聚维酮碘药膜与聚维酮碘栓随机单盲对照及开放试验治疗念球菌阴道炎  

Randomized Single - Blind Controlled and Non - Controlled Clinical Trial of Povidone - Iodine Pellicle in the Treatment of Candidalvaginitis

作　　者：胡丽娜[1] 杨竹[1] 漆洪波[1] 顾美礼[1] 张和声[2] 蒋利华 卞度宏 陈一梅 刘玉明[3] 

机构地区：[1]重庆医科大学第二临床学院妇产科,重庆400010 [2]重庆医科大学第一临床学院妇产科,重庆400046 [3]重庆市妇幼保健院,重庆400012

出　　处：《中国医药导刊》2000年第4期29-31,共3页Chinese Journal of Medicinal Guide

摘　　要：为研究聚维酮碘药膜治疗念珠菌阴道炎的疗效和安全性,以聚维酮碘栓作阳性对照,进行部分随机单盲,多中心平行对照及部分开放试验。两药分别阴道给药,聚维酮碘药膜每天100mg,连续7天,聚维酮碘栓每天200mg,连续7天。停药后5～7天内和停药月经后复查。结果表朋,随机对照试验组聚维酮碘药膜治疗近期治愈率74.3％,有效率91.4％,远期治愈率62.9％,有效率84.3％;对照组聚维酮碘栓治疗近期治愈率71.4％,有效率85.7％,远期治愈率61.4％,有效率81.4％,两种药物疗效比较,经统计学处理,差异无显著性意义(P>0.05)。开放试验组聚维酮碘药膜治疗近期治愈率75.0％,有效率82.5％,远期治愈率65.0％,有效率80.0％。提示聚维酮碘药膜治疗念珠菌阴道炎有效,用药剂量小,无明显不良反应。To research the efficacy and safety of povidone - iodine pellicle in the treatment of candidal vaginitis, a randomized, single - blind, multi - center and effectively controlled trial was conducted compared with povidone - iodine pessary. Seventy patients were given povidone - iodine pellicles via vagina 100mg daily for 7 days and another 70 patients, povidone -iodine pessaries, 200mg daily for 7 days. All patients were re - checked within 5 to 7 days after the treatment course and 3 to 7 days after the next mensis. The result showed that the short - term curative rate and effective rate were 74, 3% and 91. 4% while the long - term were 62. 9% and 84. 3% in the test group; and in the control group, the short -term curative rate and effective rate were 71.4% and 85. 7% while the long -term were 61.4% and 81.4% , respectively. There were no significant difference between two groups (P > 0. 05). A non - controlled trial of povidone - iodine pellicle was also done in 40 patients, with the short - term curative rate and effective rate 75. 0% and 82. 5% , and the long - term 65. 0% and 80. 0%, respectively. It is suggested that povidone - iodine pellicle has advantage of effectiveness, high safety, lower dosage and no evident adverse effect in the treatment of candidal vaginitis.

关 键 词：聚维酮碘药膜 念珠菌阴道炎 Ⅱ期临床试验 

分 类 号：R711.31[医药卫生—妇产科学]