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目的:观察新型MCuIUD的临床效果及安全性。方法:在国内6个临床中心按统一标准选择1100例要求使用IUD避孕的妇女,随机放置MCuIUD与TCu380AIUD各550例,定期随访观察。结果:放置满48个月时,MCuIUD组与TCu380A组的继续使用率分别为84.82/百妇女、81.62/百妇女,P>0.05;带器妊娠率分别为1.26/百妇女、1.72/百妇女,P>0.05;脱落率分别为0.42/百妇女、3.45/百妇女,差异显著,P<0.05;因症取出率分别为4.19/百妇女、5.82/百妇女,P>0.05;有主诉分别为3.77/百妇女、7.76/百妇女,差异显著,P<0.05;因计划妊娠取出后多在1年内妊娠。结论:MCuIUD脱落率极低、抗生育效果好,置、取方便,安全、有效,可逆行好,是目前比较理想的IUD,值得推广。
Objective: To observe the clinical effect and safety of new MCuIUD. Methods: A total of 1,100 women who required IUD contraception were selected according to uniform standards in 6 clinical centers in our country. 550 cases of MCuIUD and TCu380AIUD were randomized and followed up regularly. Results: After 48 months, the continuous use rates of MCuIUD group and TCu380A group were 84.82 / 100 women and 81.62 / 100 women respectively, P> 0.05; the pregnancy rates of the devices were 1.26 / 100 women and 1.72 / P> 0.05; the rate of shedding was respectively 0.42 / hundred women and 3.45 / hundred women, the difference was significant (P <0.05); the rate of removing the disease was 4.19 per hundred women and 5.82 per hundred women respectively, P> 0.05; Per hundred women, 7.76 per hundred women, the difference was significant, P <0.05; Pregnancy was planned within 1 year after planned pregnancy. Conclusion: MCuIUD shedding rate is very low, anti-fertility effect is good, easy to set, take, safe, effective and reversible good, is the ideal IUD, it is worth promoting.