清肝利胆口服液治疗新生儿黄疸的有效性和安全性评价

Effectiveness and Safety Evaluation of Liver-Clearing and Bladder-Promoting Oral Liquid in the Treatment of Neonatal Jaundice

目的:分析清肝利胆口服液联合西医常规治疗新生儿黄疸的有效性和安全性。方法:中英文网络检索清肝利胆口服液治疗新生儿黄疸的文献,英文数据库包括PubMed、Embase、The Cochrane Library;中文数据库包括中国知网(CNKI)、中国生物医学文献数据库(CBM)、维普(VIP)、万方(WanFang)、临床试验注册中心,检索时间为建库至2017年5月1日,收集清肝利胆口服液联合西医常规治疗新生儿黄疸的随机对照试验(Randomized controlled trials,RCT),运用Cochrane推荐的风险评估量表(riskofbias,ROB)对文献进行质量评估,并用RevMan软件进行Meta分析。结果:共纳入15个RCT,Meta分析显示,清肝利胆口服液联合西医常规疗法(光照疗法、肝酶诱导剂、益生菌及其他对症治疗)与单一西医疗法在有效率、日均胆红素浓度、治疗天数、住院时间、黄疸消退时间、治疗末血清胆红素水平等方面差异有统计学意义;不良反应:共7项研究425例中提及了19例轻度不良反应,主要表现为轻度腹泻、少量皮疹,均在停药后自行消退。结论:清肝利胆口服液联合西医常规治疗可明显降低胆红素浓度,缩短治疗时间,且不良反应较少。但纳入原始研究数量少且证据质量级别较低,临床运用仍需谨慎。

Objective: To analyze the effectiveness and safety of Liver-Clearing and Bladder-Promoting Oral Liquid combined with routine Western medicine in the treatment of neonatal jaundice. Methods: Literatures of Liver-Clearing and Bladder-Promoting Oral Liquid in the treatment of neonatal jaundice were searched in Chinese and English networks. English databases included PubMed,Embase and The Cochrane Library. Chinese databases included CNKI,CBM,VIP,WanFang and clinical trial registration center. The retrieval time was from the establishment of the database to May 1,2017. The randomized controlled trials ( RCTs) of Qinggan Lidan Oral Liquid ( QOL) combined with routine regimens in the treatment of neonatal jaundice were collected. The quality of the literature was assessed with the risk of bias ( ROB) recommended by Cochrane,and the meta-analysis was carried out with RevMan software. Randomized controlled trials ( RCTs) of Liver-Clearing and Bladder-Promoting Oral Liquid combined with conventional regimens in the treatment of neonatal jaundice were conducted. The quality of the literature was assessed with the risk of bias ( ROB) recommended by Cochrane,and Meta-analysis was performed with RevMan software. Results: A total of 15 RCTs ( a total of 1766 neonates with jaundice) were included. Meta-analysis showed that there were significant differences between Liver-Clearing and Bladder-Promoting Oral Liquid combined with conventional Western medicine ( including phototherapy,hepatic enzyme inducer,probiotics and other symptomatic treatment) and single Western medicine in terms of effective rate,daily average bilirubin concentration,treatment days,hospitalization time,jaundice subsidence time and serum bilirubin level at the end of treatment. Adverse reactions: Nineteen cases of mild adverse reactions were mentioned in 425 cases of seven studies. The main manifestations were mild diarrhea and a small amount of skin rash,which all subsided spontaneously after drug withdrawal. Conclusion: Liver-Clearing and Bladder-Promoting Oral Liquid combined with routine Western medicine has a remarkable efficacy on neonatal jaundice,can significantly reduce the concentration of bilirubin,shorten the treatment time,and have slight adverse reactions. However,due to the small number of original studies and the low level of evidence quality, clinical application still needs to be cautious.