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目的观察MCuⅡ功能性宫内节育器(intrauterine contraceptive device,IUD)的妊娠率、脱落率、因不良反应取出率和不良反应发生率。方法采用多中心随机对照的研究方法,对MCuⅡIUD与MCuIUD作临床效果比较。常规放置IUD,在置器后第1、3、6、12、24个月进行随访,观察临床效果和不良反应。结果共接纳对象1 000例,放置MCuⅡIUD与MCuIUD各500例,置器满24个月带器妊娠率分别为0.63%、1.45%;脱落率分别为0.42%、0.21%;因不良反应取出率分别为3.44%、3.03%;置器后各阶段不良反应(主诉)发生率及两组取出后5～12月间妊娠率的各项组间差异比较均无统计学意义(P>0.05)。MCuⅡIUD取出时探针探测IUD金属摩擦感比MCu IUD清楚(P<0.05),因此取出手术操作容易。结论 MCuⅡIUD与MCu IUD是带器妊娠率低、脱落率低、因不良反应取出率低和不良反应发生率低的IUD。MCuⅡIUD在MCuIUD基础上铜表面积增加至225mm2,符合国家标准;铜表面积增加了而不良反应未增加;取出时操作容易,证实产品改进是成功的,是值得推广的新型IUD。
Objective To observe the pregnancy rate, exfoliation rate, withdrawal rate of adverse reactions and the incidence of adverse reactions of MCuⅡ functional intrauterine contraceptive device (IUD). Methods A multicenter randomized controlled study was conducted to compare the clinical effects of MCuIIIUD and MCuIUD. The IUD was placed routinely, followed up on the 1st, 3rd, 6th, 12th and 24th months after the device was set up to observe the clinical effects and adverse reactions. Results A total of 1 000 patients were admitted and 500 MCuIIUD and MCuIUD patients were placed. The pregnancy rates of devices with full 24-month applicators were 0.63% and 1.45%, respectively. The rates of spontaneous abortion were 0.42% and 0.21% respectively. (3.44%, 3.03%). There was no significant difference in the incidence of adverse events (chief complaint) and pregnancy rates between May and December after the two sets of interventions (P> 0.05). MCuIIIUD probe detection IUD metal friction than MCuIUD clear (P <0.05), so easy to remove the operation. Conclusion MCu Ⅱ IUD and MCu IUD are low IUD with low pregnancy rate, low exfoliation rate, low rate of adverse reactions and low incidence of adverse reactions. MCu Ⅱ IUD in MCuIUD based on the copper surface area increased to 225mm2, in line with national standards; copper surface area increased without adverse reactions did not increase; easy operation removed, confirmed that the product improvement is successful, is worth promoting the new IUD.