皮肤针叩刺联合中药治疗斑秃效果的系统评价——基于GRADE证据质量评价

Cutaneous needle combined traditional Chinese medicine treatment of alopecia areata: a systematic review of randomized controlled trials

关键词:  皮肤针  斑秃  中药  系统评价  GRADE评级

Key words:  Cutaneous needle  alopecia areata  traditional Chinese medicine  systematic review  GRADE system

摘要:

[目的] 系统评价皮肤针叩刺联合中药治疗斑秃的临床疗效。[方法] 计算机检索PubMed、EMbase、ScienceDirect、Web of Science、EBSCO、CBM、CNKI、VIP和 WanFang Data,搜索关于皮肤针叩刺联合中药治疗斑秃的随机对照试验（RCT）,检索时限从建库至2015年9月。由2位评价员按照纳入与排除标准独立筛选文献、提取资料和方法学质量评价后，采用RevMan 5.3软件进行Meta分析，stata12.0软件进行发表偏倚分析，并根据GRADE系统推荐分级方法，使用 GRADE profiler3.6.1软件对纳入研究的结果证据质量进行严格评价。[结果] 最终纳入23个RCT,共计2 361例患者。Meta分析结果显示，皮肤针叩刺联合中药组在提高斑秃治疗效果的总有效率[RR=1.26,95%CI（1.21,1.31）,P<0.000 1],降低皮损积分[MD=-0.78,95%CI（-1.5,-0.06）,P=0.03],缩短显效时间[MD= -19.3,95%CI（-33.16,-5.43）,P=0.006],降低复发率[RR=0.30,95%CI（0.18,0.49）,P<0.000 01]等方面均优于对照组，其差异有统计学意义。证据等级：2个中等质量，2个低质量。[结论] 皮肤针叩刺联合中药治疗斑秃效果确切，但纳入研究质量尚有待提高，期待大样本、多中心、高质量的随机对照试验进一步加以验证，更好的将该法推广于临床实践。

Abstract:

[Objective] The article is prepared to evaluate the clinical effect of the cutaneous needle combined traditional Chinese medicine treatment of alopecia areata. [Methods] It was included randomized and quasi-randomized controlled trials on Cutaneous needle combined traditional Chinese medicine treatment of alopecia areata. This article we searched China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Wan Fang Database, SinoMed(CBM), Web of Science, EBSCO, ScienceDirect and PubMed. All searches ended in September 2015. Three independent researchers evaluated the included studies using GRADE profiler3.6.1. The extracted data and assessed were analyzed by RevMan 5.3 and stata 12.0 software with effect estimate presented as relative risk (RR), mean difference (MD) and standardized mean difference （SMD）with a 95% confidence interval (CI). [Results] Twenty-there studies involving 2361 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding and intention-to-treat analysis. Meta analyses showed cutaneous needle combined traditional Chinese medicine treatment was superior to medications regarding the total clinical effective rate：[RR=1.26, 95%CI（1.21, 1.31）, P<0.000 1]. The score of lesions integral was decreased[MD= -0.78, 95%CI（-1.5, -0.06）, P=0.03]. The time of patients with improved symptoms was cut down [MD= -19.3, 95%CI（-33.16, -5.43）, P=0.006]. And the recurrence rate was decreased[RR=0.30, 95%CI（0.18, 0.49）, P<0.000 01].There were no serious adverse effects with related to cutaneous needle combined traditional Chinese medicine treatment in the included trials. The two outcomes were moderate quality, two were low quality in the Grade system. [Conclusions] Cutaneous needle combined traditional Chinese medicine treatment to be effective in treatment of alopecia areata. However, further large, rigorous designed trials are warranted.