulin aspart amụbeghị. A na - amụrụ akụkụ nke jikọtara ọnụ - insulin degludec - na nyocha nke ọgwụ pharmacokinetic na mmadụ 24 (n = 6 / otu) nwere ọrụ imeju nkịtị ma ọ bụ nsogbu (obere, ịta ahụhụ na oke ịba ọcha n'anya) mgbe nchịkwa otu s / c dose (0.4 PIECES / n'arọ) insulin degludec. Enweghị ọdịiche dị na pharmacokinetics nke insulin degludec n'etiti ndị dị mma na ndị nwere ọrụ imeju na-arụ ọrụ (lee "Mmezi").

Na nyocha imeghe nke otu pacenti 0.06 U / n'arọ nke insulin aspart (ihe na - eme ngwa ngwa nke njikọta insulin degludec + insulin aspart), e nyefere ndị ọrịa iri abụọ na anọ (n = 6 / otu) nke nwere ogo imeju (dị nwayọ, agafeghị oke, nnukwu). N'ime ihe ọmụmụ a, achọpụtaghị njikọ n'etiti ogo ọrịa imeju na ọgwụ ọgwụ nke ọgwụ insulin.

Ọmụmụ Ihe Ọmụmụ Nchebe Ọhụrụ

Ihe omuma ndi preclinical dabere na nyocha nke nchekwa nke ogwu, ihe ojoo nke otutu ogwu ogwu, uto nke aru oru, mmuputa ahihia na omumu, ekpughere mmadu ihe o bula. Oke nke metabolic na arụmọrụ mitogenic nke insulin degludec yiri nke insulin mmadụ.

Ime na lactation

A na - egbochi ọgwụ maka ijikọ insulin degludec + insulin n'oge a dị ime, n'ihi Enweghị ahụmịhe ụlọ ọgwụ adịghị eji ya eme n'oge afọ ime. Ihe omumu banyere oru omumu ekpughere ihe di iche n'etiti insulin degludec na insulin nke mmadu na usoro imu nwa.

A na - emegide ọgwụ ndị mejupụtara insulin degludec + insulin aspart n'oge a na-enye nwa ara, n'ihi Enweghị ahụmịhe ọgwụgwọ na ụmụ nwanyị na-amụ nwa.

Nnyocha ụmụ anụmanụ egosiwo na na oke, insulin degsolec dị na mmiri ara, nsị ya na mmiri ara ara dị ala karịa na plasma ọbara. Amabeghị ma insulin degludec dị na mmiri ara nke ụmụ nwanyị.

Ọmụmụ. Ọmụmụ anụmanụ achọpụtabeghị mmetụta ọjọọ insulin degludec na ọmụmụ.

FDA Fetal Action Otu - K.

Emebeghị nnyocha ọmụmụ zuru ezu ma jisie ike maka ojiji nke njikọ nke insulin degludec + insulin na ụmụ nwanyị dị ime. Mgbe ị na-eme atụmatụ ịtụrụ ime ma ọ bụ guzobe ya, ndị ọrịa kwesịrị isoro dọkịta ha kwurịta banyere ọgwụ. Ebe ọ bụ na ọmụmụ ọmụmụ ụmụ anụmanụ anaghị ebu amụma banyere mmetụta mmadụ na-enwe, ihe ngwakọta nke insulin degludec + insulin ga-eji n'oge afọ ime naanị ma ọ bụrụ na mmetụta a tụrụ anya na ọgwụgwọ ga-akacha n'ihe ize ndụ nke nwa ebu n’afọ. Maka ndị ọrịa nwere ọrịa shuga ma ọ bụ afọ ime, inwe njikwa metabolic nke ọma tupu ịtụrụ ime na n'oge ime dị mkpa. Mkpa insulin nwere ike ibelata n’oge ọnwa atọ mbụ dị n’afọ, dịka iwu, ọ na-abawanye n’oge ọnwa nke abụọ na nke atọ wee gbadata ngwa ngwa mgbe amuchara nwa. Iji nlezianya nyochaa ọkwa nke glucose dị mkpa na ndị ọrịa a.

Amaghị ma degludec insulin insulin na mmiri ara ara. Ebe ọ bụ na ọtụtụ ihe, gụnyere insulin mmadụ, na-apụta na mmiri ara ara, ekwesịrị ịkpachara anya mgbe ị na-ejikọkọta insulin degludec + insulin na nne na-enye nwa ara. Womenmụ nwanyị ndị nwere ọrịa shuga n’oge a na-ara ara nwere ike ịchọ mgbanwe mgbanwe insulin, atụmatụ inye nri, ma ọ bụ ha abụọ.

Nsonaazụ nke ihe ndị ahụ insulin degludec + Insulin aspart

Mmetụta kachasị emetụtare na-akọkarị n'oge ọgwụgwọ bụ hypoglycemia (lee Nkọwa nke mmeghachi omume na-ezighi ezi).

Nsonaazụ niile a kọwara n'okpuru ebe a, dabere na data sitere na nnwale ụlọọgwụ, a chịkọtara ọnụ dabere na MedDRA na usoro anụ ahụ. A na-akọwapụta ntụpọ nke mmetụta ndị ọzọ dịka oge (as1 / 10), ọtụtụ mgbe (≥1 / 100 na ọgwụ ọjọọ) nwere ike itinye ndụ onye ọrịa n'ihe egwu.

Mgbe ị na - ejikọ insulin degludec + insulin aspart, mmeghachi omume a na - egbochi ọnya (gụnyere ịba ọnụ ma ọ bụ n'egbugbere ọnụ, afọ ọsịsa, ọgbụgbọ, ike ọgwụgwụ na itching) na urticaria adịkarịghị.

Mmeghachi omume nfụkasị ahụ. Mgbe ị na - eji insulin ọ bụla, gụnyere njikọta insulin degludec + insulin aspart, oke ihe egwu na - akpata ndụ nwere ike ịmalite, gụnyere anaphylaxis, mmeghachi omume anụ ahụ, angioedema, bronchospasm, hypotension na ujo, mmeghachi omume ndị a nwere ike bụrụ ihe na - eyi ndụ egwu (lee "ịkpachara anya") .

Achọpụtara hypersensitivity (gosipụtara site na ire na egbugbere ọnụ, afọ ọsịsa, ọgbụgbọ, ike ọgwụgwụ na itching) na urticaria na 0,5% ndị ọrịa na - enweta ọgwụ insulin degludec + insulin aspart.

Hypoglycemia. Hypoglycemia nwere ike itolite ma ọ bụrụ na ọgwụ insulin dị oke n’ogosi mkpa onye ọrịa nwere ya. Nnukwu hypoglycemia nwere ike ibute ọnwụ nke mmụọ na / ma ọ bụ ịmị mkpụrụ, ụbụrụ na-adị nwa oge ma ọ bụ nke na-enweghị ike ịgbanwe ọrụ ruo na nsonaazụ na-egbu egbu. Ihe mgbaàmà hypoglycemia, dịka iwu, na-etolite na mberede. Ndị a gụnyere ọsụsọ oyi, pallor nke anụ ahụ, ike ịba ụba, ụjọ ma ọ bụ ịma jijiji, nchekasị, ike ọgwụgwụ pụrụ iche ma ọ bụ adịghị ike, mgbakasị ahụ, ịtalata mgbada, ụra, agụụ siri ike, ọhụhụ ọwụwa, isi ọwụwa, ọgbụgbọ, ọrịa obi.

Lipodystrophy. Lipodystrophy (gụnyere lipohypertrophy, lipoatrophy) nwere ike ịmalite ebe a na-agba ya. Compgbaso usoro iwu maka ịgbanwe ebe injection dị n'otu mpaghara ahụ na-enyere aka belata ihe egwu nke ịmalite mmeghachi omume ọjọọ a.

Lipodystrophy. Ofnweta insulin ọgwụ ogologo oge, gụnyere njikọta insulin degludec + insulin aspart, nwere ike iduga lipodystrophy na saịtị nke inje insulin ugboro ugboro. Lipodystrophy gụnyere lipohypertrophy (nke na -akpọ anụ ahụ adipose) na lipoatrophy (na-eme ka anụ ahụ na-akpọ adipose) ma nwee ike imetụta nnweta insulin. Shouldkwesịrị ịgbanwe saịtị insulin dị n'etiti otu mpaghara ahụ iji belata ihe dị na lipodystrophy. Mmemme ụlọọgwụ ahụ kọrọ lipodystrophy na 0.1% nke ndị ọrịa, mesoo yana ngwakọta nke insulin degludec + insulin aspart.

Mmeghachi omume na ebe ntụtụ. N'ime ndị ọrịa na-enweta nchikota nke insulin degludec + insulin aspart, a hụrụ mmeghachi omume na ntinye ahụ (hematoma, mgbu, ọbara ọgbụgba mpaghara, ụkwara ume ọkụ, ọnya anụ ahụ, ọrịra ahụ, mwepụ nke anụ ahụ, itching, mgbakasị ahụ na imechi ya na saịtị ịgba ntụtụ). Ọtụtụ mmeghachi omume na saịtị ịgba ahụ dị obere, nwa oge, ma na - apụkarị site na iji ọgwụgwọ na-aga n'ihu.

Mmeghachi omume na ebe ntụtụ. Ndị ọrịa na-anata mkpokọta insulin degludec + insulin aspart nwere ike ịmalite mmeghachi omume na saịtị ịgba ahụ, gụnyere hematoma, mgbu, ọbara ọgbụgba, akpịrị, nodules, ọzịza, ịmịcha akpụkpọ ahụ, itching, mmetụta nke ikpo ọkụ, na ịmachi ebe a na-agba ya. N'ime mmemme ụlọọgwụ, a chọpụtara mmeghachi omume na saịtị ịgba ahụ na 2% nke ndị ọrịa, mesoo yana ngwakọta nke insulin degludec + insulin aspart.

Iwetara uru. A ga-ahụta oke ibu na ọgwụ insulin, gụnyere mgbe ị na - ejikọ insulin degludec + insulin aspart, ma bụrụ ihe na - egosi mmetụta anabolic nke insulin. N'ime mmemme ụlọọgwụ, ndị ọrịa nwere ọria ụdị 1 ndị natara insulin degludec + insulin asroll juputara na uru ahụ ruru 2.8 n'arọ, ndị ọrịa nwere ụdị ọrịa shuga 2 bụ ndị natara insulin degludec + insulin aspart natara nkezi 1 , 6 n'arọ.

Ọkpụkpụ edere. Insulin, tinyere njikọta insulin degludec + insulin aspart, nwere ike ibute njigide sodium na edema. N'ime mmemme ụlọọgwụ, a hụrụ edegharị mpaghara na 2.2% nke ndị ọrịa nwere ụdị oria 1 na 1.8% ndị ọrịa nwere ụdị shuga 2 bụ ndị natara njikọta nke insulin degludec + insulin aspart.

Childrenmụaka na ndị nọ n'afọ iri na ụma. A mụọla ụlọ ọgwụ ọgwụ nke nchịkọta insulin degludec + insulin na ụmụ na ndị na-eto eto na-erubeghị afọ 18 (lee. Pharmacokinetics). Emebeghị nnyocha banyere ịdị irè na nchekwa nke ụmụaka na ụmụaka.

Ndị otu ọrịa pụrụ iche. N'oge ọnwụnwa nke ụlọ ọgwụ, enweghị ọdịiche ọ bụla na ugboro ole, ụdị, ma ọ bụ nsogbu nke mmeghachi omume dị n'etiti ndị ọrịa agadi, ndị ọrịa nwere ezigharị ma ọ bụ ọrụ hepatic, na ọnụ ọgụgụ ndị ọrịa n'ozuzu ha.

Ahụmahụ Nnyocha Ọgwụ

Ebe ọ bụ na ejiri ọnọdụ dị iche iche wee duzie nnwale ndị a na-enwe, a na-enwe nsogbu ntaramahụhụ na ọmụmụ ihe ndị ọzọ na ịkọ ihe na-ebute nsonaazụ na-adakarị ahụ.

A na-enyocha nchekwa nke njikọta nke insulin degludec + insulin na ndị ọrịa nwere ụdị 1 na ụdị ọrịa shuga 2 nke ọrịa mellitus na ule 5 nke e zubere na ụkpụrụ nke "mesoo ebumnuche", na-adịgide ọnwa 6-12.

Ọmụmụ ihe nchekwa nke njikọta nke insulin degludec + insulin aspart na ndị ọrịa nwere ụdị ọrịa shuga 1 nke ọrịa mellitus gụnyere ndị ọrịa 362, nkezi oge ikpughe bụ izu iri anọ na anọ. Afọ ndụ ndị ọrịa dị afọ iri anọ na anọ, ihe dị ka 1% nke ndị ọrịa karịrị afọ 75. Iri ise na abụọ bụ ụmụ nwoke, 91% ndị nwere ntutu dị ọcha, 3% bụ ndị American-American, na 3% bụ ndị Spain. Nkezi BMI bụ 26 n'arọ / m 2. Nkezi afọ nke ọrịa shuga bụ afọ 17, na nkezi HbA_1c na mbido ọmụmụ - 8,3%. A kọrọ akụkọ banyere neuropathy, ophthalmopathy, nephropathy, na ọrịa obi na mmalite nke ọmụmụ ahụ na 19, 25, 6, na 4% nke ikpe, n'otu n'otu. Ihe pụtara GFR na mbido ọmụmụ a bụ 88 ml / min / 1.73 m 2, yana 6% nke ndị ọrịa nwere GFR erughị 60 ml / min / 1.73 mm 2.

Ọmụmụ ihe ọzọ banyere nchekwa nke njikọta nke insulin degludec + insulin aspart gụnyere ndị ọrịa 998 nwere ụdị ọrịa shuga 2 nke afọ, nkezi oge ikpughe bụ izu iri abụọ na anọ. Nkezi afọ ndị ọrịa dị afọ 58, na 3% gbagoro afọ 75. Pasent iri anọ na anọ bụ ụmụ nwoke, 44% bụ ndị nwere ntutu dị ọcha, 4% ndị American-American, na 6% bụ ndị Hispanic. Nkezi BMI bụ 29 n'arọ / m 2. Ogologo afọ nke ọrịa shuga bụ afọ iri na abụọ, nkezi HbA_1c na mbido ọmụmụ - 8.5%. A kọrọ akụkọ banyere ọrịa neuropathy, ophthalmopathy, nephropathy, na ọrịa obi na mmalite nke ọmụmụ ahụ na 15, 21, 10, na 1% nke ikpe, n'otu n'otu. Na mbu, ihe oputara GFR bu 84 ml / min / 1.73 m 2 na 11% nke ndi oria erughi 60 ml / min / 1.73 m 2.

A na-ahụta mmeghachi omume nhụjuanya (ewezuga hypoglycemia) n'oge nnwale nke ụlọ ọgwụ na ndị ọrịa nwere ụdị 1 na ụdị ọrịa shuga 2 nke mesoro na njikọta nke insulin degludec + insulin aspart. A kọwapụtara mmeghachi omume na-ezighi ezi dịka mmeghachi omume ndị emere na ≥5% nke ndị ọrịa na ọnụ ọgụgụ ọmụmụ ahụ. Achọpụtaghị hypoglycemia ma a tụlere ya na mpaghara puru iche.

A na-ahụta mmeghachi omume ọjọọ na ≥5% nke ndị ọrịa nwere ụdị ọrịa shuga 1 nke ọrịa insulin degludec + insulin aspart (N = 362)

Isi ọwụwa 9.7%.

Ọkpụkpụ akụkụ okuku ume na-efe efe 9.1%.

A na-ahụta mmeghachi omume ọjọọ na ≥5% na ụdị ọrịa shuga 2 nke ọrịa shuga insulin degludec + insulin aspart (N = 998)

Nnukwu akụkụ akụkụ okuku ume na 5.7%.

Isi ọwụwa 5.6%.

Hypoglycemia bụ mmeghachi omume kachasị njọ a na-ahụkarị na ndị ọrịa na-eji insulin eme ihe, gụnyere njikọta insulin degludec + insulin aspart (lee “cakpachara Anya)”. Ugboro ugboro nke akara hypoglycemia dabere na nkọwa ejiri maka hypoglycemia, dị ka ọrịa shuga, insulin insulin, ike nke nchịkwa glucose, ọgwụgwọ ndabere na ihe ndị ọzọ dị n'ime na mpụga maka onye ọrịa. Maka ebumnuche ndị a, ịtụle ọnọdụ nke hypoglycemia na nnwale nke nyocha nke njikọ nke insulin degludec + insulin na ntụpọ nke hypoglycemia na ndị ọrụ ndị ọzọ nwere ike iduhie ma ọ gaghị abụ onye nnọchi anya na nyocha nke hypoglycemia hụrụ na omume ụlọ ọgwụ.

Ihe a bụ ihe banyere hypoglycemia na ọmụmụ gbasara ndị ọrịa nwere ụdị 1 na ụdị shuga 2 bụ ndị natara njikọta nke insulin degludec + insulin aspart. A kọwara hypoglycemia siri ike dị ka ihe na-achọ enyemaka nke onye ọzọ ịbanye na carbohydrates, glucagon, ma ọ bụ nrụpụta ọzọ.

N'ime nyocha nke ụlọ ọgwụ, a kọwara njikọta insulin degludec + insulin aspart hypoglycemia dị ka ihe mebiri emebi hypoglycemia (1), ma ọ bụ ihe merenụ ebe nyocha glucose labolọsị ma ọ bụ nke onwe gị erughị 56 mg / dl ma ọ bụ glucose ọbara dum erughị 50 mg / dl (i.e. na ma obu n’enweghi nsogbu hypoglycemic) - (2).

Onu ogugu ndi oria nwere oria 1 n’enwela ọria di iche 1 hypoglycemia (1) ma obu hypoglycemia (2) na ule ulo ogwu okenye.

Na Ọmụmụ A, ndị ọrịa natara insulin degludec + insulin aspart (1 oge kwa ụbọchị) gbakwunyere insulin aspart (ugboro abụọ kwa ụbọchị) maka izu 52 (N = 362).

Hypoglycemia (1) 13.3%.

Hypoglycemia (2) 95%.

Onu ogugu ndi oria nwere oria abuo bu ndi nwude-ala di nma 1 (ma obu hypoglycemia) (2) na ule ulo ogwu.

N'ime ọmụmụ B, ndị ọrịa natara ọgwụ insulin degludec + insulin aspart (1 oge kwa ụbọchị), insulin dị mfe na mbụ ma ọ bụ karịa PHGP abụọ (N = 265).

Na Ọmụmụ C, ndị ọrịa natara ọgwụ insulin degludec + insulin aspart (1 oge kwa ụbọchị), insulin pre-basal (1 oge kwa ụbọchị), na 1 ma ọ bụ karịa PHGP (N = 230).

N'ime ọmụmụ D, ndị ọrịa natara ọgwụ insulin degludec + insulin aspart (ugboro abụọ n'ụbọchị), tupu 1-2 ugboro n'ụbọchị, pre / self mix, with / enweghị PHGP (N = 224).

N'ime ọmụmụ E, ndị ọrịa natara ọgwụ insulin degludec + insulin aspart (ugboro abụọ n'ụbọchị), na mbụ 1-2 ugboro n'ụbọchị basal / pre / onwe gwakọtara, yana / na-enweghị PHGP (N = 279).

Hypoglycemia (1) 0.4, 0, 3.1 na 1.4%.

Hypoglycemia (2) 49.8, 52.6, 66.1 na 73.5%.

Mmekorita

E nwere ọtụtụ ọgwụ na-emetụta mkpa maka insulin.

Enwere ike belata mkpa insulin: ọgwụ mgbochi hypoglycemic ọgwụ, glucagon-like peptide-1 agonists receptor (GLP-1), ndị na-egbochi MAO, ndị na-abụghị ndị na-ahọrọ beta-mgbochi, ACE inhibitors, salicylates, steroid anabolic na sulfonamides.

Mkpa insulin nwere ike ịbawanye elu: ogwu mgbochi homonụ, thiazide diuretics, corticosteroids, homonụ thyroid, sympathomimetics, somatropin na danazole.

Ndị na-egbochi mkpọtụ na-ekpuchi ihe mgbaàmà hypoglycemia.

Octreotide / lanreotide nwere ike ịbawanye ma wedata mkpa ahụ insulin nwere.

Ethanol nwere ike ịkwalite ma belata mmetụta hypoglycemic nke insulin.

Drugsfọdụ ọgwụ, agbakwunye na njikọta insulin degludec + insulin aspart, nwere ike imebi mbibi nke insulin degludec na / ma ọ bụ insulin aspart. Ngwakọta nke insulin degludec + insulin aspart ekwesịghị ịgbakwunye na ọgwụ infusion. Can nweghị ike ịgwakọta ọgwụ a na ọgwụ ndị ọzọ.

Site na njikọta ọgwụ insulin degludec + insulin nke ọma

Ọgwụ nke nwere ike ịbawanye oke nke hypoglycemia:ọgwụ antidiabetic Ihe mgbochi ACE ndị nnabata angiotensin II, ndị na-ekwenyeghị nha, fibrates, fluoxetine, MA inhibitors pentoxifylline, pramlintide, propoxyphenesalicylates somatostatin analogues (wdg. octreotide), sulfonamides, GLP-1 nnabata agonists, ndị na-egbochi dipeptidyl peptidase-4; ndị na-ebugharị glucose sodium ụdị 2 inhibitors (SGLT-2 inhibitors).

Site na iji ọgwụ jikọtara insulin degludec + insulin na ọgwụ ndị a, ịbelata mmụba na mmụba nke ugboro nke nyochaa ọkwa glucose.

Ọgwụ nke nwere ike belata nsonaazụ nke insulin degludec + insulin aspart (belata glucose ọbara):ọgwụ na-egbu egbu (olanzapine na clozapine), corticosteroids, danazol diuretics, estrogens, glucagon, isoniazid, nicotinic acid, ogwu gboro ya phenothiazines, progesterones (gụnyere dị ka akụkụ nke mgbochi mgbochi ọnụ), ndị na-egbochi nchebe, somatropin, ọmiko (gụnyere salbutamol, epinephrine, terbutaline), homonụ thyroid.

Site na iji ọgwụ jikọtara insulin degludec + insulin na ọgwụ ndị a, mmụba n'ọtụtụ na ugboro ole a na-elele ọkwa glucose.

Ọgwụ nke nwere ike ịbawanye ma wedata nsonaazụ nke insulin degludec + insulin aspart (na-ebelata glucose ọbara). mmanya beta-igbochi, clonidine, nnu nke lithium. Pentamidine nwere ike ibute hypoglycemia, nke nwere ike ịrịa hyperglycemia mgbe ụfọdụ.

Site na iji ọgwụ jikọtara insulin degludec + insulin na ọgwụ ndị a, enwere ike ịhazigharị dose na mmụba nke ugboro nke nyochaa glucose ogo.

Ọgwụ nke nwere ike kpuchie ihe ịrịba ama na hypoglycemia: ihe mgbochi beta, clonidine, guanethidine na reserpine. Site n'iji ijikọ insulin degludec + insulin na ọgwụ ndị a, mmụba nke ugboro nke nyochaa ọkwa glucose nwere ike ịchọ.

Dodoụbiga ya ókè

Ọtọbeghị oke ọgwụ na-eme ka mmiri ọgwụ insulin ịba ụba, ma hypoglycemia nwere ike ịmalite nke nta nke nta ma ọ bụrụ na ọgwụ dị oke elu ma e jiri ya tụnyere mkpa onye ọrịa ahụ (lee “seekpachara anya”). Onye ọrịa ahụ nwere ike iwepụ hypoglycemia dị nro site na iji glucose ma ọ bụ ngwaahịa nwere shuga site n'ọnụ. Ya mere, a na-atụ aro ka ndị ọrịa nwere ọrịa shuga na-ebu ngwaahịa nwere shuga mgbe niile.

N'ọnọdụ siri ike hypoglycemia, mgbe onye ọrịa amaghị ihe ọ bụla, ekwesịrị ịkụnye ya na glucagon (site na 0,5 ruo 1 mg) i / m ma ọ bụ s / c (enwere ike inye ya ọzụzụ site na onye zụrụ ya) ma ọ bụ na / na ngwọta nke dextrose (glucose) (enwere ike inye ya naanị onye ọrụ ahụike). Ọ dịkwa mkpa iji duzie dextrose iv bụrụ na onye ọrịa ahụ anaghị enwetaghachi mmụọ mgbe nkeji iri na ise gachara nchịkwa glucagon. Mgbe ọ nwetasịrị onwe ya, a na-adụ onye ọrịa ọdụ iri nri nwere carbohydrate iji gbochie nlọghachi hypoglycemia.

Ihe mgbochi nke bekee Insulin degludec + Insulin kewapụrụ

Hypoglycemia. Ọ bụrụ n ’iri nri ma ọ bụ mgbatị ahụ siri ike ị na-achọghị, onye ọrịa ahụ nwere ike ịmalite hypoglycemia. Hypoglycemia nwekwara ike ịmalite ma ọ bụrụ na ọgwụ insulin dị oke na mkpa onye ọrịa ahụ (lee “Side Side” and “overdose”).

Mgbe ha kwusịrị metabolism metabolism (dịka ọmụmaatụ, insulin ọgwụ siri ike), akara nke ndị ọrịa na-ahụkarị maka ha nwere ike gbanwee - ihe ga - ebute hypoglycemia, nke a ga - agwa ndị ọrịa. Mgbaàmà ndị a na - ahụkarị - ndị na - achọpụta ihe nwere ike ịpụ apụ na ọrịa shuga ogologo oge.

Ọrịa concoitant, nke na-efe efe ma na-efe efe, na -emekarị ahụ insulin nwere ahụ. Ọ dịkwa mkpa iji dozigharị dose ma ọ bụrụ na onye ọrịa ahụ nwere akụrụ na-arịa ọrịa, imeju, ma ọ bụ nsogbu adrenal, pituitary, ma ọ bụ nsogbu thyroid.

Dịka ọ dị na nhazi insulin ndị ọzọ basal ma ọ bụ nkwadebe ya na otu ihe metụtara basal, mgbake mgbe hypoglycemia na ngwakọta nke insulin degludec + insulin aspart nwere ike igbu oge.

Ihe ndị dị ize ndụ maka hypoglycemia. Ihe ize ndụ nke hypoglycemia na-abawanye site na nchịkwa glycemic kpụ ọkụ n'ọnụ. Ihe egwu nke hypoglycemia mgbe ogwu ogbugba jikọtara ya na oge insulin na-arụ ọrụ ma ọ kachasị elu mgbe mmetụta glucose na-ebelata insulin. Dịka ọ dị na nhazi insulin niile, nsonaazụ glucose nke nchikota insulin degludec + insulin aspart nwere ike ịdị iche n'oge oge dị iche iche na mmadụ dị iche iche ma ọ bụ n'oge dị iche iche n'otu ndị ahụ ma dabere n'ọtụtụ ọnọdụ, gụnyere mpaghara injection, yana ntinye ọbara na ọnọdụ okpomọkụ na saịtị ịgba ahụ. .

Ihe ndị ọzọ nwere ike ịbawanye oke nke hypoglycemia gụnyere mgbanwe nri (dịka ọmụmaatụ, ọdịnaya nke macronutrients ma ọ bụ oge nri), mgbanwe na oke mmega ahụ, ma ọ bụ mgbanwe mgbe ejiri ọnụ na ọgwụ ndị ọzọ (lee “Mmekọrịta”). Ndị ọrịa nwere akụrụ gbasara akwara ma ọ bụ enweghị nsogbu nwere ike ịnọ n'ihe egwu dị elu nke ịmalite hypoglycemia.

Usoro iji belata nsogbu nke hypoglycemia. Ndị ọrịa na ndị na-elekọta ya ga-enwe ike ịmata akara nke hypoglycemia ma were usoro kwesịrị ekwesị. Nyochaa onwe gị nke glucose ọbara na-ekere òkè dị mkpa na mgbochi na ọgwụgwọ nke hypoglycemia. N'ime ndị ọrịa nwere nnukwu ọrịa hypoglycemia na ndị ọrịa nwere ikike dị ala iji nwee mgbaàmà nke hypoglycemia, a na-atụ aro mmụba nke ugboro nke nyochaa glucose ọbara.

Hyperglycemia. Ọgwụ ezughi oke ma ọ bụ ịkwụsị ọgwụgwọ nwere ike iduga mmepe nke hyperglycemia ma ọ bụ ketoacidosis mamịrị. Na mgbakwunye, ọrịa concomitant, karịsịa ndị na-efe efe, nwere ike inye aka na mmepe nke ọnọdụ hyperglycemic na, n'ihi ya, na-eme ka ahụ insulin dịkwuo n'ahụ.

Dịka iwu, mgbaàmà mbụ nke hyperglycemia pụtara nke nta nke nta, ọtụtụ awa ma ọ bụ ụbọchị. Ihe mgbaàmà ndị a gụnyere akpịrị ịkpọ nkụ, urination ngwa ngwa, ọgbụgbọ, vomiting, ụra, akpịrị na akpọnwụ akpịrị, akpịrị ịkpọ nkụ, agụụ, agụụ acetone na ikuku ikuku. N'ime ụdị ọrịa shuga 1 nke ọrịa shuga, na-enweghị ọgwụgwọ kwesịrị ekwesị, hyperglycemia na-eduga na mmepe nke ketoacidosis mamịrị ma nwee ike ibute ọnwụ.

Maka ọgwụgwọ nke hyperglycemia siri ike, a na-atụ aro insulin na-eme ngwa ngwa.

Nyefee onye ọrịa site na usoro insulin ndị ọzọ. Ntugharị onye ọrịa na ụdị ọhụụ ma ọ bụ ịkwadebe insulin nke akara ọhụụ ma ọ bụ onye ọzọ na-emepụta ga-enwerịrị n'okpuru nlekọta ahụike siri ike. Mgbe ị na-atụgharị okwu, enwere ike ịchọ mgbanwe mmezi.

Hyperglycemia ma ọ bụ hypoglycemia na mgbanwe na usoro insulin. Mgbanwe na njirimara insulin, onye na-emepụta, ụdị ma ọ bụ ụzọ nchịkwa nwere ike imetụta njikwa glycemic ma na-ebute hypoglycemia ma ọ bụ hyperglycemia. Ekwesịrị iji nlezianya mee mgbanwe ndị a ma ọ bụrụ naanị na nlekọta nke dọkịta, ugboro ole a ga-agbakọta glucose ọbara. Maka ndị ọrịa nwere ụdị ọrịa shuga abụọ nke ọrịa mellitus, enwere ike ịchọ mgbanwe mgbanwe ụfọdụ na PHGP. Mgbe ị na-agbanwe site na ọgwụ insulin ọzọ na ọgwụgwọ yana ngwakọta nke insulin degludec + insulin aspart, ọ nwere ike ịdị mkpa ka ịhazie ọnụọgụ.

Ojiji nke otu ọgwụ thiazolidinedione na nhazi insulin. A kọrọ akụkọ banyere mmepe nke nkụda obi na ọgwụgwọ nke ndị ọrịa nwere thiazolidinediones yana njikọ insulin, ọkachasị ma ọ bụrụ na ndị ọrịa dị otú ahụ nwere ihe ndị dị ize ndụ maka ịmalite nkụchi obi. Ekwesiri iburu n'uche eziokwu a mgbe enyere ndị ọrịa ọgwụ ọgwụ na thiazolidinediones na ngwakọta nke insulin degludec + insulin aspart. Site na nhọpụta nke usoro ọgwụgwọ dị otú a, ọ dị mkpa iji nyochaa nyocha ahụike nke ndị ọrịa iji chọpụta akara na akara nke nkụda obi, mee ka ahụ dịkwuo elu na ọnụnọ nke akụkụ ụkwara elu. Ọ bụrụ na mgbaàmà nke nkụda obi na-akawanye njọ n'ime ndị ọrịa, a ga-akwụsị ịgwọ ya na thiazolidinediones.

Njide azụ na-efe efe na mmepe nke nkụda obi site na iji ihe ngọngọ gamma receptor agonists rụọ ọrụ site na onye na - ebugharị peroxisome. (peroxisome proliferator-activate receptor-gamma, PPAR gamma). Thiazolidinediones bụ ndị agonists PPARgamma nwere ike ibute njigide ọnye-mmiri tumadi mgbe ejiri ya na insulin. Idochi mbufu nwere ike ibute mmepe ma obu iwe iwe nke nsogbu nke obi daa. Ndị ọrịa na-anata insulin, gụnyere ngwakọta nke insulin degludec + insulin aspart, na agonist PPAREkwesịrị inyocha gamma maka ihe nrịba ama na mgbaàmà nke nkụda obi. Ọ bụrụ na CHF tolitere, ọ dị mkpa iji duzie usoro kwekọrọ n'ụkpụrụ nlekọta ahụ ike ugbu a ma na-atụle ịkwụsị ma ọ bụ iwetulata agonist dose PPARgamma.

Mmebi nke akụkụ nke ọhụụ. Enstụgharị uche na ọgwụ insulin na mmụba dị mma n'ịchịkwa metabolism metabolism nwere ike ibute ịbelata nwa oge na ọnọdụ ọrịa retinopathy na-arịa ọrịa shuga, ebe nkwalite ogologo oge na njikwa glycemic na-ebelata ohere nke inwe ọrịa mamị retinopathy.

Mgbochi mgbagwoju anya na nhazi insulin. A ga-agwa onye ọrịa ahụ ka o nyochaa akara ngosi dị na akara ọ bụla tupu ntụtụ ọ bụla iji zere ịgbagha njikọ insulin degludec + na mberede insulin na nhazi ndị ọzọ. Ọrịa kwesịrị ịlele dose ahụ na counter injectionor counter. Ọ dị mkpa ịgwa ndị ọrịa kpuru ìsì ma ọ bụ ndị nwere nkwarụ anya na ha chọrọ enyemaka nke ndị na - enweghị nsogbu ọhụụ ma zụọ ha ịrụ ọrụ na injector.

Ọgwụ ndị na-egbochi insulin. Mgbe ị na - eji insulin eme ihe, ịmalite ọgwụ ga - ekwe omume. N'ọnọdụ ndị a na-adịghị ahụkebe, ịmepụta ọgwụ mgbochi mmadụ nwere ike ịchọ nhazi nke insulin iji gbochie nsogbu nke hyperglycemia ma ọ bụ hypoglycemia.

Immunogenicity Dị ka ọ dị n'ụdị protein niile, ọgwụgwọ insulin nwere ike ime ka etolite ọgwụ mgbochi insulin. Nchọpụta onye na - ahụ maka ihe na - arụ ọrụ nke ukwuu dabere na nghọta na nkọwapụta nke usoro nyocha ọ nwere ike ịbụ n'ihi ọtụtụ ihe, dịka usoro nke usoro nyocha, nhazi ihe nlele, oge nnakọta, usoro ọgwụgwọ, yana ọrịa na - akpata ya. Maka ebumnuche ndị a, iji ogo nke ọgwụ nje na nchikota insulin degludec + insulin na ọkwa nke ọgwụ mgbochi na ọmụmụ ndị ọzọ ma ọ bụ ihe ndị ọzọ nwere ike iduhie.

Na nyocha n’ime ndị ọrịa nwere ụdị ọrịa shuga 1, 95.9% ndị ọrịa na-anakọta njikọ insulin degludec + insulin aspart otu ugboro n’ụbọchị nwere ule dị mma maka ọgwụ mgbochi insulin ọ dịkarịa ala otu oge n’oge ọmụmụ ihe ahụ, gụnyere 89% nke ndị ọrịa bu ụzọ nwee nsonaazụ dị mma, ebe 13% nke ndị ọrịa a ọ dịkarịa ala 1 n'oge ọmụmụ ahụ nyere nsonaazụ dị mma maka ọgwụ mgbochi insulin aspart, gụnyere 6.4% nke ndị ọrịa nwere ezigbo nsonaazụ na ntọala. Na nyocha n’ime ndị ọrịa nwere ụdị ọrịa shuga 2 dị, 67.5% nke ndị ọrịa na-anakọta njikọ insulin degludec + insulin aspart otu ugboro n’ụbọchị nwere nsonaazụ dị mma maka nyocha nke ọgwụ mgbochi insulin n’arụghị otu oge n’oge ọmụmụ ihe ahụ, gụnyere 45.4% nke ndị ọrịa onye nwere ezigbo nsonaazụ na mbido ọmụmụ a, ebe 17.1% nke ndị ọrịa a ọ dịkarịa ala 1 n'oge ọmụmụ ahụ nwalere ihe ọma maka ọgwụ mgbochi iji nweta insulin aspart, gụnyere 12.3%, nke nwere nsonaazụ dị mma na ntọala. Enwere ike ileda ọkwa nke onye na - agwọ ọrịa shuga nke 2 n'ihi mmachi enwere ike na nyocha ahụ n'ihi ọnụnọ nke insulin endogenous na samon n'ime ndị ọrịa a. Ọnụnọ nke ọgwụ mgbochi ọrịa na-emetụta arụmọrụ nwere ike ịchọ mgbanwe mgbanwe iji dozie maka ebumnuche hyper - ma ọ bụ hypoglycemia. E guzobeghi ọgwụ ndị na-egbochi ọgwụ insulin.

Hypersensitivity na mmeghachi ahụ nfụkasị. Ahụhụ na-egbu ndụ na-emetụta oke egwu, gụnyere anaphylaxis, nwere ike ịmalite site na iji ọgwụ insulin, gụnyere njikọta nke insulin degludec + insulin aspart. N'ihe banyere mmeghachi omume hypersensitivity, ọ dị mkpa ịkwụsị iji nchikota nke insulin degludec + insulin aspart, na-eduzi usoro dị ka ụkpụrụ nlekọta ahụike ma nyochaa ruo mgbe a ga-edozi mgbaàmà na akara. A na - ekwekọrịta ojiji nke ngwakọta insulin degludec + insulin aspart na ndị ọrịa nwetagoro mmeghachi omume insulin degludec ma ọ bụ insulin aspart (lee “Contraindications”).

Hypokalemia. Ihe niile insulins, gụnyere njikọta insulin degludec + insulin aspart, na-eme ka ntụgharị nke potassium si na extracellular oghere banye na sel, nke nwere ike ibute hypokalemia. Ọrịa hypokalemia a na-achịkwaghị achịkwa nwere ike ibute mkpịsị akpa ume, ventricular arrhythmias, na ọnwụ. Ọ dị mkpa iji nyochaa ọkwa nke potassium na ndị ọrịa n'ihe ize ndụ nke hypokalemia ma ọ bụrụ na enwere ihe ngosi (dịka ọmụmaatụ, ndị ọrịa na-eji ọgwụ ọjọọ na-agbadata ọkwa potassium, yana ndị ọrịa na-a drugsụ ọgwụ ndị nwere mmetụta uche na ịta potassium).

Ndị otu ọrịa pụrụ iche

Ndi okenye ndi okenye (ihe kariri 65 years). Enwere ike iji ngwakọta insulin degludec + insulin mee ihe na ndị ọrịa agadi. Ekwesịrị iji nlezianya nyochaa ọbara glucose ọbara yana nhazigharị insulin n'otu n'otu (lee "Pharmacokinetics").

Jiri ke geriatrics. N'ime ule nke ụlọ ọgwụ, ngụkọta nke 9 (2.5%) nke ndị ọrịa 362 nwere ọrịa shuga 1 nke natara insulin degludec + insulin aspart jikọtara afọ 65 ma ọ bụ karịa na 4 (1.1%) dị afọ 75 na ngafe. Ngụkọta nke 256 (25.7%) nke ndị ọrịa 998 nwere ọrịa shuga 2 bụ ndị jikọtara insulin degludec + insulin aspart bụ afọ 65 ma ọ bụ karịa na 32 (3.2%) bụ afọ 75 ma ọ bụ karịa. Nnyocha e jiri ya mee ihe ekpughereghị ọdịiche dị na nchekwa ma ọ bụ nrụpụta ọrụ nke ndị ọrịa ihe karịrị afọ 65 karịa ma e jiri ya tụnyere ndị ọrịa tọrọ.

Agbanyeghị, mgbe ejiri ya na ndị ọrịa geriatric, ekwesịrị ịkpachara anya karịa, ebe ọ bụ na enwere ike ịmasị mmetụta nke nchikota insulin degludec + na insulin na ụfọdụ ndị agadi. Ekwesịrị ịchekwa usoro izizi, mgbakwunye dose na mmezi iji zere hypoglycemia. Hypoglycemia nwere ike isi ike ịchọpụta ndị okenye.

Ndị ọrịa nwere nsogbu gbasara akụrụngwa yana ọrụ ịba ọcha n'anya. Enwere ike iji ngwakọta nke insulin degludec + insulin aspart na ndị ọrịa nwere nsogbu gbasara akụrụ na arụ ọrụ hepatic. Ekwesịrị iji nlezianya nyochaa ọbara glucose ọbara yana nhazigharị insulin n'otu n'otu (lee "Pharmacokinetics").

Ọdịda ya. N'ime ule nke ụlọ ọgwụ, ngụkọta nke ndị ọrịa 18 (5%) nwere ụdị shuga 1 bụ ndị natara njikọ insulin degludec + insulin aspart nwere GFR erughị 60 ml / min / 1.73 m 2 ma ọ bụ ihe na-erughị 1 (0.3%) ọrịa GFR erughị 30 ml / min / 1.73 m 2 ma ọ bụ ihe na-erughị. Ngụkọta nke 111 (11%) nke ndị ọrịa 998 nwere ọrịa shuga 2 bụ ndị natara njikọ insulin degludec + insulin aspart nwere GFR erughị 60 ml / min / 1.73 m 2, ọ nweghịkwa onye ọrịa nwere GFR na-erughị 30 ml / min / 1.73 m 2.

Enweghị ọdịiche dị iche iche na ọgwụ ọgwụ nke ihe ndị mejupụtara insulin degludec + insulin na nyocha nke onwe ha ma e jiri ya tụnyere ndị mmadụ na ahụike na ndị nwere ọrụ mgbazinye nsogbu. Agbanyeghị, dị ka ọ dị insulins niile, na ndị ọrịa nwere ezughi oke akụrụ, ekwesịrị ịbawanye ume na glucose, na usoro nke insulin degludec + insulin aspartate kwesịrị ka a gbanwee ya n'otu n'otu.

Imeju imeju. Enweghị ọdịiche dị iche iche na ọgwụ ọgwụ nke otu akụkụ nke ngwakọta nke insulin degludec + insulin na ngalaba nyocha onwe ha ma e jiri ya tụnyere isiokwu ndị siri ike na ndị nwere ọdịda imeju (obere, agafeghị oke na ọdịda imeju). Agbanyeghị, dịka ọ siri mee insulins niile, ekwesịrị ịbawanye ume na glucose na usoro ọnụọgụ insulin degludec + insulin na-agbaghari otu onye na ndị ọrịa arụ ọrụ imeju.

Childrenmụaka na ndị nọ n'afọ iri na ụma. A gosipụtara data pharmacokinetic dị na ngalaba Pharmacokinetics, agbanyeghị, arụmọrụ na nchekwa nke njikọta nke insulin degludec + insulin na ụmụ na ndị nọ n'afọ iri na asatọ amụbeghị, a tụrụbeghị aro maka ị ofụ ọgwụ ahụ na ụmụaka.

Ya adịla mgbe ị ga-ebugharị pen sirinji n’aka ndị ọrịa ndị ọzọ. Agaghị enyefe onye ọzọ syringe ya, agbanyeghị na agbanwere agịga. Iji onye ọrịa ọzọ nke onye ọrịa nwere nsogbu nke ibute ọrịa ọbara.

Mmetụta ikike ịkwọ ụgbọala na usoro. Ike nke ndị ọrịa itinye uche na ọnụego mmeghachi omume nwere ike ọfụma n'oge hypoglycemia, nke nwere ike ịdị ize ndụ n'ọnọdụ ebe ikike a kachasị mkpa (dịka ọmụmaatụ, mgbe ị na-anya ụgbọala ma ọ bụ jiri igwe rụọ ọrụ).

A dụrụ ndị ọrịa ọdụ ka ha mee ihe iji gbochie mmepe nke hypoglycemia mgbe ha na-anya ụgbọala.Nke a dị mkpa kachasị mkpa nye ndị ọrịa nwere mgbaàmà na-anọghị ma ọ bụ nke na-ebelata - ihe na-ebido hypoglycemia ma ọ bụ nwee ọtụtụ oge nke hypoglycemia. N'ụdị ndị a, ekwesịrị ịtụle mkpa ọ dị ịnya ụgbọ ala.