目的 系统评价苦参凝胶联合抗真菌药治疗外阴阴道假丝酵母菌病（vulvovaginal candidiasis，VVC）的临床疗效及安全性。方法 计算机检索PubMed、Web of Science、Embase、Cochrane Library、中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、维普（VIP）、万方等数据库，检索时间从建库至2021年5月31日，收集苦参凝胶联合抗真菌药治疗VVC的随机对照试验（randomized controlled trial，RCT）。依据Cochrane系统评价原则筛选文献、提取资料及评价文献方法学质量；运用RevMan 5.3软件进行Meta分析。结果 共纳入34篇文献，共计3272例患者。Meta分析结果显示，与单用抗真菌药相比，苦参凝胶联用抗真菌药能显著提高VVC患者假丝酵母菌的转阴率[RR=1.20，95% CI（1.17，1.24），P<0.000 01]，降低VVC的复发率[RR=0.25，95% CI（0.17，0.35），P<0.000 01]，且在改善阴道瘙痒[MD=-3.34，95% CI（-3.54，-3.15），P<0.000 01]、阴道疼痛[MD=-2.66，95% CI（-3.16，-2.17），P<0.000 01]、白带异常[MD=-2.87，95% CI（-3.13，-2.67），P<0.000 01]、阴道黏膜充血[MD=-3.60，95% CI（-4.02，-3.18），P<0.000 01]等症状方面优于单用抗真菌药治疗。在不良反应发生率方面，2组间差异无统计学意义[RR=0.86，95% CI（0.29，2.49），P=0.78]。结论 苦参凝胶联合抗真菌药治疗VVC能有效提高致病菌转阴率、降低复发率、加快缓解临床症状，疗效优于单用抗真菌药治疗，且临床用药安全。

Objective To systematically evaluate the clinical efficacy and safety of Kushen Gel (苦参凝胶) combined with antifungal drug in the treatment of vulvovaginal candidiasis (VVC). Methods The PubMed, Web of Science, Embase, Cochrane Library, Chinese Journal Full-text Database (CNKI), Chinese Biomedical Literature Database (CBM), VIP, Wanfang Database were electronically searched to collect randomized controlled trials (RCTs) on Kushen Gel combined with antifungal drug in the treatment of VVC. The retrieval time was from database establishment to May 31, 2021. The literatures, extracting data, the quality of the included studies were screened and evaluated based on Cochrane's systematic evaluation principles. RevMan 5.3 software was used for Meta-analysis. Results A total of 34 RCTs involving 3272 subjects were included. Meta-analysis results showed that in the patients with VVC, compared with antifungal drug alone, combination of Kushen Gel with antifungal drug can significantly increase the negative conversion rate of Candida[RR=1.20, 95% CI (1.17, 1.24), P < 0.000 01], reduce the recurrence rate of VVC[RR=0.25, 95% CI (0.17, 0.35), P < 0.000 01]. In additon, combination with Kushen Gel is superior to monotherapy with antifungal drug in improving vaginal itching[MD=-3.34, 95% CI (-3.54, -3.15), P < 0.000 01], vaginal pain[MD=-2.66, 95% CI (-3.16, -2.17), P < 0.000 01], abnormal leucorrhea[MD=-2.87, 95% CI (-3.13, -2.67), P < 0.000 01], and vaginal mucosal hyperemia[MD=-3.60, 95% CI (-4.02, -3.18), P < 0.000 01] symptoms. Otherwise, no statistically significant difference in adverse reactions rate were found between the two groups[RR=0.86, 95% CI (0.29, 2.49), P=0.78]. Conclusion In the patients of VVC, Kushen Gel combined with antifungal drug can effectively increase the negative conversion rate of pathogenic bacteria, reduce the recurrence rate, and accelerate the relief of clinical symptoms, which is superior to that of antifungal drug alone. And the combination regimen is safe in clinical application.

R285.64