壬苯醇醚避孕药膜的临床研究

CLINICAL STUDY OF THE “C-FILM”CONTAINING NONOXYNOL-9

894对健康、已育的育龄夫妇,随机分两组:447对使用壬苯醇醚方型膜,447对使用帽型膜,经两年连续观察。按生命表统计法处理数据。总使用妇女月,方型组9601,帽型组9382,随访率100%。累计停用率、妊娠率和续用率,方型组分别为16.8%、15.3%和83.2%,帽型组为18.4%、15.6%和81.6%,两组无显著差异(p>0.05)。临床和实验室资料表明壬苯醇醚药膜是安全、有效、简便、易于推广的避孕药具之一。

Eight hundred and ninety-four healthy fertile couples were selected to set up the trials of the square-shaped 'C-film' (SS) and the cap-shaped 'C-film' (CS). They were randomly assigned to two groups: 447 with SS and 447 with CS during the period of 2 years. Statistical evalution of results was performed with a life-table analysis. The total womenmonth of use was 9601 in SS and 9382 in CS, with the follow-up visits rates being 100%. The cumulative net rates of discontinuation, accidental pregnancy and continuation were 16.8%, 15.3% and 83.2%, respectively in SS, while 18.4%, 15.6% and 81.6%, in CS(p>0.05). Clinical and laboratory examinations were completed periodically to confirm the effectiveness, safety, simplicity and acceptance of the film.