醒脑静注射液治疗脑梗塞临床疗效及安全性随机对照试验的系统评价

Clinical Efficacy and Safety of Xingnaojing Injection for Cerebral Infarction: A Systematic Review

目的系统评价醒脑静与丹参等不同药物比较,治疗脑梗塞的临床疗效和安全性。方法计算机检索MEDLINE(1996～2005.4)、EMBASE(1984～2005.4)、Cochrane临床对照试验资料库(2005年第2期)、中国Cochrane中心临床对照试验资料数据库、中国生物医学文献数据库(1978～2005.4),手工检索纳入试验的所有中文及外文文献及相关文献,并逐个进行方法学质量评价,采用RevMan4.2.7软件进行Meta分析。结果共纳入13个随机对照试验(1203例患者)。Meta分析结果显示,①病死率2个研究比较了醒脑静与丹参的病死率,结果显示,差异有统计学意义[RR0.31,95%CI(0.14,0.70)];1个研究比较了醒脑静与丹参的病死率,结果显示,其差异无统计学意义[RR0.92,95%CI(0.14,6.27)]。②总有效率与丹参比较的4个研究,其差异有统计学意义[RR1.26,95%CI(1.12,1.42)];③治愈率醒脑静与各种对照措施比较,其差异均无统计学意义;④不良反应极少发生且表现轻微,使用相对安全;⑤神经功能缺损评分3个研究比较了醒脑静与丹参的治愈率,结果显示,评分前后变化值差异有统计学意义[WMD3.78,95%CI(2.30,5.26)]。结论现有的有限证据表明,醒脑静与丹参等药物比较,可以部分降低脑梗塞患者的病死率、提高总有效率;需要更多设计良好的随机、双盲、安慰剂对照试验加以证实。

Objective To assess the clinical efficacy and safety of Xingnaojing for treating cerebral infarction. Methods Randomized controlled trials (RCTs) were identified from MEDLINE (1996April 2005), EMBASE (1984April 2005), Cochrane Controlled Trials Register (Issue 2, 2005), Chinese Cochrane Centre Database, CBMdisc (1978April 2005). We handsearched the related published and unpublished data and their references. All trials about Xingnaojing injection for cerebral infarction were included. Data were extracted and evaluated by two reviewers independently with designed extraction form. RevMan 4.2.7 software was used for data analysis. Results Thirteen RCTs involving 1 203 patients were included. The results of meta-analysis were listed as the following: ① Mortality: Compared with Danshen, 2 studies showed that Xingnaojing decreased mortality statistically (RR 0.31 and 95%CI 0.14 to 0.70). Compared with cerebrolysin, 1 study showed Xingnaojing didn’t decrease the mortality (RR 0.92 , 95%CI 0.14 to 6.27); ② Total effective rate: Compared with Danshen, 4 studies showed that Xingnaojing were more effective (RR 1.26, 95%CI 1.12 to 1.42); ③ Cure rate: Compared with each control, Xingnaojing had the same cure rate; ④ Adverse effect: The number of adverse drug reaction was small and the symptoms were moderate; ⑤ Neurologic impairment score: Compared with Danshen, 3 studies showed that Xingnaojing had better improvement (WMD 3.78, 95%CI 2.30 to 5.26). Conclusions Xingnaojing may decrease the mortality and increase the total effective rate of cerebral infarction. More high quality trials are required.