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目的 :观察 2 0 0 mg、40 0 mg硝酸咪康唑栓治疗初发与复发性外阴阴道念珠菌病的疗效。方法 :设计了一开放、随机、对照平行组的多中心临床试验。试验前、用药后 2周、4周分别进行阴道分泌物念珠菌镜检与培养 ,试验前与给药后 2周进行血尿常规与肝肾功能测定 ,并填写症状与不良反应日记卡。结果 :筛选共 16 3例 ,入组 15 0例 ,完成有效病例数为 12 4例。2组对象在年龄、疾病初发或复发及疾病严重程度等方面无显著性差异 (P≥ 0 .0 5 )。2 0 0 mg与 40 0 mg对初发病例的微生物疗效 2周时分别为 97.5 % ,90 .9% ;对复发病例为 85 .7% ,94.7%。两组的总体疗效相似 ,在用药 2、4周时 ,分别为 93.4% ,91.8% ,统计学分析差异无显著性。两组症状缓解时间分别为 5天与 5天 ,亦无统计学显著差异。性生活有无对两组的疗效无显著影响。 2组疗法对初发病例与复发病例的微生物疗效相似 ,无差异。月经期对用药有影响 ,用药依从性好 ,但 40 0 mg组 (3日疗法 )依从性更高。无严重毒副反应发生。结论 :硝酸咪康唑栓 2 0 0 mg、40 0 mg对初发与复发性外阴阴道念珠菌病疗效相似 ,40 0 mg药物依从性更好
Objective: To observe the curative effect of miconazole nitrate suppository of 200 mg and 400 mg nitrofurantoin for the treatment of recurrent vulvovaginal candidiasis. METHODS: An open, randomized, controlled, parallel multicenter trial was designed. Candida vaginal secretions before and after 2 weeks and 4 weeks after treatment were microscopically examined and cultured. Before and after treatment, hematuria and liver and renal function tests were performed 2 weeks after treatment, and symptoms and adverse reaction diary cards were filled in. Results: A total of 163 cases were screened and 150 cases were enrolled. The number of effective cases was 12 4 cases. There was no significant difference between the two groups in terms of age, initial disease or relapse and severity of disease (P≥0.05). The microbiological efficacy of 200 mg and 40 mg at the first trimester was 97.5% and 90.9% at 2 weeks and 85.7% and 94.7% at the second trimester respectively. The overall efficacy of the two groups were similar, at the time of treatment of 2,4 weeks, respectively, 93.4%, 91.8%, no significant statistical difference. Symptom relief time of two groups were 5 days and 5 days, there was no statistically significant difference. Whether sexual life had no significant effect on the efficacy of the two groups. 2 groups of treatment for initial and repeated cases of microbiological efficacy similar, no difference. Menstrual period affect the medication, medication compliance, but the 40 0 mg group (3-day therapy) higher compliance. No serious side effects occurred. CONCLUSION: The miconazole nitrate suppository 200 mg and 40 mg have similar efficacy in the treatment of recurrent vulvovaginal candidiasis and the compliance with 40 0 mg is better