白灵片治疗白癜风的系统评价及荟萃分析

Evaluation of Bailing tablet in vitiligo treatment: a Meta-analysis

目的评估白灵片治疗白癜风的临床疗效及安全性。方法检索白灵片治疗白癜风的随机对照试验(RCT),检索日期截止到2017年9月5日。根据Cochrane 5.0.2手册要求,提取研究数据并评价纳入RCT的质量,使用Rev Man 5.2软件进行Meta分析,结局的效应指标以相对危险度(RR)、95%置信区间(CI)及P值形式表示。结果共纳入17项RCT,纳入的RCT方法学质量普遍较差。数据分析结果显示,试验组[白灵片联合中药或窄谱中波紫外线(NB-UVB)]的总有效率明显高于对照组(中药或NB-UVB)[RR=1.33,95%CI(1.07,1.67),P=0.01]。根据纳入研究的对照组的干预措施不同,进行亚组分析,结果显示:使用白灵片治疗白癜风的总有效率明显低于中药组、NB-UVB组及白灵片或中药联合西药药膏组[RR=0.65,95%CI(0.57,0.75),P<0.000 01],对应的结局指标分别为[RR=0.63,95%CI(0.51,0.79),P<0.000 01]、[RR=0.72,95%CI(0.61,0.84),P<0.000 1]、[RR=0.63,95%CI(0.51,0.78),P<0.000 1]。结论白灵片对于治疗白癜风具有较好的治疗效果,且未见严重的不良反应。尚不建议白灵片单药用于白癜风治疗。

Objective To evaluate the clinical efficacy and safety of Bailing tablet in the treatment of vitiligo. Methods Randomized controlled trials（RCTs） for the vitiligo treatment using Bailing tablet were retrieved, and the retrieval data were due on September 5, 2017. The Meta-analysis was performed by using Rev Man 5.2 software after data extraction, and the quality of the included researches were evaluated according to the Cochrane 5.0.2 manual requirements. The outcome indicators were expressed in relative risk（RR）, 95% confidence interval（CI） and P values. Results Total 17 RCTs were enrolled. The quality of the included researches were low. The results of data analysis showed that the total effective rate of experiment group [Bailing tablet combined with traditional Chinese medicine or narrow spectrum medium wave ultraviolet（NB-UVB）] was significantly better than that of control group（traditional Chinese medicine or NB-UVB）[RR =1.33, 95% CI（1.07, 1.67）, P=0.01]. Because of the different interventions of control group, we conducted subgroup analysis on the same interventions. However, the subgroup Meta analysis results showed that the total effective rate of using Bailing tablet alone in the treatment of vitiligo was markedly lower than the Chinese traditional medicine group, the NB-UVB group and the combination group of Bailing tablet or the traditional Chinese medicine and western medicine ointment [RR=0.65, 95%CI（0.57, 0.75）,P0.000 01]. The corresponding outcome indicators respectively were [RR=0.63, 95%CI（0.51, 0.79）,P 0.000 01], [RR =0.72, 95% CI（0.61, 0.84）, P 0.000 1] and [RR =0.63, 95% CI（0.51, 0.78）, P 0.000 1）. Conclusion Bailing tablet has certain therapeutic effect on vitiligo treatment and no serious adverse reactions. However, Bailing tablet should be used as combination with other treatments.