克霉唑阴道膨胀栓与克霉唑阴道片治疗轻中度外阴阴道假丝酵母菌病多中心、随机、开放、阳性药物平行对照临床非劣效研究

A multicenter, randomized, open and positive parallel controlled clinical study of clotrimazole vaginal expansion suppository and vaginal tablet in the treatment of mild and moderate vulvovaginal candidiasis

目的以克霉唑阴道片为阳性对照,评价克霉唑阴道膨胀栓治疗轻、中度外阴阴道假丝酵母菌病在疗效、患者满意度、不良反应及复发率方面的结果。方法本研究于2017年8月至2018年10月由5家医院共同开展,以阴道分泌物真菌培养和临床症状体征评分确诊为轻、中度外阴阴道假丝酵母菌病的患者为观察对象,采用随机、对照、开放、阳性药物平行对照的多中心非劣效性临床研究设计,纳入211例患者,按照1∶1比例以随机数字表法随机分配至试验组与对照组,试验组105例使用克霉唑阴道膨胀栓(150 mg),每晚使用1次,连用7 d;对照组106例使用克霉唑阴道片(500 mg)单次给药。分别在停药后进行2次随访,评价药物治疗效果(治愈率、总有效率、复发率),用临床症状体征评分的差值评价临床症状改善情况,同时记录患者的满意度和不良反应。结果停药后第1次随访时,试验组和对照组的治愈率[分别为66.7%(70/105)、63.2%(67/106)]和总有效率[分别为98.1%(103/105)、99.1%(105/106)],差异均无统计学意义(P>0.05)。停药后第2次随访时,试验组和对照组的复发率分别为5.7%(4/70)和14.9%(10/67),差异无统计学意义(P>0.05)。在患者满意度评价中,试验组在药物外漏项明显优于对照组(P<0.01)。不良反应主要包括阴道刺激、瘙痒和灼热感,两组不良反应发生率无差异(χ2=1.070,P=0.586)。结论在轻、中度外阴阴道假丝酵母菌病的治疗上,克霉唑阴道膨胀栓的疗效不劣于克霉唑阴道片,两者的复发率无显著差异。在患者满意度方面,克霉唑阴道膨胀栓优于克霉唑阴道片。

Objective Using clotrimazole vaginal tablet as a positive control,to evaluate the results of clotrimazole vaginal expansion suppository in the treatment of mild and moderate vulvovaginal candidiasis in terms of efficacy,patient satisfaction,side effects,and recurrence rate.Methods This study was jointly conducted by 5 hospitals from August 2017 to October 2018,patients with mild and moderate vulvovaginal candidiasis confirmed by fungal culture and symptoms scores were selected.They were randomized to experimental group and control group as 1∶1 ratio.In the experimental group(n=105),the subjects applied clotrimazole vaginal expansion suppository(150 mg)daily at night for 7 days.In the control group(n=106),the subjects used a single dose of clotrimazole vaginal tablet(500 mg).Follow-ups were performed at(8±3)and(30±5)days after the discontinuation of the drugs,respectively.The difference in clinical symptoms and signs scores was used to evaluate the improvement of clinical symptoms,and the patient′s satisfaction and side effects were recorded.Results At the first follow-up,the experimental group and control group were followed up by fungal culture on the cure rate[66.7%(70/105)versus 63.2%(67/106),P>0.05]and total effective rate[98.1%(103/105)versus 99.1%(105/106),P>0.05],the differences were not statistically significant.At the second follow-up,the recurrence rates of the experimental group and the control group were 5.7%(4/70)and 14.9%(10/67),respectively,with no significant difference(P>0.05).In the evaluation of patient satisfaction,the leakage of the drug in the experimental group was significantly better than that in the control group(P<0.01).The side effects mainly included vaginal stimulation,itching and burning sensation,and there was no statistical difference between the two groups(χ2=1.070,P=0.586).Conclusions In the treatment of mild and moderate vulvovaginal candidiasis,clotrimazole vaginal expansion suppository is no less effective than clotrimazole vaginal tablet,and there is no significant difference in the recurrence rate between the two.In terms of patient satisfaction,clotrimazole vaginal expansion suppository is superior to clotrimazole vaginal tablet.