B超监测下放置吉妮IN IUD的临床效果观察

目的:观察B超监测放置吉妮IN IUD宫内节育器的临床效果。方法:多中心随机分组在B超监测下放置吉妮IN IUD289例,TCu380A IUD 303例,分别于术后1、3、6、12、24、36个月行妇科及B超随访,以生命表方法统计结果并行显著性检验。结果:①术后疼痛TCu380A组明显高于吉妮IN组(P<0.05);术后6~36月,月经紊乱以TCu380A组为高(P<0.05)。②两组带器妊娠率均较低(吉妮IN组1.04/100妇女,TCu380A组1.32/100妇女,P>0.05);脱落率TCu380A组(6.60/100妇女)高于吉妮IN组(4.84/100妇女,P<0.05);吉妮IN组因出血和疼痛的终止率(2.77/100妇女)较TCu380A组(5.61/100妇女)低(P<0.05)。结论:吉妮INIUD具有与TCu380A IUD同样高的避孕效率,其在降低脱落率、因症取出率及副反应发生率方面优于TCu380A IUD。

Clinical Comparative Study of 592 cases of GyneFix IN and TCu380A IUD Indicated By B-ultrasonic for Three Years

Objective: To study the clinical effect of GyneFix IN and TCu380A intrauterine device (IUD) indicated By B-ultrasonic after 36 months insertion. Methods: The study was a randomized multicentric comparative clinical trial. Healthy childbearing age women were allocated into GyneFix IN set(n= 289) group and TCu380A set(n= 303) group. Each IUD was inserted indicated by B-ultrasonic and followed-up at 1, 3, 6, 12, 24, 36 months after insertion . Analysis with life table method was done and statistical analysis was adopted to compare the 2 sets. Results: (1) The number of women with complaint of pain was significantly lower in GyneFix IN set than that in TCu380A set after insertion(P<0.05). The number of women with complaint of bleeding was less in GyneFix IN set at 6-36 months after insertion(P<0.05). (2) At the end of the third year ,The pregnancy rate with IUD was all low in GyneFix IN set(1.04/100 women)and in TCu380A set(1.32/100 women, P>0.05). The expulsion rate was lower in GyneFix IN set(4.84/100 women)than that in TCu380A set(6.60/100 women, P<0.05). The termination rate for bleeding and pain was lower in GyneFix IN set(2.77/100 women)than that in TCu380A set(5.61/100 women, P<0.05). Conclusion: GyneFix IN shows the same good effectiveness as TCu380A in contraceptive efficacy, and it is better than TCu380A in the lower expulsion rate, the termination rate for bleeding and pain and the side effect.