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深圳地区TCu220IUD、γ-IUD、VCu200IUD多中心随机比较研究 被引量:16

A Randomized Multicentric Control Study of the TCU220IUD,γ- IUD, VCu200IUD of Shenzhen District
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摘要 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 efficacy and safety of TCu220IUD, γ- IUD and VCu200IUD inserted in Shenzhen childbearing age women, and select a scientific foundation fit for those women. Methods: A prospective, multicentric, random clinical study was carried out. 900 women at childbearing age were randomly divided into three groups received 3 kinds of IUD inserted by special cultural physician. All participants were followed up at 3 ,6,12,24 months, and 300 of them were followed up at 60 and 84 months. Using life - table method, we compared the 3 groups. Results; 2 years after the insertion, the pregnancy rates of TCu220IUD,γ - IUD and VCu200IUD were 1.00,0.67,0.33/100 cases respectively; the expulsion rates were 3.33,2.67,1.67/100 cases respectively; and the other causes of removal rates were 6.00,2.00,4.00/100 cases respectively. Three kinds of IUD demonstrated excellent contraceptive efficacy and were well tolerated. There were no significant difference between 3 groups. Those 300 cases followed -up 5 and 7 years indicated that the pregnancy rates, the expulsion rates and the other causes of removal rates did not increase, but the rate of IUD embed in the uterine increased in the group of γ - IUD; in the VCuIUD group the side effect such as bleeding and pain increased. Conclusion: TCu220IUD , γ-IUD and VCu200IUD have excellent contraceptive efficacy, little complication and were well tolerated. They appears to suitable for insertion in Shenzhen women.
出处 《中国计划生育学杂志》 2003年第9期545-548,共4页 Chinese Journal of Family Planning
关键词 育龄妇女 深圳市 宫内节育器 随机对照试验 安全性 TCu220IUD γ-IUD VCu200IUD Intrauterine device Copper Indomethacin Random control study
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