含25mg吲哚美辛MYCu宫内节育器应用的随机对照研究

A randomized clinical trial of intrauterine device MYCu

目的观察释放吲哚美辛的V形含铜含药宫内节育器（MYCu1UD）的临床效果及安全性。方法采用临床多中心，按统一标准选择2000例要求使用IUD避孕的妇女，随机放置MYCuIUD与T形含铜（TCu380A）IUD各1000例，放置后1、3、6、12个月时定期随访，监测效果及安全性。结果放置12个月时，MYCuIUD组与TCu380AIUD组分别使用11985．9、11753．6个妇女月，累积继续使用率分别为97．80％、94．70％；累积带器妊娠率分别为0．10％、0．31％（P〉0．05）；累积脱落（部分脱落）率MYCuIUD组为0．10％，低于TCu380AIUD组的1．73％（P〈0．01）；累积因医疗原因[出血和（或）疼痛]取出率分别为1．51％、2．94％（P〈0．05）；与IUD使用有关的终止、总终止率两组差异有统计学意义（P〈0．01）；置器后1、3、6、12个月时不规则出血、经期延长、经量增多及疼痛的发生率含吲哚美辛的MYCuIUD组明显少于不含吲哚美辛的TCu380AIUD组（P〈0．01）。结论MYCuIUD脱落率极低，抗生育效果好，置取方便、安全，置器后不良反应小，是比较理想的IUD，应推广使用。

Objective To observe safety and efficacy of intrauterine device MYCu IUD that releases indomethaein. Methods In total, 2000 women requiring IUD for contraception were chosen from domestic multiple clinical centers according to an unified standard. MYCu IUD and TCu380A IUD were randomly inserted for 1000 women each, respectively. All women were regularly followed-up one, three, six and 12 months after insertion. Results All the women were followed-up for 11 985.9 and 11 753.6 person-months in MYCu IUD and TCu380A IUD groups, respectively, with cumulative IUD application rates of 97.80% and 94. 70%, and cumulative pregnancy rates with IUD of 0. 10% and 0. 31% , respectively. Cumulative expulsion （or partial expulsion） rate in MYCu IUD group was 0. 10%, significantly lower than that in TCu380A IUD one （ 1.73% ）, P 〈0.01, and cumulative removal rate due to medical reasons （ bleeding or pain） was 1.51% and 2.94%, respectively, P 〈0. 05. Rate of IUD-associated termination and overall rate of termination differed significantly between the two groups, P 〈 0. 01. Adverse reactions one, three, six and twelve months after IUD insertion included irregular bleeding, prolonged menstruation, increased menstrual blood volume and pain, less in indomethacin-containing MYCu IUD group than those in TCu380A IUD without containing it, P 〈 0. 01. Conclusions MYCu IUD is a comparatively ideal IUD that should be promoted for extensive use, with extremely low expulsion rate, good contraceptive effect, convenience and safety in insertion and removal, and less adverse effects.