摘要
为了进一步对比两种国产皮下埋植避孕剂和Ｎｏｒｐｌａｎｔ在避孕效果、副反应和可接受性方面有无差异。方法：采用前瞻性、随机分配、定期随访的研究方法，全国有１０个临床中心分别承担国产Ⅰ、Ｉ型皮下埋植剂和Ｎｏｒｐｌａｎｔ各１００例，结果：自１９９３年开始共接收国产Ⅰ型１００１例，Ｉ型１０００例，Ｎｏｒｐｌａｎｔ９９８例。２４个月随访率为９９．２％，３６个月随访率为９９．１％。３年内仅国产Ⅰ型发生１例妊娠，Ⅰ型的净累积妊娠率为０．１每百妇女，因各种原因终止的净累积终止率国产Ⅰ、Ｉ型和Ｎｏｒｐｌａｎｔ分别为１５．１、１４．１和１２．９每百妇女，其中因月经问题而终止者占７５．１％。３６个月的续用率分别为８４．９％、８５．９％和８７．１％，３组间无差异。随访时的副反应主诉分别为２２．６％、１９．０％和１９．７％，３组之间也无差异。结论：３年的临床观察表明：两种国产皮下埋植避孕剂和Ｎｏｒｐｌａｎｔ一样，是一种高效、长效的避孕方法，在全国不同地区和群体中具有较高的可接受性，可供广大育龄妇女选用。
Objective:To compare the efficacy,side effects and acceptability of domestic subdermal implants I and II with imported Norplant. Method:A randomized prospective multicenter clinical trial was conducted in ten centers in China since 1993.Every center had recruited 100 cases each of three types of subdermal implants. Results:There were 1 001 cases of No.Ⅰ,implant 1 000 cases of NO.II implant and 998 cases of Norplant altogether.The follow up rate was 99.2% at the end of 24 months and 99.1% at the end of 36 months.One case failed in No.Ⅰimplant at 8 months after implantation and the net cumulative pregnancy rate was 0.1 per 100 womem.Total discontinuation rates were 15.1,14.1,and 12.9 per 100 women in the three groups respectively due to different reasons of termination.Among them about 75.1% was due to the menstrual problem.The continuation rate were 84.9%,85.9% and 87.1% respectively.There are no significant differences among these three types of implant.The incidence of side effect complaint were 22.6%,19.0% and 19.7% respectively at 36 months follow up. Conclusion:The result of this three years' follow up indicated that the domestic subdermal implant No.Ⅰand No.II, just as Norplant,are long term,highly effective contraceptive device and are acceptable in different areas by different people.It will be widely provided as a method of choice in China.
出处
《生殖医学杂志》
CAS
1999年第2期88-91,共4页
Journal of Reproductive Medicine
基金
国家计划生育委员会"八五"科技攻关课题
