产褥期末放置MLCu375SL和TCu380A宫内节育器多中心比较性研究

A randomized multicentre comparative trial of MLCu375SL and TCu380A inserted at the end of puerperal period

目的比较妇女产褥期末放置TCu380A和MLCu735SL的安全性、有效性和可接受性。方法在9个临床中心采用随机密闭信封，接收合格对象1，600例；观察指标：妊娠、脱落和与出血和（或）疼痛有关的取出率和副反应；置器时间：产后40～60d，随访时间：置器后1、3、6、12、24和36个月；采用SAS软件和生命表法计算分析两种宫内节育器（IUDS）使用效果，Log-Rank卡方检验各终止率间的统计学差异，比例风险模型分析使用效果的可能的影响因素。结果两种IUDS的对象特征分布均匀，无统计学差异。置器后前9个月TCu380A组的续用率低于MLCu375SL组（P〈0．05），自12个月末起，TCu380A组的累积续用率开始高于MLCu375SL组，直至36个月末，但两组间无显著差异。TCu380A组和MLCu375SL组36个月末的累积续用率分别为85．91和82．83／100妇女。MLCu375SL组的累积妊娠率始终高于TCu380A组，从24个月末开始有显著差异（P〈0．05～〈0．01）。36个月末时TCu380A组和MLCu375SL组的累积妊娠率分别为0．94和3．24／100妇女。MLCu375SL组的累积脱落率自置器后7个月开始一直高于TCu380A组，从12个月起两者间差异显著，随使用时间的延长，差异呈增大趋势。36个月末时TCu380A组和MLCu375SL组的累积脱落率分别为4．07和7．27／100妇女（P〈0．01）。未发生盆腔感染和穿孔。两组因症取出率自第3个月开始有显著差异，MLCu375SL组显著低于TCu380A组（P〈0．05～〈0．01）。结论两种IUDS的妊娠率和脱落率均较低，均为现代高效IUDS。本研究中，未发生感染、穿孔，提示产褥期末放置这两种IUDS是可行和安全的。

Objective： To assess the safety, efficacy and acceptability of intrauterine devices （IUDs） of TCu380A and MLCu375SL inserted at the end of puerperal period. Methods.. The study was conducted in 9 clinical centers and a total of 1,600 women were recruited and randomly allocated to one of two groups with the sealed envelopes. The assessment indexes were the pregnancy rate, expulsion rate, removal rate due to bleeding and/or pain, and the complaints of side-effects. IUDs were inserted in 40-60 days post partum and the follow-ups were conducted in 1, 3, 6, 12, 24 and 36th month. The SAS software, and life-table and Log-Rank X^2 were used for the determination of contraceptive efficacy of two types of IUD and the COX proportional regression model for the analysis of the probable effect factors to the efficacy of the IUDs. Results： No statistical difference was found in the users＇ characteristics between two types of IUDs. The cumulative continuation rate of TCu380A was lower than that of MLCu375SL in the first 9 months after insertion （P〈0.05）, and it was slightly higher than that of MLCu375 from 12th month to 36th month, but there was no statistical difference between two groups. The cumulative continuation rate of TCu380A and MLCu375SL at the end of 36 months was 85.91 and 82.83/100 women, respectively. The cumulative pregnant rate in MLCu375SL group was consistently higher than that in TCu380A, and the statistical difference was found between two groups since the end of 24th month （P〈0.05-〈0.01）. The cumulative pregnant rates of TCu380A and MLCu375SL groups at the end of 36 months were 0. 94 and 3.24/100 women respectively. The cumulative expulsion rate of MLCu375SL was higher than that of TCu380A since the 7th month after insertion and the statistical difference was found since the 12th month, and the difference between two groups was getting bigger as the time was getting longer. The cumulative expulsion rates of TCu380A and MLCu375SL at the end of 36 months were 4.07 and 7.27/100 women respectively （P〈0.01）. There was no infection and perforation found in the study. The removal rate due to side-effects of TCu380A was significantly higher than that of MLCu375SL since the 3rd month after insertion （P〈0.05-〈0.01）. Conclusions：Both types of IUDs have rather low pregnant and expulsion rates, and they are of high efficacy. No infection and perforation were found in the study, which suggests that the insertion of these two types of IUDs is appropriate and safe. The influences on the health of mothers and babies were not found in the study. It is suggested that the women at the end of puerperal period could chose TCu380A or MLCu375 as the suitable contraceptive method.