GyneFixIN宫内节育器避孕效果及副作用的临床研究.docVIP

GyneFixIN宫内节育器避孕效果及副作用的临床研究 【关键词】GyneFix IN 【摘要】 目的 研究GyneFix IN宫内节育器（IUD）的避孕效果和副作用。方法 采用随机对比性多中心临床研究方法，对640例健康妇女以随机方法放置GyneFix IN IUD330例及Tcu220c IUD310例，于放器后1、3、6、12个月随访，以生命表法统计两组中IUD的终止情况。结果 GyneFix IN组使用1年有1例妊娠发生，脱落和因病取出率分别为0.91%和1.21%，与IUD使用有关的终止率为2.42%，明显低于Tcu220c组的9.03%（P0.05），GyneFix IN组疼痛的主诉率也低于Tcu220c组。结论 此种无支架、铜表面积大并有固定系统的IUD，具有低脱落和改善疼痛副反应的特点，有推广价值。 关键词 宫内节育器 对比研究P style=TEXT-INDENT: 24px align=centerComparative study on GneFix IN and Tcu220c intrauterine devicesP style=TEXT-INDENT: 24px align=centerTang Hongping，Zhong Min，Wang JingP style=TEXT-INDENT: 24px align=centerDepartment of Obstetrics and Gynecology，Civil Aviation Hospital，Guangzhou510405. 【Abstract】 Objective To observe the contraceptive effects and side effects of the new intrauterine device（IUD）-GyneFix IN.Methods The present study is a randomized comparative clinical trial.640healthy women were randomly allocated into GyneFix IN group（n=330）or Tcu220c group（n=310）.Follow-up were arranged at1.3.6and12months after insertion.The discontinuation rates were calculated by life table method.Results At the end of the first year，there was1pregnancy occurred in GyneFix IN group.Its expulsion rate and removal rate for medical reasons were0.91and1.21per100women respectively.The use-related discontinuation rates was2.42，which was significantly lower than that in the Tcu220c group（9.03，P0.05）.The number of women with comˉplaint of pain was also less in GyneFix IN group.Conclusion This is the kind of the excellent performance of the new IUD which is a frameless device with high copper surface and anchoring system.Due to lower expulsion rate and less side effect of pain，it could be recommended. Key words intrauterine devices comparative study GyneFix IN宫内节育器（简称吉妮）是一种新型无支架宫内节育器（IUD），为了观察吉妮的临床性能，我们对吉妮和Tcu220c进行比较性研究，现将结果报告如下。 1 资料与方法 1.1 研究对象 选择1999年7月～2002年7月就诊于我院妇科门诊，自愿选择放置IUD，年龄20～42岁的健康妇女共640例，随机分为吉妮组330例，Tcu220c组310例。放置时间:月经规律者（周期21～35天）于月经间期（月经周期的第14天前），早孕人工流产后即刻、产后3个月以上、哺乳期妇女在产后6个月以上。近半年无反复的盆腔感染和性传播疾病。