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目的:系统评价布拉酵母菌散治疗新生儿黄疸的疗效,为临床提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、EMBASE、Cochrane对照试验中心数据库、中国生物医学文献数据库、中国期刊全文数据库、中国科技期刊全文数据库、万方数据库,全面收集布拉酵母菌散(试验组)与常规治疗(对照组)治疗新生儿黄疸的随机对照试验(RCT),对符合纳入标准的研究提取资料并进行质量评价后,采用Cochrane Rev Man5.1统计软件进行Meta分析。结果:本次统计共纳入11篇文献,合计1 217例患儿。Meta分析结果显示,试验组总有效率[RR=1.11,95%CI(1.05,1.17),I~2=0%]、黄疸消退时间[MD=1.78,95%CI(-2.29,-1.26),I~2=93%]、日均胆红素下降值[MD=12.80,95%CI(8.23,17.37),I~2=43%]均优于对照组(P均<0.01)。11篇文献中,1篇文献报道两组患儿治疗后不良反应(ADR)发生率比较差异无统计学意义,2篇文献报道两组未发生ADR,8篇文献未报道ADR情况。结论:基于当前的研究证据,布拉酵母菌散能有效辅助治疗新生儿黄疸,未发现明显不良反应,但因国内外均缺乏高质量的RCT研究,故布拉酵母菌散治疗新生儿黄疸的疗效和安全性尚需进一步评价。
Objective: To systematically evaluate the efficacy of Bladderworm Powder in the treatment of neonatal jaundice and provide evidence-based reference for clinical practice. Methods: The Cochrane Library, PubMed, EMBASE, Cochrane Central Register of Controlled Trials Database, Chinese Biomedical Literature Database, Chinese Journal Full-text Database, Chinese Science and Technology Periodical Full-text Database and Wanfang Database were searched by computer. Randomized controlled trials (RCTs) were conducted to treat jaundice in neonates with routine treatment (control group). Data were extracted and quality-evaluated after complying with inclusion criteria. Meta-analysis was performed using the Cochrane RevMan 5.1 statistical software. Results: In this survey, 11 articles were included, totaling 1 217 children. The results of Meta-analysis showed that the total effective rate of the experimental group [RR = 1.11,95% CI (1.05,1.17), I ~ 2 = 0%], jaundice regression time [MD = 1.78,95% CI (-2.29, -1.26) , I ~ 2 = 93%], and the daily average bilirubin value [MD = 12.80,95% CI (8.23,17.37), I ~ 2 = 43%] was superior to the control group (all P <0.01). Of the 11 articles, one reported no significant difference in the incidence of adverse reactions (ADR) between the two groups after treatment. Two articles reported no ADR in both groups and 8 articles did not report ADR. Conclusion: Based on the current research evidence, Bladderworm powder is an effective adjuvant treatment of neonatal jaundice and found no obvious adverse reactions. However, due to the lack of high quality RCT research both at home and abroad, Efficacy and safety still need further evaluation.