CAJ | 학술논문

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,差异无统计学意义(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.
목적 탐토함신타미신MYCu궁내절육기(IUD)적림상효과급안전성.방법 2004년10월1일지2004년12월31일,재길림대학중일련의의원、북경대학제일의원、북경대학제삼의원、길림대학제이의원、중국의과대학부속성경의원문진선택요구방치IUD피잉적육령부녀,수궤방치MYCuIUD급대조품TCu380AIUD각1000례,술후제1、3、6、12、24、36、48、60개월수방.결과 방치만60개월,MYCu조여TCu조비교,루적대기임신솔분별위2.38/매백부녀년、2.84/매백부녀년,차이무통계학의의(P＞0.05)；루적탈락솔의차위0.87/매백부녀년、2.94/매백부녀년,차이유통계학의의(P＜0.05),주요위부분탈락급하이취출；인출혈/동통루적종지솔분별위3.57/매백부녀년、4.83/매백부녀년,차이무통계학의의(P＞0.05)；방치후불량반응발생MYCu조저우TCu조,다조수거차이유통계학의의(P＜0.05).결론 MYCuIUD위일충약계결합적IUD,항생육효과호、탈락솔저、불량반응발생솔저、가역성호,우기구유방치초기출혈화동통발생솔저적특점,시비교이상적IUD.
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 childbearing 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.