三种国产宫内节育器临床多中心比较性研究——八年随访总结

全国9省市16个单位,对不锈钢金属单环(金单)、VCu200及TCu220C三种宫内节育器(IUD)进行随机临床多中心比较性研究。自1983年7月1日至1984年3月31日共接受对象4490例。八年末随访率为90.33％。三种IUD间每百妇女累积续用率的差别后期有随使用时间的增长而缩小的趋势,但96个月时仍以金单为最低,47.08％,VCu200和TCu220C各为54.05％和61.14％。VCu20O和TCu220C的妊娠率分别为10.35％和8.94％,它们间差异较前期增大,并显著地低于金单的24.14％。96个月时,金单、VCu200和TCu220C的脱落率分别为21.69％、13.05％和7.48％,三者间呈显著性差异。因出血和/或疼痛取器,八年中金单最低,前期VCu200略低于TCu220C,96个月时仍以金单为最低,VCu200略高于TCu220C,但二种带铜IUD间无差别。三种IUD使用情况城市与农村比较,城市的累积续用率均高于农村;妊娠、脱落和个人原因停用农村均高于城市。用COX比例风险模型和似然比检验分析,发现妊娠和脱落均受年龄、过去使用IUD、本次IUD类型和孕次的影响,显示了两种带铜IUD的妊娠和脱落风险远小于金单;出血和/或疼痛受孕次和本次IUD类型的影响,金单的出血和/或疼痛风险小于两种带铜IUD,总的失败风险受年龄、本次IUD类型、过去使用IUD和孕次的影响,显示了直至使用八年金单的失败风?

A Multicentre Comparative Clinical Study of Three Types of IUD,Stainless Steel Ring, VCu200 and TCu220C (eight years follow up)

The Stainless steel ring, VCu200 and TCu220C were in randomized comparison for eight years in a cohort of 4490 subjects covering 16 centres in 9 provinces and municipalites. The follow-up rate at the end of 8 years was 90. 33%. Woman years of use were 8243. 7 for Steel ring,8486. 8 for VCu200 and 8765. 4 for TCu220C. Cumulative continuation rates were 47. 06 per 100 at 8 years for Steel ring,54. 05 per 100 for VCu200 and 61. 14 per 100 for TCu220C. Trie cumulative pregnancy rates for VCu200 and TCu220C were significantly lower, 10. 35 per 100 and 8. 94 per 100 respectively, than that for Steel ring, 24. 14 per 100. There were significant differences in the eight-years expulsion rates among Steel ring (21. 69%), VCu200 ( 13. 05%) and TCu220C (7. 48%). The removal for bleeding and/or pain was the lowest in Steel ring, and no significant differences were found between VCu200C and TCu220C,but there was a higher trend of remoral in VCu200 at the end of eight years than in TCu220C. The discontinued use for desire to become pregnant in rural areas was very significantly higher than in urban areas. The risk of pregnancy and expulsion were affected by age at insertion .previous usft of IUD, types of IUD in this study and gravidity prior to insertion. This implies that the risks of pregnancy and expulsion for VCu200 and TCu220C were Significantly lower than that for Steel ring. The factors ,gravidity prior insertion and types of IUD,in this study,affected the removal for bleeding and/or pain. The risk of removal for bleeding and/or pain in Steel ring was lower than those in other two types of copper-bearing IUDs. Failure risks were affected by age at insertion,types of IUD in this study, previous use of IUD and gravidity . The failure risk in Steel ring was still higher than those in VCu200 and TCu220C at the end of eight years. The study suggests that TCu220C provides good long-term safety,efficacy and acceptability.