复方木尼孜其颗粒辅助治疗黄褐斑疗效与安全性的系统评价

Therapeutic Efficacy and Safety of Compound Muni Ziqi Granules in the Adjuvant Treatment of Chloasma:A Systematic Review

目的:系统评价复方木尼孜其颗粒辅助治疗黄褐斑的疗效与安全性,为临床治疗提供循证参考。方法:计算机检索中国期刊全文数据库、中文科技期刊数据库、万方数据库、Medline和Embase,收集复方木尼孜其颗粒单独或者联合常规药物(试验组)对比常规药物(对照组)治疗黄褐斑疗效[总有效率及痊愈率,血清雌二醇(E_2)、卵泡刺激素(FSH)、黄体生成素(LH)下降水平]与安全性(不良反应发生情况)的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取,并按照Cochrane系统评价员手册5.1.0进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入12项RCT,合计1 100例患者。Meta分析结果显示,试验组患者的总有效率[OR=2.84,95%CI(2.20,3.67),P<0.001]、痊愈率[OR=2.11,95%CI(1.59,2.79),P<0.001]、血清E2下降水平[OR=-98.64,95%CI(-110.84,-86.44),P<0.001]、FSH下降水平[OR=-1.85,95%CI(-2.58,-1.11),P<0.001]、LH下降水平[OR=-5.85,95%CI(-6.83,-4.87),P<0.001]均显著优于对照组,差异均有统计学意义;试验组少数患者出现月经量增多、月经量减少、暂时性色素沉着、一过性全身倦怠无力,均不影响治疗。结论:复方木尼孜其颗粒辅助治疗黄褐斑临床疗效确切,有效性较好,不良反应轻微。

OBJECTIVE：To systematically evaluate therapeutic efficacy and safety of Compound muni ziqi granules in the adjuvant treatment of chloasma, and to provide evidence-based reference for clinical treatment. METHODS： Retrieved from Chinese Journal Full-text Database（CJFD）,China Scientific Journal Database（CSJD）,Wanfang database,Medline and Embase,randomized controlled trials（RCTs）about therapeutic efficacy（total response rate,cure rate,the decrease level of E2,FSH and LH in serum） and safety of Compound muni ziqi granules alone or combined with routine drug（trial group） vs. routine drug（control group）in the treatment of chloasma were collected. Meta-analysis was conducted by using Rev Man 5.3 statistical software after data extraction of clinical studies meeting inclusion criteria and quality evaluation with Cochrane systematic evaluator manual5.1.0. RESULTS：Totally 12 RCTs were enrolled,involving 1 100 patients. Results of Meta-analysis showed that total response rate[OR=2.84,95%CI（2.20,3.67）,P〈0.001],cure rate [OR=2.11,95%CI（1.59,2.79）,P〈0.001],decrease level of E2[OR=-98.64,95%CI（-110.84,-86.44）,P〈0.001],decrease level of FSH [OR=-1.85,95%CI（-2.58,-1.11）,P〈0.001] and decrease level of LH [OR=-5.85,95% CI（-6.83,-4.87）,P〈0.001] in trial group were significantly better than control group,with statistical significance. In trial group,a few patients suffered from the increase of menstruation,the decrease of menstruation,temporary pigmentation and transient burnout;but all symptoms did not affect the treatment. CONCLUSIONS：Compound muni ziqi granules show definite clinical efficacy and good response rate in the adjuvant treatment of chloasma with mild ADR.