#16
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îáîáðÿëêà íå ðàáîòàåò
Ñàìà õîòåëà ñêàçàòü ïðî ýòî, íî åùå âîò åñòü êàêèå ìûñëè: àêòèëèçå êàê-òî áûëà íà âîîðóæåíèè îáëàñòíîé áîëüíèöû. Âìåñòå ñî ñòðåïòîêèíàçîé èñïîëüçîâàëàñü äëÿ òðîìáîëèçèñà ïðè ÎÈÌ. Îá èíñóëüòàõ íèêòî è íå çàèêíóëñÿ. È åùå: ñåé÷àñ èäåò çàêóïêà îòå÷åñòåííîãî îáîðóäîâàíèÿ â ãîðîäà è âåñè, èíîãäà (ïî ñîáñòâåííîìó è ÷óæîìó îïûòó) ñîâåðøåííî áåññìûñëåííàÿ - îãðîìíûå äåíüãè íà âåòåð. Ó íàñ áîëüíûõ ñàõàðíûì äèàáåòîì òåïåðá ïîñëå ëå÷åíèÿ (èíîãäà íå ïîêàçàííîãî) â ñòàöèîíàðå åùå è â ñàíàòîðèé îòïðàâëÿþò, íà äîëå÷èâàíèå. ×òî îíè òàì äåëàþò - çàãàäêà. À äåíåã íà îäíîãî áîëüíîãî - ïðèìåðíî êàê íà àêòèëèçå. Ìåæäó òåì, åñëè áîëüíîé ïîñòóïàåò â êåòîàöèäîòè÷åñêîé êîìå, ó íàñ íåò âîçìîæíîñòè îïðåäåëèòü êàëèé è pH Äåíüãè-òî òðàòÿòñÿ, òîëüêî íå íà òî, ÷òî íóæíî.
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Àííà, âðà÷-ýíäîêðèíîëîã Âîðîíåæ, êëèíèêà Íåïëàöåáî |
#17
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Âñòóïëþ â äèñêóññèþ êàê ÷åëîâåê, êîòîðûé ìîæåò è äîëæåí...
Äëÿ íà÷àëà, äëÿ òåõ, êòî åùå íå çíàåò ß ðàáîòàþ âðà÷îì â ÎÐÈÒ. Îäíàêî, de-facto, íàø ÎÐÈÒ ÿâëÿåòñÿ êàðäèîáèòîì. Ò.å., â àñáîëþòíîì áîëüøèíñòâå ñëó÷àåâ ìû ëå÷èì (è, ãîâîðÿò, õîðîøî ëå÷èì!) îñòðûå èíôàðêòû, à òàêæå æèçíåííî îïàñíûå íàðóøåíèÿ ðèòìà è ïðîâîäèìîñòè, òÿæåëóþ ñåðäå÷íóþ íåäîñòàòî÷íîñòü è ò.ï.  òî æå âðåìÿ, êðîìå îñíîâíîé òàê ñêàçàòü ñïåöèàëèçàöèè, ìû ðàáîòàåì åùå è êàê îáùàÿ òåðàïåâòè÷åñêàÿ ðåàíèìàöèÿ, "ïðèêðûâàÿ" íåñêîëüêî êëèíèê Êëèíè÷åñêîãî Öåíòðà ÌÌÀ (äëÿ âíóòðèãîñïèòàëüíûõ îñòðûõ ñèòóàöèé). Òàêèì îáðàçîì, â ñëó÷àå ðàçâèòèÿ âíóòðèãîñïèòàëüíîãî èíñóëüòà (>90% - èøåìè÷åñêèå), ýòè áîëüíûå ïîïàäàþò ê íàì. Òåõíè÷åñêîå îáåñïå÷åíèå ñëåäóþùåå: ÊÒ è ÌÐÒ òîëüêî ïî áóäíÿì ñ 9-00 äî 18-00 (îõ, ñêîëüêî âðåìåíè ìû ïûòàåìñÿ óáåäèòü íà÷àëüñòâî, ÷òî îòñóòñâèå ýêñòðåííîãî ÊÒ â êëèíè÷åñêîì öåíòðå - ïîëíîå è àáñîëþòíîå áåçîáðàçèå...). Àëüòåïëàçû - çàëåéñÿ!!! (îñîáåííîñòè ñíàáæåíèÿ êðóïíîãî ãîñóäàðñòâåííîãî ìåäèöèíñêîãî ó÷ðåæäåíèÿ ôåäåðàëüíîãî ïîä÷èíåíèÿ ). Äåæóðíûé íåâðîëîã äîñòóïåí, êàê ïðàâèëî, â òå÷åíèå 1 ÷àñà (õîòÿ ýòî, ñòðîãî ãîâîðÿ, ôîðìàëüíîñòü, äèàãíîç ÈÈ ìû è ñàìè ñïîñáíû ïîñòàâèòü). Íó òàê âîò, ê ÷åìó ýòî ÿ? À ê òîìó, ÷òî ïðè âñåì íàøåì æåëàíèè è âîçìîæíîñòÿõ, ìû òàê è íå ñäåëàëè íè îäíîãî òðîìáîëèçèñà ïðè äîêàçàííîì ÈÈ ìåíåå 3 ÷àñîâ. ÊÒ åñòü òîëüêî äíåì, à â ýòî âðåìÿ êðóãîì ìíîãî îñìîòðèòåëüíîãî îïàñëèâîãî íà÷àëüñòâà . Òàê âîò è æèâåì... Âïðî÷åì, ÿ îñîçíàþ, ÷òî ãëàâíîå - íà÷àòü. Ïàðó ðàç ñäåëàåøü òðîìáîëèçèñ, à òàì óæ ýòî ïåðåñòàíåò áûòü "íîâîñòüþ" è ñòàíåò ïðèìåíÿòüñÿ ñàìî ñîáîé . |
#18
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Ïîçâîëþ ñåáå âñòðÿòü. 8 ëåò îòðàáîòàë â íåéðîñîñóäèñòîé ðåàíèìàöèè â ÃÊÁ¹6. Ïûòàëèñü ïðîâîäèòü òðîìáîëèçèñ ïðè ÈÈ â îñòðåéøåì ïåðèîäå (1995-1997ãã.). Ïðè îáøèðíûõ èíôàðêòàõ ìîçãà íåñêîëüêî ðàç ïîëó÷èëè ãåìîððàãè÷åñêîå ïðîïèòûâàíèå èøåìè÷åñêîãî î÷àãà.
Ñîãëàøóñü, ÷òî ïðèíöèïû ÅÂÌ â ïîëüçó ëèçèñà. Íî ïîïàñòü íà "êðàñíûé" òðîìá, ïðè êîòîðîì ëèçèñ ýôôåêòèâåí - òîæå ëîòåðåÿ! Ïîýòîìó, íà ìîé âçãëÿä, äëÿ òîãî, ÷òîáû ëèçèðîâàòü ÈÈ, ñòîèò ó÷èòûâàòü äâå âåùè: äîêàçàííîñòü òðîìáîýìáîëè÷åñêîãî õàðàêòåðà ÈÈ è îòñóòñòâèå îêêëþçèðóþùåãî ïðîöåññà â ÌÀÃ, ÈÌÕÎ. |
#19
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Ïîìíèòñÿ, îäèí ðàç ó íàñ ñ Àíåé âñå ñîâïàëî. È ÊÒ ñäåëàëè è àëüòåïëàçà áûëà... Óâû, èíñóëüò îêàçàëñÿ ãåìîððàãè÷åñêèé. Òàê ÷òî ñäåëàòü òðîìáîëèçèñ íå óäàëîñü. Åùå íåñêîëüêî ðàç ââîäèëè àëüòåïëàçó (âíóòðèàðòåðèàëüíî) ëþäè, êîòîðûå ó íàñ çàíèìàþòñÿ ñòåíòèðîâàíèåì ñîííûõ. À òàê, êàê ñïðàâåäëèâî ñêàçàëà Àíÿ, ìû áû è ðàäû, íî íå ìîæåì.
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#20
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Öèòàòà:
Ïîêà ó íàñ äàëüøå ðàçãîâîðîâ äåëî íå èäåò, êàíàäöû, íàïðèìåð, è ó ïàöèåíòîâ ñòàðøå 80 ëåò òðîìáîëèçèñ ïðîâîäÿò... Óæîñ ... Öèòàòà:
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#21
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Ðåàëüíûé èíñóëüò ïîñòóïàåò â ëå÷åáíèöó ÷åðåç 6, à òî è 12 ÷àñîâ. Òàê ÷òî ðå÷ü òîëüêî î âíóòðèáîëüíè÷íûõ. Òàê è ñ íèìè ãåìîððîé, äàæå è äíåì. Ïîêà ñ ÊÒ äîãîâîðèøüñÿ, ïîêà òî, ïîêà ñå - "çîëîòîé ÷àñ" òþ-òþ. Äà è îïðåäåëåííàÿ ðåøèìîñòü àäìèíèñòðàöèè íóæíà. È åùå. Ìíå êàæåòñÿ, ÷òî ãîðàçäî áîëüøóþ ïîëüçó â íàøåé ñòðàíå ïðèíåñåò íå òðîìáîëèçèñ, à âíåäðåíèå íîðìàëüíûõ ðåàáèëèòàöèîííûõ ïðîãðàìì (ýòî íå â ïîðÿäêå ïðîòèâîïîñòàâëåíèÿ). Îíè è ýôôåêòèâíû è áåçîïàñíû. Íî ãîðàçäî áåëåå òðóäîåìêè. È åùå ñîçäàíèå ñïåöèàëèçèðîâàííûõ èíñóëüòíûõ ÁÈÒîâ. À òî èõ â Ìîñêâå-òî âñåãî - íè÷åãî.
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#22
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Öèòàòà:
Ó íàñ íà "Áàñìàíêå" áûëà ïåðâàÿ â Ìîñêâå íåéðîñîñóäèñòàÿ ðåàíèìàöèÿ. Òîãäà, â ñåðåäèíå 80-õ, æåñòêî ñîáëþäàëèñü ñðîêè ïðåáûâàíèÿ íà ðåàíèìàöèîííîé êîéêå - ÈÈ 3 äíÿ, ÃÈ-5 äíåé. À äàëüøå - ïëåãèÿ - íå ïëåãèÿ - â íåâðîëîãè÷åñêîå îòäåëåíèå. Ñåé÷àñ âñå èçìåíèëîñü, íàñêîëüêî ÿ â êóðñå |
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#23
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Óâàæàåìûå êîëëåãè!
À êàê Âàì íðàâèòñÿ ýòî ñîîáùåíèå: Thrombolytic Therapy for Acute Stroke in Late Pregnancy With Intra-Arterial Recombinant Tissue Plasminogen Activator David M. Johnson MD; David C. Kramer MD*; Ezra Cohen MD; Meredith Rochon MD; Mara Rosner MD; and Jesse Weinberger MD From the Departments of Neurosurgery, Radiology, Anesthesiology, Neurology, Obstetrics, Gynecology, and Reproductive Science, Mount Sinai Medical Center, New York, NY. Background and Purpose--The most common presentation of ischemic stroke related to pregnancy is arterial occlusion, occurring during the third trimester or postpartum. The authors present the first successful administration of intra-arterial cerebral tissue plasminogen activator to treat an embolic cerebral vascular accident in a 37-week parturient resulting in complete recovery of neurological function. Methods--The patient presented with left hemiplegia, left-sided neglect, and aphasia. Right internal carotid artery cerebral angiogram showed occlusion of the mid-M1 segment of the middle cerebral artery (MCA). After 15 mg of tissue plasminogen activator was administered via intra-arterial route, there was greatly improved retrograde flow through the posterior communication artery and the MCA territory. Results--A reduction in size of the MCA occlusion was noted with improvement of antegrade flow through the MCA. Three days after the procedure, the patient was induced successfully and delivered a healthy infant vaginally. Conclusion--This report describes the use of intra-arterial tissue plasminogen activator in the setting of stroke in late pregnancy. Âåäü áåðåìåííîñòü äî ñèõ ïîð ñ÷èòàåòñÿ ïðîòèâîïîêàçàíèåì ê ïðîâåäåíèþ ÒËÒ. |
#24
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Öèòàòà:
Óäèâëåí ÷òî ïðîïóñòèë ýòó òåìó. Õîòÿ ñîçäàíà îíà íåìíîãî íå â òîì ðàçäåëå. Ïî ñóòè ýòî áîëüøå ïðîáëåìà íåâðîëîãèè, ÷åì ÀÈÐ. Äàæå áîëåå - ïðîáëåìà íå èíòåíñèâêè, à îðãàíèçàöèè. Ìû çàíèìàåìñÿ ïåðìàíåòíî ýòèì âîïðîñîì ñ 2002 ãîäà. Ñ ìàÿ 2006 îôèöèàëüíî äëÿ ïðîâåäåíèÿ òðîìáîëèçèñà ãîòîâî âñå ÷òî ìîæíî, è íå òîëüêî â îäíîé êëèíèêå. Îäíàêî íà íàñòîÿùèé ìîìåíò íåõâàòàåò ãëàâíîãî - ïàöèåíòîâ! Âñå æäåì. Ïî ñóòè âñÿêðûâàåòñÿ ãëîáàëüíåéøèé ïëàñò ïðîáëåì îðãàíèçàöèè íåâðîëîãè÷åñêîé ïîìîùè ïàöèåíòó íà äîãîñïèòàëüíîì ýòàïå. Âñå íà÷èíàåòñÿ ñ íåîáðàçîâàííîñòè ïàöèåíòîâ, íåäîâåðèÿ ê îòå÷åñòâåííîé ìåäèöèíå. Âåäü ÷òîáû âñå ïîäïàäàëî â ñðîêè - íåîáõîäèìî äîñòàâèòü áîëüíîãî â ñòàöèîíàð â òå÷åíèå 2-õ ÷àñîâ îò íà÷àëà èíñóëüòà. À äëÿ ýòîãî áîëüíîìó íàäî ñäåëàòü âûçîâ â òå÷åíèå ïðèìåðíî 1 ÷ 20 ìèí ïîñëå ïîÿâëåíèÿ ïåðâûõ ñèìïòîìîâ. Êîíå÷íî òàêèå áîëüíûå åñòü, íî êàê íàçëî ó íèõ â íàëè÷èè ïðîòèâîïîêàçàíèÿ. Ò.å. ÷òîáû êàê-òî ñèñòåìà çàðàáîòàëà, ïðåæäå âñåãî íàäî íà÷èíàòü ñ ìîùíåéøåé ïðîïàãàíäû èç ÑÌÈ è ïðî÷èõ îáó÷àþùèõ ïðîãðàìì äëÿ ïàöèåíòîâ. À ñ ïðèñêîðáèåì ìîæíî ñêàçàòü, ÷òî íà ýòî äåíåã íàäî ãîðàçäî áîëüøå, ÷åì íà ïðèîáðåòåðèå ïðåïàðàòîâ è îñíàùåíèÿ. ÈÌÕÎ íà ñåãîäíÿøíèé äåíü öåðåáðàëüíûé òðîìáîëèçèñ îñòàåòñÿ íîâîé òåõíîëîãèåé, ìîäíîé ôèøêîé. Ðåàëüíûõ ïåðñïåêòèâ åãî ðàçâèòèÿ â Ðîññèè ïîêà íå âèäíî. |
#25
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Íàñêîëüêî ÿ ïîíÿë îïèñûâàëè òðîìáîëèçèñ -ÌÅÑÒÍÎ ïîä êîòðîëåì àðòåðèîãðàììû
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#26
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Öèòàòà:
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#27
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Âîïðîñ ÷òî ëó÷øå:Ñèñòåìíûé òðîìáîëèçèñ èëè èíòðààðòåðèàëüíûé â îñòðîì ïåðèîäå ÈÈ ñåé÷àñ àêòèâíî äèñêóòèðóåòñÿ:
Èíòðà-àðòåðèàëüíîå ââåäåíèå óðîêèíàçû óëó÷øàåò ïðîãíîç ïðè êàðäèîýìáîëè÷åñêîì èíñóëüòå è ìîæåò ñòàòü àëüòåðíàòèâîé òðîìáîëèçèñó òêàíåâûì àêòèâàòîðîì ïëàçìèíîãåíà. Ä-ð Takeshi Inoue è åãî êîëëåãè (Íàöèîíàëüíûé Ñåðäå÷íî-ñîñóäèñòûé Öåíòð, Îñàêà) ïîÿñíÿþò, ÷òî â ßïîíèè ïðèìåíåíèå òêàíåâîãî àêòèâàòîðà ïëàçìèíîãåíà (ÒÀÏ) äëÿ òðîìáîëèçèñà åùå íå ïîëó÷èëî îôèöèàëüíûé ñòàòóñ. Ïîýòîìó ïðè îñòðîé îêêëþçèè öåðåáðàëüíûõ ñîñóäîâ ÷àñòî ïðèìåíÿåòñÿ èíòðà-àðòåðèàëüíîå ââåäåíèå óðîêèíàçû (ÓÊ). Ïðåèìóùåñòâàìè ïîñëåäíåé, ïî ñðàâíåíèþ ñ ÒÀÏ, ìîæåò áûòü è áîëüøåå òåðàïåâòè÷åñêîå îêíî (6 ÷ ïðîòèâ 3 ÷).  ðàìêàõ èññëåäîâàíèÿ J-MUSIC (Japan Multicenter Stroke Investigators Collaboration) àâòîðû ñðàâíèëè äàííûå 91 ïàöèåíòà ñ êàðäèîýìáîëè÷åñêèì èíñóëüòîì, ïîñòóïàâøåãî â ñòàöèîíàð â ïåðâûå 4.5 ÷ è ïîëó÷àâøåãî ÓÊ èíòðà-àðòåðèàëüíî, è ïîêàçàòåëè ãðóïïû êîíòðîëÿ (182 áîëüíûõ ñ èíñóëüòîì, íå ïîëó÷àâøèõ ÓÊ). Îêàçàëîñü, ÷òî áëàãîïðèÿòíûé êëèíè÷åñêèé èñõîä, îöåíèâàåìûé ïî ìîäèôèöèðîâàííîé øêàëå Rankin ïðè âûïèñêå, äîñòîâåðíî ÷àùå íàáëþäàëñÿ â ãðóïïå ÓÊ: 50.5% ïðîòèâ 34.1% â ãðóïïå êîíòðîëÿ. Ðàçëè÷èÿ â óðîâíå ñìåðòíîñòè (11.0% è 13.3%, ñîîòâåòñòâåííî) íå äîñòèãàëè ñòàòèñòè÷åñêîé çíà÷èìîñòè. Ïî ïðîäîëæèòåëüíîñòè ïðåáûâàíèÿ â ñòàöèîíàðå îáå ãðóïïû íå ðàçëè÷àëèñü. "Òàêèì îáðàçîì, òðîìáîëèçèñ ñ ïîìîùüþ èíòðà-àðòåðèàëüíîãî ââåäåíèÿ ÓÊ ýôôåêòèâåí ó áîëüíûõ ñ îñòðûì èøåìè÷åñêèì èíñóëüòîì è ïîçâîëÿåò ðàñøèðèòü òåðàïåâòè÷åñêîå îêíî… Ýòî ïîçâîëÿåò âûïîëíÿòü òðîìáîëèçèñ ó áîëüøåãî ÷èñëà ïàöèåíòîâ", çàêëþ÷àþò èññëåäîâàòåëè åëè â íîâîì íîìåðå Cerebrovascular Diseases. Cerebrovasc Dis 2005;19:225-8. Êîìáèíèðîâàííûé, âíóòðèâåííûé è èíòðààðòåðèàëüíûé, òðîìáîëèçèñ ñóùåñòâåííî ýôôåêòèâíåå, ÷åì èçîëèðîâàííûé, ó áîëüíûõ ñ èøåìè÷åñêèì èíñóëüòîì. Ä-ð M Flaherty è åãî êîëëåãè (Ìåäèöèíñêèé Öåíòð Óíèâåðñèòåòà Öèíöèíàòè, Îãàéî) îáúÿñíÿþò, ÷òî ïðåèìóùåñòâî êîìáèíèðîâàííîãî, âíóòðèâåííîãî (ÂÂ) è èíòðààðòåðèàëüíîãî (ÈÀ), òðîìáîëèçèñà - âîçìîæíîñòü ðàííåé äîñòàâêè ðåêîìáèíàíòíîãî òêàíåâîãî àêòèâàòîðà ïëàçìèíîãåíà (ðòÀÏ) íåïîñðåäñòâåííî ê òðîìáó. Àâòîðû îáñëåäîâàëè 62 áîëüíûõ ñ îñòðûì èøåìè÷åñêèì èíñóëüòîì, îòâå÷àâøèõ ñòàíäàðòíûì ïîêàçàíèÿì ê òðîìáîëèçèñó. Âíà÷àëå ïàöèåíòû ïîëó÷àëè  èíôóçèþ ðòÀÏ (0.6 ìã/êã, â òå÷åíèå 30 ìèíóò), çàòåì âûïîëíÿëàñü àíãèîãðàôèÿ öåðåáðàëüíûõ ñîñóäîâ è ÈÀ ââåäåíèå 22 ìã ðòÀÏ, â òå÷åíèå 2 ÷. Ëå÷åíèå íà÷èíàëîñü â ñðåäíåì ÷åðåç 129 ìèíóò ïîñëå ïîÿâëåíèÿ ïåðâûõ ñèìïòîìîâ. ×åðåç 3 ìåñÿöà ôóíêöèîíàëüíûé êëèíè÷åñêèé èñõîä áûë áëàãîïðèÿòåí ó 50% áîëüíûõ (áàëëû 0-2 ïî ìîäèôèöèðîâàííîé øêàëå Rankin). Îáùàÿ ñìåðòíîñòü áûëà äîñòàòî÷íî íèçêîé (18%), ñèìïòîìíîå êðîâîòå÷åíèå èç öåðåáðàëüíûõ ñîñóäîâ îòìå÷àëîñü ó 8% ïàöèåíòîâ. Îäíàêî ñðåäè ëèö ñòàðøå 80 ëåò ýòè ïîêàçàòåëè óâåëè÷èâàëèñü äî 63% è 25%, ñîîòâåòñòâåííî.  ýòîé âîçðàñòíîé ãðóïïå áûë õóæå è ôóíêöèîíàëüíûé ñòàòóñ ó÷àñòíèêîâ. Ñåé÷àñ ä-ð Flaherty è åãî êîëëåãè ïëàíèðóþò íîâîå, êðóïíîå ðàíäîìèçèðîâàííîå êëèíè÷åñêîå èñïûòàíèå, â êîòîðîì áóäåò ñðàâíèâàòüñÿ ýôôåêòèâíîñòü ÂÂ/ÈÀ è òîëüêî  òðîìáîëèçèñà. Neurology 2005;64:386-8. Intravenous Tirofiban With Intra-Arterial Urokinase and Mechanical Thrombolysis in Stroke. Preliminary Experience in 11 Cases Salvatore Mangiafico MD; Martino Cellerini MD*; Patrizia Nencini MD; Gianfranco Gensini MD; and Domenico Inzitari MD From the Neuroradiology Unit (S.M., M.C.), Careggi Hospital, Florence, Italy; and the Departments of Neurological and Psychiatric Sciences (P.N., D.I.) and Critical Care Medicine and Surgery (G.G.), University of Florence, Italy. * To whom correspondence should be addressed. E-mail: [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] . Background and Purpose--To evaluate preliminarily efficacy and safety of intravenous tirofiban combined with mechanical clot disruption and urokinase in patients with stroke attributable to major cerebral artery occlusion. Methods--Eleven consecutive patients with stroke attributable to acute occlusion of a major cerebral artery were treated with an intravenous bolus injection of the platelet glycoprotein IIb/IIIa antagonist tirofiban combined with heparin and by endovascular procedures including mechanical thrombolysis and locally delivered urokinase. Of the 11 cases, 9 involved angioplasty and 2 only microcatheter and microguidewire manipulation. Results--There were 7 patients with internal carotid or middle cerebral artery occlusion treated within 6 hours and 4 patients with basilar artery occlusion treated within 12 hours of symptom onset. Median National Institutes of Health Stroke Scale (NIHSS) score on admission was 20. After the interventional procedure, vessel recanalization was partial (thrombolysis in myocardial infarction grade flow 2 [TIMI 2]) in 7 patients and absent or insufficient in 4 patients. Twenty-four hours after the procedure, all the patients but 1 improved substantially, and on control angiography, the occluded vessel was totally patent (TIMI 3) in 10 of the 11 patients. One patient with partial recanalization did not improve and died 3 months later from pulmonary embolism. Neither a symptomatic intracerebral hemorrhage nor systemic bleedings requiring blood transfusion occurred in any patient. At discharge, median NIHSS score was 2. The 3-month outcome was excellent in 8 patients (modified Rankin Scale [mRS] 0 to 1), good in 2 patients (mRS 2), and poor in 1 patient (mRS 6). Conclusions--The combination of intravenous tirofiban with intra-arterial mechanical clot disruption and urokinase may be successful in reopening an occluded major cerebral vessel without increasing the hemorrhagic risk and with good functional outcome. This strategy cannot be recommended as the systematic treatment of stroke attributable to major cerebral artery occlusion until tested in a controlled study design. |
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À âîò âîïðîñ èíòðààðòåðèàëüíîãî (ñåëåêòèâíîãî) òðîìáîëèçèñà êàê ðàç áîëåå äåòàëüíûé è îñíàùåí÷åñêèé, ÷åì ãëîáàëüíî îðãàíèçàöèîííûé.
Íàñêîëüêî ïîìíþ èíòðààðòåðèàëüíî óðîêèíàçó íà÷àëè ââîäèòü óæå äàâíî. Òóò åñòü âàæíîå îòëè÷èå: äîëæåí áûòü ñïåöèàëüíî ïðîó÷åííûé ÷åëîâåê ñ îïûòîì. Íàâåðíîå â Ðîññèè åãî ïîëó÷èòü ñëîæíîâàòî.  îäíîé ôðàçå â ÷åì áóäåò çàêëþ÷àòüñÿ ìåòîäèêà: ââåäåíèå ìèêðîêàòåòåðîì ïðåïàðàòà ïîä êîíòðîëåì àíãèîãðàôèè äî òðîìáà, è ïîñëå òðîìáà, ïðîòûêàÿ åãî. Ïîëó÷àåòñÿ è õèìè÷åñêîå ðàçðóøåíèå è, îò÷àñòè, ìåõàíè÷åñêîå. Åæåëè íåñåëåêòèâíûé ïòðîìáîëèçèñ ìîæåò ïðîâîäèòü øèðîêèé êðóã âðà÷åé, òî òàêèì þâåëèðíûì äåéñòâàì íàäî åùå îáó÷èòüñÿ. |
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Ïðè ÎÈÌ èíòðààðòåðèàëüíûé òðîìáîëèçèñ íå ïðèæèëñÿ. Ïîñìîòðèì, êàê áóäåò â ýòîì ñëó÷àå. Ïîêà, íà ñåé ìîìåíò, îáùåïðèçíàííîé ñ÷èòàåòñÿ ìåòîäèêà ñèñòåìíîãî òðîìáîëèçèçà òîëüêî ïðåïåðàòîì t-Pa. Ñ÷èòàåòñÿ ïåðñïåêòèâíûì ïðèìåíåíèå äåñìîòåïëàçû, íî ýòî åùå íà ñòàäèè èçó÷åíèÿ.
Dose Escalation of Desmoteplase for Acute Ischemic Stroke (DEDAS) Evidence of Safety and Efficacy 3 to 9 Hours After Stroke Onset Anthony J. Furlan, MD; Dirk Eyding, PhD; Gregory W. Albers, MD; Yasir Al-Rawi, MD; Kennedy R. Lees, MD; Howard A. Rowley, MD; Christian Sachara; Mariola Soehngen, MD; Steven Warach, MD, PhD; Werner Hacke, MD for the DEDAS Investigators From The Cleveland Clinic (A.F.), Department of Neurology, Cleveland, Ohio; PAION Deutschland GmbH (D.E., Y.A.-R., M.S.), Aachen, Germany; the Stanford Stroke Center (G.A.), Palo Alto, Calif; the Western Infirmery (K.R.L.), University Department of Medicine & Therapeutics, Glasgow, United Kingdom; the University of Wisconsin (H.A.R.), Department of Radiology, Madison, Wis; the ClinResearch GmbH (C.S.), Köln, Germany; the NINDS (S.W.), Bethesda, Md; and the Department of Neurology (W.H.), University of Heidelberg, Heidelberg, Germany. Correspondence to Anthony J. Furlan, MD, The Cleveland Clinic, Department of Neurology, S91, 9500 Euclid Ave, Cleveland, OH 44195, USA. E-mail [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] Background and Purpose— Desmoteplase is a novel plasminogen activator with favorable features in vitro compared with available agents. This study evaluated safety and efficacy of intravenous (IV) desmoteplase in patients with perfusion/diffusion mismatch on MRI 3 to 9 hours after onset of acute ischemic stroke. Methods— DEDAS was a placebo-controlled, double-blind, randomized, dose-escalation study investigating doses of 90 µg/kg and 125 µg/kg desmoteplase. Eligibility criteria included baseline National Institute of Health Stroke Scale (NIHSS) scores of 4 to 20 and MRI evidence of perfusion/diffusion mismatch. The safety end point was the rate of symptomatic intracranial hemorrhage. Primary efficacy co-end points were MRI reperfusion 4 to 8 hours after treatment and good clinical outcome at 90 days. The primary analyses were intent-to-treat. Before unblinding, a target population, excluding patients violating specific MRI criteria, was defined. Results— Thirty-seven patients were randomized and received treatment (intent-to-treat; placebo: n=8; 90 µg/kg: n=14; 125 µg/kg: n=15). No symptomatic intracranial hemorrhage occurred. Reperfusion was achieved in 37.5% (95% CI [8.5; 75.5]) of placebo patients, 18.2% (2.3; 51.8) of patients treated with 90 µg/kg desmoteplase, and 53.3% (26.6; 78.7) of patients treated with 125 µg/kg desmoteplase. Good clinical outcome at 90 days occurred in 25.0% (3.2; 65.1) treated with placebo, 28.6% (8.4; 58.1) treated with 90 µg/kg desmoteplase and 60.0% (32.3; 83.7) treated with 125 µg/kg desmoteplase. In the target population (n=25), the difference compared with placebo increased and was statistically significant for good clinical outcome with 125 µg/kg desmoteplase (P=0.022). Conclusions— Treatment with IV desmoteplase 3 to 9 hours after ischemic stroke onset appears safe. At a dose of 125 µg/kg desmoteplase appeared to improve clinical outcome, especially in patients fulfilling all MRI criteria. The results of DEDAS generally support the results of its predecessor study, Desmoteplase in Acute Ischemic Stroke (DIAS). DIAS Desmoteplase In Acute ischaemic Stroke Status Trial complete. Results published in January of 2005. A dose-ranging Phase III trial is being planned. Purpose To assess the safety and thrombolytic efficacy of intravenous desmoteplase (vampire bat plasminogen activator) in patients with acute ischemic stroke. Intervention(s) Desmoteplase (Thrombolytic agent; reportedly selective for fibrin-bound plasminogen) Trial Location(s) Austria, Belgium, Finland, France, Germany, Norway, Singapore, Spain, Sweden, Switzerland, UK, Australia Year Published: 2005 Year Presented: 2004 Study Size Actual: 102 Study Size Planned: 104 Number of Centers 44 Ages Eligible: 18-85 Maximum time from onset: 9 hours Design Study Design: Randomized, multi-center, multinational, double-blind, placebo-controlled, dose escalating trial. Inclusion Criteria: Patients between 18 and 85 years of age, who are between 3 and 9 hours post-ischemic stroke, who score between 4 and 20 on the National Institute of Health Stroke Scale (NIHSS) and show signs of cortical involvement, who receive MRI screening within 8 hours of their strokes that show a perfusion-weighted imaging (PWI) abnormality =< 2 cm in diameter in the hemispheric gray matter, that also either shows no diffusion-weighted imaging (DWI) abnormality, or a PWI/DWI mismatch > 20%, were eligible for the study. Exclusion Criteria: Females of childbearing potential, persons who weigh < 50 kg (110 lbs), who are ineligible to receive medication within 30 minutes of their MRI, whose strokes are idiopathic, who have a prestroke modified Rankin score (MRS) > 1, who have a history of intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), arteriovenous malformation, or aneurysm, whose clinical presentation suggests SAH, who use oral anticoagulants or have an international normalized ratio (INR) > 1.7, who have received heparin within 48 hours or who have a partial thromboplastin time (PTT) > 1.5 times the normal value, who use glycoprotein Iib/IIIa inhibitors, or who have any condition that would confer additional risk while receiving trial medication, will be excluded from the study. Patient Involvement: Upon admission, prospective participants will undergo a complete history and physical, an MRI, laboratory tests, and other trial-related assessments in order to determine trial eligibility. Desmoteplase will be administered to participants in a single-bolus IV infusion. Patients will undergo 11 assessments during the 3-month trial, in addition to another assessment upon discharge from the hospital. Primary Outcome: Safety: frequency of symptomatic ICH. Efficacy: reperfusion, assessed by MRA, magnetic resonance angiography; and 90-day clinical outcome, determined by NIHSS, MRS, Barthel Index (BI) scores, and mortality rates. Results Part 1: Symptomatic ICH was observed in 4 of the 13 (30.8%) patients in the high-dose group (37.5/50 mg), as well as in 4 of the 17 (23.5%) patients in the low-dose group (25 mg). There were no hemorrhages in the placebo group. Based on this data, trial coordinators continued the study using considerably lower dosage tiers. Part 2: Of the 45 desmoteplase-treated patients, one (2.2%) experienced symptomatic ICH. There were no hemorrhages in the placebo group (n=11). For efficacy, greater improvement in reperfusion was observed in the desmoteplase-treated patients (20 of 42 total; 47.6%), as opposed to patients in the placebo group (2 of 10; 20%). Statistical significance for reperfusion was demonstated in the two higher-dose groups (90 µ/kg and125 µ/kg, p=0.0349 and 0.0012 respectively). 90 day outcome followed a similar dose-dependent trend, with significant improvment observed among the patients (9 of 15) in the high-dose desmoteplase group (p=0.0090). Source of Information Correspondence from Paion. Presented at the 29th International Stroke Conference (February 2004). Stroke. Jan 2005;36:66-73. Web Links and Publications Paion Gmbh |
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 ïðîäîëæåíèå:
The Desmoteplase in Acute Ischemic Stroke Trial (DIAS). A Phase II MRI-Based 9-Hour Window Acute Stroke Thrombolysis Trial With Intravenous Desmoteplase.Stroke. Jan 2005;36:66-73. Desmoteplase In Acute ischemic Stroke (DIAS). Ongoing Clinical Trials Session, 28th International Stroke Conference, 2003 [PDF Format] DIAS-2 Desmoteplase in Acute Ischemic Stroke-2 Status Trial is in the planning stages. Purpose To deterine the safety and efficacy of recombinant desmoteplase in acute ischemic stroke. Intervention(s) Desmoteplase (Thrombolytic agent; reportedly selective for fibrin-bound plasminogen) Study Size Planned: 186 Maximum time from onset: 9 hours Design Study Design: Randomized, double-blind, placebo-controlled, dose-ranging trial. Inclusion Criteria: Stable ischemic stroke, NIHSS score between 4 and 20, ability to treat within 3-9 hours of stroke onset. Patient Involvement: Patients will be randomized to receive either placebo, or one of two doses of desmoteplase (90 µ/kg or 125 µ/kg). Primary Outcome: Safety endpoint is the frequency of symptomatic intracranial hemorrhage. Efficacy endpoint is infarct volume at 90 days (as measured by MRI). Secondary Outcome(s): 90 day clinical outcome as measured by NIHSS, modified Rankin, and Barthel Index scores. Source of Information Paion press release. Web Links and Publications Paion Gmbh DEDAS Dose escalation study of desmoteplase in acute ischemic stroke Status Enrollment concluded in November of 2004 with 38 patients. Follow-up is ongoing. (Note: This is the US twin study to the DIAS trial.) Purpose To assess the safety and thrombolytic efficacy of intravenous desmoteplase (vampire bat plasminogen activator) in patients with acute ischemic stroke. Intervention(s) Desmoteplase (Thrombolytic agent; reportedly selective for fibrin-bound plasminogen) Trial Location(s) United States Study Size Actual: 38 Number of Centers 15 Ages Eligible: 18-85 Maximum time from onset: 9 hours Design Study Design: Multicenter, multinational, double-blind, placebo-controlled, randomized Phase II trial. Inclusion Criteria: Patients between 18 and 85 years of age, who are between 3 and 9 hours post-ischemic stroke, who score between 4 and 20 on the National Institute of Health Stroke Scale (NIHSS) and show signs of cortical involvement, who receive MRI screening within 8 hours of their strokes that show a perfusion-weighted imaging (PWI) abnormality =< 2 cm in diameter in the hemispheric gray matter, that also either shows no diffusion-weighted imaging (DWI) abnormality, or a PWI/DWI mismatch > 20%, are eligible for the study. Exclusion Criteria: Females of childbearing potential, persons who weigh < 50 kg (110 lbs), who are ineligible to receive medication within 30 minutes of their MRI, whose strokes are idiopathic, who have a prestroke modified Rankin score (MRS) > 1, who have a history of intracranial hemorrhage (ICH), subarachnoid hemorrhage (SAH), arteriovenous malformation, or aneurysm, whose clinical presentation suggests SAH, who use oral anticoagulants or have an international normalized ratio (INR) > 1.7, who have received heparin within 48 hours or who have a partial thromboplastin time (PTT) > 1.5 times the normal value, who use glycoprotein Iib/IIIa inhibitors, or who have any condition that would confer additional risk while receiving trial medication, will be excluded from the study. Patient Involvement: Upon admission, prospective participants will undergo a complete history and physical, an MRI, laboratory tests, and other trial-related assessments in order to determine trial eligibility. Desmoteplase will be administered to participants in a single-bolus IV infusion. Patients will undergo 11 assessments during the 3-month trial, in addition to another assessment upon discharge from the hospital. Primary Outcome: The 90-day clinical outcome, determined by NIHSS, MRS, Barthel Index (BI) scores, and mortality rates, as well as the 30-day biological outcome, measured in areas of PWI and DWI deficits on MRI, PWI/DWI mismatch, change in reperfusion of the affected artery at 4-8 h from baseline (assessed by MRA, magnetic resonance angiography), and incidence of symptomatic ICH. Source of Information Correspondence from Paion. Web Links and Publications Paion Gmbh |