三种国产宫内节育器临床多中心比较性研究（十年随访总结）

A Multicentre Comparative Clinical Study of Three Types of IUD(Ten Years Follow up)

在全国９省市１７个中心，对不锈钢金属单环（金单），ＶＣｕ２００及ＴＣｕ２００ｃ三种宫内节育器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日共收集５０９０例。第１０年末的随访率为９１．２６％。ＴＣｕ２２０ｃ第１０年末每百妇女累积续用率为５６．７４，显著地高于金单（４４．７７）和ＶＣｕ２００（４４．５６）。ＴＣｕ２２０ｃ和ＶＣｕ２００的累积妊娠率分别为每百妇女９．６９和１０．７０，显著地低于金单的２３．４７。第１０年末时，金单的累积脱落率为２１．７９％，ＶＣｕ２００为１６．４８％，ＴＣｕ２２０ｃ为８．２８％，三种宫内节育器间存在显著性差异。因出血和／或疼痛取器，金单最低；从第７年开始，ＶＣｕ２００因出血和／或疼痛取器逐渐高于ＴＣｕ２２０ｃ，到第１０年末时其间显示出显著性差异，取出的ＶＣｕ２００中发现有些已散架成铜丝剥落。ＶＣｕ２００组自第５年起，因个人原因取器分别显著地高于金单和ＴＣｕ２２０ｃ，变换避孕方法者比以前增多，变换避孕方法的要求主要来自使用者，取器时发现有的无几丝，Ｘ光或Ｂ起检查发现有些器已变形。农村因要求妊娠而取器者极为显著地高于城市地区。建议ＶＣｕ２００的使用期限可定为５?

he Stainless steel ring(SSR), VCu200andTCu220C were in randomized comparison for ten yeays in cohort of 5090 subjects covering 17centres for 9 provinces andmunicipalities.The follow -up rate at the end of ten years was 91, 26%. The comulativecontinuation rates were 44.77 per 100 women at the end of ten years for SSR,44.56 for VCu200and 5674 forTCu220c.The cumulative pregnancy rates at the end of ten years for TCu220c and VCu200were significantly lower, 9. 69 per 100 women and 10.70 respectively, than that for SSR, 23.47. There were significant differences In ten years'expulsion rates among SSR(21.79%),VCu200(16.48%)and TCu220c(8.28%). The removal for bleeding and/ or pain was thelowest in SSR; and since 7th years follow- up, the rate was gradually getting higher in VCu200 than that in TCu220c, then emerged the significantly difference between them at the end of ten years observation, and finding that some VCu200 removed were out of shape or with less copper wire. The discontinuation due to personal reasons in VCu200 were signifiicantly higher than that in SSR and TCu200c at the endof ten year, since 5th year observation, the switching of VCu200 to other IUD or methods was getting more then before; and some device deformation and no tail thread were found at the removal time. Thedlsconlinued use for desire to become pregnancy in rural area was extremely higher than that in urban area. It is suggested that the lifespan ofVCu200 in this study,which had been improved about in 1984, might be five years.The study revealed that TCu220c as comared with other two devices had good long term safety, efficacy and acceptability.