置入MCu功能性宫内节育器1050例临床试验报告

The Clinial Study of 1 050 Cases Who Used the MCuIUD.

目的:研究新型MCu功能性宫内节育器(MCuIUD)的临床效果及可接受性。方法:由四个临床中心自 1997年9月～1998年9月进行1 050例临床观察,其中有 109例与TCu220C进行了随机抽样对比观察,随访率>98％。结果:1 050例使用12个月妊娠率及脱落率均为0,续用率为99.62/百妇女。放置 MCuIUD与 TCu220C各 109例,观察 12个月,续用率分别为99.08/百妇女和88.07/百妇女;两组累积妊娠率分别为 0和2.75/百妇女;两组累积脱落率各为0和0.92/百妇女;两组因症取出症率为0.92/百妇女、7.34/百妇女,经统计学处理,P<0.05,有显著性差异。副反应发生率两组P<0.01,差异非常显著。结论:MCuIUD组临床效果优于 TCu220C组,其抗生育效果好、脱落率低、副反应小、安全、适应证较广泛,取得国内外IUD应用中前所未有的临床效果。该产品已获国家医疗器械注册证,它的广泛应用将给广大育龄妇女在选择新的避孕工具方面提供良好的机会。

Objective:To investigate the clinical effect and acceptability of the new type functional intrauterine device: MCuIUD. Methods: In the four clinical centre, we investigated 1050 cases since 1997. 9 to 1998. 9. Among these cases,about 109 cases was made randomly selected contrast observation with the people who used the TCu220c. The following visit rate>98%. Result: Among the 1050 cases who used the MCuIUD,the pregnancy rate and natural dropping rate are zero;continuous using rate is 99.62%. Randomly inserted MCuIUD and TCu220c both 109 cases,after 12 months observation,the two terms' continuous using rate are 99.08% and 88.07% ;pregnancy rale are 0 and 2.75%;natural dropping rate are 0 and 0.92% ;removing rate for side-effect are 0.92% and 7. 34%. According statis-tics analysis P<0.05,it has significance difference. Side-effect rate P<0.01 ,it has significance differ-ence too. Conclusion: The clinical effect of the MCuIUD term is better than that of the TCuIUD term. The MCuIUD has better contraceptive effect,lower natural dropping rate,less side-effect secu-rity and general administration. It has got the Rejistery Certification from the Medicine Supervision and Management Bureau of China. The use of MCuIUD will benefit all the mature women.