长春西汀注射液治疗急性脑梗死的系统评价

Vinpocetine Injection for Treatment of Acute Ischemic Stroke:A Systematic Review

目的:系统评价长春西汀注射液治疗急性脑梗死的疗效及安全性。方法:检索长春西汀注射液治疗急性脑梗死的随机对照试验(RCT)研究文献,按Cochrane系统评价方法对纳入文献进行资料提取和质量评价,筛选合格研究,而后采用RevMan 5.0软件进行Meta分析。结果:共纳入15个RCT,合计1 526例患者,其中治疗组770例,对照组756例。各项纳入的研究其基线资料具有可比性,均报道采用随机方法但仅有1例提及采用随机数字表法,且未提及盲法和分配隐藏情况。未检索到报道终点指标的研究,对替代指标的Meta分析结果显示:在治疗有效率方面,长春西汀注射液与其他药和常规治疗比较,其差异有统计学意义(OR=2.58,95%CI=1.96～3.40);对于神经功能缺损评分的改善,长春西汀注射液与其他药和常规治疗比较,其差异有统计学意义(WMD=1.58,95%CI=1.13～2.02)。不良反应极少发生,且反应轻微,使用相对安全。结论:本系统评价结果提示,长春西汀注射液治疗急性脑梗死疗效显著,且对神经功能障碍有良好改善作用。但由于本系统评价纳入研究的质量较低,影响了结果的论证强度,因此上述结论应谨慎对待,并期待更多高质量的随机、双盲、对照试验以提供更高质量的证据。

OBJECTIVE：To conduct a systematic evaluation on the efficacy and safety of vinpocetine injection for acute ischemic stroke. METHODS： The randomized controlled trials （RCTs） on vinpocetine for acute ischemic stroke was retrieved. Data collection and quality of the included RCTs were performed using Cochrane systematic evaluation method with qualified RCTs screened, then recta-analyses were conducted by using RevMan 5.0 software. RESULTS： A total of 15 RCTs involving 1 526 cases were included with 770 cases in the treatment group and 756 in the control group. The baseline data of each included RCT have comparability. Randomization was reported in all yet random digits table was used in only 1 case. The blinding method and allocation concealment were unreported. The studies in which there was report of endpoint indicator were failed to be retrieved. Mata-analysis on surrogate indicators demonstrated that there were statistical significances between vinpocetine injection and other medications or conventional therapy in effective rate （OR --2. 58, 95% CI = 1.96-3.40） and in the improvement of neurologic impairment scores （ WMD = 1.58,95% CI =1.13-2. 02）. The adverse drug reaction was extremely less frequent and mild thus vinpocetine injection was safe to use. CONCLUSION：The systematic evaluation on vinpocetine injection revealed that vinpocetine is quite effective for acute ischemic stroke and it can improve the nerve dysfunction. This conclusion should be treated with caution because of the poor quality of the included RCTs which may impact the power of the proof. More randomized double-blind control trials with high quality are needed to orovide high-qualitv evidence.