瘢痕子宫放置2种宫内节育器临床效果研究

Clinical Outcomes of Two Intrauterine Devices in Women with Scarred Uterus

目的:观察瘢痕子宫放置吉妮致美宫内节育器(IUD)和TCu220C IUD的使用效果。方法:采用随机对照研究,将2012年1月—2013年11月在杭州市计划生育宣传技术指导站符合条件的剖宫产后瘢痕子宫妇女434例随机分别放置吉妮致美IUD(224例)和TCu220C IUD(210例),比较避孕效果和不良反应的发生情况。结果:434例观察对象12个月末失访率为0.92%(4/434),观察期间无子宫穿孔、盆腔感染及IUD宫外异位。在使用IUD失败原因中,吉妮致美IUD、TCu220C IUD的脱落和下移、带器妊娠的发生率分别为0.90%、3.37%和0.90%、3.85%,吉妮致美组均低于TCu220C组,差异有统计学意义(P<0.05);因症取出率吉妮致美IUD为3.60%,TCu220C IUD为2.88%,差异无统计学意义(P>0.05),其中吉妮致美IUD以痛经、经期延长为主,TCu220C IUD以经量增多、经期延长和异常出血为主。与IUD使用相关的终止率比较,吉妮致美组低于TCu220C组,差异有统计学意义(P<0.05)。放置3个月、12个月后不良反应比较,吉妮致美组的出血增多、点滴出血发生率低于TCu220C组,差异均有统计学意义(P<0.05)。结论:吉妮致美IUD较TCu220C IUD更适用于剖宫产后的瘢痕子宫妇女,具有更低的脱落和下移率、带器妊娠率以及更少的不良反应。

Objective： To observe the clinical effectiveness of Gynefix intrauterine device （IUD） and TCu220C IUD in those women with scarred uterus. Methods：In this randomized control study, 434 women with scarred uterus, who had a history of cesarean section, in our institution from Jan 2012 to Nov 2013 were treated with Gynefix IUD （224 cases） and TCu220C IUD （210 cases）. The contraceptive effect and side effect in two groups were compared. Results：There were 4 women（0.92%） who lost the follow-up visit. There were no uterine perforation, pelvic infection and the IUD ectopia outside uterine. There were significant differences in the rate of expulsion and moving down （0.90%vs. 3.37%） and the rate of pregnancy with IUD （0.90% vs. 3.85%） between the Gynefix IUD group and the TCu220C IUD group （P〈0.05）. However, there was not significant difference in the rate of removing IUD between two groups （3.60%vs. 2.88%, P〉0.05）. The main side effects in the Gynefix IUD group were dysmenorrhea and menostaxis, while three main side effects in the TCu220C IUD group were menorrhagia, menostaxis and abnormal bleeding. The rate of discontinuation in the Gynefix IUD group was significantly lower than that in the TCu220C IUD group （P〈0.05）. Meanwhile, the rates of menorrhagia and bleeding spotting in the Gynefix IUD group during 3 and 12 month follow-up visiting were significantly lower than those in the TCu220C IUD group （P〈0.05）. Conclusions：Gynefix IUD, with lower rates of expulsion and moving down, pregnancy with IUD, and less side effects compared with TCu220C IUD, is more suitable for those women with scarred uterus who had the history of cesarean section.