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目的:观察MCuⅡ功能性宫内节育器(MCuⅡIUD)的有效性、安全性及副反应。方法:按统一标准在国内不同地域5个观察单位随机放置MCuⅡIUD与MCu IUD各500例,术后定期随访。结果:放置满36个月,MCuⅡIUD组与MCu IUD组的带器妊娠率分别为0.86/百妇女年和1.45/百妇女年;脱落率分别为0.65/百妇女年和0.66/百妇女年;因出血/疼痛取出率分别为3.89/百妇女年和3.48/百妇女年;副反应发生率分别为7.29%和5.44%,差异均无统计学意义(P>0.05)。希望妊娠取器后两组妊娠率分别为85.7%和82.4%,差异无统计学意义(P>0.05),MCuⅡIUD取器时探针探测金属摩擦感清楚,更容易操作。结论:MCuⅡIUD与MCu IUD同是带器妊娠率低、脱落率低、因副反应取出率低和副反应发生率低的IUD。MCuⅡIUD在MCu IUD基础上铜表面积增加至225 mm2,符合国家标准;铜表面积增加了,副反应未增加;取出时操作容易,证实产品改进是可取的,值得推广。
Objective: To observe the efficacy, safety and side effects of MCuⅡ functional intrauterine device (MCuⅡIUD). Methods: According to the uniform standard, 500 cases of MCuⅡIUD and MCu IUD were randomly placed in 5 observation units in different regions in China. The patients were followed up regularly. Results: After 36 months of placement, the pregnancy rates of the devices with MCuⅡIUD and MCu IUD were 0.86 per 100 women and 1.45 per hundred women, respectively; the rates of exfoliation were 0.65 per hundred women and 0.66 per hundred women, respectively Bleeding / pain removal rates were 3.89 per hundred women and 3.48 per hundred women, respectively; the incidence of side effects was 7.29% and 5.44%, respectively, with no significant difference (P> 0.05). It is hoped that the gestation rate of the two groups after pregnancy is 85.7% and 82.4%, respectively, with no significant difference (P> 0.05). Conclusion: MCuⅡIUD and MCu IUD are the same as IUD with low pregnancy rate, low exfoliation rate, low side effects and low incidence of side effects. MCu Ⅱ IUD in the MCu IUD based on the copper surface area increased to 225 mm2, in line with national standards; copper surface area increased, the side effects did not increase; easy operation removed, confirmed that product improvement is desirable, it is worth promoting.