双黄连颗粒联合阿奇霉素干混悬液治疗小儿支原体肺炎Meta分析

Meta-analysis of ShuangHuangLian Granule Combined with Azithromycin Dry Suspension in Treating Mycoplasma Pneumonia in Children

目的系统评价双黄连颗粒联合阿奇霉素干混悬液治疗小儿支原体肺炎有效性和安全性,为临床用药提供参考。方法通过CNKI、维普、万方、中国生物医学、PubMed等数据库检索,收集双黄连颗粒联合阿奇霉素干混悬液治疗小儿支原体肺炎的随机对照试验,检索期限均为各库建库起至2021年4月,根据纳入和排除标准筛选文献,采用Cochrane系统评价员手册推荐的偏移风险评估工具对纳入文献质量进行评价,Review Manager 5.4.1软件进行Meta分析,StataSE 16软件进行Egger′s检验,并运用GRADE系统对结局指标的证据质量和推荐等级进行分级。结果纳入研究15篇,共计1792例患者,纳入研究总体质量不高。Meta分析结果显示,试验组总有效率高于对照组〔RR=1.16,95%CI(1.29,1.68),P<0.00001〕,差异有统计学意义;试验组在减少咳嗽消失时间〔MD=-3.42,95%CI(-4.42,-2.42),P<0.00001〕、体温恢复时间〔MD=-1.81,95%CI(-2.67,-0.95),P<0.00001〕、肺罗音消失时间〔MD=-2.80,95%CI(-3.44,-2.15),P<0.00001〕、住院时间〔MD=-4.15,95%CI(-5.47,-2.83),P<0.00001〕有显著优势,对其四个指标基于给药方式进行亚组分析,均优于对照组;在不良反应方面,试验组能减少患者恶心呕吐〔RR=0.33,95%CI(0.19,0.60),P=0.0003〕、腹痛腹泻〔RR=0.43,95%CI(0.26,0.71),P=0.001〕,差异有统计学意义;但出现肝肾功能异常〔RR=0.33,95%CI(0.11,1.01),P=0.05〕、皮疹〔RR=0.52,95%CI(0.26,1.07),P=0.08〕,差异无统计学意义。发表偏倚结果显示,本研究可能存在发表偏倚。GRADE评价结果显示,1个结局指标为中级,4个指标为低级,4个为极低级。结论双黄连颗粒联合阿奇霉素干混悬液治疗小儿支原体肺炎比单独使用阿奇霉素干混悬液,有更高的安全性和有效性,但纳入文献的结局指标等级较低,影响结果的可靠性,未来仍需更多大样本、高质量的随机双盲试验做进一步验证。

OBJECTIVE To systematically evaluate the effectiveness and safety about ShuangHuangLian granule combines with azithromycin dry suspension in the treatment of mycoplasma pneumonia in children,and to provide reference for clinical medication.METHODS First,the randomized controlled trials(RCT)of ShuangHuangLian granule combines with azithromycin dry suspension in the treatment of mycoplasma pneumonia in children were collected from different databases,such as CNKI,VIP,Wanfang,CBM,PubMed and other databases,from the date of their establishment to April 2021.Second,collected studies were screened based on inclusion and exclusion criteria.And evaluating the quality of the included studies by the deviation risk assessment tool which recommended by the Cochrane System Reviewer′s Manual.Third,using RevMan 5.4.1 software to have a Meta-ananlysis.Fourth,using StataSE 16 software to perform Egger′s regression symmetry test.Finally,the evidence quality was evaluated according to the GRADE profile.RESLUTS A total of 1792 patients were enrolled in 15 articles which were included.The results of Meta-analysis showed that the effective rate of the test group was higher than that of the control group〔RR=1.16,95%CI(1.29,1.68),P<0.00001〕,and the difference was statistically significant.The experimental group had significant advantages in reducing the time in cough to disappear〔MD=-3.42,95%CI(-4.42,-2.42),P<0.00001〕,the recovering time of body temperature〔MD=-1.81,95%CI(-2.67,-0.95),P<0.00001〕,the vanishing time of Pulmonary rales〔MD=-2.80,95%CI(-3.44,-2.15),P<0.00001〕,hospital stays〔MD=-4.15,95%CI(-5.47,-2.83),P<0.00001〕,and Sub-group analysis of the four indicators which based on the method of administration was better than the control group.In terms of adverse reactions,the experimental group could reduce incidence about patients′nausea and vomiting〔RR=0.33,95%CI(0.19,0.60),P=0.0003〕、abdominal pain and diarrhea〔RR=0.43,95%CI(0.26,0.71),P=0.001〕,and the difference was statistically significant.There was no statistic difference on reducing incidence of that abnormal liver and kidney function〔RR=0.33,95%CI(0.11,1.01),P=0.05〕,skin rash〔RR=0.52,95%CI(0.26,1.07),P=0.08〕.The publication bias results showed that this study may had publication bias.The evaluation(GRADE)results showed that 1 outcome index was intermediate,4 indicators were low,and others were very low.CONCLUSION ShuangHuangLian granule combines with azithromycin dry suspension in the treatment of pediatric mycoplasma pneumonia is safer and more effective than azithromycin dry suspension alone.However,the level of outcome indicators which included in the literature is lower,and can affect the reliability of the results.More large-sample and high-quality randomized double-blind trials are needed for further verification.