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目的了解国产女用避孕套(阴道套)的临床避孕效果。方法将603对育龄期志愿者夫妇随机分成两组,其中304对使用阴道套避孕(阴道套组),299对使用阴茎套避孕(阴茎套组)。随访6个月,以生命表法统计、Logrank检验比较两组的妊娠率、因症停用率和其他原因停用率等。603对夫妇使用前后宫颈刮片和阴道脱落细胞检查均无异常。结果6个月的随访率,阴道套组和阴茎套组分别为901%和9967%;两组粗累积妊娠率分别为106/100妇女和169/100妇女,粗累积因症停用率分别为139/100妇女和034/100妇女,差异无显著性(P均>0.05)。但其他原因停用,阴道套组显著高于阴茎套组(P<0.01),主要原因是半数以上志愿者试验前已习惯使用阴茎套。结论国产阴道套的临床避孕效果与阴茎套一样,是安全、可靠的。
Objective To understand the clinical contraceptive effect of domestic female condoms (vaginal cuffs). Methods A total of 603 pairs of couples of childbearing age were randomly divided into two groups, of which 304 were vaginal contraceptives (vaginal) and 299 were condoms (penile condom). Followed up for 6 months, according to the life table method, Logrank test compared the pregnancy rate, discontinuation rate due to disease and other reasons out of rate. 603 couple before and after the use of cervical smears and vaginal exfoliated cells were no abnormalities. Results The 6-month follow-up rate was 901% and 9967% for the vaginal and penile sets, respectively. The cumulative pregnancy rates of the two groups were 106 / 100 and 1.69 / 100 respectively Cumulative withdrawal rate was 1.39 / 100 women and 0.34 / 100 women, the difference was not significant (P all> 0.05). However, for other reasons, the vaginal group was significantly higher than the penile group (P <0.01). The main reason was that more than half of the volunteers had been accustomed to using the condom before the experiment. Conclusion Domestic vaginal sets of clinical contraception and condom effect, is safe and reliable.