月经间期放置MYCu宫内节育器临床效果的比较性研究

A clinical comparative study on insertion of MYCu and TCu380A intrauterine devices at menstrual interphase

目的:了解第三代爱母宫内节育器(MYCu IUD)在月经间期放置的临床效果、副作用及对生活质量的影响。方法:对要求放置IUD避孕的育龄妇女,在月经间期随机放置MYCu IUD(MYCu组,368例)与TCu 380AIUD(TCu380A组,369例),放置后1、3、6、12个月随访观察,记录使用情况。结果:置器后12个月MYCu组与TCu 380A组随访率分别为99.45%、100.00%;置器12个月累积续用率分别为每百妇女年94.02、91.87(P>0.05);带器妊娠率分别为每百妇女年0.56、0.00(P=0.1703);脱落率分别为每百妇女年0.57、1.95(P=0.0947);无因IUD下移而停用者;因症终止率分别为每百妇女年3.01、6.03(P=0.0849)。置器后1、3、6个月副作用发生率MYCu组明显低于TCu380A组(P<0.05)。两组对象相关生活质量均得到改善。结论:放置MYCu IUD较TCu 380AIUD疼痛和出血的副作用少,续用率、避孕效果与TCu 380AIUD相当,是一种临床效果好、副作用发生率较低的新型IUD。

Objectivei To compare the effectiveness, side effects and life quality of MYCu intrauterine device （IUD） in healthy Chinese women. Methods.. The women of childbearing age seeking for IUD insertion were randomly divided into MYCu （n=368） and TCu380A （n=369） groups. And IUD was inserted at the menstrual interphase. The follow-up visits were carried out in 1, 3, 6 and 12 months to compare the clinical effects of two IUDs. Results： The follow-up rates in 12 months were 99.45% and 100.00% in MYCu group and TCu380A group, respectively. The cumulative con- tinuous rate in 12 months was 94.02 and 91.87 per 100 woman-years, respectively （P〉0.05）. The pregnancy rate with IUD in situ were 0.56 and 0.00 per 100 woman-years, respectively （P=0.1703）. The expulsion rate were 0.57 and 1.95 per 100 woman-years, respectively （P =0.0947）. No IUD removal due to lower position was found. The removal rates due to bleeding and paining were 3.01 and 6.03 per 100 woman-years, respectively （P=0.0849）. The side effects were less common in MYCu group than in TCu380A group in 1, 3 and 6 months （P〈0.05）. Life qualities were improved in both groups. Conclusion.. Compared with TCu380A IUD, MYCu IUD shows similar continuous rate and pregnancy rate, lower pain as well as bleeding rates. Therefore, it is a kind of IUD with priorities of better clinical effectiveness and lower side-effects.