B超监测下吉妮和TCu 380 A宫内节育器592例临床分析

目的:①多中心观察B超监测下放置吉妮和TCu380A宫内节育器(IUD)并随访12月的临床效果;②探讨吉妮IUD近期脱落的原因。方法:随机分组并在B超监测下放置吉妮IUD289例,TCu380AIUD303例,术后1、3、6、12月定期妇科及B超随访,记录受试对象病史、术时和术后情况,用SPSS10.0软件包进行数据处理,以生命表方法统计结果并行显著性检验。结果:①术后疼痛症状发生情况TCu380AIUD组明显高于吉妮IUD组,差异有显著性(P<0.05);术后6、12月随访月经紊乱以TCu380AIUD组为高,差异有显著性(P<0.05)。②术后6月、12月生命表结果提示吉妮IUD组因出血和疼痛的终止率较TCu380AIUD组低,差异有显著性(P<0.05)。③子宫后位者易发生带器妊娠,脱落与月经量及置器医生放置IUD质量有关。结论:吉妮IUD的避孕效果与国际推荐使用的TCu380AIUD一致,置器后出血和疼痛副反应少于后者。引入B超监测IUD放置过程对杜绝放置的不安全隐患有重要作用,也是在监控和验证放置IUD质量、年轻医生的培训过程及基层推广应用中必须注意的问题。

Clinical comparative study of 592 cases of GyneFix IN & TCu380A IUD indicated by B-ultrasonic

Objective:To evaluated clinical efficacy of GyneFix IN and TCu380A IUD indicated by B-ultrasonic after 12 months insertion and to explore the reasons of expulsion in late time after insertion .Methods:The study is a randomized multicentric comparative clinical trial. Health childbearing age women were allocated into GyneFix IN group (n= 289), TCu380A group (n= 303). The IUD was inserted indicated by B-ultrasonic. All the participants followed-up were arranged at 1, 3, 6, 12 months after insertion. The status of medical history, at insertion and after-insertion were recorded to analyze and compare with life table method.Results:(1) The number of women with complaint of pain was significantly lower in GyneFix IN group than that in TCu380A group after insertion (P<0.05). The number of women with complaint of bleeding was less in GyneFix IN group at 6,12 months after insertion (P<0.05). (2) The result of life-table method of pregnancy with IUD, expulsion and use IUD-related discontinuation was not statistically difference; The discontinuation rate of bleeding and expulsion was less in GyneFix IN group (0.35/100 women) than that in TCu380A group (2.97/100 women, P<0.05). (3) The pregnancy with IUD was high in retroversion flexion of uterus (P<0.05); The expulsion was high in the cases of too much menses-amount and by insertion of the two doctors (P<0.05).Conclusion:The contraceptive efficacy in GyneFix IN IUD is the same excellent as TCu380A IUD, and the side effect is lower than latter's. It is important to control and test & verify the quality of inserted-IUD indicated by B-ultrasonic, to avoid hidden dangers of insecurity, especially in training doctors and extending appliance in the basic units of medicine & family planning service.