法舒地尔对蛛网膜下腔出血患者脑血管痉挛的疗效及安全性的系统评价和荟萃分析

Efficacy and Safety of Fasudil on Cerebral Vasospasm in Patients with Subarachnoid Hemorrhage: A System Evaluation and Meta-analysis

关键词:  法舒地尔  蛛网膜下腔出血  脑血管痉挛  临床转归  荟萃分析

Key words:  fasudil  subarachnoid hemorrhage  cerebral vasospasm  clinical outcome  meta-analysis

摘要:

目的 评价法舒地尔对蛛网膜下腔出血患者脑血管痉挛的疗效及安全性。方法 检索中国学术期刊全文数据库、学位论文和会议论文数据库、维普期刊检索、万方数据库、中华医学会数字期刊数据库，以及Pubmed，Cochrane library，OVID和EMBase数据库；以Jadad质量评分标准对文献质量进行评价；以Review Manager 4.2软件进行荟萃分析，全面评价法舒地尔对预防和治疗脑血管痉挛的疗效及安全性。结果 9个研究符合纳入标准，832例患者分别完成了不同指标的试验观察；法舒地尔组患者症状性脑血管痉挛和数字减影血管造影确诊的脑血管痉挛发生比率仅为对照组的48%(OR=0.48，P=0.000 5)和40%(OR=0.40，P=0.000 4)；所有病例脑梗死和脑血管痉挛病例脑梗死的发生比率分别为对照组的50%(OR=0.50，P=0.000 9)和43%(OR=0.43，P=0.000 8)；完全康复患者的比率较对照组增加107%(OR=2.07，P=0.00 9)；与尼莫地平相比，法舒地尔可显著改善治疗2周时患者的意识水平(法舒地尔/尼莫地平：WMD=0.95，P＜0.000 01)；两组不良反应差异无统计学意义(P>0.05)。结论 法舒地尔极大地降低了蛛网膜下腔出血患者脑血管痉挛和脑梗死的发生比率，显著改善了蛛网膜下腔出血患者的临床转归，可显著改善蛛网膜下腔出血患者急性期的意识水平；法舒地尔不良反应的发生比率与尼莫地平相当。

Abstract:

OBJECTIVE To evaluate the efficacy and safety of fasudil on cerebral vasospasm in subarachnoid hemorrhage. METHODS The therapeutic and preventive effect of fasudil, as well as the effect of improving clinical outcome in subarachnoid hemorrhage was estimated through system evaluation and meta-analysis of clinical controlled trials. RESULTS Nine studies met the incorporating standard. The experimental observation of different index in 832 patients was accomplished. Ratio of cerebral vasospasm that had clinical symptom or which was diagnosed with digital subtraction angiography in fasudil group was only 48%(OR=0.48, P=0.000 5) and 40%(OR=0.40, P=0.000 4) of that of control group. Ratio of cerebral infarction caused by all reasons or that by cerebral vasospasm in fasudil group was 50%(OR=0.50, P=0.000 9) and 43%(OR=0.43, P=0.000 8) of control group. To compare with control group, ratio of patients with complete recovery increased 107% in fasudil group. To compare with nimodipine, fasudil could ameliorated the level of consciousness significantly in patients that had been treated 2 weeks(fasudil versus nimodipine: WMD=0.95, P<0.000 01). There was no significant difference of adverse effects between 2 groups(P>0.05). CONCLUSION Fasudil could decrease the rate of cerebral vasospasm and cerebral infarction happening enormously in subarachnoid hemorrhage. Fasudil could ameliorate clinical outcome significantly in subarachnoid hemorrhage. Fasudil could improve the level of consciousness significantly in subarachnoid hemorrhage during acute stage. The ratio of adverse effects of fasudil and nimodipine was almost the same.