活性γ型IUD(记忆合金)与TCu380AIUD的多中心随机对照临床研究  

Multicenter Randomized Controlled Clinical Trial of g-IUD (Memory Alloy) and TCu380A-IUD

作　　者：刘晓瑷[1] 方爱华[1] 黄紫蓉[2] 刘延[3] 程丽村 范晓芳 陆娟 王亚妹 吕燕萍 龚菊华 毛晓燕[10] 张文琴 肖江 王建华 徐红 康建中[1] 

机构地区：[1]上海交通大学医学院附属国际和平妇幼保健院,上海200030 [2]上海复旦大学妇产科医院,上海200011 [3]上海交通大学医学院附属瑞金医院,上海200025 [4]长宁区妇幼保健院,上海200051 [5]普陀区妇幼保健院,上海200060 [6]杨浦区妇幼保健院,上海200082 [7]松江区妇幼保健院,上海201600 [8]嘉定区妇幼保健院,上海201800 [9]浦东新区妇幼保健院,上海201206 [10]浦东新区人民医院,上海201200 [11]闵行区中心医院,上海201100 [12]青浦区中心医院,上海201700 [13]光明医院,上海201300 [14]嘉定区中心医院,上海201800

出　　处：《生殖与避孕》2011年第3期179-185,共7页Reproduction and Contraception

摘　　要：目的:观察活性γ-IUD(记忆合金)的妊娠率、脱落率、因症取出率和续用率、副作用及对生活质量的影响。方法:采用多中心随机对照的研究方法,对活性γ-IUD(记忆合金)与TCu380AIUD作临床效果比较。按常规要求放置IUD,在置器后的第3、6、12个月进行随访,观察临床效果和副作用。结果:共接纳对象1 987例,活性γ组993例,T-IUD组994例,对象的临床特征组间基本相似。置器后12个月的随访率活性γ组和T-IUD组分别为87.0%和86.6%;置器1年净累积续用率活性γ-IUD组为93.40%,T-IUD组为88.67%(P<0.01)。置器1年时粗累积脱落率活性γ-IUD组和T-IUD组分别为每100妇女年1.57和1.91(P>0.05),带器妊娠率分别为每100妇女年0.68和0.12(P<0.01);因IUD下移停用率分别为每100妇女年1.88和4.20(P<0.01);因出血停用率分别为每100妇女年1.13和4.10(P<0.01);因疼痛而停用、因症取出及非因症取出率组间相似。置器后各阶段副反应主诉的发生率活性γ-IUD组均明显低于T-IUD组(P<0.05)。生活质量均得到改善。结论:活性γ-IUD(记忆合金)比TCu380AIUD续用率高,下移和出血副反应少,是一种临床效果较好、副反应发生率较低的新型IUD。Objective： To evaluate the pregnancy rate,expulsion rate,termination rate due to symptom,cumulative continuous rate,side effects and life quatity of γ-IUD（memory alloy） in healthy Chinese women.Methods： This was a multicenter randomized controlled clinical study.γ-IUD（memory alloy） and TCu380A IUD（T-IUD group,as the control） were placed routinely.The follow-up visit was carried out in 3,6 and 12 months later to compare the clinical effects of two IUDs.Results： A total of 1 987 women were recruited（993 women in γ-IUD group and 994 in T-IUD group）.The clinical characteristics of women in two groups were similar.Follow-up rate in 12 months was 87.0% in γ-IUD group and 86.6% in T-IUD group.The net cumulative continuous rate in 12 months was 93.4% in γ-IUD group and 88.7% in T-IUD group（P0.01）.To compare the gross cumulative termination rate in 12 months of two groups,the expulsion rate was similar which was 1.57 and 1.91 per 100 women year in γ-IUD and T-IUD groups,respectively（P0.05）,the pregnancy rate was 0.68 and 0.12 per 100 women year（P0.01）,removed rate due to lower position IUD was 1.88 and 4.20 per 100 women year（P0.01）,removed rate due to bleeding was 1.13 and 4.10 per 100 women year（P0.01）,and removed rate due to pain or other reasons was similar in both groups.The side effects were less common in γ-IUD group than in T-IUD group（P0.05）.Life quality was improved in both groups.Conclusion： Compared with TCu380A IUD,γ-IUD possess the higher continuous rate,lower displacement and bleeding problem.Therefore,it is a new kind of IUD with priority of better clinical effectiveness and lower side-effects.

关 键 词：宫内节育器(IUD) 活性γ型 记忆合金 TCU380A 随机对照试验 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]