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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 evaluate the performance and safety of the new female condom. Methods: In February 2010, an uncontrolled clinical trial was conducted in Shanghai Putuo District, Luwan District, Xuhui District and Chongming County. A total of 60 eligible couples were enrolled. Each couple used 4 new female condoms in 1 month. Each was given a follow-up visit to the designated place after use and completed the usage log, questionnaire and adverse event notification form. Results: Fifty-nine out of 60 couples were followed up and 234 condoms were used. Two of them were opened but not used, with a total failure rate of 0.85%, a non-clinical failure. The total clinical failure rate was 4.27%, in which the dislocation rate was 2.14%, the incidence rate was 0.85%, and the rate of slipping was 1.28%. In 15 cases (6.41%) mild adverse reactions occurred, no serious adverse events were found. Conclusion: The new female condom used in this survey has good performance and high safety.