百令胶囊辅助治疗儿童原发性肾病综合征有效性与安全性的Meta分析

Meta Analysis of Efficacy and Safety of Bailing Capsule in the Adjuvant Treatment of Primary Nephrotic Syndrome in Children

目的系统评价百令胶囊辅助治疗儿童原发性肾病综合征的临床疗效与安全性。方法综合检索中国知网(CNKI)、万方数据知识服务平台(Wanfang)、维普中文期刊(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、the Cochrane Library、Embase等国内外数据库,收集建库至2020年8月有关百令胶囊治疗儿童原发性肾病综合征的随机对照试验。由2名研究员进行文献的筛选和信息提取,并采用RevMan 5.3、Stata 16.0软件和GRADE分级软件进行结局指标的分析和证据质量评价。结果最终纳入研究12项,涉及患者988例,试验组493例,对照组495例。Meta分析结果显示,与对照组相比,试验组能显著提高儿童原发性肾病综合征的临床有效率[RR=1.24,95%CI(1.16,1.32),P<0.000 01]和血浆白蛋白水平[RR=7.18,95%CI(6.51,7.84),P<0.000 01]、降低24 h尿蛋白定量[MD=-1.42,95%CI(-1.63,-1.21),P<0.000 01]、血清总胆固醇[MD=-1.36,95%C(I-1.52,-1.19),P<0.000 01]和纤维蛋白原[MD=-1.00,95%C(I-1.19,-0.80),P<0.000 01]水平,且未发生任何不良反应。亚组分析显示,联合用药不同可能与24 h尿蛋白水平改变有关,相关结局指标的GRADE证据质量评级为中、低级。结论百令胶囊辅助治疗可进一步提高儿童原发性肾病综合征的临床疗效,且安全性良好,具有一定的临床应用前景。

Objective To systematically evaluate the efficacy and safety of Bailing capsule in the adjuvant treatment of children with primary nephrotic syndrome.MethodsThe databases at home and abroad, including CNKI,Wanfang,VIP,SinoMed,PubMed,the Cochrane Library,and Embase,were searched comprehensively to collect relevant randomized controlled studies of Bailing capsule as the adjuvant treatment for primary nephrotic syndrome in children from the establishment of the database to August 2020. Two investigators independently completed the literature screening and information extraction, and used RevMan 5.3, Stata 16.0 software and GRADE classification software to analyze the outcome indicators and the quality of evidence.Results12 eligible studies were finally included,involving a total of 988 samples(493 in the experimental group and 495 in the control group). The overall quality of the included studies was general. Compared with the control group,meta-analysis results showed that the experimental group could significantly improve the clinical effective rate of children with primary nephrotic syndrome[RR=1.24,95% CI(1.16,1.32),P<0.000 01] and plasma albumin level[RR=7.18,95% CI(6.51,7.84),P<0.000 01],reduce 24 h urinary protein [MD=-1.42,95% CI(-1.63,-1.21),P<0.000 01]and total cholesterol [MD=-1.36, 95% CI(-1.52,-1.19), P<0.000 01], and fibrinogen level[MD=-1.00,95% CI(-1.19,-0.80),P<0.000 01]. There were no adverse reactions documented. Consideration of subgroup analysis indicated that different combinations of drugs may be the source of heterogeneity in 24 h urinary protein related to studies. According to the GRADE criteria, the evidence quality rating of related outcome indicators is mostly moderate and low.Conclusion Bailingcapsule used for adjuvant therapy can further improve the clinical efficacy of children with primary nephrotic syndrome,and it is safe and has a certain clinical application prospect.