Polatti Franco, Nappi Rossella Elena, Brundu Benedetta, Fantuzzi Mario, Frisenda Linda
Department of Obstetrics/Gynaecology, University of Pavia, Policlinico San Matteo, Pavia, Italy.
Arzneimittelforschung. 2003;53(10):730-7. doi: 10.1055/s-0031-1299819.
The dose-effect relationship of nifuratel (CAS 4936-47-4) + nystatin (CAS 1400-61-9, CAS 34786-70-4) (Macmiror Complex) in topical treatment of vulvo-vaginitis was studied.
Sixty patients with Trichomoniasis and/or Candidiasis were randomized to: 1) nifuratel 125 mg/nystatin 50000 IU, 2) nifuratel 250 mg/nystatin 100000 IU, 3) nifuratel 500 mg/nystatin 200000 IU. Undistinguishable ovules were intravaginally applied qd for 10 days. The dose-effect relationship was assessed by ANCOVA.
After 5 days the microbiological cure rate occurred in 10% of patients in the least dose, in 40% in the middle dose and in 85% in the highest dose group (P = 0.000). After 10 days of treatment, the microbiological cure rate increased to 45%, 84%, and 95%, respectively (P = 0.007). Clinical signs and symptoms gradually disappeared in a dose- and time-dependent manner. No relapse has been observed after 10 day-follow up on 46 patients.
The results confirmed a linear relationship between nifuratel + nystatin dose and effect. The least effective dose was nifuratel 250 mg + nystatin 100,000 IU once daily for 5 days and the best dose in terms of risk/benefit ratio was nifuratel 500 mg + nystatin 200,000 IU once daily for 5 days.
研究硝呋太尔（化学物质登记号4936-47-4）+制霉菌素（化学物质登记号1400-61-9、34786-70-4）（麦咪诺复合制剂）局部治疗外阴阴道炎的剂量效应关系。
将60例滴虫病和/或念珠菌病患者随机分为：1）硝呋太尔125mg/制霉菌素50000IU组，2）硝呋太尔250mg/制霉菌素100000IU组，3）硝呋太尔500mg/制霉菌素200000IU组。将外观无差异的栓剂每日阴道内给药1次，共10天。采用协方差分析评估剂量效应关系。
5天后，最低剂量组10%的患者微生物学治愈率达到标准，中等剂量组为40%，最高剂量组为85%（P=0.000）。治疗10天后，微生物学治愈率分别升至45%、84%和95%（P=0.007）。临床体征和症状呈剂量和时间依赖性逐渐消失。46例患者随访10天未观察到复发情况。
结果证实了硝呋太尔+制霉菌素的剂量与疗效之间存在线性关系。最低有效剂量为硝呋太尔250mg+制霉菌素100000IU，每日1次，连用5天；就风险/效益比而言，最佳剂量为硝呋太尔500mg+制霉菌素200000IU，每日1次，连用5天。
