含吲哚美辛MYCu宫内节育器应用60个月的随机对照研究  

A random control study of indomethacin-containing MYCu intrauterine contraceptive device for 60 months

作　　者：王立岩[1] 李淑芝[2] 武淑英[3] 赵艳晖[4] 王玉[5] 

机构地区：[1]吉林大学中日联谊医院妇产科,长春130031 [2]北京大学第一医院妇产科 [3]北京大学第三医院妇产科 [4]吉林大学第二医院妇产科 [5]中国医科大学附属盛京医院妇产科

出　　处：《中华医学杂志》2013年第7期496-499,共4页National Medical Journal of China

摘　　要：目的探讨含吲哚美辛MYCu宫内节育器（IUD）的临床效果及安全性。方法2004年10月1日至2004年12月31日，在吉林大学中日联谊医院、北京大学第一医院、北京大学第三医院、吉林大学第二医院、中国医科大学附属盛京医院门诊选择要求放置IUD避孕的育龄妇女，随机放置MYCuIUD及对照品TCu380AIUD各1000例，术后第1、3、6、12、24、36、48、60个月随访。结果放置满60个月，MYCu组与TCu组比较，累积带器妊娠率分别为2．38／每百妇女年、2．84／每百妇女年，差异无统计学意义（P〉0．05）；累积脱落率依次为0．87／每百妇女年、2．94／每百妇女年，差异有统计学意义（P〈0．05），主要为部分脱落及下移取出；因出血／疼痛累积终止率分别为3．57／每百妇女年、4．83／每百妇女年，差异元统计学意义（P〉0．05）；放置后不良反应发生MYCu组低于TCu组，多组数据差异有统计学意义（P〈0．05）。结论MYCuIUD为一种药械结合的IUD，抗生育效果好、脱落率低、不良反应发生率低、可逆性好，尤其具有放置初期出血和疼痛发生率低的特点，是比较理想的IUD。Objective To explore the clinical efficacy and safety of MYCu intrauterine contraceptive device （IUD） containing indomethacin. Methods From October 1 to December 31, 2004, women of child- bearing age requiring IUD for contraception were chosen from the Outpatient Departments of China-Japan Friendship Hospital of Jilin University, Peking University First Hospital, Peking University Third Hospital, Jilin University Second Hospital and Affiliated Shengjing Hospital of China Medical University. They were randomly inserted with MYCuIUD and control TCu380A IUD each for 1000 cases and followed up at 1, 3, 6, 12, 24, 36, 48 and 60 months post-insertion. Results When MYCu IUD group and TCu380A group 60 months post-insertion were compared, the cumulative pregnancy rates with IUD in situ were 2. 38/100 women per year and 2. 84/100 women per year respectively. And the difference had no statistical significance （ P 〉 0. 05 ） ; the cumulative expulsion rates, mostly of partial expulsion and downward movement, were 0. 87/100 women per year and 2.94/100 women per year respectively. And the difference had statistical significance（ P 〈 0. 05 ） ; the cumulative termination rates due to bleeding/pain were 3.57/100 women per year and 4. 83/100 women per year respectively. And the difference had no statistical significance （ P 〉 0. 05 ）; Side effects in MYCu group were less pronounced than those in TCu group. And the inter-group differences had statistical significance （ P 〈 0. 05 ）. Conclusion As a comparatively ideal medicated medical device, MYCu IUD has an excellent contraceptive efficacy, a low rate of expulsion and side effects and good reversibility. Particularly a low occurrence rate of bleeding and pain during early insertion is recommended. Its life expectancy is 15 years. And its contraceptive effectiveness and safety after 5 years should be examined during further follow-ups.

关 键 词：宫内避孕器 含药 铜 临床对照试验 

分 类 号：R169.4[医药卫生—公共卫生与预防医学]