不同时期放置宫内节育器TCu380A的临床效果比较

Efficacy of intrauterine device TCu380A when inserted in four different periods The Research

目的比较月经间期、人工流产负压吸引术后即时、哺乳早期和哺乳晚期放置含铜宫内节育器（IUD）TCu380A的临床使用效果。方法采用多中心比较性临床研究方法，自2004年7月1日-2005年6月30日，在11个省市的50家计划生育和医疗服务机构，分别在月经间期、负压吸引术后即时、哺乳早期和哺乳晚期给健康育龄期妇女放置TCu380AIUD，比较避孕效果、失败率和副反应发生情况。结果共接收观察对象2293例，其中，月经间期、负压吸引术后即时、哺乳早期和哺乳晚期分别为852、591、451和399例。1年末的失访率为0．44％（10／2293）；观察期间无子宫穿孔和盆腔感染发生。在TCu380AIUD使用的各种失败原因中，4种不同时期的带器妊娠率均较低（终止率≤0．51／百妇女年）；下移取出率，以哺乳晚期最高（终止率为8．08／百妇女年），负压吸引术后即时最低（终止率为3．97／百妇女年），4种不同时期间比较，差异有统计学意义（P〈0．05）；完全脱落率和部分脱落率以哺乳晚期最低，终止率分别为0．25、0．26／百妇女年；4种不同时期的疼痛和（或）出血取出率分别为1．94、1．73、1．42和1．33／百妇女年，但差异无统计学意义（P〉0．05）。结论4种不同时期放置TCu380AIUD均安全可行，效果可靠。

Objective To compare the effectiveness of TCu380A intrauterine device （IUD） inserted in menstrual interval, immediately after vacuum aspiration, and early and later lactation periods. Methods A comparative, muhicentre clinical trial was performed. Totally 2293 eligible women were inserted TCu380A IUD during the above mentioned 4 different period. Results Among 2293 women, 852 cases inserted in menstrual interval, 591 cases of them immediately inserted after vacuum aspiration, and 451 cases and 399 cases of them inserted at early and later lactation periods. By the end of 1st year, no uterine perforation and pelvic inflammatory disease were found. The pregnancy rates with IUD in situ from the four groups were low （ ~〈0. 51/hundred women year）. The rate of removal for displacement in the group of later lactation period was the highest （8. 08/hundred women year）, while the lowest （3.97/hundred women year） in the group of immediately after vacuum aspiration. There were significant difference among the four groups （ P 〈 0. 05 ）. The lowest rates of the total or partial expulsion were in the later lactation group, which were 0. 25 and 0. 26/hundred women year. The medical removal rate for bleeding and （or） pain in the four groups were 1.94, 1.73, 1.42 and 1.33/hundred women year, and there were no significantly difference among the four groups （P 〉 0. 05 ）. Conclusion Insertion of TCu380A IUD in the above mentioned four periods are feasible, safe and effectiveness.