杞菊地黄丸联合常规西药治疗干眼随机对照试验的系统评价及Meta分析

Clinical efficacy of Qiju Dihuang pill combined with conventional western medicine in treatment of dry eye:a systematic review and meta-analysis of randomized controlled trials

目的系统评价杞菊地黄丸联合常规西药治疗干眼的有效性和安全性。方法检索2010年7月—2019年7月中国期刊全文数据库(CNKI)、万方数据库、维普中文期刊数据库(VIP)、中国生物医学文献数据库(CBM)、PubMed、The Cochrane Library等中英文数据库,纳入以杞菊地黄丸联合西药作为干预措施治疗干眼的临床随机对照试验研究(RCTs),对纳入的研究进行质量评价。采用Stata15.1软件对总有效率、泪膜分泌量、泪膜破裂时间、干眼症状评分为结局指标的研究进行Meta分析。结果最终纳入9篇RCTs,共742例患者。Meta分析结果表明,与单纯西药治疗相比,杞菊地黄丸联合西药治疗干眼的能提高总有效率(OR=1.27,95%CI[1.08,1.50],Z=2.89,P=0.004)、泪膜破裂时间(SMD=1.73,95%CI[1.19,2.27],Z=6.33,P=0.000)、泪液分泌量(SMD=0.95,95%CI[0.78,1.12],Z=2.66,P=0.008),降低干眼症状评分(SMD=-0.71,95%CI[-1.11,-0.30],Z=5.40,P=0.000),差异均具有统计学意义。结论杞菊地黄丸联合西药治疗干眼的临床疗效优于单纯西药治疗,可改善干眼患者各项临床症状及体征,安全性较高。

OBJECTIVE To systematically evaluate the efficacy and safety of Qiju Dihuang pill combined with conventional western medicine in the treatment of dry eye.METHODS CNKI,Wanfang,VIP,CBM,PubMed and the Cochrane database were searched from July 2010 to July 2019.Randomized controlled trials(RCTs)of Qiju Dihuang pill combined with western medicine were included in the Chinese and English databases and their quality was evaluated.Stata15.1 software was used to conduct a meta-analysis on the total effective rate,tear film secretion,tear film rupture time and dry eye symptom score.RESULTS Nine RCTs including 742 patients were included.The results of meta-analysis showed that compared with western medicine alone,Qiju Dihuang pill combined with western medicine could improve the total effective rate(OR=1.27,95%CI[1.08,1.50],Z=2.89,P=0.004),tear film ruptur e time(SMD=1.73,95%CI[1.19,2.27],Z=6.33,P=0.000),tear secretion volume(SMD=0.95,95%CI[0.78,1.12],Z=2.66,P=0.008),and reduce dry eye symptom score(SMD=-0.71,95%CI[-1.11,-0.30],Z=5.40,P=0.000).CONCLUSIONS Qiju Dihuang pill combined with western medicine in the treatment of dry eye had better clinical efficacy than that of western medicine alone.It alleviated the clinical symptoms and signs of patients with dry eye,with high safety.