放置元宫铜300、TCu380A及活性165 IUD 12个月效果观察

目的:观察元宫铜300、TCu380A和活性165宫内节育器(IUD)使用效果,探讨改善其使用价值的途径。方法:采用多中心随机比较性临床研究方法,自2007年7月3日~2008年11月21日,在全国6个省22家计划生育服务机构,对符合条件的健康育龄期妇女,随机分别放置元宫铜300、TCu380A或活性165IUD,比较避孕效果、失败率和不良反应的发生情况。结果:共接收观察对象3299例,放置元宫铜300、TCu380A和活性165IUD分别为1104、1104和1091例。12个月末失访率为0.24%(8/3299)。观察期间无子宫穿孔和盆腔感染发生。在IUD使用失败的各种原因中,3种IUD带器妊娠、下移取出终止率比较,差异均无统计学意义(P0.05);完全脱落以活性165最高(终止率为2.09/百妇女年),与元宫铜300(终止率为0.84/百妇女年)和TCu380AIUD(终止率为0.75/百妇女年)分别比较,差异均有统计学意义(P0.05);放置活性165IUD有4例发生意外妊娠(终止率为0.38/百妇女年),其他两种IUD各有1例(终止率均为0.11/百妇女年)。3种IUD中因出血和(或)疼痛的终止率以元宫铜300IUD最高,TCu380AIUD次之,活性165IUD最低,差异有统计学意义(P0.05)。结论:3种IUD各有优缺点,应综合考虑适用对象与IUD的特点,以提高IUD的实际使用价值。

Clinical effectiveness of Yuangong copper 300, copper T 380A and medicated copper ring 165 intrauterine devices

Objective： To observe the clinical effectiveness of Yuangong copper 300 （YGCu300）, copper T 380A （TCu380A） and medicated copper ring 165 （MCR165） intrauterine devices （IUDs）, and to explore the way to improve their use. Methods： A randomized, comparative, multi-- centre clinical trial was performed between July 3, 2007 and November 21, 2008. Totally 3299 eligible women were recruited and administered three types of IUDs randomly during their intermenstrum. Results： Among the 3299 women, 8（0.24 %） were excluded because of uncompleted the first year --follow up. There were 1104, 1104 and 1091 cases were inserted YGCu300, TCu380A and MCR165 IUDs, respectively. By the end of the first year, the pregnancy with IUD in situ among three groups were no significantly differences （P〈0.05）. The discontinuation rates of all expulsion of the three groups were similar（P〉0.05）. The rate of the total expulsion of MCR165 IUD （2.09 per hundred women year） was the highest, and there was significant difference between it and YGCu300 （0.84 per hundred women year） and TCu380A IUDs （0.75 per hundred women year） respectively （P〈0.05）. Four cases of unwanted pregnancy were found in the group of MCR165 IUD. The medical removal rate for bleeding/pain of three types of IUDs were 4.67 per hundred women year, 2.61 per hundred women year and 1.61 per hundred women year, showing significant differences among three groups （P〈0.05）. Conclusion： The three types of IUDs have different advantages and shortcomings. We should choose IUD for women according to their situation and the characteristic of IUD, and to improve the actual value of IUD in use.