四种型号国产宫内节育器的比较

国内5省市对3种新型国产宫内节育器(IUD)包括 TCu200c、宫形器及磁硅器与TCu220c进行随机临床多中心比较性研究。自1987年8月～1988年2月共接受合格对象4 003例。2年随访率99.9％。TCu220c、宫形器和磁硅器2年累积净妊娠率分别为1.6％、2.0％、6.2％和5.2％。两种 TCuIUD 妊娠率较宫形器、磁硅器显著低(P<0.001)脱落率分别为1.5％、1.6％、0.9％和1.9％均低于2％,与 IUD 有关的出血、疼痛、出血和疼痛取出率,分别为1.3％、1.1％、2.3％和2.9％,两种 TCu IUD显著低于宫形器和磁硅器(P<0.05和0.01)。2年修正后续用率分别为95.6％、95.3％和90.6％。以两种 TCu IUD 最高,与后两者相比有显著差异(P<0.001)。

A multicenter comparative clinical study of 4 types of domestic intrauterine devices

A muhicenter comparative study of the perfor-mance of TCu 200c,uterine-like and magne-tic silicone rubber intrauterine devices(IUD) withTCu 220c as the control device in a cohort of 4 003subjects was carried out in 5 provincial and municipalfamily planning research centers in China.The 2years follow-up rate of the study was 99.9% and thenet cumulative continuation rates per 100 women re-lated to IUD use were 95.6%,95.3%,90.6% and90.0% respectively,which illustrated the higher con-tinuation rate of both TCu IUDs.However,the preg-nancy rate of TCu IUDs were 1.6%(TCu 220c) and2.0%(TCu 200c) while the uterine-like and magne-tic silicone rubber IUDs were 6.2% and 5.2% respec-tively.Expulsion rate of 4 types IUD were 1.5%,1.6%,0.9% and 1.9% respectively.There was nosignificant differences.The removal rates for bleed-ing,pain or both related to the 4 types of IUD were1.3%,1.1%,2.3% and 2.9% respectively.The re-moval rate of both the TCu IUDs were significantlylower than the other 2 devices.