复方氟米松软膏治疗皮炎湿疹的系统评价

Efficacy and Safety of Compound Flumetasone Ointment for Neurodermatitis and Chronic Eczema: A Systematic Review

目的系统评价复方氟米松软膏外涂治疗神经性皮炎、慢性湿疹的有效性与安全性。方法计算机检索Medline、Cochrane图书馆、EMbase、中国生物医学文献数据库、中国期刊全文数据库和万方数字化期刊全文数据库,检索时间跨度为上述数据库建库至2012年12月,语种限于英、中文,纳入复方氟米松软膏外涂治疗神经性皮炎、慢性湿疹的随机对照试验(RCT),采用RevMan 5.0软件进行Meta分析。结果共纳入22个RCT,包括2 049例患者。Meta分析结果显示外用复方氟米松软膏(或联合抗组胺药)治疗2、3、4周的疗效均显著高于其他外用糖皮质激素制剂,差异有统计学意义[RR=1.39,95%CI(1.30,1.50),P<0.000 01;RR=1.25,95%CI(1.15,1.37),P<0.000 01;RR=1.21,95%CI(1.11,1.33),P<0.000 1]。复方氟米松软膏外用可引起不同程度的红斑、脱屑、烧灼、刺痛、刺痒等暂时性轻微的不良反应,未见严重不良反应发生。结论有限的证据表明,复方氟米松软膏外用治疗神经性皮炎及慢性湿疹安全、有效。由于该系统评价存在局限性,结论尚需高质量、大规模、多中心、大样本的RCT加以证实。

Objective To assess the efficacy and safety of compound flumetasone ointment for neurodermatitis and chronic eczema. Methods We searched the Medline, Cochrane Central Register of Controlled Trials, EMbase, CBM, CNKI and Wanfang Data to collect randomized controlled trials （RCTs） of compound flumetasone ointment for neurodermatitis and chronic eczema; the retrieval time started from founded date to December 2012. The language was confined to English and Chinese. We performed meta-analyses using the Cochrane Collaboration＇s RevMan 5.0 Software. Results A total of 22 RCTs involving 2 049 patients with neurodermatitis and chronic eczema were included and assessed. At the end of the 2rid, 3rd and 4th week, the efficacy of topical compound flumetasone ointment （or combined with oral antihistamines） was obviously higher than that of other topical corticosteroid preparations [RR=1.39, 95%CI（1.30, 1.50）, P 〈 0.000 01; RR=1.25, 95%CI（1.15, 1.37）, P 〈 0.000 01; RR=1.21, 95%CI（1.11, 1.33）, P 〈 0.000 1]. Only temporary and slight adverse effects, such as erythema, desquamation, burning and tingling were observed, whereas no serious adverse effects were reported. Condusions The limited evidence demonstrates that topical compound flumetasone ointment （or combined with oral antihistamines） is safe and efficient. More large sampled and multiple central RCTs are required to verify these conclusions owing to the limitations of the present study.