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目的:对TCu220IUD、γ-IUD、VCu200IUD在深圳地区育龄妇女中使用的有效性、安全性进行评价,为筛选适合深圳地区育龄妇女使用的IUD提供科学依据。方法:采用前瞻性、多中心随即对比临床研究方法,对900例适龄妇女由经过专门培训的医生放置上述3种IUD各300例,于置器后3、6、12、24个月随访,并对其中300例增加了60、84个月随访,以寿命表方法统计3种IUD的终止情况。结果:3种IUD放置24个月后的带器妊娠率分别为TCu220IUD1.00/100妇女、γ-IUD 0.67/100妇女、VCu200IUD 0.33/100妇女;脱落率分别为TCu220IUD 3.33/100妇女、γ-IUD2.67/100妇女、VCu200IUD 1.67/100妇女,因症终止率分别为TCu220IUD 6.00/100妇女、γ-IUD 2.00/100妇女、VCu200IUD 4.00/100妇女,3组比较无统计学差异,均显示出良好的避孕效果和可接受性。300例5年和7年的随访表明,3组带器妊娠、脱落及因症终止率未随时间延长而明显增加;但γ-IUD发生嵌顿的可能性增加;VCu200IUD 7年后出血、疼痛等副反应增多。结论:TCu220IUD、γ-IUD、VCu200IUD避孕效果可靠、并发症少、可接受性好,均的作为深圳地区推荐使用的IUD。
Objective: To evaluate the effectiveness and safety of TCu220IUD, γ-IUD and VCu200IUD in women of childbearing age in Shenzhen, and to provide a scientific basis for screening IUDs suitable for women of childbearing age in Shenzhen. METHODS: A prospective, multicenter randomized comparative clinical study was conducted in 900 women of the appropriate age who were followed up by 3, 6, 12, and 24 months of follow-up with a specially trained physician in each of the three IUDs 300 of them were followed up for 60 and 84 months respectively, and the termination of three kinds of IUDs was counted by life table method. Results: The pregnancy rates of the devices with TCU220IUD1.00 / 100, γ-IUD 0.67 / 100 and VCu200IUD 0.33 / 100 were 24 months after the three kinds of IUD placement respectively; the rates of shedding were TCu220IUD 3.33 / 100 women, γ- IUD2.67 / 100 women, VCu200IUD 1.67 / 100 women, due to disease termination rates were TCu220IUD 6.00 / 100 women, γ-IUD 2.00 / 100 women, VCu200IUD 4.00 / 100 women, the three groups showed no statistically significant differences were shown Good contraceptive effect and acceptability. Three hundred and five years and seven years of follow-up showed that the pregnancy, exfoliation and discontinuation rate of the three groups of devices did not significantly increase with time, but the possibility of incarceration with γ-IUD increased. After seven years, VCu200UD bleeding and pain Side effects such as increased. Conclusion: TCu220IUD, γ-IUD, VCu200IUD contraceptive effect is reliable, less complications, acceptable, both as the recommended IUD in Shenzhen.