丁苯酞用于血管性认知功能障碍患者有效性与安全性Meta分析

目的：系统评价丁苯酞用于血管性认知功能障碍（VCI）患者的有效性和安全性。方法：检索PubMed、Embase、Cochrane library、CNKI、万方电子数据库，同时进行手工检索，收集国内外2000-2017年7月公开发表的关于丁苯酞用于治疗VCI的随机对照研究。依据纳入和排除标准筛选文献，对纳入文献进行方法学质量评估。采用RevMan 5.3软件统计学分析。结果：共纳入30个研究（共2 875例）。Meta分析结果表明，丁苯酞组与对照组相比，能够显著改善患者MMSE评分（SMD=1.16，95% CI：0.89~1.2，P<0.000 01），ADL评分（SMD=2.25，95% CI：1.65~2.85，P<0.000 01）和CDR评分（SMD=-1.50，95% CI：-2.13~-0.87，P<0.000 01）。有9个研究测定血浆SOD含量，丁苯酞相比对照组可改善血浆SOD含量（SMD=1.94，95% CI：1.76~2.11，P<0.000 01），4个研究测定血浆MDA水平，丁苯酞相比对照组可改善血浆MDA含理（MD=-2.65，95% CI：-3.53~-1.77，P<0.000 01）。剔除低评分的研究，敏感性分析结果不变。19个研究报道了药品不良事件，主要为胃肠道等轻微不良反应，一般可耐受。结论：丁苯酞用于VCI治疗有一定疗效且安全性较好，但纳入的文献质量不高，需更多高质随机双盲对照试验进一步证实。

Meta-analysis of efficacy and safety in patients receiving butylphthalide against vascular cognitive impairment

OBJECTIVE To evaluate the efficacy and safety of butylphthalide in patients with vascular cognitive impairment (VCI).METHODS Electronic database including PubMed,Embase,Cochrane library,and CNKI were retrieved for randomized controlled trials (RCT) about the use of butylphthalide for treatment of VCI from 2000 to July 2017.At the same time,manual search based on reviews and meta-analysis was carried out to collect other eligible RCTs.Two reviewers independently screened trials,extracted data,and evaluated the quality of included trials.RevMan 5.3 was used for statistical analysis.RESULTS Totally 30 studies were included (2 875 cases).Meta-analysis showed that butylphthalide significantly improved MMSE scores compared with the control group (SMD=1.16,95%CI:0.89-1.2,P<0.000 01),ADL (SMD=2.25,95%CI:1.65-2.85,P<0.000 01),CDR (SMD=-1.50,95%CI:-2.13——0.87,P<0.000 01) and SOD (SMD=1.94,95%CI:1.76-2.11,P<0.000 01).Plasma levels of MDA were measured in four studies,and meta-analysis indicated that butylphthalide was associated with lower MDA than the control group (MD=-2.65,95%CI:-3.53——1.77,P<0.000 01).Sensitivity analysis showed identical results with primary analysis.Adverse drug events related to butylphthalide were mainly mild and generally tolerable.CONCLUSION Butylphthalide has a better efficacy and safety in the treatment of VCI,but the quality of the studies is low,and more high quality RCTs are needed to confirm these results.