Feigin V L, Doronin B M, Popova T F, Gribatcheva E V, Tchervov D V
Department of Epidemiology and Preventive Medicine, Institute of Internal Medicine, Siberian Branch of the Russian Academy of Medical Science, Novosibirsk, Russia.
Eur J Neurol. 2001 Jan;8(1):81-5. doi: 10.1046/j.1468-1331.2001.00181.x.
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.
本研究旨在评估长春西汀(一种阿朴长春胺酸的合成乙酯)治疗急性缺血性卒中疗效的临床试验的安全性和可行性。连续纳入30例经计算机断层扫描确诊为急性缺血性卒中且在卒中发作72小时内可接受药物治疗的患者。患者被随机分配接受单独低分子右旋糖酐或低分子右旋糖酐联合长春西汀治疗。不良结局定义为死亡或Barthel指数<70或Rankin评分3 - 5分。采用意向性分析。所有住院急性缺血性卒中患者中十分之一符合试验条件。30例符合条件的患者接受单独低分子右旋糖酐治疗(平均年龄57.9±11.6岁,n = 15)或低分子右旋糖酐联合长春西汀治疗(平均年龄60.8±6.6岁,n = 15)。两个治疗组在主要预后变量方面具有可比性。根据改良Barthel指数定义,3个月随访时不良结局的相对风险(RR)降低30%(RR = 0.7;95%置信区间[CI]0.1 - 3.4),根据改良Rankin评分定义降低60%(RR = 0.4,95%CI:0.1 - 1.7)。在随访3个月时,长春西汀治疗组的美国国立卫生研究院(NIH - NINDS)卒中量表评分略显著更好(P = 0.05,方差分析)。未观察到显著不良反应。这项初步研究表明,对长春西汀治疗急性缺血性卒中进行全面的随机双盲、安慰剂对照试验是可行且必要的。