灯盏花注射液治疗出血性中风急性期临床疗效的系统评价

System evaluation of clinical effect on Dengzhanhua Injection in the treatment of acute hemorrhagic stroke

目的系统评价灯盏花注射液治疗出血性中风急性期的临床疗效及安全性。方法搜集灯盏花注射液治疗出血性中风急性期随机对照试验文献,筛选合格研究,应用Jadad评分法进行质量评价,运用异质性检验、Meta-分析、漏斗图分析等方法统计相关数据。结果 8项研究符合纳入标准,Jadad评分显示均属低质量文献。Meta-分析结果显示,总有效率比较的合并RR(99%CI)为1.20(1.04,1.39),需治疗的患者数(99%CI)为6.67(3.85,33.3);神经功能缺损评分、脑出血量变化比较的WMD(99%CI)分别为-3.53(-4.40,-2.65)、-3.72(-4.79,-2.65)。结论统计结果提示灯盏花注射液有益于改善出血性中风急性期神经功能缺损状况,对促进血肿吸收有积极意义,且安全性较好。

Objective To systematically review the clinical effect and safety of Dengzhanhua Injection in the treatment of acute hemorrhagic stroke. Methods Randomized controlled trial literatures on the treatment of acute hemorrhagic stroke by Dengzhanhua Injection were collected, sieved based on certain criteria, and applied with Jadad scoring method to evaluate their qualities and other methods like tests for heterogeneity, Meta-analysis and funnel-plot analysis, etc to obtain statisti- cal data. Results 8 trials were in accordance with the inclusive criteria, but they were all inferior quality based on Jadad scoring. Meta-analysis showed that the total effect rate of combined relative risk （RR） was 1.20 （1.04, 1.39） （99%CI）, the number needed to treat was 6.67 （3.85, 33.3） （99%C/）, and Weighted Mean Difference （WMD） in comparison of neurologi- cal deficit score and comparison of cerebral hemorrhage quantity change were -3.53 （-4.40, -2.65） and -3.72 （-4.79, - 2.65） respectively （99%CI）. Conclusion Statistical results indicate that Dengzhanhua injection is beneficial to better neuro- logical deficit status of acute hemorrhagic stroke and promote the absorption of hematoma with a good safety.