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目的:系统评价清开灵注射液辅助治疗小儿肺炎的有效性和安全性.方法:计算机检索Web of science、Embase、Cochrane Library、Pubmed、CNKI、万方数据库、VIP、中国生物医学数据库(CBM)电子数据库,纳入清开灵注射液辅助治疗小儿肺炎的随机对照试验(RCT),由两名研究者独立选择试验和评价质量,提取有效数据,应用RevMan 5.3.3软件进行Meta分析.结果:共纳入RCT 22项,病例共计2 400例.Meta分析显示,在常规治疗基础上辅以清开灵注射液治疗小儿肺炎,在总有效率、体温恢复正常时间、咳嗽消失时间、肺部哆音消失时间、呼吸频率改善时间、呕吐改善时间等方面均优于单纯常规治疗(P＜0.05),但不会缩短住院时间(P＞0.05).结论:现有文献支持清开灵注射液辅助治疗小儿肺炎,但由于现有支持文献质量不高,仍有待更多高质量、大样本、多中心的RCT加以验证.“,”Objective:To systemically review the effectiveness and safety of Qingkailing injection in the treatment of pediatric pneumonia.Methods:The databases of Web of science,Embase,Cochrane Libray,Pubmed,CNKI,Wan Fang,VIP and CBM were retrieved for collecting the randomized controlled trials (RCT) about the treatment of pediatric pneumonia with Qingkailing injection.The selection and data collection were conducted independently by two investigators,and the included studies were assessed.All the Meta-analyses were performed by Review Manager 5.3.3.Results:Twenty-two RCTs and 2,400 cases were included.From the results of Meta-analysis,the effectiveness of Qingkailing group was superior to the control group in the overall efficiency,defervescence time,cough disappeared time,rales disappeared time,breathing rate improvement time,vomiting improvement time (P＜0.05),but the length of hospital stay was not reduced by the addition of Qingkailing injection (P＞0.05).Conclusion:The existing literature supports the treatment of pediatric pneumonia by Qingkailing injection.However,due to the low quality of supporting documents,more high quality,large samples and multi-center RCTs are still needed to be verified.