Study on the efficacy of ketoconazole suppositories in the treatment of severe vulvovaginal candidiasis
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 ex-perimental group and the control group in a 1:1 ratio using a random number table method:136 cases in the experimen-tal 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 sta-tistically 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,and burning sensation.The incidence of adverse effects in the experimental group was lower than that in the control group(P＜0.001).Conclusion In the treatment of severe vulvovaginal candidiasis,the clinical and fungal efficacy of ketoconazole suppos-itories is not inferior to that of miconazole nitrate suppositories.The recurrence rate and incidence of adverse effects of ke-toconazole suppositories are lower than those of miconazole nitrate suppositories.
国家科技期刊平台
NSTL
万方数据
