目的 评价苦参凝胶联合口服氟康唑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 采用多中心、随机、双盲、安慰剂对照的临床试验设计。招募2024年6月—2025年10月于4家医院就诊的VVC患者，按1∶1比例随机分为安慰剂组和苦参凝胶组。两组均单次口服氟康唑150 mg，在此基础上，苦参凝胶组经阴道给予苦参凝胶，安慰剂组给予外观、性状一致的安慰剂凝胶，均连续用药14 d。主要疗效指标为停药后7～10 d的临床总有效率；次要疗效指标包括阴道微生态指标至少4项恢复正常的患者比例，外阴瘙痒、疼痛及分泌物症状完全消失时间，阴道清洁度、停药后25～31 d的真菌学复发率；同时观察不良事件以评价安全性。结果 共93例患者随机入组。停药后第7～10天访视时，苦参凝胶组临床总有效率显著高于安慰剂组（87.50% vs 65.00%，P＝0.033 9）。苦参凝胶组至少4项阴道微生态指标恢复正常的比例显著高于安慰剂组（97.50% vs 77.50%，P＝0.014 3）。苦参凝胶组外阴瘙痒消失时间、疼痛消失时间及异常分泌物消失时间均短于安慰剂组，但无统计学差异。停药后第25～31天随访时，苦参凝胶组真菌学复发率为10.53%（2/19），低于安慰剂组的23.81%（5/21）。两组不良事件发生率较低，且组间差异无统计学意义，均未发生严重不良事件。结论 在常规口服氟康唑治疗基础上联合使用苦参凝胶能有效缓解VVC患者临床症状，显著提升临床治疗有效率，促进阴道微生态恢复，有利于降低复发率，且安全性良好。

Objective To evaluate the clinical efficacy and safety ofKushen Gel combined with oral fluconazole in the treatment of vulvovaginal candidiasis (VVC). Methods A multicenter, randomized, double-blind, placebo-controlled trial was conducted. Patients with VVC who visited four hospitals between June 2024 and October 2025 were recruited and randomly assigned in a 1∶1 ratio to the placebo group or the Kushen Gel group. Both groups received a single oral dose of fluconazole 150 mg. Additionally, the Kushen Gel group received intravaginal Kushen Gel, while the placebo group received a placebo gel with identical appearance and properties, both for 14 consecutive days. The primary efficacy endpoint was the clinical response rate at 7—10 days after drug discontinuation. Secondary efficacy endpoints included the proportion of patients with normalization of at least four vaginal microecological indicators, time to complete resolution of vulvar pruritus, pain, and abnormal discharge, vaginal cleanliness, and mycological recurrence rate at 25—31 days after drug discontinuation. Adverse events were monitored to evaluate safety. Results A total of 93 patients were randomized. At the 7—10 days post-treatment follow-up visit, the clinical response rate in the Kushen Gel group was significantly higher than that in the placebo group (87.50% vs 65.00%, P = 0.033 9). The proportion of patients achieving normalization of at least four vaginal microecological indicators was significantly higher in the Kushen Gel group compared with the placebo group [97.50% vs 77.50%, P = 0.0143]. The times to resolution of vulvar pruritus, pain, and abnormal discharge in the Kushen Gel group were all shorter than those in the placebo group, but the differences were not statistically significant (P > 0.05). At the 25—31 days post-treatment follow-up, the mycological recurrence rate was 10.53% (2/19) in the Kushen Gel group, which was lower than that in the placebo group (23.81%, 5/21). The incidence of adverse events was low in both groups, with no statistically significant difference between groups (P > 0.05), and no serious adverse events occurred. Conclusion The combination of Kushen Gel with oral fluconazole can alleviate clinical symptoms, enhance short-term clinical efficacy, and may help reduce the recurrence rate, as well as, the recovery of vaginal microecology in patients with VVC. The treatment is safe and possesses significant clinical value.

R285.64

国家自然科学基金（81771530）