血必净注射液辅助治疗卒中相关性肺炎的Meta分析

Meta Analysis of Xuebijing Injection in Treating Stroke-Associated Pneumonia

目的:卒中相关性肺炎(Stroke-associated Pneumonia,SAP)为急性脑卒中患者新发的肺部炎症性疾病。本文评价血必净注射液(Xuebijing injection)辅助治疗SAP的有效性和安全性。方法:检索相关数据库建库至2020年11月05日收录的关于血必净注射液辅助治疗卒中相关性肺炎的随机对照研究(randomized controlled trial,RCT),根据纳入和排除标准,采用NoteExpress软件对文献进行筛选,RevMan 5.4分析数据。结果:共检索出文献111篇,最终纳入18项研究,共1433例患者,其中试验组725例,对照组708例。Meta分析结果显示,血必净注射液联合西医常规治疗①在主要结局指标方面:降低炎症指标MD_(CRP)=-15.78,95%CI[-20.34,-11.22],P<0.00001;MD_(WBC计数)=-6.98,95%CI[-9.43,-4.53],P<0.00001;MD_(PCT)==-0.70,95%CI[-1.07,-0.32],P<0.01,提高有效率RR=1.26,95%CI[1.18,1.34],P<0.00001;②对于次要结局指标:降低MD_(TNF-α)=-8.30,95%CI[-12.26,-4.34],P<0.00001;MD_(IL-6)=-8.69,95%CI[-15.54,-1.85],P=0.01、改善症状体征MD_(退热时间)=-0.74,95%CI[-0.89,-0.59],P<0.00001;MD_(咳嗽缓解时间)=-1.87,95%CI[-2.1,-1.65],P<0.00001、降低APACHⅡ评分MD=-6.25,95%CI[-8.75,-3.76],P<0.0001、减少NIHSS评分MD=-4.14,95%CI[-7.33,-0.95],P=0.01、缩短住院时间MD=-4.83,95%CI[-6.42,-3.23],P<0.00001方面优于单纯西医常规治疗,且差异有统计学意义。有4项研究提及不良反应。GRADE软件分析显示以上结局指标的证据质量级别均为低和极低。结论:血必净注射液联合西医常规治疗SAP具有较好效果,观察指标优于单纯西医常规治疗,其安全性较好。

Objective:To evaluate the efficiency and safety of Xuebijing Injection in the treatment of stroke-associated pneumonia(SAP),a new lung inflammation in acute stroke patients.Methods:Randomized controlled studies(RCTs)concerning the adjuvant treatment of SAP with Xuebijing Injection were retrieved from related databases from their inception to November 5,2020.According to the inclusion and exclusion criteria,literature screening was conducted by NoteExpress,followed by data analysis with RevMan 5.4.Results:A total of 18 trials were screened out from the obtained 111 papers,involving 1433 cases(725 in the experimental group and 708 in the control group).As revealed by Meta analysis,Xuebijing Injection combined with conventional western medicine was significantly superior to conventional western medicine in improving①the primary outcomes like inflammation indicators[MD_(CRP)=-15.78,95%CI(-20.34,-11.22),P<0.00001;MD_(WBC count)=-6.98,95%CI(-9.43,-4.53),P<0.00001;MD_(PCT)==-0.70,95%CI(-1.07,-0.32),P<0.01]and the effective rate[RR=1.26,95%CI(1.18,1.34),P<0.00001],as well as②the secondary outcomes including inflammation factors[MD_(TNF-α)=-8.30,95%CI(-12.26,-4.34),P<0.00001;MD_(IL-6)=-8.69,95%CI(-15.54,-1.85),P=0.01],symptoms and signs[MD_(antipyretic time)=-0.74,95%CI(-0.89,-0.59),P<0.00001;MD_(cough relief time)=-1.87,95%CI(-2.1,-1.65),P<0.00001],APACHⅡscore[MD=-6.25,95%CI(-8.75,-3.76),P<0.0001],NIHSS score[MD=-4.14,95%CI(-7.33,-0.95),P=0.01],and hospital stay[MD=-4.83,95%CI(-6.42,-3.23),P=0.01<0.00001].The adverse actions were mentioned in four studies.GRADE revealed that the quality of the abovementioned outcomes was rated as low and extremely low.Conclusion:Xuebijing Injection combined with conventional western medicine is better than conventional western medicine in the treatment of SAP,with good safety.