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为验证FR IUD的避孕效果和可接受性,全国5省市对芙蓉宫内节育器(FR组)和MLCu375SL(ML组)进行了随机比较性研究。自1995年12月～1996年5月接受对象SR组、ML组各500例,术后6、12个月门诊随访,随访率99.7％,一年末每百妇女净累积续用率FR组91.77、ML组92.37(P>0.05),妊娠率分别为1.26、1.06,脱落率2.71、2.90,两种IUD放置后的副反应发生率除经量增多ML组高于FR组(P<0.01)外,其他各种副反应发生率两组间差异不显著。结果提示,FR IUD避孕效果与ML IUD相似,已被育龄妇女接受,可供临床选用。
To verify the contraceptive efficacy and acceptability of FR IUD, five provinces and cities across the country conducted a randomized comparative study of Furong intrauterine device (FR group) and MLCu375SL (ML group). From December 1995 to May 1996, 500 subjects in SR group and ML group were followed up, with a follow-up of 6 and 12 months postoperatively. The follow-up rate was 99.7%. The net FRR of 91 patients per 100 women at the end of the year was 91.77, ML group 92.37 (P> 0.05), the pregnancy rates were 1.26,1.06, the shedding rates were 2.71 and 2.90 respectively. The incidence of side effects after IUD placement was higher than that in FR group (P <0.01) The incidence of other side effects was not significantly different between the two groups. The results suggest that the FR IUD contraceptive effect is similar to ML IUD and has been accepted by women of childbearing age for clinical use.