醒脑静注射液治疗脑出血的系统评价

Xingnaojing Injection for Intracerebral Hemorrhage: A Systematic Review

目的系统评价醒脑静注射液能否改善脑出血患者的功能性结局及导致不良反应。方法通过计算机检索、手工检索及向药厂索取资料,全面收集全世界范围内醒脑静注射液治疗脑出血的随机对照试验(RCT),并按Cochrane协作网推荐的方法进行系统评价。结果共纳入13个RCT(1035例患者),其中3个试验报告了死亡或依赖人数,11个试验在治疗末进行了神经功能缺损评价,所有试验均未观察到严重不良反应。Meta分析结果显示,①死亡/依赖:3个试验(204例患者)于随访结束后对患者的日常生活能力进行了评价,醒脑静注射液治疗组与对照组比较有减少患者死亡/依赖的趋势,但差异无统计学意义[Peto-OR=0.57,95%CI(0.32,1.01)]。②不良反应:未观察到严重不良反应。③神经功能缺损程度:11个试验(915例患者)在治疗末进行了神经功能缺损程度的评价,醒脑静注射液治疗组与对照组比较能显著改善神经功能缺损,差异有统计学意义[Peto-OR=3.70,95%CI(2.67,5.13)]。结论现有的临床研究证据显示,与对照组比较,醒脑静注射液有减少脑出血患者的死亡/依赖的趋势,能改善患者的神经功能缺损,但因研究质量及研究样本的局限性,尚需进行高质量、大样本的随机对照试验予以进一步证实。

Objective To determine whether Xingnaojing injection can improve functional outcome without causing harm in patients with intracerebral hemorrhage. Methods We searched the electronic bibliographic databases： Cochrane Central Register of Controlled Trials （CENTRAL, Issue 3, 2007）, MEDLINE （1996 to November 2007）, EMBASE （1984 to November 2007） and China Biological Medicine Database （1978 to November 2007）. We also did handsearching to identify other published and unpublished data. Data were extracted and evaluated by two reviewers independently with a designed extraction form. The Cochrane Collaboration＇s RevMan 4.2.10 was used for data analysis. Results Thirteen randomized trials involving 1035 patients were included. The number of people who had died or were dependent at the end of long-term follow-up （at least 3 months） were reported in three trials. Eleven trials measured neurological deficit at the end of treatment. No severe adverse events were reported. The results of meta-analyses indicated that Xingnaojing injection might decrease the number of death or dependency compared to the control group, but the difference was not statistically significant （Peto-OR 0.57, 95% CI 0.32 to 1.01）; and Xingnaojing injection were associated with a significant improvement in neurological deficit （Peto-OR 3.70, 95%CI 2.67 to 5.13）. Conclusion The evidence currently available showed that Xingnaojing injection may decrease the risk of death or dependency, and can also reduce neurological deficit in patients with intracerebral hemorrhage. However, more high-quality trials are needed.