三种国产宫内节育器临床多中心比较性研究——(五年随访总结)

全国13省市共23个单位,对不锈钢金属单环、V Cu200及T Cu220c三种宫内节育器(IUD)进行随机临床多中心比较性研究。自1987年7月1日至1984年3月31日共接受对象6236例。五年末随访率为96.0%。60个月时每百妇女累积续用率以金单为最低,55.8%,V Cu及T Cu各为68.8%及72.4%。V Cu和T Cu的妊娠率分别为7.32%和7.24%,显著地低于金单的20.2%。60个月时金单、V Cu和T Cu的脱落率分别为19.0%、9.7%和5.6%,三者间呈显著性差异。因出血和/或疼痛取出率以金单为最低,二种带铜宫内节育器间无差别。三种IUD使用情况城市与农村间比较,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比例危险模型和似然比检验,发现金单的失败危险与以下因素有关:年龄、过去IUD使用史、劳动姿态、孕次和宫腔深度;前四个因素对VCu失败危险有影响;TCu失败危险除与前三个因有关外,哺乳期放器对其失败危险亦有影响。年龄和孕次均影响三种IUD的妊娠危险;过去IUD使用史分别作用于金单和VCu;宫腔深度分别影响金单和TCu的妊娠。T Cu的脱落仅受哺乳期放器影响;年龄、孕次、过去IUD使用史影响着VCu的脱落;金单脱落除上述三因素外,还受宫腔深度的影响,且前三个因素均呈极显著性差异。

A Multicentre Comparative Clinical Study of 3 Types of IUD——(5 years follow up)

A multicentre comparative clinical study of the Stainless steel ring,VCu200and TCu 220 c in a cohort of 6236 subjects was carried out in 23 centres in 13 provincesand municipalities.The follow-up rate at the end of 5 years was 96.0%.Woman years ofuse were 6802.8 for Steel ring, 8373.3 for VCu 200 and 8712.3 for TCu 220 c.Five—yeargross cumulatve continuation rates per 100 women were 55.8,68.8 and 72.4 respectively.VCu 200 and TCu 220 c had significantly lower pregnancy rates,7.32% and 7.24% res-pectively, while that with Steel ring was 20.21%.There were significant differences inthe five-year expulsion rates among Steel ring(19.0%),VCu 200(9.7%)and TCu 220 c(5.6%). The removal for bleedinn and/or pain was the lowest in Steel ring and no signi-ficant differences were found between VCu 200 and TCu 220 c.The rates of pregnancy,ex-pulsion and discontinued use for personal reasons in rural area were higher than in urbanarea.The expulsion risk of TCu 220 c was only affected by insertion during lactation pe-riod:the factors for expulsion of VCu 200 were age, gravida,previous IUD use: besides thethree factors above,in which there were extremely significant differences respectively;theexpulsion of steel ring was influenced by the length of the uterine cavity.