#1
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Byetta!!! íàêîíåö-òî.
Íå ìîãó íå ïîäåëèòüñÿ, óâàæàåìûå êîëëåãè, ñâîèì îïûòîì ïðèìåíåíèÿ íîâîãî êëàññà ïðåïàðàòîâ äëÿ DMT2. Åñëè ó êîãî åñòü ñîáñòâåííûå íàáëþäåíèÿ - ïðåäëàãàþ îáñóäèòü. Ïðåïàðàò Byetta, ÿâëÿåòñÿ ïåðâûì èç íîâîãî êëàññà ïðåïàðàòîâ- àãîíèñòîì GIP-1 è ïðåäíàçíà÷àí ëäÿ ëå÷åíèÿ ïàöèåíòîâ â äèàáåòîì âòîðîãî òèïà, êîòîðûå íå äîñòèãëè êîíòðîëÿ íà ìåòôîðìèíå è ñóëüôîíóðåå. Ýòî íàêîíåö-òî ÏÅÐÂÛÉ ÏÐÅÏÀÐÀÒ íà êîòîðîì äèàáåòèêè õóäåþò ñ ãàðàíòèåé (20-30 lb â ãîä). Ïðè ýòîì â îòëè÷èè îò ñêàæåì Àêêîìïëèè ïðîöåññ ïîõóäàíèÿ ïëàâíî ïðîäîëæàåòñÿ íà ïðîòÿæåíèè âñåãî âðåìåíè òåðàïèè. Ïðåïàðàò íå òîëüêî ðåãóëèðóåò ïðàíäèàëüíóþ ñåêðåöèþ èíñóëèíà, íî è äîêàçàíî óâåëèâàåò á-êëåòî÷íóþ ìàññó ïóòåì ïðîëèôåðàöèè è äèôôåðåíöèðîâêè êàìáèàëüíûõ êëåòîê. Ê ñîæàëåíèþ ïîêà ïðåïàðàò äîñòóïåí òîëüêî â èíúåêöèîííîé ôîðìå, õîòÿ òàáëåòèðîâàííûé âàðèàíò áóäåò äîñòóïåí ÷åðåç 2-3 ãîäà (ôàçà 2). Ïîêà ìîðå âîñòîðãîâ. Ïðîáëåìà - ãàñòðîïàðåç, íî íà ïðàêòèêå îêàçûâàåòñÿ, ÷òî ãàñòðîïàðåç íàïðîòèâ óëó÷øàåòñÿ. Ó÷èòûâàÿ ñïîñîáíîñòü ïðåïàðàòà óâåëè÷èâàòü á-êëåòî÷íóþ ìàññó ñåé÷àñ îí èçó÷àåòñÿ ó MDT1.
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#2
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Ê íàì ( ò.å â íàøó ñòðàíó )- ïðåïàðàò ïðèõîäèò íà èñïûòàíèÿ.
Âîîáùå ïóòü ýêçåíàòèäà ( ïîä ýòèì èìåíåì ó ïðåïàðàòà êóäà áîëüøå ññûëîê) áûë íå èç ëåãêèõ, íî â íàñòîÿùåå âðåìÿ óæå äîêëàäû îá ýòîì ïðåïàðàòå áûëè è íà ïëåíàðíîé ëåêöèè â Àôèíàõ, è áûëî íåñêîëüêî ïîñòåðîâ. Âîò óæå ãîä êàê ìû ðàññêàçûâàåì âðà÷àì îá ýòîì ïðåïàðàòå, ïðàâäà,ñêîðåå îá ýêçîòè÷åñêîì èñòî÷íèêå,ïîñëóæèâøåì åãî íàõîäêå. À ñ àêêîìïëèåé óæå äîëæíû íà÷èíàòü ðàáîòàòü ( êëèíè÷åñêèå èñïûòàíèÿ óæå äîëæíû ñòàðòîâàòü).
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Ã.À. Ìåëüíè÷åíêî |
#3
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Ñûëîê 178 - âîò îäíà èç íèõ.....
Glucagon-like peptide-1 as a treatment option for type 2 diabetes and its role in restoring beta-cell mass. Gallwitz B. Department of Medicine IV, Eberhard-Karls-University, Otfried-Muller-Strasse 10, D-72076 Tubingen, Germany. [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] The "incretin effect" describes the enhanced insulin response from orally ingested glucose compared with intravenous glucose leading to identical postprandial plasma glucose excursions. It makes up to 60% of the postprandial insulin secretion but is diminished in type 2 diabetes. Gastrointestinal hormones promoting the incretin effect are called incretins. Glucagon-like peptide- 1 (GLP-1) is an important incretin. In vitro and animal data have demonstrated that GLP-1 increases beta-cell mass by stimulating islet cell neogenesis and by inhibiting apoptosis of islets. The improvement of beta-cell function can be indirectly observed from the increased insulin secretory capacity of humans receiving GLP-1 or incretin mimetics that act like GLP-1. Furthermore, GLP-1 inhibits glucagon secretion and rarely causes hypoglycemia. It may represent an attractive therapeutic method for type 2 diabetes because of its multiple effects, including a slowing of gastric emptying and the simulation of satiety by acting as a transmitter in the CNS. Native GLP-1 is degraded rapidly upon intravenous or subcutaneous administration and is therefore not feasable for routine therapy. Long-acting GLP-1 analogs (e.g., Liraglutide [Novo Nordisk, Copenhagen, Denmark]) and exenadin-4 (Exenatide [Eli Lilly, Indianapolis, IN]) that are resistant to degradation, called "incretin mimetics," are being investigated in clinical trials. Dipeptidyl peptidase IV inhibitors (e.g., Vildagliptin [Novartis, Basel, Switzerland]) that inhibit the enzyme responsible for incretin degradation are also under study. PS - Âàøà ñòàòüÿ, Àëåñêàíäð, î ïðèñûëêå êîòîðîé â "Ïðîáëåìû ..." ÿ Âàñ ïðîñèëà, ïðèíÿòà â ïÿòíèöó íà ðåäêîëëåãèè- ìíå î÷åíü ýòî ïðèÿòíî.
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Ã.À. Ìåëüíè÷åíêî |
#4
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Ó ìåíÿ íà Áàéåòå ñåé÷àñ ïðèìåðíî 15 ÷åëîâåê. Ïîêà î÷åíü èíòåðåñíî.  ÷àñòíîñòè ó ìíîãèõ èç íèõ óäàëîñü ïîëíîñòüþ óáðàòü ñóëüôîíóðåþ. Íåêîòîðîå îïåñåíèå âûçûâàåò òîøíîòà, îñîáåííî ïðè íà÷àëå òåðàïèè, íî ó áîëüøèíñòâà îíà ïðîøëà î÷åíü áûñòðî. Ïîñìîòðèì ÷òî áóäåò äàëüøå. Ïðåäâàðèòåëüíûå äàííûå îáåùàþò ïðèìåðíî 1% ñíèæåíèå HbA1C.
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#5
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Î÷åíü èíòåðåñíî è î÷åíü çäÎðîâî!
Ïåðåä ñàìûì îòïóñêîì ìû ñ êîëëåãîé îòïðàâèëè ñòàòüþ ïî ìåòàáîëè÷åñêîìó ñèíäðîìó â "Consilium Med.", ãäå â îáçîðå îáñóæäàåì ýòè ïðåïàðàòû, êàê ïåðñïåêòèâíûå. Êàê æå çàìå÷àòåëüíî ÷èòàòü îòçûâû êîëëåã î ïðàêòè÷åñêîì èõ ïðèìåíåíèè! Òåïåðü áóäåì æäàòü, êîãäà î÷åðåäü äîéä¸ò è äî íàøèõ áîëüíûõ. |
#6
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Öèòàòà:
[Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] Ê ýòîìó ñòîèò, íàâåðíîå, äîáàâèòü, ÷òî áèîëîãè ñîîáùàëè î ýêçåíàòèäå çàäîëãî äî òîãî, êàê èì çàèíòåðåñîâàëèñü ôàðìàöåâòû. Ïðàâäà, ýòî âðåìÿ íåñðàâíèìî ìåíüøåå, ÷åì òî, êîòîðîå ïîíàäîáèëîñü, ÷òîáû «âñïîìíèëè», ê ïðèìåðó, î ãèðóäèíå. |
#7
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Äîëæíà èçâèíèòüñÿ- ÿ ãîâîðèëà, ÷òî ÝÊÇÀÍÀÒÈÄ ÍÀ×ÍÅÒ èñïûòûààòüñÿ â íàøåé ñòðàíå, à , îêàçûâàåòñÿ ( êàê áûñòðî ëåòèò âðåìÿ) ê íàñòîÿùåìó âðåìåíè óæå ÇÀÂÅÐØÅÍÎ åãî èçó÷åíèå ó 70 ïàöèåíòîâ íàøåé ñòðàíå, âêëþ÷åííûõ â ìåæäóíàðîäíîå èññëåäîâàíèå.Îòçûâû ïðîô. Ì.Â. Øåñòêîâîé, ó êîòîðîé ïðåïàðàò áûë íà èçó÷åíèè, î÷åíü áëàãîïðèÿòíûå. õîòÿ ãàñòðî- èíòåñòèíàëüíûå AE â ïåðâóþ íåäåëþ ïî÷òè ó âñåõ.
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Ã.À. Ìåëüíè÷åíêî |
#8
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Öèòàòà:
 áëèæàéøåå âðåìÿ â Ðîññèè ñòàðòóþò èññëåäîâàíèÿ ïî ðèìîíàáàíó (ó÷àñòèå â ìåæäóíàðîäíûõ èññëåäîâàíèÿõ). Ñóäÿ ïî äàííûì RIO-EUROPE è äðóãèõ èññëåäîâàíèé, - òîæå èíòåðåñíûå ïåðñïåêòèâû... [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] |
#9
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Äà, ïðîòîêîëû ñîãëàñîâàíû, è èññëåäîâàíèÿ íà÷íóòñÿ.
Çàêóïêà ýêçàíàòèäà - íàâåðíî. Âåäü ïî äèàáåòó ó íàñ âñå ïðåïàðàòû ïðèõîäÿò ê ïàöèåíòàì äîñòàòî÷íî áûñòðî.Áîëåå òîãî, ñåé÷àñ áóäåò ïðèíÿòî ðåøåíèå ïî ëåêàðñòâàì- ñèðîòêàì, íå çàðåãèòñðèðîâàííûì â ñòðàíå( äëÿ íàñ ýòî ÷ðåçâû÷àéíî âàæíî- èìåþ â âèäó ëèçîäðåí è ñèíàêòåí êàê äèàãíîñòèêóì). Åñëè âðà÷ ñ÷èòàåò íóæíûì, âûïèñûâàåòñÿ ðåöåïò. ñîãëàñîâûâàåòñÿ ðàçðåøåíèå ñ ÌÇ - è "òàìîæíÿ äàåò äîáðî" ( ñ)...
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Ã.À. Ìåëüíè÷åíêî |
#10
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Ïðîøó ïðîùåíèÿ, ÷òî âìåøèâàþñü.
Ãàëèíà Àôàíàñüåâíà, íàñêîëüêî ÿ ïîíèìàþ, ðåøåíèå ïî «ïðåïàðàòàì-ñèðîòêàì» óæå ïðèíÿòî.
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Ñ óâàæåíèåì, Âàëåðèé Âàëåðüåâè÷ Ñàìîéëåíêî |
#11
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Ïîêà íå çíàþ- áóäåò ñîâåùàíèå â ñåðåäèíå îêòÿáðÿ. ß íàïðàâèëà äàííûå î ëèçîäðåíå è ñèíàêòåíå, ïî ñïðåþ ìèíèðèíó ñêàçëè- íå íàäî, ñêîðî çàðåãèñòðèðóþò. Áîëüøå íèêòî èäåé íå äàåò - íåáèäî èñïûòûâàåì, àíäðîãåëü - õîòü ñàìè áóäåì ìàçàòüñÿ, ñòîëüêî íà èñïûòàíèÿ ïðèõîäèò, áîëüøå íè ó êîãî èäåé íåò. Åñòü ëè ïðåäëîæåíèÿ ?
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Ã.À. Ìåëüíè÷åíêî |
#12
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Öèòàòà:
Ãàëèíà Àôàíàñüåâíà, êîëëåãè! Íå ÿñíà ìíå èç äîêóìåíòà ñîáñòâåííî òåõíîëîãèÿ ïîëó÷åíèÿ òàêèõ ïðåïàðàòîâ. Õîòåëîñü áû óòî÷íèòü êîíêðåòíûé ïîðÿäîê äåéñòâèé â ñëó÷àå íåîáõîäèìîñòè íàçíà÷åíèÿ íåçàðåãèñòðèðîâàííîãî ïðåïàðàòà.  "Ïîëîæåíèè î ïîðÿäêå ïðèìåíåíèÿ ëåêàðñòâåííûõ ñðåäñòâ ó áîëüíûõ ïî æèçíåííûì ïîêàçàíèÿì (óòâ. ïðèêàçîì Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ è ñîöèàëüíîãî ðàçâèòèÿ ÐÔ îò 9 àâãóñòà 2005 ã. N 494)" ñêàçàíî: "3.  ñëó÷àå íåîáõîäèìîñòè èíäèâèäóàëüíîãî ïðèìåíåíèÿ ïî æèçíåííûì ïîêàçàíèÿì ëåêàðñòâåííîãî ñðåäñòâà, íåçàðåãèñòðèðîâàííîãî íà òåððèòîðèè Ðîññèéñêîé Ôåäåðàöèè, ðåøåíèå î íàçíà÷åíèè óêàçàííîãî ïðåïàðàòà ïðèíèìàåòñÿ êîíñèëèóìîì ôåäåðàëüíîé ñïåöèàëèçèðîâàííîé ìåäèöèíñêîé îðãàíèçàöèè, îôîðìëÿåòñÿ ïðîòîêîëîì è ïîäïèñûâàåòñÿ ãëàâíûì âðà÷îì èëè äèðåêòîðîì ôåäåðàëüíîé ñïåöèàëèçèðîâàííîé ìåäèöèíñêîé îðãàíèçàöèè. 4. Ïåðåä íà÷àëîì ïðèìåíåíèÿ ëå÷àùèé âðà÷ äîëæåí ïðîèíôîðìèðîâàòü ïàöèåíòà (â ñëó÷àÿõ, óñòàíîâëåííûõ çàêîíîäàòåëüñòâîì Ðîññèéñêîé Ôåäåðàöèè, ðîäèòåëåé èëè çàêîííûõ ïðåäñòàâèòåëåé) î ëåêàðñòâåííîì ñðåäñòâå, îá îæèäàåìîé ýôôåêòèâíîñòè ïðåäëàãàåìîé òåðàïèè, î áåçîïàñíîñòè ëåêàðñòâåííîãî ñðåäñòâà, ñòåïåíè ðèñêà äëÿ ïàöèåíòà, à òàêæå î äåéñòâèÿõ â ñëó÷àå íåïðåäâèäåííûõ ýôôåêòîâ âëèÿíèÿ ëåêàðñòâåííîãî ñðåäñòâà íà ñîñòîÿíèå åãî çäîðîâüÿ. 5. Íå ðàçðåøåííûå ê ïðèìåíåíèþ, íî íàõîäÿùèåñÿ íà ðàññìîòðåíèè â óñòàíîâëåííîì ïîðÿäêå, ëåêàðñòâåííûå ñðåäñòâà ìîãóò èñïîëüçîâàòüñÿ â èíòåðåñàõ èçëå÷åíèÿ ïàöèåíòà òîëüêî ïîñëå ïîëó÷åíèÿ åãî äîáðîâîëüíîãî ïèñüìåííîãî ñîãëàñèÿ, à äëÿ ëå÷åíèÿ ëèö, íå äîñòèãøèõ âîçðàñòà, óñòàíîâëåííîãî ÷àñòüþ âòîðîé ñòàòüè 24 Îñíîâ çàêîíîäàòåëüñòâà Ðîññèéñêîé Ôåäåðàöèè îá îõðàíå çäîðîâüÿ ãðàæäàí, òîëüêî ïðè íåïîñðåäñòâåííîé óãðîçå èõ æèçíè è ñ ïèñüìåííîãî ñîãëàñèÿ èõ çàêîííûõ ïðåäñòàâèòåëåé. 6. Ââîç íåçàðåãèñòðèðîâàííûõ ëåêàðñòâåííûõ ñðåäñòâ, ïðåäíàçíà÷åííûõ äëÿ áîëüíûõ ïî æèçíåííûì ïîêàçàíèÿì, îñóùåñòâëÿåòñÿ â ïîðÿäêå, îïðåäåëÿåìîì çàêîíîäàòåëüñòâîì Ðîññèéñêîé Ôåäåðàöèè. 7. Ââîçèìûå ëåêàðñòâåííûå ñðåäñòâà ïîäëåæàò ãîñóäàðñòâåííîìó êîíòðîëþ êà÷åñòâà â ïîðÿäêå, îïðåäåëÿåìîì çàêîíîäàòåëüñòâîì Ðîññèéñêîé Ôåäåðàöèè." Èòàê, âðà÷ ñ÷èòàåò, ÷òî åãî ïàöèåíòó, ïî æèçíåííûì ïîêàçàíèÿì íåîáõîäèì ïðåïàðàò, íåçàðåãèñòðèðîâàííûé â ÐÔ. Êàêîâ äàëüíåéøèé ïîðÿäîê äåéñòâèé âðà÷à, ÷òîáû ïðåïàðàò "äîø¸ë" äî ïàöèåíòà? |
#13
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Êñòàòè, íà îáñóæäåíèè ýêçàíàòèäà â÷åðà íåîæèäàííî î÷åíü ïîìîãëà èíôîðìàöèÿ îò Àëåêñà- áûë âûðàæåííûé ñêåïñèñ âíà÷àëå ó íå çíàâøèõ î ïðåïàðàòå ó÷àñòíèêàõ äèñêóññèè- òàê ÷òî ðóñìåäñåðâåð î÷åíü äàæå âàæíóþ ñëóæáó ñîñëóæèë...
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Ã.À. Ìåëüíè÷åíêî |