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
10.3760/cma.j.cn112141-20200403-00293
- VernacularTitle: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
- Author:
Lei ZHANG
1
;
Qinping LIAO
;
Chaohua WANG
;
Dai ZHANG
;
Ruifang AN
;
Jianhua ZHENG
;
Ying WANG
;
Qiongqiong ZHANG
;
Rui CHEN
Author Information
1. 清华大学附属北京清华长庚医院 清华大学临床医学院妇产科 102218
- From:
Chinese Journal of Obstetrics and Gynecology
2020;55(10):697-702
- CountryChina
- Language:Chinese
-
Abstract:
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.
