固定式宫内节育器和TCu380A宫内节育器15年临床对比研究  

Fifteen Year′s Clinical Experience of Flexigard IUD and TCu380A IUD

作　　者：尉建霞[1] 韩丽晖[1] 

机构地区：[1]首都医科大学附属北京妇产医院,北京100026

出　　处：《实用妇产科杂志》2010年第9期697-700,共4页Journal of Practical Obstetrics and Gynecology

基　　金：世界卫生组织人类生殖研究发展和培训中心资助项目(编号:88902)

摘　　要：目的:探讨固定式宫内节育器(固定式IUD)和TCu380A IUD远期应用的效果,观察15年IUD铜结构的保留状况。方法:采用前瞻性临床对比研究方法,共接收受试者200例,固定式IUD组和TCu380A组各100例。于置器后3个月、6个月、12个月及以后每年随访1次,15年时测定受试者血浆中的铜离子含量,并根据年龄设立对照组。整理全部资料,进行统计学分析。结果:两组受试者各年粗累积妊娠率比较,差异无统计学意义(P>0.05)。妊娠与置器时年龄有关(P<0.05)。固定式IUD第1年的粗累积脱落率显著高于TCu380A组(P<0.01)。5年末、15年末两组的粗累积继续使用率比较,差异无统计学意义(P>0.05)。15年末,两组各年主诉的发生率比较,差异无统计学意义(P>0.05)。两组各年的粗累积因症取出率比较,差异无统计学意义(P>0.05)。宫颈细胞学检查未见肿瘤细胞。使用超过15年的受试者血浆铜离子水平两组间比较差异无统计学意义(P>0.05),与正常对照组相比,差异亦无统计学意义(P>0.05)。结论:固定式IUD和TCu380A IUD使用15年的避孕效果基本相似,均为高效、长效、安全的宫内节育器。Objective ：To evaluate the long-term efficacy and safety of Flexigard IUD and TCu380A IUD, and to investigate the residual copper ion in blood after fifteen years＇use. Methods： Prospective clinical trial was designed to recruit 200 volunteers who equally were divided into two groups （ one group received Flesigard IUD, the other group had TCu380A IUD）. All the women were followed up at 3, 6, and 12 months after IUD insertion and yearly thereafter. The blood copper level was checked in 15 years after IUD insertion. Results：There was no significant difference between the two groups in the cumulative pregnancy rate per year （P 〉 0.05）, Pregnancy rate was correlated with the women＇s age when IUD was inserted（ P 〈0.05）, Oneyear expulsion rate of Flexigard IUD was significantly higher than that of TCu380A（ P 〈0.01 ）. There was no significant difference in the consecutive usage rate of IUD at 5 and 15 years＇ insertion between the two groups（P〉0.05）. Also, between the two groups, the yearly main complaint rates and lUD removal rate were no difference （ P 〉0.05）. No cervical cancer was found by pap test. There was no significant difference in the blood copper level among the two groups and control group after 15 years observation （P 〉 0.05）. Conclusions ：The contraceptive effect of Flexigard IUD and TCu380A is equivalent, and both are long-term, highly effective, and safe IUD.

关 键 词：宫内节育器 避孕效果 副反应 

分 类 号：R169.1[医药卫生—公共卫生与预防医学]