#1
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Íàôòèäðîôóðèë...
Êîëëåãè, ñîñóäèñòûå õèðóðãè!
Ñêàæèòå, ïîæàëóéñòà - ÷òî âû äóìàåòå îá ýôôåêòèâíîñòè íàôòèäðîôóðèëà ïðè ïåðåìåæàþùåéñÿ õðîìîòå? Íàñêîëüêî ÿ ïîìíþ, â TASC II îí íàðÿäó ñ öèëîñòàçîëîì áûë îòíåñåí ê ñðåäñòâàì ñ äîêàçàííîé ýôôåêòèâíîñòüþ íà ýòîé ñòàäèè ÕÀÍ (â îòëè÷èå îò ïåíòîêñèôèëëèíà è äð.). Ïðåïàðàò âðîäå ñòàðûé, íî â Ðîññèè áûë ìàëîäîñòóïåí. Ñåé÷àñ âðîäå ïîÿâèëñÿ... (Äóçîôàðì)  îáùåì, ëó÷øå ëè îí ïåíòîêñèôèëëèíà ïî êàêèì-òî ïàðàìåòðàì? |
#2
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Ïðîøó ïðîùåíèÿ çà âìåøàòåëüñòâî, íî, ì.á., áóäåò ïîëåçíûì òàêîé îáçîð:
Systematic review of the efficacy of cilostazol, naftidrofuryl oxalate and pentoxifylline for the treatment of intermittent claudication - Br J Surg. 2012 Dec;99(12):1630-8. - [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ]. Öèòàòà:
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#3
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Áîëüøîå ñïàñèáî, Âàñèëèé!
Íî ýòè äàííûå â îáùåì-òî èçâåñòíû. Âîïðîñ ìîé, ïðèìåíÿåò ëè åãî êòî-íèáóäü ñåé÷àñ, ïðåïàðàò âåäü ñòàðûé... Êàê èçâåñòíî, êëèíè÷åñêèé îïûò ÷àñòî äîïîëíÿåò è ðàçâèâàåò òî, ÷òî ìû çíàåì èç RCT... |
#4
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åñòü åùå òàêàÿ ïóáëèêàöèÿ:
Naftidrofuryl for intermittent claudication: meta-analysis based on individual patient data [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] è æåëàòåëüíà óâåðåííîñòü, ÷òî áîëãàðû òàêè òåñòèðîâàëè ñâîé äæåíåðèê ê îðèãèíàëó â ïëàíå áèîýêâèâàëåíòíîñòè, ïðåæäå, ÷åì çàïóñêàòü íà ðûíîê, à èíà÷å îæèä. ýôôåêò ìîæåò áûòü åùå íèæå...
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Èñêðåííå, Âàäèì Âàëåðüåâè÷. |
#5
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Ïîïûòàëñÿ ïîíÿòü, åñòü ëè îí, îðèãèíàëüíûé íàôòèäðîôóðèë, - è [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ]... Îðàíæåâàÿ êíèãà FDA è ëèñò ãåíåðèêîâ EMA ñ ïðåïàðàòîì íå çíàêîìû.
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#6
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Åñëè âåðèòü ýòîé ññûëêå, òî
Naftidrofuryl oxalate Brand name, manufacturer (Praxilene®, Merk Serono).2 Other manufacturers Actavis UK, Kent Pharmaceuticals, Mylan, Teva UK.24 [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ]
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Èñêðåííå, Âàäèì Âàëåðüåâè÷. |
#7
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Äà, ïîõîæå íà òî, ñïàñèáî. Õîòÿ drugs.com îòíîñÿò ìåðêîâñêèé ïðàêñèëåí â ìíîãî÷èñëåííóþ ãðóïïó brand names ñ óêàçàíèåì íà õîæäåíèå òàêîãî íàçâàíèÿ íà Ôèëèïïèíàõ è â Òóíèñå, à òàêæå êîå-ãäå â Åâðîïå, íî íå â ÑØÀ...
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#8
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Îòñóòñòâèå â ÑØÀ ñâÿçàíî ñ òåì, ÷òî ïðåïàðàò íèêîãäà íå ïîëó÷àë îäîáðåíèÿ ÔÄÀ (ïîòîìó êàê îðèãèíàëüíûé ïðîèçâîäèòåëü íèêîãäà íå ïîäàâàë äîêóìåíòû íà ýòî èç-çà èñòå÷åíèÿ ïàòåíòà íà ïðåïàðàò è îòñóòñòâèÿ æåëàíèÿ ïðîäàâàòü äàííûé ïðåïàðàò íà àìåð. ðûíêå), âîò ôðàãìåíò íåäàâíåé ïóáëèêàöèè:
Cilostazol, the leading pharmacologic agent for IC in the United States, was approved by the US Food and Drug Administration (FDA) in 1999 based on controversial data. Meanwhile, naftidrofuryl, the first-line pharmacologic agent for IC in the United Kingdom and Europe, has never been approved by the FDA and therefore is not available in the United States. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect impossible. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted, because the manufacturers of these agents have much to lose and little to gain from such a study. --- The limits of evidence in drug approval and availability: a case study of cilostazol and naftidrofuryl for the treatment of intermittent claudication. Clin Ther 2014 Aug 8;36(8):1290-301. Åñëè ãîâîðèòü íàïðèìåð òî÷êó çðåíèÿ áðèòàíöåâ, òî òîëüêî Praxilene (èëè åãî äæåíåðèêè, ïîòîìó ÷òî äåøåâëå) îäîáðåí ñ ïîçèöèè Cost-Effectiveness: According to the guidance, Praxilene is recommended for the treatment of intermittent claudication in people with peripheral arterial disease for whom vasodilator therapy is considered clinically appropriate. However, as Praxilene is also available in generic forms, NICE added that the drug should prescribed and dispensed in its cheaper generic form... NICE Recommends Generic Praxilene for Intermittent Claudication But Rejects Pletal, Trental 400, and Hepoxal [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] Êàê ïîíÿë èç ïðî÷èòàííîãî, íà îñíîâàíèè 4 ÐÊÈ èç Ôðàíöèè è 2 ÐÊÈ èç Ãåðìàíèè (ãäå òåñòèðîâàëñÿ îðîãèíàëüíûé naftidrofuryl) äàííûå î åãî ýôôåêòå ïðîòèâ ïëàöåáî ïîëó÷åíû òîëüêî (èëè ïðåèìóùåñòâåííî) íà äîçå 600 ìã â ñóòêè, õîòÿ ðåêîìåíäîâàííàÿ äîçà 1-2 (ïî 100 ìã) òàáë. 3 ðàçà â äåíü, òàê ÷òî áóäåò ëè òàêîé æå ýôôåêò íà ìåíüøåé ñóò. äîçå - íåèçâåñòíî Naftidrofuryl for intermittent claudication (Review) [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ]
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Èñêðåííå, Âàäèì Âàëåðüåâè÷. |
#9
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Åñëè æå ãîâîðèòü î ñðàâíèòåëüíîé ýôôåêòèâíîñòè òðåíòàëà è íàôðîíèëà, òî õîòÿ è ïîñëåäíèé âûãëÿäèò ëó÷øå, íî âñåõ ïîáåæäàåò ôèççàðÿäêà:
In 5 level 2 studies, physical training increased pain-free and total walking distance significantly (139.0 m [95% confidence interval {CI}, 31.0 to 246.9 m] and 179.1 m [95% CI, 60.2 to 298.1 m], respectively). In a level 3 study, smoking cessation resulted in a nonsignificant increase in total walking distance of 46.7 m (95% CI, -19.3 to 112.7 m). In 6 level 1 studies, pentoxifylline increased both pain-free and total walking distance by 21.0 m (95% CI, 0.7 to 41.3 m) and 43.8 m (95% CI, 14.1 to 73.6 m), respectively. In 4 level 1 trials, nafronyl significantly increased pain-free walking distance (58.6 m [95% CI, 30.4 to 86.8 m]) and total walking distance (71.2 m [95% CI, 13.3 to 129.0 m]). [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ]
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Èñêðåííå, Âàäèì Âàëåðüåâè÷. |
#10
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Ñïàñèáî!
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#11
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Äîáðûé äåíü, Îëåã. Ñïðîñèë íàøèõ ñîñóäèñòûõ. Íèêîãäà åãî íå èñïîëüçîâàëè. À òû ïëàíèðóåøü åãî ó ïàöèåíòîâ ñ ñäñ? Âðÿä ëè îí áóäåò ðàáîòàòü.
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#12
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Êîíêðåòíî ïî ïåðåìåæàþùåé õðîìîòå äèàáåòè÷åñêîãî ãåíåçà âîò ÷òî óäàëîñü íàéòè:
Patients with type 1 diabetes mellitus were excluded from the NCIS trial and other studies included in the Cochrane review. Twenty percent of the patients in the NCIS trial had type 2 diabetes and they were stratified between treatment groups. There was no significant difference in results in this study between those with or without diabetes. The whole database of the Cochrane individual patient data meta-analysis included 13.4% patients with type 2 diabetes. Key point There was no difference in therapeutic efficacy of naftidrofuryl between patients with type 2 diabetes and those without. îòñþäà [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ]
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Èñêðåííå, Âàäèì Âàëåðüåâè÷. |
#13
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Íåò, Âàäèì Âàëåðüåâè÷, ÿ èìåë ââèäó ïàöèåíòîâ íå ïðîñòî ñ äèàáåòîì, à ñ äèàáåòñòîïîé. Ýòî îñíîâíàÿ ãðóïïà ïàöèåíòîâ, ñ êîòîðûìè ðàáîòàåò Îëåã Âèêòîðîâè÷.
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