星蒌承气汤加减治疗脑卒中急性期的系统评价

Systematic Assessment of Xinglou Chengqi Decoction for Treatment of Acute Stroke

目的系统评价星蒌承气汤加减治疗脑卒中急性期的疗效性与安全性。方法应用计算机、手工结合方式在全面检索中国学术期刊全文数据库、万方知识服务平台等数据库中进行文献检索,搜集1991年—2014年相关文献,纳入合格的随机对照文献后,按照CoChrane协作网标准,应用Jadad评分法给予质量评价,应用RevMan5.1软件进行Meta分析。结果经筛选纳入19篇文献,共1 467例,治疗组755例,对照组712例,各研究基线可比。应用Jadad量表评价文章质量,1篇试验得5分属高质量文献,5篇试验得3分属中等质量文献,其余均低于3分属低质量文献。Meta分析结果显示:星蒌承气汤加减联合西药常规治疗在提高脑卒中病急性期总的临床疗效[RR=1.29,95%CI(1.22,1.37)]、降低神经功能缺损评分[WMD=-4.29,95%CI(-6.13,-2.45)]、降低大便症状积分[WMD=-3.63,95%CI(-4.33,-2.93)]、降低中医证候积分[WMD=-3.01,95%CI(-4.31,-1.7)]、提高日常生活活动能力[WMD=9.07,95%CI(5.46,12.67)]、降低高切血黏度[WMD=-0.93,95%CI(-1.4,-0.46)]、低切血黏度[WMD=-1.68,95%CI(-2.95,-0.4)]、纤维蛋白[WMD=-0.5,95%CI(-0.96,-0.04)]方面均优于治疗组。在降低脑卒中病死率[OR=0.59,95%CI(0.26,1.34),P=0.21]及血CRP[WMD=-0.66,95%CI(-2.08,0.76),P=0.36]方面无统计学意义。结论目前拥有的数据表明,星蒌承气汤加减联合西药常规治疗脑卒中急性期的疗效是优于对照组的,但尚不认为其具有降低急性脑卒中病死率的作用。受纳入文献质量和数量的限制,仍然需要纳入更多高质量、多中心、大样本量,且应该经过严格设计的随机双盲对照试验支持临床疗效。

Objective The objective was to systematically assess curative effect and security of Xinglou Chengqi decoction（XCD）for treatment of acute stroke.Methods The databases including China Journal Full Text Database （CJFD）and WanFangDatabase from 1991 to 2014 were retrieved for collecting the randomized controlled trials literature that met inclusion criteria.Thequality of collected literature was evaluated according to the RevMan 5.1 software,and Jadad scoring method recommended by Co- chrane Collaboration was used in meta analysis.Results There were 19 literature included 1 467 cases,there were 755 cases intreatment group （treating with XCD and its additional and subtractive recipes combining western medicine）and 712 in control group（treating only with western medicine）.The baseline data was comparability.Based on Jadad scale scoring,there were lots of lowquality literatures getting under 3 scores,except 1 high quality literature getting 5 scores and 5 middle quality literatures getting 3scores.This Meta analysis result showed that treatment group was better than the control group in improving total clinical curativeeffect[RR = 1.29,95% CI （1.22,1.37）],decreasing NIHSS [WMD= -4.29,95% CI （-6.13,-2.45）],reducing TCM syndromeintegrals [WMD= -3.01,95% CI （-4.31,-1.7）],reducing stool syndrome integrals [WMD= -3.63,95% CI （-4.33,-2.93）], improving activity of daily living [WMD= 9.07,95% CI （5.46,12.67）],reducing high plasma viscosity [WMD= -0.93,95% CI （-1.4,-0.46）],reducing low plasma viscosity [WMD= -1.68,95% CI（- 2.95,- 0.40）],reducing fibrinogen [WMD= -0.5,95% CI（-0.96,-0.04）].In the treatment group the case mortality [OR = 0.59,95% CI （0.26,1.34）,P = 0.21]and CRP[WMD= -0.66,95% CI（-2.08,0.76）,P = 0.36]had no statistical meaning.Conclusion The current evidence showed treatment group hasd better effec- tiveness when compared with control group,but there was not enough evidence to support it could reduce the case mortality.Be- cause of the limitation of literature quantity and quality,higher quality,rigorous design,large sample,multiple center and doubleblind randomized controlled trials were needed to support the clinical effectiveness.