国产凤康^(TM)牌与进口Femidom~牌聚氨酯女用安全套性能的随机交叉试验研究

Functional performance of phoenurse^(TM) polyurethane female condoms and Femidom~ polyurethane female condoms:a randomized crossover trial among female sex workers in China

目的通过临床实验比较国产凤康牌TM聚氨酯女用安全套(FC2)和进口Femidom牌聚氨酯女用安全套(FC1)的性能。方法采用随机交叉实验方法,从2007年9月到12月底,在南方沿海的一个小城市进行了随机交叉实验研究。结果291名性工作者一共使用了3 428个FC2和3 369个FC1。27.1%的人认为FC2的外观设计好,22%的人认为FC1的设计好。两种女用安全套在使用时破裂(FC2=2.9%,FC1=3.6%)、一次放置到位(FC2=63.1%,FC1=65.4%)、感觉有外环(FC2=58.1%,FC1=59.3%)、感觉有内环(FC2=48.7%,FC1=50.7%)、阴茎从套外进入(FC2=11.8%,FC1=12.9%)、外环被压到阴道内(FC2=8.0%,FC1=7.1%)、有不适感(FC2=31.6%,FC1=29.4%)等方面没有明显差异。结论国产凤康牌女用安全套(FC2)和进口Femidom牌女用安全套(FC1)在基本性能方面相似。更多的女性工作者认为FC2的外观设计较好。

Objective To compare the functional performance of Femidom polyurethane female condoms （FC1） with phoenurseTM female condoms （FC2） among female sex workers （FSWs） in China. Methods A study of crossover design with simple randomization of the sequence of the two types of condoms was conducted in a small southern coastal city of Guangdong province from September to December of 2007. Results A total of 3 428 FC2 and 3 369FC1 condoms were used by 291 female sex workers. Of them 27.1% appreciated FC2＇s better external design while 22% spoke highly of FC1 ＇s design. The cumulative clinical breakages （condoms break during sex intercourse） of two types of condoms were similar （FC2-2.9 % ;FC1-3.6 % ）. There was no significant difference between them in terms of one time correct placement （FC2-63. 1% ;FC1-65.4%）,feeling of outer-ring （FC2-58.1% ;FC1-59.3%） or inner-ring （ FC2-48.7 % ; FC1-50.7% ）, discomfort during sex （ FC2-31.6 % ; FC1-29.4 % ）, incorrect penetration （ pe his between condom and vaginal wall） （ FC1,12.9% ; FC2,11.8 % ）, and outer ring displacement （the condom was pushed inside the vagina） （FC1-7.1% and FC2-8.0%）. Conclusion There is no difference in the functional performance between FC1 and FC2. More participants think that FC2 has better external design than FC1 （FC2- 27.1% ;FC1-22%）.