乳酸菌阴道胶囊治疗外阴阴道假丝酵母病的效果评价OA
Evaluation of the efficacy of Lacidophilin Vaginal Capsules in the treatment of vulvovag-inal candidiasis
目的:评价在氟康唑治疗基础上联用乳酸菌阴道胶囊治疗外阴阴道假丝酵母病(VVC)的有效性与安全性.方法:采用随机、开放、阳性药平行对照、多中心临床研究设计,试验组60 例(氟康唑+乳酸菌阴道胶囊),对照组 66 例(单用氟康唑),评估综合疗效和安全性.结果:(1)治疗 7~9d 后,试验组治愈率为 50%,显著高于对照组的12.1%;治疗21~23d 后,试验组治愈率升至 95%,与治疗 7~9d 比较,差异有统计学意义(P<0.001).(2)治疗7~9d 后,试验组临床症状改善显著优于对照组[2.0(1.0,4.0)分 vs 4.0(2.0,5.0)分,P<0.001].(3)试验组病原学治愈率:治疗 7~9d 后为 25%,21~23d 后提高至80%.(4)无严重不良事件发生.结论:乳酸菌阴道胶囊联合氟康唑能有效改善 VVC 局部症状和体征,一定程度上清除病原体,短期(7~9d)有效,长期(21~23d)用药可进一步提升疗效,且安全性良好.
Objective:To evaluate the efficacy and safety of Lacidophilin Vaginal Cap-sules as an adjunctive therapy to fluconazole in the treatment of vulvovaginal candidiasis(VVC).Methods:A randomized,open-label,positive-drug parallel-controlled,multicenter clin-ical trial was conducted.The experimental group(n= 60)received fluconazole plus Lacidophil-in Vaginal Capsules,while the control group(n=66)received fluconazole alone.Comprehen-sive efficacy and safety endpoints were assessed.Results:(1)At 7~9 days follow-up,the clini-cal cure rate was 50%in the experimental group,significantly exceeding 12.1%in the control group.By the 21~23 days follow-up,the cure rate in the experimental group increased to 95%,representing a statistically significant improvement from the 7~9 days time point(P<0.001).(2)Symptom scores at 7~9 days were significantly lower in the experimental group[median score:2.0(IQR:1.0,4.0)vs 4.0(IQR:2.0,5.0);P<0.001].(3)The mycological cure rate in the experimental group increased from 25%at 7~9 days to 80%at 21~23 days.(4)No serious adverse events were documented in either group.Conclusion:Adjunctive use of Lacidophilin Vaginal Capsules with fluconazole effectively alleviates local symptoms and signs of VVC and facilitates pathogen clearance to a certain degree.The combination demonstrates short-term efficacy(7~9 days),with further therapeutic improvement following extended treatment(21~23 days),and exhibits a favorable safety profile.
王靖怡;张璐;吴江南;曹远奎;隋龙;丛青
复旦大学附属妇产科医院 宫颈与阴道早期疾病诊疗中心,上海 200011复旦大学附属妇产科医院 宫颈与阴道早期疾病诊疗中心,上海 200011复旦大学附属妇产科医院 临床研究中心,上海 200011复旦大学附属妇产科医院 宫颈与阴道早期疾病诊疗中心,上海 200011复旦大学附属妇产科医院 宫颈与阴道早期疾病诊疗中心,上海 200011复旦大学附属妇产科医院 宫颈与阴道早期疾病诊疗中心,上海 200011
医药卫生
外阴阴道假丝酵母病氟康唑乳酸菌阴道胶囊随机对照研究
Vulvovaginal candidiasisFluconazoleLacidophilin vaginal capsulesRandomized controlled trial
《现代妇产科进展》 2026 (6)
425-428,4
国家重点研发项目(No:2025YFC2708403)国家自然科学基金面上项目(No:82573189)上海市卫生健康委员会智慧医疗项目(No:2025ZHYL006)上海市卫生健康委员会医学新技术研究与转化种子项目(No:2025ZZ2007)
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