中国中药杂志

2022, v.47(10) 2802-2810

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冰黄肤乐软膏治疗湿疹有效性和安全性的系统评价与Meta分析
Systematic review and Meta-analysis of efficacy and safety of Binghuang Fule Ointment in treatment of eczema

杨硕;吕健;王连心;谢雁鸣;
YANG Shuo;LYU Jian;WANG Lian-xin;XIE Yan-ming;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Xiyuan Hospital, China Academy of Chinese Medical Sciences;

摘要(Abstract):

为系统评价冰黄肤乐软膏治疗湿疹的有效性和安全性,该研究通过检索中国知网(CNKI)、维普(VIP)、万方(Wanfang)、中国生物医学文献服务系统(SinoMed)、PubMed、Web of Science、Cochrane Library、EMbase数据库,有效筛选冰黄肤乐软膏治疗湿疹的随机对照试验(RCTs),采用RevMan 5.4软件对最终纳入文献进行Meta分析。共纳入19项RCTs,总样本量1 919例,其中试验组973例,对照组946例。Meta分析结果显示:(1)冰黄肤乐软膏+西医常规的疗效积分指数≥60%(临床有效率)(RR=1.32,95%CI[1.13,1.55],P=0.000 4)优于西医常规,复发率(RR=0.37,95%CI[0.20,0.65],P=0.000 7)低于西医常规,不良反应(RR=1.05,95%CI[0.52,2.15],P=0.88)与西医常规差异无统计学意义;(2)单用冰黄肤乐软膏的疗效积分指数≥60%(临床有效率)(RR=1.20,95%CI[1.09,1.33],P=0.000 3)优于西医常规,不良反应(RR=0.92,95%CI[0.45,1.89],P=0.82)与西医常规差异无统计学意义;(3)冰黄肤乐软膏+西医常规或单用冰黄肤乐软膏的症状体征有效缓解(临床有效率)(RR=1.41,95%CI[1.07,1.85],P=0.01)优于西医常规。结果表明,冰黄肤乐软膏+西医常规或单用冰黄肤乐软膏治疗湿疹相较于西医常规治疗效果好,复发率低,安全性与西医常规治疗相当,临床用药可以借鉴。但由于纳入文献质量较低,故今后仍需更多大样本、多中心、方法学质量高的RCT进一步验证冰黄肤乐软膏治疗湿疹的疗效和安全性。
To expeditiously assess the efficacy and safety of Binghuang Fule Ointment in the treatment of eczema, we screened out the papers with randomized controlled trials(RCTs) for studying the efficacy of Binghuang Fule Ointment in the treatment of eczema from CNKI, VIP, Wanfang, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase and then performed Meta-analysis of the included studies via RevMan 5.4. A total of 19 studies were included, involving 1 919 cases(973 cases in the experimental group and 946 cases in the control group). Meta-analysis results showed that Binghuang Fule Ointment combined with conventional western medicine had better efficacy score index(clinical effectiveness ≥60%)(RR=1.32, 95%CI[1.13, 1.55], P=0.000 4) and lower recurrence rate(RR=0.37, 95%CI[0.20, 0.65], P=0.000 7) than conventional western medicine alone. The adverse reactions(RR=1.05, 95%CI[0.52, 2.15], P=0.88) did not show significant difference between the two groups. The application of Binghuang Fule Ointment alone had better efficacy score index(clinical effectiveness≥60%)(RR=1.20, 95%CI[1.09, 1.33], P=0.000 3) than conventional western medicine alone and the adverse reactions(RR=0.92, 95%CI[0.45, 1.89], P=0.82) insignificantly different from conventional western medicine alone. Binghuang Fule Ointment alone or combined with conventional western medicine demonstrated better effective in remission of symptoms and signs(clinical effectiveness)(RR=1.41, 95%CI[1.07, 1.85], P=0.01) than conventional western medicine alone. Compared with the single application of western medicine, Binghuang Fule Ointment alone or combined with conventional western medicine has better curative effect, low recurrence rate, and equivalent safety in the treatment of eczema. Nevertheless, owing to the low quality of the included papers, randomized controlled trials with large sample size, multiple centers, high methodological quality are needed to further verify the efficacy and safety of Binghuang Fule Ointment in the treatment of eczema.

关键词(KeyWords): 冰黄肤乐软膏;湿疹;系统评价;Meta分析
Binghuang Fule Ointment;eczema;systematic review;Meta-analysis

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1707400);; 国家自然科学基金面上项目(81973982)

作者(Authors): 杨硕;吕健;王连心;谢雁鸣;
YANG Shuo;LYU Jian;WANG Lian-xin;XIE Yan-ming;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Xiyuan Hospital, China Academy of Chinese Medical Sciences;

DOI: 10.19540/j.cnki.cjcmm.20220215.501

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