The 45 references with contexts in paper G. Gorodetskaya I., E. Shikh V., M. Zhuravleva V., S. Serebrova Yu., E. Sokova A., O. Muslimova V., T. Aleksandrova V., I. Mazerkina A., S. Rudnev G., Г. Городецкая И., Е. Ших В., М. Журавлева В., С. Сереброва Ю., Е. Сокова А., О. Муслимова В., Т. Александрова В., И. Мазеркина А., С. Руднев Г. (2018) “Взаимозаменяемость препаратов, содержащих глибенкламид // Interchangeability of glibenclamide-containing drugs” / spz:neicon:vedomostincesmp:y:2017:i:4:p:199-211

1
Scientific substantiation, development and improvement of methodology for assessment of medicinal products interchangeability. Research report (intermediate). FSBI «SCEEMP» of the Ministry of Health of Russia; advisors: Romanov BK, Prokofiev AB, Yagudina RI; prepared by: Alyautdin RN, Zhuravleva MV. Moscow; 2015.
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    Ôåäåðàöèè ïåðâûì èç âñåõ âîçìîæíûõ àíàëîãîâ; 2) åãî êà÷åñòâî, ýôôåêòèâíîñòü è áåçîïàñíîñòü äîëæíû áûòü äîêàçàíû íà îñíîâàíèè ðåçóëüòàòîâ äîêëèíè÷åñêèõ èññëåäîâàíèé ëåêàðñòâåííûõ ñðåäñòâ (ËÑ) è êëèíè÷åñêèõ èññëåäîâàíèé ËÏ, ïðîâåäåííûõ â ñîîòâåòñòâèè ñ òðåáîâàíèÿìè ÷àñòè 3 ñò. 18 Ôåäåðàëüíîãî çàêîíà Ðîññèéñêîé Ôåäåðàöèè îò 12 àïðåëÿ 2010 ã. ¹ 61-ÔÇ «Îá îáðàùåíèè ëåêàðñòâåííûõ ñðåäñòâ »
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    . Öåëü ðàáîòû— àíàëèç è îáîñíîâàíèå îñíîâíûõ ôàêòîðîâ, îïðåäåëÿþùèõ âçàèìîçàìåíÿåìîñòü ïðåïàðàòîâ, ñîäåðæàùèõ ãëèáåíêëàìèä. Ãëèáåíêëàìèä (ãëèáóðèä), àêòèâíîå âåùåñòâî ïðåïàðàòîâ äëÿ ëå÷åíèÿ ñàõàðíîãî äèàáåòà (ÑÄ), ïðèìåíÿåòñÿ ñ 1969 ãîäà.

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    Ïî îòíîøåíèþ ê ðåôåðåíòíîìó ïðåïàðàòó ìàíèíèë 5 ìã âñå âîñïðîèçâåäåííûå ïðåïàðàòû ãëèáåíêëàìèäà ñ çàìåäëåííûì âñàñûâàíèåì â ýòîé äîçèðîâêå ìîãóò áûòü ïðèçíàíû âçàèìîçàìåíÿåìûìè ïðè ñîîòâåòñòâèè êðèòåðèÿì âçàèìîçàìåíÿåìîñòè
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    . 2. Ïðåïàðàò ãëèáîìåò, ñîäåðæàùèé ãëèáåíêëàìèä 2,5 ìã è ìåòôîðìèí 400 ìã ÿâëÿåòñÿ ðåôåðåíòíûì äëÿ âîñïðîèçâåäåííûõ ïðåïàðàòîâ ñ òîé æå äîçèðîâêîé è çàìåäëåííûì âñàñûâàíèåì. Ïðåïàðàò áîëåå àêòèâåí, ÷åì ðàâíàÿ äîçà ãëèáåíêëàìèäà íåìèêðîíèçèðîâàííîãî ïðè ìîíîòåðàïèè.

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4 p. No. SR 115111740009. Deposited in CITIS on 16.02.2016, No. IKRBS 216021650027 (in Russian). 2. Mashkovsky MD. Medicines. V. 1. Moscow: Meditsina; 1984 (in Russian).
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    Ãëèáåíêëàìèä (ãëèáóðèä), àêòèâíîå âåùåñòâî ïðåïàðàòîâ äëÿ ëå÷åíèÿ ñàõàðíîãî äèàáåòà (ÑÄ), ïðèìåíÿåòñÿ ñ 1969 ãîäà. Îðèãèíàëüíûé ïðåïàðàò äàîíèë 5 ìã âûïóñêàåò «Ñàíîôè-Àâåíòèñ», â íàñòîÿùåå âðåìÿ â Ðîññèè íå çàðåãèñòðèðîâàí.  ÑÑÑÐ èñïîëüçîâàëèñü äàîíèë (Þãîñëàâèÿ) è ìàíèíèë (ÃÄÐ)
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    .  Ðîññèè ðåôåðåíòíûì ïðåïàðàòîì ãëèáåíêëàìèäà ñòàë ìàíèíèë ïðîèçâîäñòâà «Áåðëèí-Õåìè ÀÃ/Ìåíàðèíè Ãðóïï»: îáû÷íàÿ ôîðìà 5 ìã è ìèêðîíèçèðîâàííàÿ ôîðìà 3,5 ìã, 1,75 ìã. Ðåôåðåíòíûì êîìáèíèðîâàííûì ïðåïàðàòîì (ãëèáåíêëàìèä è ìåòôîðìèí) ÿâëÿåòñÿ ãëèáîìåò («Ëàáîðàòîðèÿ Ãóèäîòòè Ñ.ï.

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Dedov II, Shestakova MV, Mayorov AYu, Vikulova OK, Galstyan GR, Kuraeva TL, et al. Standards of specialized diabetes care. Diabetes mellitus 2017; 20(1S): 1–112 (in Russian).
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    Ñàõàðíûé äèàáåò — ýòî ãðóïïà ìåòàáîëè÷åñêèõ (îáìåííûõ) çàáîëåâàíèé, õàðàêòåðèçóþùèõñÿ õðîíè÷åñêîé ãèïåðãëèêåìèåé, êîòîðàÿ ÿâëÿåòñÿ ðåçóëüòàòîì íàðóøåíèÿ ñåêðåöèè èíñóëèíà, äåéñòâèÿ èíñóëèíà èëè îáîèõ ýòèõ ôàêòîðîâ. Õðîíè÷åñêàÿ ãèïåðãëèêåìèÿ ïðè ÑÄ ñîïðîâîæäàåòñÿ ïîâðåæäåíèåì, äèñôóíêöèåé è íåäîñòàòî÷íîñòüþ ðàçëè÷íûõ îðãàíîâ, îñîáåííî ãëàç, ïî÷åê, íåðâîâ, ñåðäöà è êðîâåíîñíûõ ñîñóäîâ
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    . Â îöåíêå ñîñòîÿíèÿ óãëåâîäíîãî îáìåíà àêòóàëüíûì ÿâëÿåòñÿ îïðåäåëåíèå ãëèêåìèè íàòîùàê è ïîñëå åäû. Â 2011 ãîäó Âñåìèðíàÿ îðãàíèçàöèÿ çäðàâîîõðàíåíèÿ (ÂÎÇ) ïðèçíàëà âîçìîæíîñòü èñïîëüçîâàòü ïîêàçàòåëü ãëèêèðîâàííîãî ãåìîãëîáèíà (HbA1c) äëÿ äèàãíîñòèêè ñàõàðíîãî äèàáåòà.

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    ÑÄ ãåíåòè÷åñêè íåîäíîðîäåí è ìîæåò ïðîòåêàòü ñ ïðåèìóùåñòâåííîé èíñóëèíîðåçèñòåíòíîñòüþ (ÈÐ) ïðè îòíîñèòåëüíîé èíñóëèíîâîé íåäîñòàòî÷íîñòè èëè ñ ïðåèìóùåñòâåííûì äåôåêòîì ñåêðåöèè èíñóëèíà ïðè ÈÐ èëè áåç íåå
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    . Ñåêðåöèÿ èíñóëèíà (êàê áàçàëüíàÿ, òàê è ïîñòïðàíäèàëüíàÿ) îñóùåñòâëÿåòñÿ â äâóõ ñî÷åòàþùèõñÿ ïóëüñèðóþùèõ ðåæèìàõ ñ ïåðèîäè÷íîñòüþ 6–10 ìèí (âûñîêî÷àñòîòíûå êîëåáàíèÿ) è 90 ìèí (óëüòðàäèàííûå êîëåáàíèÿ).

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Kukes VG, Sychev DA, Andreev DA, Arkhipov VV, Batischeva GA, Berdnikova NG, et al. Ñlinical pharmacology. 5th ed. Moscow: GEOTAR-Media; 2015 (in Russian).
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    Ýòî ïðîèñõîäèò êàê ñ óæå èìåþùèìèñÿ ãðàíóëàìè, òàêèñíîâûìè, îáðàçóþùèìèñÿ â ïðîöåññå ñèíòåçà èíñóëèíà. Âòîðàÿ ôàçà áîëåå äëèòåëüíàÿ, ñåêðåöèÿ èíñóëèíà íàðàñòàåò ïîñòåïåííî è ïðîäîëæàåòñÿ äî íîðìàëèçàöèè óðîâíÿ ãëþêîçû
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    . Ïðè ÑÄ 2 òèïà àáñîëþòíûé äåôåêò ñåêðåöèè èíñóëèíà ïîÿâëÿåòñÿ ëèøü íà ïîçäíèõ ñòàäèÿõ çàáîëåâàíèÿ, à áîëüøóþ ÷àñòü ïåðèîäà áîëåçíè èìååòñÿ ñîõðàíåííàÿ è äàæå (íà ðàííèõ ñòàäèÿõ) óñèëåííàÿ ôóíêöèÿ áåòà-êëåòîê ïîäæåëóäî÷íîé æåëåçû, êîòîðàÿ ïîñòåïåííî ñíèæàåòñÿ [5, 6].

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    îáû÷íûé ãëèáåíêëàìèä èìååò áîëüøèéÒ1/2çà ñ÷åò óâåëè÷åíèÿ âðåìåíè âñàñûâàíèÿ), áîëåå ïîëíàÿ àáñîðáöèÿ ìèêðîíèçèðîâàííîé ôîðìû, êîòîðàÿ ëó÷øå ðàñòâîðÿåòñÿ, ñîçäàåò òàêóþ æå ïðîäîëæèòåëüíîñòü äåéñòâèÿ, êàê è ó îáû÷íîãî ãëèáåíêëàìèäà (24 ÷). Ñóòî÷íàÿ äëèòåëüíîñòü äåéñòâèÿ ñàìîãî àêòèâíîãî ïðåïàðàòà èç ãðóïïû ÏÑÌ ÿâëÿåòñÿ íåäîñòàòêîì, ïîñêîëüêó ñîçäàåò óãðîçó äëèòåëüíûõ è òÿæåëûõ ãèïîãëèêåìèé
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    . Ãëèáåíêëàìèä ïî÷òè ïîëíîñòüþ ìåòàáîëèçèðóåòñÿ â ïå÷åíè èçîôåðìåíòîì CYP2C9 (CYP3A4 ñòåíêè êèøêè èãðàåò âñïîìîãàòåëüíóþ ðîëü) ñ îáðàçîâàíèåì íåàêòèâíûõ ìåòàáîëèòî⠗ 4-òðàíñ-ãèäðîêñè-ãëèÐèñ. 1.Ñðàâíåíèå ôàðìàêîêèíåòè÷åñêèõ êðèâûõ ìèêðîíèçèðîâàííîé è íåìèêðîíèçèðîâàííîé ôîðì ãëèáóðèäà [22] áåíêëàìèäà (Ì1) è 3-öèñ-ãèäðîêñè-ãëèáåíêëàìèäà (M2), êîòîðûå ýêñêðåòèðóþòñÿ ïî÷êàìè è ïå÷åíüþ ïðèìåðíî ïîðîâí

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    Ãåïàòîòîêñè÷åñêèå ýôôåêòû òðåáóþò íåìåäëåííîé îòìåíû ïðåïàðàòà, ïîñêîëüêó ìîãóò ïðèâåñòè ê æèçíåóãðîæàþùåé ïå÷åíî÷íîé íåäîñòàòî÷íîñòè. Íåæåëàòåëüíûå ðåàêöèè ãëèáåíêëàìèäà ÷àñòî íîñÿò äîçîçàâèñèìûé õàðàêòåð
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    . Ïîòåíöèàë âàðèàáåëüíîñòè òåðàïåâòè÷åñêîãî ýôôåêòà è ðàçâèòèå íåæåëàòåëüíûõ ðåàêöèé ìîãóò áûòü ñâÿçàíû ñ õàðàêòåðèñòèêàìè àêòèâíîãî âåùåñòâà.  2010 ãîäó â ñèñòåìàòè÷åñêîì îáçîðå îöåíèâàëèñü íåæåëàòåëüíûå ðåàêöè ãëèáåíêëàìèäà.

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     òðåõ èç 11 èññëåäîâàíèé îòìå÷àëîñü ïîâûøåíèå ÷àñòîòû ãèïîãëèêåìèé ó ïàöèåíòîâ, ïîëó÷àâøèõ ìîíîòåðàïèþ íåìèêðîíèçèðîâàííûì ãëèáåíêëàìèäîì [28].  ðàíäîìèçèðîâàííîì ñðàâíèòåëüíîì èññëåäîâàíèè ñ ïðèìåíåíèåì äâîéíîãî ñëåïîãî ìåòîäà êîíòðîëÿ Òàáëèöà 2 ÏÅÐÅ×ÅÍÜ ÍÅÆÅËÀÒÅËÜÍÛÕ ÐÅÀÊÖÈÉ, ÂÛÇÛÂÀÅÌÛÕ ÏÐÅÏÀÐÀÒÀÌÈ ÑÓËÜÔÎÍÈËÌÎ×ÅÂÈÍÛ
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    ×àñòûåÐåäêèå Ìåòàáîëè÷åñêèå: – ãèïîãëèêåìèÿ – ïîâûøåíèå ìàññû òåëà Æåëóäî÷íî-êèøå÷íûå íàðóøåíèÿ: – ïîòåðÿ àïïåòèòà – îòðûæêà – èçæîãà – òîøíîòà è èçðåäêà ðâîòà – îùóùåíèå òÿæåñòè â ýïèãàñòðèè – ìåòåîðèçì – àáäîìèíàëüíûå áîëè – äèàðåÿ èëè çàïîð Êîæíûå ðåàêöèè: – êîðåïîäîáíàÿ ñûïü – ïÿòíèñòî-ïàïóëåçíàÿ ñûïü – êðàïèâíèöà – äèñóëüôèðàìîïîäîáíàÿ ðåàêöèÿ Êîæíûå ðåàêöèè(ìîãóò ñîïðîâîæäàòüñÿ çóäîì): – ôî

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    Ïðè íàçíà÷åíèè ïàöèåíòó ïðåïàðàòà, ñîäåðæàùåãî ãëèáåíêëàìèä, ñ äðóãîé ñêîðîñòüþ âñàñûâàíèÿ êîíòðîëü ñàõàðà â êðîâè îáÿçàòåëåí.  ñîîòâåòñòâèè ñ ñîâðåìåííûìè Àëãîðèòìàìè ñïåöèàëèçèðîâàííîé ìåäèöèíñêîé ïîìîùè áîëüíûì ñàõàðíûì äèàáåòîì
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    , ãëèáåíêëàìèä íå ðåêîìåíäîâàí äëÿ ìîíîòåðàïèè ïðè âïåðâûå âûÿâëåííîì ÑÄ ëèöàì ñòàðøå 60 ëåò. Ïðåïàðàòû ãëèáåíêëàìèäà íå ðåêîìåíäóåòñÿ íàçíà÷àòü ïàöèåíòàì ñ èøåìè÷åñêîé áîëåçíüþ ñåðäöà (èíôàðêò ìèîêàðäà â àíàìíåçå, øóíòèðîâàíèå/ñòåíòèðîâàíèå êîðîíàðíûõ àðòåðèé, ïîðàæåíèå îäíîãî èëè íåñêîëüêèõ êîðîíàðíûõ ñîñóäîâ), ñ èøåìè÷åñêèì èëè ãåìîððàãè÷åñêèì èíñóëüòîì â àíàìíåçå, ñ çàáîëåâàíèåì ïåðèôåðè÷åñêèõ

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Robertson RP, Porte D. The glucose receptor a defective mechanism in diabetes mellitus distinct from the beta adrenergic receptor. J Clin. Invest. 1973; 52(4): 870–6.
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    Ïðè ÑÄ 2 òèïà àáñîëþòíûé äåôåêò ñåêðåöèè èíñóëèíà ïîÿâëÿåòñÿ ëèøü íà ïîçäíèõ ñòàäèÿõ çàáîëåâàíèÿ, à áîëüøóþ ÷àñòü ïåðèîäà áîëåçíè èìååòñÿ ñîõðàíåííàÿ è äàæå (íà ðàííèõ ñòàäèÿõ) óñèëåííàÿ ôóíêöèÿ áåòà-êëåòîê ïîäæåëóäî÷íîé æåëåçû, êîòîðàÿ ïîñòåïåííî ñíèæàåòñÿ
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    . Óñòîé÷èâîñòü ê ãèïåðèíñóëèíåìèè è ñêîðîñòü ðàçâèòèÿ èñòîùåíèÿ ñåêðåòîðíîãî àïïàðàòà ïîäæåëóäî÷íîé æåëåçû ãåíåòè÷åñêè äåòåðìèíèðîâàíû [7]. Ïðè ïðîãðåññèðóþùåì óìåíüøåíèè êîëè÷åñòâà áåòà-êëåòîê è ïîñòåïåííîé ïîòåðå èìè ñïîñîáíîñòè ðåàãèðîâàòü íà ãèïåðãëèêåìèþ ñ ðàçâèòèåì èíñóëèíîâîé íåäîñòàòî÷íîñòè ê òåðàïèè äîáàâëÿþòñÿ ËÑ, ñòèìóëèðóþùèå ñåêðåöèþ èíñóëèíà — ïðåïàðàòû ÏÑÌ.

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Reaven GM. Banting lecture 1988. Role of insulin resistance in human disease. Diabetes 1988; 37(12): 1595–1607.
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    Ïðè ÑÄ 2 òèïà àáñîëþòíûé äåôåêò ñåêðåöèè èíñóëèíà ïîÿâëÿåòñÿ ëèøü íà ïîçäíèõ ñòàäèÿõ çàáîëåâàíèÿ, à áîëüøóþ ÷àñòü ïåðèîäà áîëåçíè èìååòñÿ ñîõðàíåííàÿ è äàæå (íà ðàííèõ ñòàäèÿõ) óñèëåííàÿ ôóíêöèÿ áåòà-êëåòîê ïîäæåëóäî÷íîé æåëåçû, êîòîðàÿ ïîñòåïåííî ñíèæàåòñÿ
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    . Óñòîé÷èâîñòü ê ãèïåðèíñóëèíåìèè è ñêîðîñòü ðàçâèòèÿ èñòîùåíèÿ ñåêðåòîðíîãî àïïàðàòà ïîäæåëóäî÷íîé æåëåçû ãåíåòè÷åñêè äåòåðìèíèðîâàíû [7]. Ïðè ïðîãðåññèðóþùåì óìåíüøåíèè êîëè÷åñòâà áåòà-êëåòîê è ïîñòåïåííîé ïîòåðå èìè ñïîñîáíîñòè ðåàãèðîâàòü íà ãèïåðãëèêåìèþ ñ ðàçâèòèåì èíñóëèíîâîé íåäîñòàòî÷íîñòè ê òåðàïèè äîáàâëÿþòñÿ ËÑ, ñòèìóëèðóþùèå ñåêðåöèþ èíñóëèíà — ïðåïàðàòû ÏÑÌ.

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Matschinsky F, Liang Y, Kesavan P, Wang L, Froguel P, Velho G, et al. Glucokinase as pancreatic beta cell glucose sensor and diabetes gene. J Clin Invest. 1993; 92(5): 2092–8.
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    Ïðè ÑÄ 2 òèïà àáñîëþòíûé äåôåêò ñåêðåöèè èíñóëèíà ïîÿâëÿåòñÿ ëèøü íà ïîçäíèõ ñòàäèÿõ çàáîëåâàíèÿ, à áîëüøóþ ÷àñòü ïåðèîäà áîëåçíè èìååòñÿ ñîõðàíåííàÿ è äàæå (íà ðàííèõ ñòàäèÿõ) óñèëåííàÿ ôóíêöèÿ áåòà-êëåòîê ïîäæåëóäî÷íîé æåëåçû, êîòîðàÿ ïîñòåïåííî ñíèæàåòñÿ [5, 6]. Óñòîé÷èâîñòü ê ãèïåðèíñóëèíåìèè è ñêîðîñòü ðàçâèòèÿ èñòîùåíèÿ ñåêðåòîðíîãî àïïàðàòà ïîäæåëóäî÷íîé æåëåçû ãåíåòè÷åñêè äåòåðìèíèðîâàíû
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    [7]
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    . Ïðè ïðîãðåññèðóþùåì óìåíüøåíèè êîëè÷åñòâà áåòà-êëåòîê è ïîñòåïåííîé ïîòåðå èìè ñïîñîáíîñòè ðåàãèðîâàòü íà ãèïåðãëèêåìèþ ñ ðàçâèòèåì èíñóëèíîâîé íåäîñòàòî÷íîñòè ê òåðàïèè äîáàâëÿþòñÿ ËÑ, ñòèìóëèðóþùèå ñåêðåöèþ èíñóëèíà — ïðåïàðàòû ÏÑÌ.

8
Shestakova MV. Actual clinical practice of treatment of diabetes type 2 in the Russian Federation according to the prospective open observational program «DIA-CONTROL». Diabetes Mellitus 2011; (4): 75–80 (in Russian).
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    Íàèáîëåå ÷àñòî (áîëåå ÷åì â 70 % ñëó÷àåâ) ïàöèåíòû ïîëó÷àþò ïðåïàðàòû II ïîêîëåíèÿ (ãëèêëàçèä, ãëèáåíêëàìèä) èëè III ïîêîëåíèÿ (ãëèìåïèðèä). ÏÑÌ â 50 % ñëó÷àåâ èñïîëüçóþòñÿ êàê ìîíîïðåïàðàòû äëÿ ìîíîòåðàïèè, à â îñòàëüíûõ ñëó÷àÿõ íàçíà÷àþòñÿ ñ äðóãèìè ñàõàðîñíèæàþùèìè ËÑ, â òîì ÷èñëå è â âèäå êîìáèíèðîâàííûõ ïðåïàðàòîâ
    Exact
    [8]
    Suffix
    . ÔÀÐÌÀÊÎÄÈÍÀÌÈÊÀ ÃËÈÁÅÍÊËÀÌÈÄÀ Ãëèáåíêëàìèä äåéñòâóåò íà ðåöåïòîðû ñóëüôîíèëìî÷åâèíû (SUR), êîòîðûå ïðåäñòàâëÿþò ñîáîé ðåãóëÿòîðíóþ ñóáúåäèíèöó ÀÒÔ-çàâèñèìîãî K+-êàíàëà. Ðàçëè÷àþò äâà òèïà ýòèõ ðåöåïòîðî⠗ SUR1, ëîêàëèçóþùèåñÿ íà ïîâåðõíîñòè ìåìáðàí áåòà-êëåòîê ïîäæåëóäî÷íîé æåëåçû, ó÷àñòâóþùèå â ðåãóëÿöèè ñåêðåöèè èíñóëèíà è ñòèìóëèðóåìûå âñåìè ÏÑÌ, è SUR2, ðàñïîëàãàþùèåñÿ â ìèîêàðäå (SUR2

9
Ashcroft FM, Gribble FM. ATP-sensitive K+channels and insulin secretion: their role in helht and disease. Diabetologia 1999; 42(8): 903–19.
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    Ïàðàëëåëüíî îòêðûâàþòñÿ ïîòåíöèàë-çàâèñèìûå Ñà++-êàíàëû, ÷òî îáåñïå÷èâàåò áûñòðîå ïîñòóïëåíèå â öèòîïëàçìó èîíîâ êàëüöèÿ, íàêîïëåíèå êîòîðûõ â áåòà-êëåòêàõ ïîäæåëóäî÷íîé æåëåçû âûçûâàåò ýêçîöèòîç ãðàíóë è âûñâîáîæäåíèå èíñóëèíà èç êëåòêè
    Exact
    [9]
    Suffix
    . Ãëèáåíêëàìèä, ïîìèìî ñóëüôîíèëìî÷åâèííîé ãðóïïèðîâêè, ñîäåðæèò åùå áåíçàìèäíóþ ãðóïïó, êîòîðàÿ òàêæå ñâÿçûâàåòñÿ ñ SUR; ñ÷èòàåòñÿ, ÷òî òàêàÿ ñòðóêòóðà îáóñëîâëèâàåò íàèáîëüøóþ êîíñòàíòó ñðîäñòâà ËÑ ê ðåöåïòîðó [10].

10
Nedosugova LV, Balabolkin MI. Algorithm treatment diabetes type 2 diabetes. Moscow: MedExpertPress; 2008 (in Russian).
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    Ãëèáåíêëàìèä, ïîìèìî ñóëüôîíèëìî÷åâèííîé ãðóïïèðîâêè, ñîäåðæèò åùå áåíçàìèäíóþ ãðóïïó, êîòîðàÿ òàêæå ñâÿçûâàåòñÿ ñ SUR; ñ÷èòàåòñÿ, ÷òî òàêàÿ ñòðóêòóðà îáóñëîâëèâàåò íàèáîëüøóþ êîíñòàíòó ñðîäñòâà ËÑ ê ðåöåïòîðó
    Exact
    [10]
    Suffix
    . Òàáëèöà 1 ÖÅËÅÂÛÅ ÓÐÎÂÍÈ HbA1c  ËÅ×ÅÍÈÈ ÑÀÕÀÐÍÎÃÎ ÄÈÀÁÅÒÀ Ó ÏÀÖÈÅÍÒΠÐÀÇËÈ×ÍÛÕ ÂÎÇÐÀÑÒÍÛÕ ÃÐÓÏÏ Ñîñòîÿíèå ïàöèåíòà Öåëåâûå óðîâíè HbA1c Â, % Ìîëîäîé âîçðàñò (äî 44 ëåò) Ñðåäíèé âîçðàñò (45–59 ëåò) Ïîæèëîé âîçðàñò (60–74 ëåò) è/èëè îæèäàåìàÿ ïðîäîëæèòåëüíîñòü æèçíè ìåíåå 5 ëåò Íåò òÿæåëûõ îñëîæíåíèé è/èëè ðèñêà òÿæåëîé ãèïîãëèêåìèè è ÑÑÎ <6,5<7,0<7,5 Åñòü òÿæåëûå îñëîæíåíèÿ è/èëè ðèñê òÿæåëîé ã

11
Muller G, Hartz D, Punter J, Okonomopulos R, Kramer W. Differential interaction of glimepiride and glibenclamide with the beta–cell sulfonylurea receptor. I. Binding characteristics. Biochim Biophys Acta 1994; 1191(2): 267–77.
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    (45–59 ëåò) Ïîæèëîé âîçðàñò (60–74 ëåò) è/èëè îæèäàåìàÿ ïðîäîëæèòåëüíîñòü æèçíè ìåíåå 5 ëåò Íåò òÿæåëûõ îñëîæíåíèé è/èëè ðèñêà òÿæåëîé ãèïîãëèêåìèè è ÑÑÎ <6,5<7,0<7,5 Åñòü òÿæåëûå îñëîæíåíèÿ è/èëè ðèñê òÿæåëîé ãèïîãëèêåìèè è ÑÑÎ <7,0<7,5<8,0 Ãëèáåíêëàìèä îáëàäàåò ñàìûì ñèëüíûì, ïî ñðàâíåíèþ ñ äðóãèìè ÏÑÌ, ñðîäñòâîì ê SUR1, îïðåäåëÿþùèì ïîñòîÿííûé äëèòåëüíûé ñàõàðîñíèæàþùèé ýôôåêò ïðåïàðàòà
    Exact
    [11]
    Suffix
    . Ãëèáåíêëàìèä î÷åíü ñèëüíî ñòèìóëèðóåò âòîðóþ ôàçó ñåêðåöèè èíñóëèíà (ïðè íîðìîãëèêåìèè è ãèïåðãëèêåìèè) [12]. Îñîáåííîñòè ðåöåïòîðíîãî âçàèìîäåéñòâèÿ, ïðî÷íîñòü ñâÿçè ñ SUR1óñèëèâàþò ïîñòïðàíäèàëüíóþ è áàçàëüíóþ ñåêðåöèþ èíñóëèíà, ñîçäàâàÿ óãðîçó ãèïîãëèêåìèè [13].

12
Cozma LS, Luzio SD, Dunseath GJ, Langendorg KW, Pieber T, Owens DR. Comparison of the effects of three insulinotropic drugs on plasma insulin levels after a standard meal. Diabetes Care 2002; 25(8): 1271–6.
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    îñëîæíåíèé è/èëè ðèñêà òÿæåëîé ãèïîãëèêåìèè è ÑÑÎ <6,5<7,0<7,5 Åñòü òÿæåëûå îñëîæíåíèÿ è/èëè ðèñê òÿæåëîé ãèïîãëèêåìèè è ÑÑÎ <7,0<7,5<8,0 Ãëèáåíêëàìèä îáëàäàåò ñàìûì ñèëüíûì, ïî ñðàâíåíèþ ñ äðóãèìè ÏÑÌ, ñðîäñòâîì ê SUR1, îïðåäåëÿþùèì ïîñòîÿííûé äëèòåëüíûé ñàõàðîñíèæàþùèé ýôôåêò ïðåïàðàòà [11]. Ãëèáåíêëàìèä î÷åíü ñèëüíî ñòèìóëèðóåò âòîðóþ ôàçó ñåêðåöèè èíñóëèíà (ïðè íîðìîãëèêåìèè è ãèïåðãëèêåìèè)
    Exact
    [12]
    Suffix
    . Îñîáåííîñòè ðåöåïòîðíîãî âçàèìîäåéñòâèÿ, ïðî÷íîñòü ñâÿçè ñ SUR1óñèëèâàþò ïîñòïðàíäèàëüíóþ è áàçàëüíóþ ñåêðåöèþ èíñóëèíà, ñîçäàâàÿ óãðîçó ãèïîãëèêåìèè [13].  2009 ãîäó èçó÷àëîñü âëèÿíèå ãåíåòè÷åñêîãî ïîëèìîðôèçìà SUR1(Nikolac N. et al.

13
Hosker JP, Rudenski AS, Burnett MA, Matthews DR, Turner RC. Similar reduction of first- and second-phaseâ-cell responses at three different glucose levels in type II diabetes and the effect of gliclazide therapy. Metabolism 1989; 38(8): 767–72.
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    Ãëèáåíêëàìèä î÷åíü ñèëüíî ñòèìóëèðóåò âòîðóþ ôàçó ñåêðåöèè èíñóëèíà (ïðè íîðìîãëèêåìèè è ãèïåðãëèêåìèè) [12]. Îñîáåííîñòè ðåöåïòîðíîãî âçàèìîäåéñòâèÿ, ïðî÷íîñòü ñâÿçè ñ SUR1óñèëèâàþò ïîñòïðàíäèàëüíóþ è áàçàëüíóþ ñåêðåöèþ èíñóëèíà, ñîçäàâàÿ óãðîçó ãèïîãëèêåìèè
    Exact
    [13]
    Suffix
    .  2009 ãîäó èçó÷àëîñü âëèÿíèå ãåíåòè÷åñêîãî ïîëèìîðôèçìà SUR1(Nikolac N. et al.). Áûëî ïîêàçàíî, ÷òî ïàöèåíòû ñ ãåíîòèïîì C/C SUR1 16 ýêçîíà (äèêîãî òèïà) èìåëè äîñòîâåðíî áîëåå íèçêèå óðîâíè HbA1c, ÷åì ïàöèåíòû ñ ãåíîòèïîì T/T.

14
Nikolac N, Simundic AM, Katalinic D, Topic E, Cipak A, Zjacic Rotkvic V. Metabolic control in type 2 diabetes is associated with sulfonylurea receptor-1 (SUR-1) but not with KCNJ11 polymorphisms. Arch Med Res. 2009; 40(5): 387–92.
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    Áûëî ïîêàçàíî, ÷òî ïàöèåíòû ñ ãåíîòèïîì C/C SUR1 16 ýêçîíà (äèêîãî òèïà) èìåëè äîñòîâåðíî áîëåå íèçêèå óðîâíè HbA1c, ÷åì ïàöèåíòû ñ ãåíîòèïîì T/T. Ïàöèåíòû ñ ãåíîòèïîì G/G SUR131 ýêçîíà èìåëè ñóùåñòâåííî áîëåå âûñîêèå óðîâíè HbA1c ïî ñðàâíåíèþ ñ ïàöèåíòàìè-íîñèòåëÿìè ãåíîòèïà A/A
    Exact
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    . Ãëèáåíêëàìèä îáëàäàåò è ýôôåêòàìè, íå ñâÿçàííûìè ñ ïàíêðåàòè÷åñêèìè áåòà-êëåòêàìè. Ê ýòèì ýôôåêòàì, â ÷àñòíîñòè, îòíîñÿòñÿ ïîâûøåíèå ÷óâñòâèòåëüíîñòè ïåðèôåðè÷åñêèõ òêàíåé, â ïåðâóþ î÷åðåäü æèðîâîé è ìûøå÷íîé, ê èíñóëèíó è âîçðàñòàíèå óñâîåíèÿ ãëþêîçû êëåòêàìè: óâåëè÷åíèå ÷èñëà èíñóëèíîâûõ ðåöåïòîðîâ, óëó÷øåíèå èíñóëèí-ðåöåïòîðíîãî âçàèìîäåéñòâèÿ, âîññòàíîâëåíèå òðàíñäóêöèè ïîñòðåöåïòîðíîãî ñèãí

15
Holstein A, Hahn M, Stumvoll M, Kovacs P. The E23K variant of KCNJ11 and the risk for severe sulfonylurea-induced hypoglycemia in patients with type 2 diabetes. Horm Metab Res. 2009; 41(5): 387–90.
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    Áûëî ïîêàçàíî, ÷òî ïàöèåíòû ñ ãåíîòèïîì C/C SUR1 16 ýêçîíà (äèêîãî òèïà) èìåëè äîñòîâåðíî áîëåå íèçêèå óðîâíè HbA1c, ÷åì ïàöèåíòû ñ ãåíîòèïîì T/T. Ïàöèåíòû ñ ãåíîòèïîì G/G SUR131 ýêçîíà èìåëè ñóùåñòâåííî áîëåå âûñîêèå óðîâíè HbA1c ïî ñðàâíåíèþ ñ ïàöèåíòàìè-íîñèòåëÿìè ãåíîòèïà A/A
    Exact
    [14, 15]
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    . Ãëèáåíêëàìèä îáëàäàåò è ýôôåêòàìè, íå ñâÿçàííûìè ñ ïàíêðåàòè÷åñêèìè áåòà-êëåòêàìè. Ê ýòèì ýôôåêòàì, â ÷àñòíîñòè, îòíîñÿòñÿ ïîâûøåíèå ÷óâñòâèòåëüíîñòè ïåðèôåðè÷åñêèõ òêàíåé, â ïåðâóþ î÷åðåäü æèðîâîé è ìûøå÷íîé, ê èíñóëèíó è âîçðàñòàíèå óñâîåíèÿ ãëþêîçû êëåòêàìè: óâåëè÷åíèå ÷èñëà èíñóëèíîâûõ ðåöåïòîðîâ, óëó÷øåíèå èíñóëèí-ðåöåïòîðíîãî âçàèìîäåéñòâèÿ, âîññòàíîâëåíèå òðàíñäóêöèè ïîñòðåöåïòîðíîãî ñèãí

16
Balabolkin MI, Kreminskaya VM, Klebanova EM. Modern tactics of treatment of diabetes mellitus type 2. Consilium medicum 2001; 3(11): 535–40 (in Russian).
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    Ê ýòèì ýôôåêòàì, â ÷àñòíîñòè, îòíîñÿòñÿ ïîâûøåíèå ÷óâñòâèòåëüíîñòè ïåðèôåðè÷åñêèõ òêàíåé, â ïåðâóþ î÷åðåäü æèðîâîé è ìûøå÷íîé, ê èíñóëèíó è âîçðàñòàíèå óñâîåíèÿ ãëþêîçû êëåòêàìè: óâåëè÷åíèå ÷èñëà èíñóëèíîâûõ ðåöåïòîðîâ, óëó÷øåíèå èíñóëèí-ðåöåïòîðíîãî âçàèìîäåéñòâèÿ, âîññòàíîâëåíèå òðàíñäóêöèè ïîñòðåöåïòîðíîãî ñèãíàëà
    Exact
    [16]
    Suffix
    . Íà óðîâíå ïå÷åíè ýòè ýôôåêòû ïðèâîäÿò ê òîðìîæåíèþ ãëþêîíåîãåíåçà [17]. Âíåïàíêðåàòè÷åñêèé ìåõàíèçì äåéñòâèÿ ãëèáåíêëàìèäà ñïîñîáñòâóåò óòèëèçàöèè äîïîëíèòåëüíîãî êîëè÷åñòâà ãëþêîçû è ñíèæåíèþ óðîâíÿ ãëèêåìèè, ÷òî íàðÿäó ñ îáåñïå÷åíèåì âûñîêîé ýôôåêòèâíîñòè ïðåïàðàòà äîïîëíèòåëüíî çà ñ÷åò íåðåãóëèðóåìîé àêòèâíîñòè âåäåò ê ðàçâèòèþ ãèïîãëèêåìèé [18].

17
Nyomba BL, Freymond D, Raz I, Stone K, Mott DM, Bogardus C. Skeletal muscle glycogen synthase activity in subjects with non-insulin-dependent diabetes mellitus after glyburide therapy. Metab Clin Exp. 1990; 39(3): 1204–10.
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    Ê ýòèì ýôôåêòàì, â ÷àñòíîñòè, îòíîñÿòñÿ ïîâûøåíèå ÷óâñòâèòåëüíîñòè ïåðèôåðè÷åñêèõ òêàíåé, â ïåðâóþ î÷åðåäü æèðîâîé è ìûøå÷íîé, ê èíñóëèíó è âîçðàñòàíèå óñâîåíèÿ ãëþêîçû êëåòêàìè: óâåëè÷åíèå ÷èñëà èíñóëèíîâûõ ðåöåïòîðîâ, óëó÷øåíèå èíñóëèí-ðåöåïòîðíîãî âçàèìîäåéñòâèÿ, âîññòàíîâëåíèå òðàíñäóêöèè ïîñòðåöåïòîðíîãî ñèãíàëà [16]. Íà óðîâíå ïå÷åíè ýòè ýôôåêòû ïðèâîäÿò ê òîðìîæåíèþ ãëþêîíåîãåíåçà
    Exact
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    . Âíåïàíêðåàòè÷åñêèé ìåõàíèçì äåéñòâèÿ ãëèáåíêëàìèäà ñïîñîáñòâóåò óòèëèçàöèè äîïîëíèòåëüíîãî êîëè÷åñòâà ãëþêîçû è ñíèæåíèþ óðîâíÿ ãëèêåìèè, ÷òî íàðÿäó ñ îáåñïå÷åíèåì âûñîêîé ýôôåêòèâíîñòè ïðåïàðàòà äîïîëíèòåëüíî çà ñ÷åò íåðåãóëèðóåìîé àêòèâíîñòè âåäåò ê ðàçâèòèþ ãèïîãëèêåìèé [18].

18
Fronzo RA, Simonson DC. Oral sulfonylurea agents suppress hepatic glucose production in non-insulin-dependent diabetic individuals. Diabetes Care 1984; 7(1): 72–80.
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    Âíåïàíêðåàòè÷åñêèé ìåõàíèçì äåéñòâèÿ ãëèáåíêëàìèäà ñïîñîáñòâóåò óòèëèçàöèè äîïîëíèòåëüíîãî êîëè÷åñòâà ãëþêîçû è ñíèæåíèþ óðîâíÿ ãëèêåìèè, ÷òî íàðÿäó ñ îáåñïå÷åíèåì âûñîêîé ýôôåêòèâíîñòè ïðåïàðàòà äîïîëíèòåëüíî çà ñ÷åò íåðåãóëèðóåìîé àêòèâíîñòè âåäåò ê ðàçâèòèþ ãèïîãëèêåìèé
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    [18]
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    . Ãëèáåíêëàìèä âëèÿåò íà SUR2àìèîêàðäà è SUR2bàðòåðèàëüíûõ ñîñóäîâ, ñíèæàÿ «èøåìè÷åñêîå ïðåêîíäèöèîíèðîâàíèå »ìèîêàðäà. Ôåíîìåí «èøåìè÷åñêîãî ïðåêîíäèöèîíèðîâàíèÿ »(àäàïòàöèè ìèîêàðäà ê áóäóùåé èøåìèè) âîçìîæåí òîëüêî ïðè îòêðûòûõ ÀÒÔ-çàâèñèìûõ Ê+-êàíàëàõ â ìåìáðàíàõ ìèîêàðäà è áëîêèðóåòñÿ ãëèáåíêëàìèäîì [19].

19
Klepzig H, Kober G, Matter C, Luus H, Schneider H, Boedeker KH, et al. Sulfonylureas and ischemic preconditioning. A double-blind, placebo-controlled evolution of glimepiride and glibenclamide. Eur Heart J. 1999; 20(6): 439–46.
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    Ãëèáåíêëàìèä âëèÿåò íà SUR2àìèîêàðäà è SUR2bàðòåðèàëüíûõ ñîñóäîâ, ñíèæàÿ «èøåìè÷åñêîå ïðåêîíäèöèîíèðîâàíèå »ìèîêàðäà. Ôåíîìåí «èøåìè÷åñêîãî ïðåêîíäèöèîíèðîâàíèÿ »(àäàïòàöèè ìèîêàðäà ê áóäóùåé èøåìèè) âîçìîæåí òîëüêî ïðè îòêðûòûõ ÀÒÔ-çàâèñèìûõ Ê+-êàíàëàõ â ìåìáðàíàõ ìèîêàðäà è áëîêèðóåòñÿ ãëèáåíêëàìèäîì
    Exact
    [19]
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    . ÊËÈÍÈ×ÅÑÊÀß ÔÀÐÌÀÊÎËÎÃÈß ÃËÈÁÅÍÊËÀÌÈÄÀ Àáñîðáöèÿ Ãëèáåíêëàìèä ÿâëÿåòñÿ ñëàáîé êèñëîòîé, ðàñòâîðèìîñòü â âîäå — 0,1 ìã/ìë ïðè 25 °Ñ. Ïàðàìåòðû ðàñòâîðåíèÿ çàâèñÿò îò ðÍ ñðåäû è ðàçìåðà ÷àñòèö ãëèáåíêëàìèäà [20, 21].

20
Bartsch SE, Abberger T, Griesser UJ. Melt granulation of solid dispersions — granulation mechanism, tableting and dissolution behavior. Abstr. 17th Congress of the Austrian Pharmaceutical Society. Graz, 24–26 April, 2003.
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    ÊËÈÍÈ×ÅÑÊÀß ÔÀÐÌÀÊÎËÎÃÈß ÃËÈÁÅÍÊËÀÌÈÄÀ Àáñîðáöèÿ Ãëèáåíêëàìèä ÿâëÿåòñÿ ñëàáîé êèñëîòîé, ðàñòâîðèìîñòü â âîäå — 0,1 ìã/ìë ïðè 25 °Ñ. Ïàðàìåòðû ðàñòâîðåíèÿ çàâèñÿò îò ðÍ ñðåäû è ðàçìåðà ÷àñòèö ãëèáåíêëàìèäà
    Exact
    [20, 21]
    Suffix
    . Óëó÷øåíèå ôàðìàêîêèíåòè÷åñêèõ ñâîéñòâ äîñòèãàåòñÿ îïòèìèçàöèåé àáñîðáöèè, ÷òî îòðàæàåòñÿ è íà íåêîòîðûõ äðóãèõ õàðàêòåðèñòèêàõ. Îáû÷íàÿ (íåìèêðîíèçèðîâàííàÿ) ôîðìà ãëèáåíêëàìèäà íà÷èíàåò àáñîðáèðîâàòüñÿ èç ÆÊÒ â òå÷åíèå ïåðâîãî ÷àñà ïîñëå ïðèåìà è ñîñòàâëÿåò 48–84 %, íî ïðîöåññ ðàñòÿíóò âî âðåìåíè, èTmaxìîæåò äîñòèãàòü 4–6 ÷.

21
Wei H, Lobenberg R. Biorelevant dissolution media as a predictive tool for glyburide a class II drug. Eur J Pharm Sci. 2006; 29(1): 45–52.
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    ÊËÈÍÈ×ÅÑÊÀß ÔÀÐÌÀÊÎËÎÃÈß ÃËÈÁÅÍÊËÀÌÈÄÀ Àáñîðáöèÿ Ãëèáåíêëàìèä ÿâëÿåòñÿ ñëàáîé êèñëîòîé, ðàñòâîðèìîñòü â âîäå — 0,1 ìã/ìë ïðè 25 °Ñ. Ïàðàìåòðû ðàñòâîðåíèÿ çàâèñÿò îò ðÍ ñðåäû è ðàçìåðà ÷àñòèö ãëèáåíêëàìèäà
    Exact
    [20, 21]
    Suffix
    . Óëó÷øåíèå ôàðìàêîêèíåòè÷åñêèõ ñâîéñòâ äîñòèãàåòñÿ îïòèìèçàöèåé àáñîðáöèè, ÷òî îòðàæàåòñÿ è íà íåêîòîðûõ äðóãèõ õàðàêòåðèñòèêàõ. Îáû÷íàÿ (íåìèêðîíèçèðîâàííàÿ) ôîðìà ãëèáåíêëàìèäà íà÷èíàåò àáñîðáèðîâàòüñÿ èç ÆÊÒ â òå÷åíèå ïåðâîãî ÷àñà ïîñëå ïðèåìà è ñîñòàâëÿåò 48–84 %, íî ïðîöåññ ðàñòÿíóò âî âðåìåíè, èTmaxìîæåò äîñòèãàòü 4–6 ÷.

22
Karpov OI. Micronized glibenclamide — a modification of the dosage form and kinetics aimed at the result. Russian medical journal 2006; (26): 1940–3 (in Russian).
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    Äîáàâëåíèå â òàáëåòêó â êà÷åñòâå âñïîìîãàòåëüíîãî âåùåñòâà ìåòèëãèäðîêñèýòèëöåëëþëîçû óëó÷øàåò ðàñòâîðåíèå ìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà, êîíöåíòðàöèÿ ïðåïàðàòà â ïëàçìå êðîâè âîçðàñòàåò â 3–5 ðàç ïî ñðàâíåíèþ ñ îáû÷íîé ôîðìîé
    Exact
    [22]
    Suffix
    . Óêîðî÷åíèå ïåðèîäà àáñîðáöèè ïðè óëó÷øåíèè ôàðìàêîêèíåòè÷åñêèõ ñâîéñòâ ïîçâîëÿåò ïðèíèìàòü ïðåïàðàò íåïîñðåäñòâåííî ïåðåä åäîé. Ïîëíîå ðàñòâîðåíèå âûñîêîäèñïåðñíîé ôîðìû (ìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà) â æåëóäêå â òå÷åíèå 5 ìèí îáåñïå÷èâàåò áîëåå áûñòðóþ àáñîðáöèþ (Tmax1–2 ÷) è ïî÷òè 100 % áèîäîñòóïíîñòü.

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    Ãëèáåíêëàìèä ïî÷òè ïîëíîñòüþ ìåòàáîëèçèðóåòñÿ â ïå÷åíè èçîôåðìåíòîì CYP2C9 (CYP3A4 ñòåíêè êèøêè èãðàåò âñïîìîãàòåëüíóþ ðîëü) ñ îáðàçîâàíèåì íåàêòèâíûõ ìåòàáîëèòî⠗ 4-òðàíñ-ãèäðîêñè-ãëèÐèñ. 1.Ñðàâíåíèå ôàðìàêîêèíåòè÷åñêèõ êðèâûõ ìèêðîíèçèðîâàííîé è íåìèêðîíèçèðîâàííîé ôîðì ãëèáóðèäà
    Exact
    [22]
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    áåíêëàìèäà (Ì1) è 3-öèñ-ãèäðîêñè-ãëèáåíêëàìèäà (M2), êîòîðûå ýêñêðåòèðóþòñÿ ïî÷êàìè è ïå÷åíüþ ïðèìåðíî ïîðîâíó [25]. Àêòèâíîñòü CYP2C9 çàâèñèò îò ðÿäà ýíäîãåííûõ è ýêçîãåííûõ ôàêòîðîâ. Ãåí, êîäèðóþùèé ýòîò èçîôåðìåíò, îáëàäàåò ãåíåòè÷åñêèì ïîëèìîðôèçìîì.

23
Glyburide Micronized Description. Available from: https://www.drugs.com/ pro/glyburide-micronized.html.
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    Ëó÷øåå ñîâïàäåíèåCmaxñ ïèêîì ïîñòïðàíäèàëüíîé ãèïåðãëèêåìèè è âîçìîæíîñòü çà ñ÷åò áîëüøåé áèîäîñòóïíîñòè èñïîëüçîâàòü ìåíüøèå äîçû îòíîñÿòñÿ ê äîñòîèíñòâàì ìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà
    Exact
    [23]
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    . Ðàñïðåäåëåíèå è ñâÿçü ñ áåëêîì Ïîäàâëÿþùàÿ ÷àñòü ÏÑÌ öèðêóëèðóåò â êðîâè â ñâÿçàííîì ñ áåëêîì âèäå (äî 99 %). Îáúåì ðàñïðåäåëåíèÿ (Vd) ãëèáåíêëàìèäà îòíîñèòåëüíî íåâåëèê: 9–10 ë. Áèîòðàíñôîðìàöèÿ Ãëèáåíêëàìèä ïî÷òè ïîëíîñòüþ ìåòàáîëèçèðóåòñÿ â ïå÷åíè èçîôåðìåíòàìè CYP3A4 è CYP2C9.

24
Christ OE, Heptner W, Rupp W. Investigations on absorption, excretion and metabolism in man after administration of14C-labelled HB 419. Horm Metab Res. 1969; 1 (Suppl. l): 51–4.
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    îáû÷íûé ãëèáåíêëàìèä èìååò áîëüøèéÒ1/2çà ñ÷åò óâåëè÷åíèÿ âðåìåíè âñàñûâàíèÿ), áîëåå ïîëíàÿ àáñîðáöèÿ ìèêðîíèçèðîâàííîé ôîðìû, êîòîðàÿ ëó÷øå ðàñòâîðÿåòñÿ, ñîçäàåò òàêóþ æå ïðîäîëæèòåëüíîñòü äåéñòâèÿ, êàê è ó îáû÷íîãî ãëèáåíêëàìèäà (24 ÷). Ñóòî÷íàÿ äëèòåëüíîñòü äåéñòâèÿ ñàìîãî àêòèâíîãî ïðåïàðàòà èç ãðóïïû ÏÑÌ ÿâëÿåòñÿ íåäîñòàòêîì, ïîñêîëüêó ñîçäàåò óãðîçó äëèòåëüíûõ è òÿæåëûõ ãèïîãëèêåìèé
    Exact
    [4, 24]
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    . Ãëèáåíêëàìèä ïî÷òè ïîëíîñòüþ ìåòàáîëèçèðóåòñÿ â ïå÷åíè èçîôåðìåíòîì CYP2C9 (CYP3A4 ñòåíêè êèøêè èãðàåò âñïîìîãàòåëüíóþ ðîëü) ñ îáðàçîâàíèåì íåàêòèâíûõ ìåòàáîëèòî⠗ 4-òðàíñ-ãèäðîêñè-ãëèÐèñ. 1.Ñðàâíåíèå ôàðìàêîêèíåòè÷åñêèõ êðèâûõ ìèêðîíèçèðîâàííîé è íåìèêðîíèçèðîâàííîé ôîðì ãëèáóðèäà [22] áåíêëàìèäà (Ì1) è 3-öèñ-ãèäðîêñè-ãëèáåíêëàìèäà (M2), êîòîðûå ýêñêðåòèðóþòñÿ ïî÷êàìè è ïå÷åíüþ ïðèìåðíî ïîðîâí

25
Gorodetsky VV, Gorodetskaya GI, Shikh EV, Zhukovskaya AV. Can we cause a drug induction of izoenzymes of cytochrome P450, metabolizing sulfonylureas in patients with type 2 diabetes mellitus with polymorphism of genes, encoding these izoensymes? Medicines and rational pharmacotherapy 2013; (2): 20–6 (in Russian). Available from: http:// macff.ru/images/arhiv/2013-2.pdf.
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    ïî÷òè ïîëíîñòüþ ìåòàáîëèçèðóåòñÿ â ïå÷åíè èçîôåðìåíòîì CYP2C9 (CYP3A4 ñòåíêè êèøêè èãðàåò âñïîìîãàòåëüíóþ ðîëü) ñ îáðàçîâàíèåì íåàêòèâíûõ ìåòàáîëèòî⠗ 4-òðàíñ-ãèäðîêñè-ãëèÐèñ. 1.Ñðàâíåíèå ôàðìàêîêèíåòè÷åñêèõ êðèâûõ ìèêðîíèçèðîâàííîé è íåìèêðîíèçèðîâàííîé ôîðì ãëèáóðèäà [22] áåíêëàìèäà (Ì1) è 3-öèñ-ãèäðîêñè-ãëèáåíêëàìèäà (M2), êîòîðûå ýêñêðåòèðóþòñÿ ïî÷êàìè è ïå÷åíüþ ïðèìåðíî ïîðîâíó
    Exact
    [25]
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    . Àêòèâíîñòü CYP2C9 çàâèñèò îò ðÿäà ýíäîãåííûõ è ýêçîãåííûõ ôàêòîðîâ. Ãåí, êîäèðóþùèé ýòîò èçîôåðìåíò, îáëàäàåò ãåíåòè÷åñêèì ïîëèìîðôèçìîì. Ëó÷øå âñåãî èçó÷åíû îäíîíóêëåîòèäíûå ïîëèìîðôèçìû — «ìåäëåííûå »àëëåëüíûå âàðèàíòû CYP2C9*2 è CYP2C9*3, èõ íîñèòåëüñòâî àññîöèèðîâàíî ñ ïîâûøåííûì ðèñêîì ðàçâèòèÿ ãèïîãëèêåìèè [26].

26
Surendiran A, Pradhan SC, Agraval A, Subrahmanyam DK, Rajan S, Anichavezhi D, et al. Influence of CYP2C9 gene polymorphism on response to glibenclamide in type 2 diabetes mellitus patients. Eur J Clin Pharmacol. 2011; 67(8): 797–801.
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    Ãåí, êîäèðóþùèé ýòîò èçîôåðìåíò, îáëàäàåò ãåíåòè÷åñêèì ïîëèìîðôèçìîì. Ëó÷øå âñåãî èçó÷åíû îäíîíóêëåîòèäíûå ïîëèìîðôèçìû — «ìåäëåííûå »àëëåëüíûå âàðèàíòû CYP2C9*2 è CYP2C9*3, èõ íîñèòåëüñòâî àññîöèèðîâàíî ñ ïîâûøåííûì ðèñêîì ðàçâèòèÿ ãèïîãëèêåìèè
    Exact
    [26]
    Suffix
    . CYP2C9 ó÷àñòâóåò â áèîòðàíñôîðìàöèè ìíîãèõ ËÑ, âêëþ÷àÿ ÏÑÌ, íåñòåðîèäíûå ïðîòèâîâîñïàëèòåëüíûå ïðåïàðàòû, â òîì ÷èñëå ñåëåêòèâíûå èíãèáèòîðû ÖÎÃ-2, ôåíèòîèí, íåïðÿìûå àíòèêîàãóëÿíòû (âàðôàðèí, àöåíîêóìàðîë).

27
Rudakova IP, Ilyina IG, Skachilova SYa, Melentieva TA, Mikhalev OV, Samylina IA. Polymorphism and properties of drugs. Pharmacy 2009; (8): 42–4 (in Russian).
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    Êîíêóðèðóÿ çà áåëêè êðîâè, ñóëüôàíèëàìèäû1äëèòåëüíîãî äåéñòâèÿ, ïðîèçâîäíûå ñàëèöèëîâîé êèñëîòû, ôèáðàòû òàêæå ïîâûøàþò ïëàçìåííóþ êîíöåíòðàöèþ ÏÑÌ. Èíäóêòîðû ñîîòâåòñòâóþùèõ èçîôåðìåíòîâ CYP450, íàïðèìåð, ðèôàìïèöèí, áàðáèòóðàòû ñïîñîáñòâóþò ñíèæåíèþ ïëàçìåííîé êîíöåíòðàöèè ñîîòâåòñòâóþùèõ ÏÑÌ è èõ ãèïîãëèêåìèçèðóþùåé àêòèâíîñòè
    Exact
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    . ÍÅÆÅËÀÒÅËÜÍÛÅ ÐÅÀÊÖÈÈ, ÂÛÇÛÂÀÅÌÛÅ ÃËÈÁÅÍÊËÀÌÈÄÎÌ Ïðè ïðèìåíåíèè ãëèáåíêëàìèäà, êàê è ëþáîãî äðóãîãî ÏÑÌ, èìååòñÿ áîëüøèé èëè ìåíüøèé ðèñê âîçíèêíîâåíèÿ ãèïîãëèêåìèè, ÷òî ñâÿçàíî ñ ãëþêîçîíåçàâèñèìûì äåéñòâèåì ïðåïàðàòà.

28
Zilov AV, Morgunova TB, Terekhova AL. The frequency of hypoglycemia and cardiovascular disorders in patients treated with sulfonylureas compared with other secretagogues: a systematic review. Diabetes Mellitus 2010; (2): 85–90 (in Russian).
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     2010 ãîäó â ñèñòåìàòè÷åñêîì îáçîðå îöåíèâàëèñü íåæåëàòåëüíûå ðåàêöè ãëèáåíêëàìèäà.  òðåõ èç 11 èññëåäîâàíèé îòìå÷àëîñü ïîâûøåíèå ÷àñòîòû ãèïîãëèêåìèé ó ïàöèåíòîâ, ïîëó÷àâøèõ ìîíîòåðàïèþ íåìèêðîíèçèðîâàííûì ãëèáåíêëàìèäîì
    Exact
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    .  ðàíäîìèçèðîâàííîì ñðàâíèòåëüíîì èññëåäîâàíèè ñ ïðèìåíåíèåì äâîéíîãî ñëåïîãî ìåòîäà êîíòðîëÿ Òàáëèöà 2 ÏÅÐÅ×ÅÍÜ ÍÅÆÅËÀÒÅËÜÍÛÕ ÐÅÀÊÖÈÉ, ÂÛÇÛÂÀÅÌÛÕ ÏÐÅÏÀÐÀÒÀÌÈ ÑÓËÜÔÎÍÈËÌÎ×ÅÂÈÍÛ [4] ×àñòûåÐåäêèå Ìåòàáîëè÷åñêèå: – ãèïîãëèêåìèÿ – ïîâûøåíèå ìàññû òåëà Æåëóäî÷íî-êèøå÷íûå íàðóøåíèÿ: – ïîòåðÿ àïïåòèòà – îòðûæêà – èçæîãà – òîøíîòà è èçðåäêà ðâîòà – îùóùåíèå òÿæåñòè â ýïèãàñòðèè – ìåòåîðèçì – àáäî

29
Carlson RF, Isley WL, Ogrinc FG, Klobucar TR. Efficacy and safety of reformulated, micronized glyburide tablets in patients with non-insulin-dependent diabetes mellitus: a multicenter, double-blind, randomized trial. Clin Ther. 1993; 15(5): 788–96.
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    Ïðè ïðèìåíåíèè îáû÷íîãî ãëèáåíêëàìèäà â äîçå 5 ìã AUCîêàçàëàñü áîëüøå (746 ìêã·÷/ë). Êîíå÷íûìè òî÷êàìè èññëåäîâàíèÿ ÿâëÿëèñü ñòåïåíü êîìïåíñàöèè (â ãðóïïàõ íå ðàçëè÷àëàñü) è óðîâåíü HbA1c (7,5 % ïðè ïðèåìå îáû÷íîé ôîðìû, 7,4 % ïðè èñïîëüçîâàíèè ìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà)
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    . Äëÿ íåìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà 5 ìã ðåêîìåíäîâàí ïðèåì ïðåïàðàòà â çàâèñèìîñòè îò âîçðàñòà, òÿæåñòè òå÷åíèÿ äèàáåòà, êîíöåíòðàöèè ãëþêîçû â êðîâè (íàòîùàê è ÷åðåç 2 ÷ ïîñëå åäû). Íà÷àëüíàÿ äîçà ñîñòàâëÿåò 0,5–1 òàáëåòêà (2,5–5 ìã) îäèí ðàç â ñóòêè.

30
State register of medicines. Available from: https://grls.rosminzdrav.ru (in Russian).
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    êîæíàÿ) Ãåïàòîòîêñè÷åñêèå ýôôåêòû: – òðàíçèòîðíîå ïîâûøåíèå – àêòèâíîñòè ïå÷åíî÷íûõ ôåðìåíòî⠖ ãåïàòèò – âíóòðèïå÷åíî÷íûé õîëåñòàç (õîëåñòàòè÷åñêàÿ æåëòóõà) – ïå÷åíî÷íàÿ íåäîñòàòî÷íîñòü 1Ïëþñ êîíêóðåíòíîå ïîäàâëåíèå ôåðìåíòàòèâíîãî ðàñùåïëåíèÿ ÏÑÌ â ïå÷åíè è ïðÿìàÿ ñòèìóëÿöèÿ ñåêðåòîðíîé àêòèâíîñòè áåòà-êëåòîê ïîäæåëóäî÷íîé æåëåçû. Òàáëèöà 3 ÇÀÐÅÃÈÑÒÐÈÐÎÂÀÍÍÛÅ Â ÐÎÑÑÈÈ ÏÐÅÏÀÐÀÒÛ ÃËÈÁÅÍÊËÀÌÈÄÀ
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    Òîðãîâîå íàèìåíîâàíèå ïðåïàðàòà, ïðîèçâîäèòåëü Ñîñòàâ îäíîé òàáëåòêè Äåéñòâóþùåå âåùåñòâî, ìã Âñïîìîãàòåëüíûå âåùåñòâà, ìã ÌÀÍÈÍÈË Áåðëèí-Õåìè/ À. Ìåíàðèíè ãëèáåíêëàìèä — 5,000 Ëàêòîçû ìîíîãèäðàò — 90,000; êðàõìàë êàðòîôåëüíûé — 48,697; ìàãíèÿ ñòåàðàò — 1,500; òàëüê — 2,250; æåëàòèí — 2,550; êðàñèòåëü ïóíöîâûé [Ïîíñî 4R] (Å 124) — 0,003 ÌÀÍÈÍÈË Áåðëèí-Õåìè/ À.

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    Îáû÷íî â 2 ïðèåìà — óòðîì è âå÷åðîì, â ðåäêèõ ñëó÷àÿõ — 3 ðàçà â ñóòêè â çàâèñèìîñòè îò ñîñòîÿíèÿ óãëåâîäíîãî îáìåíà è ðàíåå ïðîâîäèìîé òåðàïèè, ñ ïîñëåäóþùèì åæåíåäåëüíûì òèòðîâàíèåì äîçû ïîä êîíòðîëåì ñîñòîÿíèÿ óãëåâîäíîãî îáìåíà. Ìàêñèìàëüíàÿ ñóòî÷íàÿ äîçà — 6 òàáëåòîê ïðåïàðàòà
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    .  2001 ãîäó â Ðîññèè èçó÷àëàñü ýôôåêòèâíîñòü êîìáèíèðîâàííîãî ïðåïàðàòà ãëèáîìåò ñ ôèêñèðîâàííîé äîçèðîâêîé ìåòôîðìèíà 400 ìã è ãëèáåíêëàìèäà 2,5 ìã â îäíîé òàáëåòêå. Èññëåäîâàíèå äëèëîñü 3 ìåñÿöà, âêëþ÷àëî 200 èñïûòóåìûõ, èññëåäîâàòåëè íå çàôèêñèðîâàëè òÿæåëûõ ãèïîãëèêåìèé è ïðèáàâêè ìàññû òåëà ó ïàöèåíòîâ.

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    ÓÐÎÂÍß HbA1c  ÍÀ×ÀËÅ È ÊÎÍÖÅ ÈÑÑËÅÄÎÂÀÍÈß (n= 600 ÷åëîâåê) [32] HbA1c, % Äî èññëåäîâàíèÿ, % Ïîñëå èññëåäîâàíèÿ, % <7,51020 7,5–9,02065 >9,07015 Ðèñ. 2.Ñðàâíåíèå ôàðìàêîêèíåòè÷åñêèõ êðèâûõ íåìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà â ñâîáîäíîé ìèêðîíèçèðîâàííîé ôîðìå è ôèêñèðîâàííîé êîìáèíàöèè (ãëþêîâàíñ) ñ ìåòôîðìèíîì [33] Òàáëèöà 5 ÇÀÐÅÃÈÑÒÐÈÐÎÂÀÍÍÛÅ Â ÐÎÑÑÈÈ ÊÎÌÁÈÍÈÐÎÂÀÍÍÛÅ ÏÐÅÏÀÐÀÒÛ ÃËÈÁÅÍÊËÀÌÈÄÀ
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    Òîðãîâîå íàèìåíîâàíèå ïðåïàðàòà, ïðîèçâîäèòåëü Ñîñòàâ îäíîé òàáëåòêè Äåéñòâóþùåå âåùåñòâî, ìã Âñïîìîãàòåëüíûå âåùåñòâà, ìã ÌÅÒÃËÈÁ (ÇÀÎ «Êàíîíôàðìà ïðîäàêøí», Ðîññèÿ) ìåòôîðìèíà ãèäðîõëîðèä — 400; ãëèáåíêëàìèä — 2,5 êàëüöèÿ ãèäðîôîñôàòà äèãèäðàò — 44; êðàõìàë êóêóðóçíûé — 39; êðîñêàðìåëëîçà íàòðèÿ — 12; ìàêðîãîë (ïîëèýòèëåíãëèêîëü 6000) — 12; íàòðèÿ ñòåàðèëôóìàðàò — 3; ïîâèäîí — 52; öåëëþëîçà ìèê

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    1-7006 (ãîòîâàÿ ñìåñü äëÿ îáîëî÷êè, ñîñòîÿùàÿ èç ãèäðîêñèïðîïèëìåòèëöåëëþëîçû (ãèïðîìåëëîçû) è ïîëèýòèëåíãëèêîëÿ (ìàêðîãîëà) â ñîîòíîøåíèè 90:10); íàòðèÿ ñàõàðèíàò; âàíèëèí ðûå âûâîäÿòñÿ ïî÷êàìè (40 %) è ñ æåë÷üþ (60 %). Ïåðèîä ïîëóâûâåäåíèÿ — îò 4 äî 11 ÷. Áèîäîñòóïíîñòü ãëþêîâàíñà, ñîãëàñíî èíñòðóêöèè, èäåíòè÷íà ñâîáîäíîé êîìáèíàöèè îáîèõ êîìïîíåíòîâ, à ôàðìàêîêèíåòèêà ìåòôîðìèíà íå èçìåíÿåòñÿ
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    . Ýòî âåðíî ïðè óñëîâèè, ÷òî îòäåëüíî âçÿòûå ïðåïàðàòû ïðèíèìàþòñÿ âìåñòå ïåðåä åäîé, à ìèêðîíèçàöèÿ ãëèáåíêëàìèäà â ïðåïàðàòå ñðàâíåíèÿ ñîïîñòàâèìà ïî ïðîöåíòíîìó ðàñïðåäåëåíèþ ìèêðî÷àñòèö îïðåäåëåííûõ ðàçìåðîâ ñ ìèêðîíèçàöèåé ãëèáåíêëàìèäà â ãëþêîâàíñå.

31
Antsiferov MB, Mayorov AYu. Use of combined oral glucose reducing drug Glibomet in the treatment of patients with type 2 diabetes mellitus. Moscow: Berlin-Chemie/Menarini Group; 2001 (in Russian).
Total in-text references: 1
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    Èññëåäîâàíèå äëèëîñü 3 ìåñÿöà, âêëþ÷àëî 200 èñïûòóåìûõ, èññëåäîâàòåëè íå çàôèêñèðîâàëè òÿæåëûõ ãèïîãëèêåìèé è ïðèáàâêè ìàññû òåëà ó ïàöèåíòîâ. Àíàëîãè÷íûå äàííûå ïîëó÷èëè â èññëåäîâàíèè ñ ó÷àñòèåì 600 ïàöèåíòîâ
    Exact
    [31, 32]
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    . Ïðèìåðîì ôèêñèðîâàííîé êîìáèíàöèè, ñîäåðæàùåé ãëèáåíêëàìèä (2,5 ìã èëè 5 ìã) è ìåòôîðìèí (500 ìã), ÿâëÿåòñÿ ãëþêîâàíñ. Ãëèáåíêëàìèä ïðåäñòàâëåí â âèäå ìèêðîíèçèðîâàííîé ôîðìû, ïèê êîíöåíòðàöèè ãëèáåíêëàìèäà â ïëàçìå íàñòóïàåò ðàíüøå, ÷åì ïðè èñïîëüçîâàíèè àíàëîãè÷íîé êîìáèíàöèè ñ íåìèêðîíèçèðîâàííîé ôîðìîé, ÷òî ïîçâîëÿåò ïðèíèìàòü ïðåïàðàò âìåñòå ñ åäîé.

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Ametov AS. Diabetes mellitus type 2. Problems and solutions. Moscow: GEOTAR-Media; 2012 (in Russian).
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    Èññëåäîâàíèå äëèëîñü 3 ìåñÿöà, âêëþ÷àëî 200 èñïûòóåìûõ, èññëåäîâàòåëè íå çàôèêñèðîâàëè òÿæåëûõ ãèïîãëèêåìèé è ïðèáàâêè ìàññû òåëà ó ïàöèåíòîâ. Àíàëîãè÷íûå äàííûå ïîëó÷èëè â èññëåäîâàíèè ñ ó÷àñòèåì 600 ïàöèåíòîâ
    Exact
    [31, 32]
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    . Ïðèìåðîì ôèêñèðîâàííîé êîìáèíàöèè, ñîäåðæàùåé ãëèáåíêëàìèä (2,5 ìã èëè 5 ìã) è ìåòôîðìèí (500 ìã), ÿâëÿåòñÿ ãëþêîâàíñ. Ãëèáåíêëàìèä ïðåäñòàâëåí â âèäå ìèêðîíèçèðîâàííîé ôîðìû, ïèê êîíöåíòðàöèè ãëèáåíêëàìèäà â ïëàçìå íàñòóïàåò ðàíüøå, ÷åì ïðè èñïîëüçîâàíèè àíàëîãè÷íîé êîìáèíàöèè ñ íåìèêðîíèçèðîâàííîé ôîðìîé, ÷òî ïîçâîëÿåò ïðèíèìàòü ïðåïàðàò âìåñòå ñ åäîé.

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    Ñâÿçü ñ áåëêàìè ïëàçìû ñîñòàâëÿåò 99 %. Ìåòàáîëèçèðóåòñÿ â ïå÷åíè ñ îáðàçîâàíèåì äâóõ íåàêòèâíûõ ìåòàáîëèòîâ, êîòîÒàáëèöà 4 ÄÈÍÀÌÈÊÀ ÐÀÑÏÐÅÄÅËÅÍÈß ÏÀÖÈÅÍÒΠ ÇÀÂÈÑÈÌÎÑÒÈ ÎÒ ÓÐÎÂÍß HbA1c  ÍÀ×ÀËÅ È ÊÎÍÖÅ ÈÑÑËÅÄÎÂÀÍÈß (n= 600 ÷åëîâåê)
    Exact
    [32]
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    HbA1c, % Äî èññëåäîâàíèÿ, % Ïîñëå èññëåäîâàíèÿ, % <7,51020 7,5–9,02065 >9,07015 Ðèñ. 2.Ñðàâíåíèå ôàðìàêîêèíåòè÷åñêèõ êðèâûõ íåìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà â ñâîáîäíîé ìèêðîíèçèðîâàííîé ôîðìå è ôèêñèðîâàííîé êîìáèíàöèè (ãëþêîâàíñ) ñ ìåòôîðìèíîì [33] Òàáëèöà 5 ÇÀÐÅÃÈÑÒÐÈÐÎÂÀÍÍÛÅ Â ÐÎÑÑÈÈ ÊÎÌÁÈÍÈÐÎÂÀÍÍÛÅ ÏÐÅÏÀÐÀÒÛ ÃËÈÁÅÍÊËÀÌÈÄÀ [30] Òîðãîâîå íàèìåíîâàíèå ïðåïàðàòà, ïðîèçâîäèòåëü Ñîñòàâ îäíîé òà

33
Donahue SR, Turner KC, Patel S. Pharmacokinetics and pharmacodynamics of glyburide/metformin tablets (Glucovance) versus equivalent doses of glyburide and metformin in patients with type 2 diabetes. Clin Pharmacokinet. 2002; 41(15): 1301–9.
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    ìåòàáîëèòîâ, êîòîÒàáëèöà 4 ÄÈÍÀÌÈÊÀ ÐÀÑÏÐÅÄÅËÅÍÈß ÏÀÖÈÅÍÒΠ ÇÀÂÈÑÈÌÎÑÒÈ ÎÒ ÓÐÎÂÍß HbA1c  ÍÀ×ÀËÅ È ÊÎÍÖÅ ÈÑÑËÅÄÎÂÀÍÈß (n= 600 ÷åëîâåê) [32] HbA1c, % Äî èññëåäîâàíèÿ, % Ïîñëå èññëåäîâàíèÿ, % <7,51020 7,5–9,02065 >9,07015 Ðèñ. 2.Ñðàâíåíèå ôàðìàêîêèíåòè÷åñêèõ êðèâûõ íåìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà â ñâîáîäíîé ìèêðîíèçèðîâàííîé ôîðìå è ôèêñèðîâàííîé êîìáèíàöèè (ãëþêîâàíñ) ñ ìåòôîðìèíîì
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    Òàáëèöà 5 ÇÀÐÅÃÈÑÒÐÈÐÎÂÀÍÍÛÅ Â ÐÎÑÑÈÈ ÊÎÌÁÈÍÈÐÎÂÀÍÍÛÅ ÏÐÅÏÀÐÀÒÛ ÃËÈÁÅÍÊËÀÌÈÄÀ [30] Òîðãîâîå íàèìåíîâàíèå ïðåïàðàòà, ïðîèçâîäèòåëü Ñîñòàâ îäíîé òàáëåòêè Äåéñòâóþùåå âåùåñòâî, ìã Âñïîìîãàòåëüíûå âåùåñòâà, ìã ÌÅÒÃËÈÁ (ÇÀÎ «Êàíîíôàðìà ïðîäàêøí», Ðîññèÿ) ìåòôîðìèíà ãèäðîõëîðèä — 400; ãëèáåíêëàìèä — 2,5 êàëüöèÿ ãèäðîôîñôàòà äèãèäðàò — 44; êðàõìàë êóêóðóçíûé — 39; êðîñêàðìåëëîçà íàòðèÿ — 12; ìàêðîãîë (ï

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    R. et al., 2002)AUC ãëþêîâàíñà óâåëè÷èëàñü â 2 ðàçà äî 3 ÷ äíÿ [p< 0,001], õîòÿ âåëè÷èíàAUCâ òå÷åíèå èíòåðâàëà ââåäåíèÿ áûëà ýêâèâàëåíòíà äëÿ îáåèõ êîìïîçèöèé. Áûë ñäåëàí âûâîä î íåýêâèâàëåíòíîñòè ðàâíûõ äîç ãëèáåíêëàìèäà â ñâîáîäíîé êîìáèíàöèè ñ ìåòôîðìèíîìèâìèêðîíèçèðîâàííîé ôîðìå â ôèêñèðîâàííîé êîìáèíàöèè â ïðåïàðàòå ãëþêîâàíñ
    Exact
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    . Ïðè îäíîâðåìåííîì ïðèåìå ñ ïèùåé àáñîðáöèÿ ìåòôîðìèíà ñíèæàåòñÿ è çàäåðæèâàåòñÿ, ÷òî ïîçâîëÿåò óìåíüøèòü åãî íåáëàãîïðèÿòíîå âëèÿíèå íà ÆÊÒ. Â òàáëåòêå ãëþêîâàíñà ìåòôîðìèí óñèëèâàåò àáñîðáöèþ ãëèáåíêëàìèäà.

34
Nikonova TB. Modern algorithm for the treatment of type 2 diabetes mellitus. To whom and how to prescribe combined hypoglycemic preparations. Consilium medicum 2008; 10(9): 25–9 (in Russian).
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    Ó ïàöèåíòîâ ñ HbA1ñ, ïðåâûøàþùèì 8 %, ãëþêîâàíñ ïðè ìåíüøèõ äîçèðîâêàõ ñíèæàë HbA1ñ íà 3,2 %, â òî âðåìÿ êàê íåìèêðîíèçèðîâàííûé ãëèáåíêëàìèä â êîìáèíàöèè ñ ìåòôîðìèíîì — íà 1,9 %. Ó ïàöèåíòîâ ñ HbA1ñ ìåíåå 8 % ÷àùå èìåëè ìåñòî ãèïîãëèêåìèè
    Exact
    [34]
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    . Ìàêñèìàëüíàÿ ñóòî÷íàÿ äîçà ãëþêîâàíñà ñîñòàâëÿåò 15–20 ìã, ïðåäïî÷òèòåëåí ïðèåì âî âðåìÿ çàâòðàêà è â óæèí (äëÿ ñíèæåíèÿ ðèñêà íî÷íîé ãèïîãëèêåìèè ñóòî÷íóþ äîçó äåëÿò â ñîîòíîøåíèè 2:1). Ãëþêîâàíñ ÿâëÿåòñÿ ñàìûì àêòèâíûì ïðåïàðàòîì ãëèáåíêëàìèäà.

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Eadala P, Waud JP, Matthews SB, Green JT, Campell AK. Quantifying the «hidden» lactose in drugs used for the treatment of gastrointestinal conditions. Aliment Pharmacol Ther. 2009; 29(6): 677–87.
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    Ïðåïàðàòû ãëèáåíêëàìèäà ñîäåðæàò ëàêòîçó, ïîýòîìó èõ ïðèìåíåíèå íå ðåêîìåíäîâàíî ïàöèåíòàì ñ ðåäêèìè íàñëåäñòâåííûìè çàáîëåâàíèÿìè, ñâÿçàííûìè ñ íåïåðåíîñèìîñòüþ ãàëàêòîçû, äåôèöèòîì ëàêòàçû èëè ñèíäðîìîì ãëþêîçî-ãàëàêòîçíîé ìàëüàáñîðáöèè. Ïðèñóòñòâèå ëàêòîçû â òàáëåòêå ìîæåò áûòü çíà÷èìî äëÿ àáñîðáöèè è íîñèò äîçîçàâèñèìûé õàðàêòåð
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    . Ïðåïàðàòû íåìèêðîíèçèðîâàííîãî ãëèáåíêëàìèäà, âûïóñêàåìûå ðàçíûìè ïðîèçâîäèòåëÿìè, ñîäåðæàò ëàêòîçó â ðàçíûõ êîëè÷åñòâàõ.  òàáëåòêè ãëèáåíêëàìèäà äîáàâëÿþòñÿ äåçèíòåãðàíòû äëÿ îáëåã÷åíèÿ ðàñòâîðåíèÿ (êðàõìàë, ïîâèäîí, íàòðèÿ êðàõìàë ãëèêîëÿò).

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Trofimov SV. High molecular cellulose esters. Mechanism of action in sustained release matrix tablets. Dissolution profile of active drug depending on molecular weight and hydrophilic properties of polymers. Pharmacy & Pharmacology 2015; 3(5): 18–25 (in Russian).
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    Âçÿòûå â ýêâèâàëåíòíûõ êîëè÷åñòâàõ, îíè äàþò ðàçíûå ðåçóëüòàòû ïî ñêîðîñòè âûñâîáîæäåíèÿ àêòèâíîé ñóáñòàíöèè. Ýòî çàâèñèò îò ìîëåêóëÿðíîé ìàññû, ãèäðîôèëüíîñòè, ñïîñîáíîñòè ê íàáóõàíèþ. Îáðàçîâàíèå ãåëÿ íà îïðåäåëåííîì ýòàïå ïðåïÿòñòâóåò ðàñòâîðåíèþ
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    [36]
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    . Ïðè ïðîèçâîäñòâå â ñîñòàâ ââîäÿò ëóáðèêàíòû äëÿ óìåíüøåíèÿ ñèëû òðåíèÿ, âîçíèêàþùåé âñëåäñòâèå êîíòàêòà ðàáî÷èõ ÷àñòåé ìàøèíû ñ òàáëåòî÷íîé ìàññîé. Òàê, ïðåïàðàòû ãëèáåíêëàìèäà ìîãóò ñîäåðæàòü ìàãíèÿ ñòåàðàò, êðåìíèÿ äèîêñèä êîëëîèäíûé.

37
Mogilyuk V. Lubricants for solid dosage forms: Compritol 888 ATO and Precirol ATO 5. Pharmaceutical industry 2010; (6): 60–3 (in Russian).
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    Òàê, ïðåïàðàòû ãëèáåíêëàìèäà ìîãóò ñîäåðæàòü ìàãíèÿ ñòåàðàò, êðåìíèÿ äèîêñèä êîëëîèäíûé. Ëóáðèêàíòû ìîãóò âëèÿòü íà êèíåòèêó âûñâîáîæäåíèÿ äåéñòâóþùåãî âåùåñòâà èç òàáëåòêè, à òàêæå íà âðåìÿ äåçèíòåãðàöèè òàáëåòêè, åå ïðî÷íîñòü
    Exact
    [37]
    Suffix
    . Ïðàâèëà íàäëåæàùåé äèñòðèáüþòîðñêîé ïðàêòèêè (Good Distribution Practice, GDP)íàïðàâëåíû íà îáåñïå÷åíèå ñîõðàíåíèÿ êà÷åñòâà ëåêàðñòâåííûõ ïðåïàðàòîâ, â òîì ÷èñëå ãëèáåíêëàìèäà, ïðè åãî äâèæåíèè îò ïðîèçâîäèòåëÿ äî ïîòðåáèòåëÿ.

38
Suleiman MS, Najib NM. Isolation and physicochemical characterization of solid forms of glibenclamide. Int J Pharm.1989; 50(2): 103–9.
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    Prefix
    Ðàñòâîðèìîñòü ãëèáåíêëàìèäà ñíèæàåòñÿ ñ óâåëè÷åíèåì òåìïåðàòóðû, è, ñîãëàñíî ýêñïåðèìåíòàëüíûì èññëåäîâàíèÿì, ïðè 37 °Ñ ðàñòâîðèìîñòü ãëèáåíêëàìèäà ïðèìåðíî â 4,7 ðàç íèæå åãî ðàñòâîðèìîñòè ïðè 25 °Ñ
    Exact
    [38, 39]
    Suffix
    . Ìèêðîíèçèðîâàííûé ãëèáåíêëàìèä ìåíåå ñòàáèëåí, ÷åì íåìèêðîíèçèðîâàííûé, ìîæåò ñëåæèâàòüñÿ [40]. Ñòàíäàðò GCP (Good Clinical Practice, íàäëåæàùàÿ êëèíè÷åñêàÿ ïðàêòèêà)— ìåæäóíàðîäíûé ñòàíäàðò ýòè÷åñêèõ íîðì è êà÷åñòâà íàó÷íûõ èññëåäîâàíèé, êîòîðûå ïîäðàçóìåâàþò ó÷àñòèå ÷åëîâåêà â êà÷åñòâå èñïûòóåìîãî (êëèíè÷åñêèå èññëåäîâàíèÿ).

39
Yalkowsky SH, He Y. Handbook of aqueous solubility data. New York: CRC Press; 2003.
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    Prefix
    Ðàñòâîðèìîñòü ãëèáåíêëàìèäà ñíèæàåòñÿ ñ óâåëè÷åíèåì òåìïåðàòóðû, è, ñîãëàñíî ýêñïåðèìåíòàëüíûì èññëåäîâàíèÿì, ïðè 37 °Ñ ðàñòâîðèìîñòü ãëèáåíêëàìèäà ïðèìåðíî â 4,7 ðàç íèæå åãî ðàñòâîðèìîñòè ïðè 25 °Ñ
    Exact
    [38, 39]
    Suffix
    . Ìèêðîíèçèðîâàííûé ãëèáåíêëàìèä ìåíåå ñòàáèëåí, ÷åì íåìèêðîíèçèðîâàííûé, ìîæåò ñëåæèâàòüñÿ [40]. Ñòàíäàðò GCP (Good Clinical Practice, íàäëåæàùàÿ êëèíè÷åñêàÿ ïðàêòèêà)— ìåæäóíàðîäíûé ñòàíäàðò ýòè÷åñêèõ íîðì è êà÷åñòâà íàó÷íûõ èññëåäîâàíèé, êîòîðûå ïîäðàçóìåâàþò ó÷àñòèå ÷åëîâåêà â êà÷åñòâå èñïûòóåìîãî (êëèíè÷åñêèå èññëåäîâàíèÿ).

40
Trofimov SV, Stepanova EF. Medicinal forms of glibenclamide: modern technologies for an actual problems’ solution. Development and registration of medicines 2014; (7): 64–7 (in Russian).
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    Ðàñòâîðèìîñòü ãëèáåíêëàìèäà ñíèæàåòñÿ ñ óâåëè÷åíèåì òåìïåðàòóðû, è, ñîãëàñíî ýêñïåðèìåíòàëüíûì èññëåäîâàíèÿì, ïðè 37 °Ñ ðàñòâîðèìîñòü ãëèáåíêëàìèäà ïðèìåðíî â 4,7 ðàç íèæå åãî ðàñòâîðèìîñòè ïðè 25 °Ñ [38, 39]. Ìèêðîíèçèðîâàííûé ãëèáåíêëàìèä ìåíåå ñòàáèëåí, ÷åì íåìèêðîíèçèðîâàííûé, ìîæåò ñëåæèâàòüñÿ
    Exact
    [40]
    Suffix
    . Ñòàíäàðò GCP (Good Clinical Practice, íàäëåæàùàÿ êëèíè÷åñêàÿ ïðàêòèêà)— ìåæäóíàðîäíûé ñòàíäàðò ýòè÷åñêèõ íîðì è êà÷åñòâà íàó÷íûõ èññëåäîâàíèé, êîòîðûå ïîäðàçóìåâàþò ó÷àñòèå ÷åëîâåêà â êà÷åñòâå èñïûòóåìîãî (êëèíè÷åñêèå èññëåäîâàíèÿ).

41
ApprovedDrug Products with Therapeutic Equivalence Evaluations. 37th edition. 2017. Available from: https:// goo.gl/LAUEC2.
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    Áèîýêâèâàëåíòíîñòü ïðåïàðàòîâ ãëèáåíêëàìèäà Ãëèáåíêëàìèä (â ÑØÀ — ãëèáóðèä) âõîäèò â «Îðàíæåâóþ êíèãó »ëåêàðñòâåííûõ ïðåïàðàòîâ, äëÿ êîòîðûõ õàðàêòåðíî íàëè÷èå òåîðåòè÷åñêèõ èëè äîêàçàííûõ â êëèíè÷åñêèõ èññëåäîâàíèÿõ ïðîáëåì áèîýêâèâàëåíòíîñòè. Ðåêîìåíäóåìûå ïðåäåëû äîâåðèòåëüíîãî èíòåðâàëà 80–125 %
    Exact
    [41]
    Suffix
    .  íàñòîÿùåå âðåìÿ íà îòå÷åñòâåííîì ðûíêå ëåêàðñòâåííûõ ñðåäñòâ ïðåäñòàâëåíû ÷åòûðå ãðóïïû ïðåïàðàòîâ ãëèáåíêëàìèäà. 1. Äëÿ íåìèêðîíèçèðîâàííîé ôîðìû ãëèáåíêëàìèäà êðèòè÷åñêè çíà÷èìîé ÿâëÿåòñÿ àáñîðáöèÿ, êîòîðàÿ âëèÿåò íà âðåìÿ ïðèåìà ïðåïàðàòà ïî îòíîøåíèþ ê âðåìåíè ïðèåìà ïèùè è ñëóæèò ïðè÷èíîé ñëîæíîñòè ïîäòâåðæäåíèÿ áèîýêâèâàëåíòíîñòè â ýòîé ãðóïïå.

42
Romanov BK, Sakaeva IV, Bunyatyan ND, Vasiliev AN, Bondarev VP, Prokofiev AB, et al. The algorithm of evaluation of interchangeability of pharmaceuticals. Medical Journal of the Russian Federation 2015; (5): 43–6 (in Russian).
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    Äëÿ ãëèáåíêëàìèäà äîñòîâåðíî áîëüøèé óäåëüíûé âåñ (p< 0,05) áûë ó âàðèàíòà çàìåí, êîãäà òîëüêî îäèí èç âîñïðîèçâåäåííûõ ëåêàðñòâåííûõ ïðåïàðàòîâ ïðèâîäèë ê íåæåëàòåëüíûì ðåàêöèÿì (ãåïàòîòîêñè÷íîñòü) â 90,0 % ñëó÷àåâ. Èññëåäîâàíèå ïîäòâåðäèëî âîçìîæíîñòü ïðèìåíåíèÿ âîñïðîèçâåäåííûõ ïðåïàðàòîâ äëÿ áîëüøèíñòâà çàðåãèñòðèðîâàííûõ ïðåïàðàòîâ ãëèáåíêëàìèäà â Ðîññèè
    Exact
    [42]
    Suffix
    . Íà ïðàêòèêå î ãèïîãëèêåìèè, íå òðåáóþùåé ãîñïèòàëèçàöèè, îáû÷íî â îðãàíû ôàðìàêîíàäçîðà íå ñîîáùàþò. Ñíèæåíèå ðèñêîâ ïðîèñõîäèò ïóòåì ðàñøèðåíèÿ ïðîòèâîïîêàçàíèé. ÇÀÊËÞ×ÅÍÈÅ Äîñòèæåíèå öåëåâûõ çíà÷åíèé HbA1 îò 6,5 äî 7,5 % ïðè èñïîëüçîâàíèè ãëèáåíêëàìèäà ñîïðÿæåíî ñ ðèñêîì ðàçâèòèÿ ãèïîãëèêåìè÷åñêèõ ñîñòîÿíèé, èìåííî ïîýòîìó âîïðîñ âçàèìîçàìåíÿåìîñòè ñòîèò î÷åíü îñòðî.

43
Bukatina TM, Kazakov AS, Velts NYu, Darmostukova MA, Zatolochina KE, Alyautdin RN, et al. Ketoacidosis as unexpected adverse reaction SGLT2inhibitor. Safety and Risk of Pharmacotherapy 2016; (4): 22–5 (in Russian).
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    ìèîêàðäà â àíàìíåçå, øóíòèðîâàíèå/ñòåíòèðîâàíèå êîðîíàðíûõ àðòåðèé, ïîðàæåíèå îäíîãî èëè íåñêîëüêèõ êîðîíàðíûõ ñîñóäîâ), ñ èøåìè÷åñêèì èëè ãåìîððàãè÷åñêèì èíñóëüòîì â àíàìíåçå, ñ çàáîëåâàíèåì ïåðèôåðè÷åñêèõ àðòåðèé (ñ ñèìïòîìàòèêîé èëè áåç), ñ ñåðäå÷íîé íåäîñòàòî÷íîñòüþ, ñ õðîíè÷åñêîé áîëåçíüþ ïî÷åê (ÑÊÔ < 60 ìë/ìèí/1,73 ì2), ñ îæèðåíèåì. HbA1ñ îò 7,6 äî 9 % ó ïàöèåíòîâ áåç êåòîàöèäîçà
    Exact
    [43]
    Suffix
    è ñîñóäèñòîé ïàòîëîãèè ïðè íåêîòîðîì ñòàæå äèàáåòà â ñîñòàâå êîìáèíèðîâàííîé òåðàïèè — íèøà, çàíèìàåìàÿ ïðåïàðàòàìè, ñîäåðæàùèìè ãëèáåíêëàìèä. Ïðè ïëàíèðîâàíèè êëèíè÷åñêèõ èññëåäîâàíèé öåëåñîîáðàçíî îïðåäåëåíèå ïîëèìîðôèçìà ôåðìåíòà CYP2C9.

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Chuchalin AG, Hohlov AL, eds. Federal guidance on the use of drugs (formulary system). Issue XVIII. Moscow: Vidoks; 2017 (in Russian).
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     èíñòðóêöèè ê ïðåïàðàòàì ãëèáåíêëàìèäà îáÿçàòåëüíî äîëæíî áûòü óêàçàíèå íà òî, ñîäåðæèòñÿ ëè ãëèáåíêëàìèä â ìèêðîíèçèðîâàííîé ôîðìå èëè â íåìèêðîíèçèðîâàííîé. Îáÿçàòåëüíîé ÷àñòüþ êîíòðîëÿ êà÷åñòâà ïðåïàðàòîâ, ñîäåðæàùèõ ãëèáåíêëàìèä, äîëæåí ñòàòü ìîíèòîðèíã íåæåëàòåëüíûõ ðåàêöèé ìåòîäîì àíàëèçà ñïîíòàííûõ ñîîáùåíèé
    Exact
    [44]
    Suffix
    . Òàêèì îáðàçîì, óñòàíîâëåíèå âçàèìîçàìåíÿåìîñòè ïðåïàðàòîâ ãëèáåíêëàìèäà ÿâëÿåòñÿ ñëîæíîé, íî ðåøàåìîé çàäà÷åé [45]. ËÈÒÅÐÀÒÓÐÀ 1. Íàó÷íîå îáîñíîâàíèå, ðàçðàáîòêà è ñîâåðøåíñòâîâàíèå ìåòîäîëîãèè îöåíêè âçàèìîçàìåíÿåìîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ.

45
Scientific substantiation, development and improvement of methodology for assessment of medicinal products interchangeability. Research report (intermediate). FSBI «SCEEMP» of the Ministry of Health of Russia; advisors: Romanov BK, Prokofiev AB, Yagudina RI; prepared by: Alyautdin RN, Zhuravleva MV. Moscow; 2016. 365 p.
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    Îáÿçàòåëüíîé ÷àñòüþ êîíòðîëÿ êà÷åñòâà ïðåïàðàòîâ, ñîäåðæàùèõ ãëèáåíêëàìèä, äîëæåí ñòàòü ìîíèòîðèíã íåæåëàòåëüíûõ ðåàêöèé ìåòîäîì àíàëèçà ñïîíòàííûõ ñîîáùåíèé [44]. Òàêèì îáðàçîì, óñòàíîâëåíèå âçàèìîçàìåíÿåìîñòè ïðåïàðàòîâ ãëèáåíêëàìèäà ÿâëÿåòñÿ ñëîæíîé, íî ðåøàåìîé çàäà÷åé
    Exact
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    . ËÈÒÅÐÀÒÓÐÀ 1. Íàó÷íîå îáîñíîâàíèå, ðàçðàáîòêà è ñîâåðøåíñòâîâàíèå ìåòîäîëîãèè îöåíêè âçàèìîçàìåíÿåìîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ. Îò÷åò î ÍÈÐ (ïðîìåæóòî÷íûé). ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè; ðóê.