两种女用安全套使用性能的随机交叉试验研究  

A randomized comparative cross-over trial of functional performance of two female condoms

作　　者：席毛毛[1,2] 汪燕 贾丽丽 肖义青 李谦[1,2] 程怡民[2] 

机构地区：[1]北京协和医学院研究生院,100730 [2]国家人口计生委科学技术研究所 [3]青岛市经济技术开发区妇幼保健所

出　　处：《中国计划生育学杂志》2014年第6期390-393,398,共5页Chinese Journal of Family Planning

基　　金：国家科技部科技型中小企业技术创新基金(16508c2621R00165);天津市科技型中小企业技术创新基金项目(082XCXS F03000)

摘　　要：目的：通过临床试验比较国产凤康牌TM女用安全套（FC）和进VIFemaleCondom牌FC的使用性能。方法：从2013年4～10月，在青岛市黄岛区妇幼保健所纳入符合条件的已婚育龄妇女采用随机交叉试验的方法进行调查。结果：共调查300人次，最终纳入分析问卷290份。在使用性能上，除内陷率（国产3．00％、进口2．21％）两种FC无统计学差异外，FC的临床破裂率（国产0．41％；进口0．03％），错插率（国产4．21％；进口1．93％）及滑脱率（国产6．89％；进口4．97％）等方面，进口均小于国产（P〈0．05）。结论：我国普通人群中使用的两种FC，进口FC的使用性能优于国产FC，在外观、气味方面的满意度两者基本相同。Objective： To compare the functional performance of domestic phoenurseTM female condom （FC1） and im ported female condom （FC2） through clinical trials. Methods： Eligible married women in maternal and child health care centers of Qingdao Economic and Technological Development Zone were investigated using the method of randomized cross-over trial from April to October, 2013. Results： A total of 300 women were investigated, and 290 questionnaires were included in final analysis. As for the performance, there were no significant differences in the breakage rate （FC1=0.41%; FC2=0.03%）, the misinsertion rate （FC1=4.21% FC2=1.93%） and the slipping rate （FC1= 6.89%; FC2 = 4.97 % ） between two kinds of FC, while the rate of pressing ring into the invagination in FC1 （3.00% ） was significantly higher than that of FC2 （2.21%）. Conclusion： The functional performance of FC2 is better than FC1 in the general population of China, but these two kinds of condoms have the same satisfaction for the appearance and the odor.

关 键 词：女用安全套 普通人群 使用性能 随机交叉试验 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]