GyneFixIN与Tcu380A宫内节育器的随机比较性临床研究.docVIP

GyneFix IN与Tcu 380A宫内节育器的随机比较性临床研究 吴尚纯 胡 静 吴明辉 翁梨驹 吴学浙 庄留琪 曹晓明 朱筱玲 经小平 王伟澄 杨秀兰 高亚杰 丛 捷 冯缵冲 [摘要]目的：观察新型GyneFix IN宫内节育器（IUD）的临床性能。方法：采用随机对比性多中心临床研究方法，对607例健康经产妇女由经过培训的专人以随机方法于月经间期放置GyneFix IN IUD302例（GyneFix IN组）及TCu380A IUD305例（TCu 380A组），于放器后1、3、6和12个月随访，以生命表法统计两种IUD的终止情况。结果：GyneFix IN 组使用1年无妊娠发生，脱落和因症取出率分别为每百妇女2.67和1.02，与IUD使用有关的终止率为每百妇女3.66，明显低于TCu380A组的每百妇女7.88（P0.05）。GyneFixIN组疼痛的主诉率也落低于TCu380A组。结论：此种无支架、铜表面积大并有固定系统的IUD，由经过培训的人员放置，具有低脱落率和改善疼痛副反应的特点，有推广前景。 [关键词]宫内避孕器 随机对照试验 铜 Randomized Comparative Study of GyneFix IN and TCu 380A Intrauterine Devices Wu Shangchun*，Hu JLNG*， Wu MLNGhui， et al. *National Research Institute for Family plannLNG，BeijLNG 100081 [Abstract] Objective To observe the clinical performances of the new intrauterine device（IUD）-GyneFix IN. Methods The present study is a randomized comparative clinical trial. 607 healthy parous women were randomly allocated into GyneFix IN group （n=302） or TCu 380A group （n =305），IUD was inserted durthe menstrual interval by the trained investigators. Follow-up were arranged at 1，3，6 and 12 months after insertion. The discontinuation rates were calculated by life table method. Results At the end of the first year， there was no pregnancy occurred in GyneFix IN group. Its expulsion rate and removal rate for medical reasons were 2.67 and 1.02 per 100 women respectively. The use-related discontinuation rates was 3.66，which was significanty lower than that in the TCu 380A group （7.88， P0.05） The number of women with complaint of pain was also less in GyneFix IN group. Conclusion The excellent performance of the new IUD which is a frameless device with high copper surface and anchoring system was confirmed by this multicentre trial. Due to lower expulsion rate and less side effecte of pain，it could be recommended. [Key words] Intrautrine devices ，Randomized controlled trials Intrauterine devices，copper 三、终止情况 以生命表法计算的两种IUD放置后3和12个月的各种原因终止率见表2。TCu380A组有1例带器妊娠，两组主要的终止原因均为脱落，GyneFix IN组8例，累积终止率为2.7/10