Vinpocetine treatment in acute ischaemic stroke: a pilot single-blind randomized clinical trial

被引:46
作者
Feigin, VL
Doronin, BM
Popova, TF
Gribatcheva, EV
Tchervov, DV
机构
[1] Univ Auckland, Clin Trials Res Unit, Auckland 1, New Zealand
[2] Russian Acad Med Sci, Inst Internal Med, Dept Epidemiol & Prevent Med, Siberian Branch, Novosibirsk, Russia
[3] Novosibirsk Med Univ, Dept Neurol & Neurosurg, Novosibirsk, Russia
关键词
controlled trial; ischaemic stroke; randomized; vinpocetine;
D O I
10.1046/j.1468-1331.2001.00181.x
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
The aim of the study was to assess the safety and feasibility of a clinical trial on the effect of vinpocetine, a synthetic ethyl ester of apovincamine, in acute ischaemic stroke. Thirty consecutive patients with computed tomography verified diagnosis of acute ischaemic stroke, who could receive drug treatment within 72 h of stroke onset, were enrolled. The patients were randomly allocated to receive either low-molecular weight dextran alone or in combination with vinpocetine. Poor outcome was defined as being dead or having a Barthel index of < 70 or a Rankin score of 3-5. Intention-to-treat analysis was applied. One-tenth of all hospitalized patients with acute ischaemic stroke were eligible for the trial. Thirty eligible patients were treated with either low-molecular weight dextran alone (mean age 57.9 +/- 11.6 years, n = 15) or in combination with vinpocetine (mean age 60.8 +/- 6.6 years, n = 15). The two treatment groups were comparable with respect to major prognostic variables. A relative risk (RR) reduction of poor outcome at 3 months follow-up was 30% (RR = 0.7; 95% confidence interval [CI] 0.1-3.4), as defined by the modified Barthel Index, and 60% as defined by the modified Ranking score (RR = 0.4, 95% CI: 0.1-1.7). The National Institute of Health (NIH-NINDS) Stroke Scale score was marginally significantly better in the vinpocetine treated group at 3 months of follow-up (P = 0.05, ANOVA). No significant adverse effects were seen. This pilot study shows that a full-scale randomized double-blind, placebo-controlled trial of vinpocetine treatment in acute ischaemic stroke is feasible and warranted.
引用
收藏
页码:81 / 85
页数:5
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