Zirong Huang, Junqing Wu, Coffey Patricia S, Kilbourne-Brook Maggie, Yufeng Zhang, Wang Caiyan, Hongxin Zhao, Bin Wen, Yuyan Li, Hongbo Pei
Obstetrics and Gynaecology Hospital of the Fudan University Medical Centre, Shanghai, China.
Eur J Contracept Reprod Health Care. 2012 Jun;17(3):212-8. doi: 10.3109/13625187.2012.663016. Epub 2012 Apr 12.
The Woman's Condom, a second-generation female condom, is poised for introduction in China.
This single-arm couples' use study was conducted in China in 2010 to assess performance and safety of the Woman's Condom and feasibility of mobile phone technology to record adherence data.
Sixty couples were enrolled in this study, and 59 couples completed all four of the condom uses, resulting in 234 condom uses. Two condoms were opened but not used. Total breakage was 0.85% (two non-clinical breakages). Misdirection (2%), invagination (0.85%) and slippage (1%) were consistent with data on condom failure from other studies. Total clinical failure was 4%. Fifteen mild and no serious adverse events were reported during the study.
This study has shown that in China, the Woman's Condom performs well. Mobile phones cannot yet replace the use of a coital log and questionnaire. Further work on effectiveness is required.
第二代女用避孕套——女用安全套即将在中国推出。
2010年在中国进行了这项单臂夫妇使用情况研究，以评估女用安全套的性能和安全性，以及利用手机技术记录使用依从性数据的可行性。
本研究招募了60对夫妇，59对夫妇完成了全部四次避孕套使用，共使用了234次避孕套。有两个避孕套被打开但未使用。总破损率为0.85%（两次非临床破损）。方向错误（2%）、内陷（0.85%）和滑脱（1%）与其他研究中避孕套失败的数据一致。总临床失败率为4%。研究期间报告了15起轻微不良事件，无严重不良事件。
本研究表明，在中国，女用安全套性能良好。手机尚不能取代性交记录日志和问卷的使用。还需要进一步开展有效性方面的工作。
