新型女用安全套的使用性能调查研究

Investigation on functional performance of a female condom in Shanghai users

目的:评估新型女用安全套的使用性能及安全性。方法:2010年2月在上海市普陀区、卢湾区、徐汇区及崇明县开展无对照的临床试验研究。共招募60对符合条件的夫妇,每对夫妇在1个月内使用4只新型女用安全套,每一只使用完后到指定地点接受随访,填写使用日志、调查表及不良反应事件表等。结果:60对夫妇中有59对完成随访,共使用234只安全套。其中2只被打开但未使用,总失败率0.85%,为非临床失败。总临床失败率为4.27%,其中错位率2.14%,内陷率0.85%,滑脱率是1.28%。有15例(6.41%)发生轻微不良反应,未发现严重不良事件。结论:本次调查的新型女用安全套使用性能良好,安全性高。

Objective： To assess the functional performance and safety of a female condom in Shanghai users. Methods： The single - arm clinical trial was conducted in Shanghai in 2010. We recruited 60 couples from four districts of the city. The cou-ples were asked to use the female condom at home and four times of condom uses were finished within 1 month. After each condom use, the users were interviewed and asked to complete condom use questionnaires, a diary and an adverse event note. Results ： Fifty - nine couples completed all of four condom uses, and a total of 234 condom were used, with 2 condoms opened but not used. Total breakage was 0.85% （two non - clinical breakages）. Misdirection （2.1%） , invagination （0.85% ） and slippage （ 1.3% ） were consistent with data on condom failure from other studies. Total clinical failure was 4.3%. Fifteen mild adverse reactions were reported during the study. There was no serious adverse event recorded. Conclusion： This kind of female condom performed well in Shanghai users.