香莲栓治疗复发性外阴阴道念珠菌病的前瞻双盲多中心随机对照研究  

Effects of Xianghan Suppository on RVVC:A prospective,double-blind,multicenter randomized controlled study

作　　者：范瑞强[1] 陈信生[1] 杨洁 袁小红[1] 袁娟娜[1] 陈颐[1] 周蜻 李恒[4] 谢波[5] 查旭山[6] 

机构地区：[1]广东省中医院,广州510120 [2]海南省皮肤病医院,海口570206 [3]云南省中医院,昆明650021 [4]湖北省中医院,武汉430061 [5]广东省第二中医院,广州510095 [6]广州中医药大学第一附属医院,广州510405

出　　处：《中华中医药杂志》2016年第2期696-700,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家"十一五"科技支撑计划项目(No.2008BAI53B041)~~

摘　　要：目的:评价中药香莲栓外用治疗复发性外阴阴道念球菌病(RVVC)的疗效及安全性。方法:采用前瞻性、双盲双模拟、多中心、随机对照方法,将248例RVVC患者随机分成两组,至少完成1次观察的患者有235例,其中中药香莲栓+硝酸咪康唑栓模拟剂组(治疗组)116例、硝酸咪康唑栓+香莲栓模拟剂组(对照组)119例,观察两组患者真菌转阴率、复发率、主要症状体征评分、生活质量评分及安全监测指标,比较两组的疗效和安全性。结果:治疗组治疗RVVC的治愈率、有效率、真菌转阴率、主要症状体征评分、生活质量评分与对照组比较差异无统计学意义,均未出现严重不良反应。结论:中药香莲栓与硝酸咪康唑栓治疗RVVC疗效相当,安全性较好,具有推广应用前景。Objective：To evaluate the curative effect and security of treating recurrent vulvovaginal candidiasis（RWC）with external application of Xianglian Suppository.Methods：Two hundred and thirty-five cases of RWC patients were randomly divided into two groups according to prospective,double-blind,multicenter randomized controlled method.There were 116 cases of patients in combination of Xianglian Suppository and miconazole nitrate suppository placebo group,and 119 cases of patients in combination of miconazole nitrate Suppository and Xianglian Suppository placebo group.The curative effect and safety of the two groups were compared by measuring the indicators as negative conversion rate of fungus,relapse rate,scores of main symptoms and signs,score of life quality and safety monitoring indicators.Results：The difference in curative rate,effective rate,negative conversion rate of fungus,scores of main symptoms and signs,and score of life quality of patients in Xianglian Suppository treatment group and control group was not significant.There was no serious adverse reaction.Conclusion：The curative effect of Xianglian Suppository was equivalent to that of miconazole nitrate suppository in treating RWC,which was worth to be popularized and applied with good safety.

关 键 词：双盲双模拟 随机对照 多中心 香莲栓 复发性外阴阴道念珠菌病 

分 类 号：R271.9[医药卫生—中西医结合]