酮康唑栓治疗重度外阴阴道假丝酵母菌病有效性研究  

Study on the efficacy of ketoconazole suppositories in the treatment of severe vulvovaginal candidiasis

作　　者：米兰[1] 张岱[1] 樊尚荣[2] 薛敏[3] 薛凤霞[4] 安瑞芳[5] 张蕾 王威[7] 王悦[8] 孙宇辉[9] MI Lan;ZHANG Dai;FAN Shang-rong;XUE Min;XUE Feng-xia;AN Rui-fang;ZHANG Lei;WANG Wei;WANG Yue;SUN Yu-hui(Peking University First Hospital,Beijing 100034,China;不详)

机构地区：[1]北京大学第一医院,北京100034 [2]北京大学深圳医院,广东深圳518036 [3]中南大学湘雅三医院,湖南长沙410013 [4]天津医科大学总医院,天津300052 [5]西安交通大学第一附属医院,陕西西安710061 [6]北京清华长庚医院,北京102218 [7]北京大学第三医院,北京100191 [8]浙江大学医学院附属妇产科医院,浙江杭州310006 [9]哈尔滨医科大学附属第一医院,黑龙江哈尔滨150001

出　　处：《中国实用妇科与产科杂志》2024年第3期340-343,共4页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：国家自然科学基金(62273326)。

摘　　要：目的 评价酮康唑栓治疗重度外阴阴道假丝酵母菌病的有效性、不良反应及复发率。方法 2022年4月至2023年10月由9家医院共同开展,以阴道分泌物真菌培养和临床症状及体征评分确诊为重度外阴阴道假丝酵母菌病的患者为观察对象,采用前瞻性随机、阳性药物平行对照的多中心临床研究设计,共纳入253例患者,按照1∶1比例以随机数字表法分配至研究组与对照组:研究组136例使用酮康唑栓每晚400mg阴道给药,连用6d;对照组117例使用硝酸咪康唑阴道软胶囊400mg阴道给药,连用6d。分别在停药后10d及30d进行2次随访,评价药物治疗效果;以症状及体征评分下降≥67%为临床痊愈,临床痊愈且真菌学阴性的患者占比为临床总有效率(主要疗效指标),同时记录患者的不良反应。结果 停药后10d随访时,临床总有效率研究组和对照组分别为84.6%、78.6%;真菌学痊愈率研究组为87.5%、对照组为83.8%;临床痊愈率研究组为91.2%、对照组为88.0%,上述指标两组差异均无统计学意义。停药后30d临床痊愈率研究组为91.9%、对照组为81.1%,差异无统计学意义;真菌学复发率研究组为14.8%,对照组为26.7%,差异有统计学意义(P=0.039)。不良反应主要包括阴道刺激、瘙痒和灼热感,研究组不良反应发生率低于对照组(P<0.001)。结论 在重度外阴阴道假丝酵母菌病的治疗方面,酮康唑栓的临床疗效及真菌学疗效不劣于硝酸咪康唑阴道软胶囊,酮康唑栓的复发率及不良反应发生率低于硝酸咪康唑阴道软胶囊。Objective To evaluate the efficacy,adverse reactions,and recurrence rate of ketoconazole suppositories in the treatment of severe vulvovaginal candidiasis,using miconazole nitrate vaginal soft capsules as a positive control drug.Methods This study was jointly conducted by 9 hospitals from April 2022 to October 2023,with patients diagnosed with severe vulvovaginal candidiasis as observation subjects.A prospective randomized,positive drug parallel controlled multicentered clinical study design was adopted,and 253 patients were included.They were randomly assigned to the experimental group and the control group in a 1:1 ratio using a random number table method:136 cases in the experimental group were treated with ketoconazole suppositories administered intravaginally at 400mg per night for 6 consecutive days,while 117 cases in the control group were treated with miconazole nitrate vaginal soft capsules at 400mg administered intravaginally for 6 consecutive days.Two follow-up visits were conducted at 10 and 30 days after finishing of drugs to evaluate the effectiveness of drug treatment.A decrease of≥67%in symptom and sign scores and a negative fungal test were used as clinical recovery criteria,and adverse effects of the patients were recorded.Results At the 10th day follow-up after stopping medication,the total clinical effective rates of experimental group and control group were 84.6%and 78.6%,respectively;the fungal recovery rate was 87.5%and 83.8%in experimental group and control group respectively;the clinical recovery rates were 91.2%in the experimental group and 88.0%in the control group;there was no statistical difference in the obove indexes between the two groups.The clinical recovery rates of the two groups at 30 days after discontinuation were 91.9%and 81.1%,respectively,with no statistically significant difference;the fungal recurrence rate was 14.8%in the experimental group and 26.7%in the control group,with a significant difference(P=0.039).Adverse effects mainly included vaginal irritation,itching,

关 键 词：酮康唑 重度外阴阴道假丝酵母菌病 治疗 

分 类 号：R711.7[医药卫生—妇产科学]