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目的:探讨MCuⅡ功能性宫内节育器(MCuⅡIUD)的临床使用效果和安全性。方法:在我国不同地域进行多中心随机对照研究,分别放置MCuⅡIUD、MCu功能性宫内节育器(MCuIUD)及TCu220C IUD各500例,放置后1月、3月、6月、12月随访。结果:放置满12月,MCuⅡIUD组累积带器妊娠率为0.20/百妇女,各组间比较,差异无统计学意义(P>0.05)。MCuⅡIUD组累积脱落率为0.20/百妇女,与MCu IUD组比较,差异无统计学意义(P>0.05),与TCu220CIUD组比较,差异有统计学意义(P<0.05)。4次随访总的副反应发生率MCuⅡIUD组、MCu IUD组与TCu220C IUD组间比较,差异均有统计学意义(P<0.05),MCuⅡIUD组与MCu IUD组间比较差异无统计学意义(P>0.05);其副反应主要为月经异常、不规则流血、腰腹疼痛和白带增多。3组因症取出率依次为2.21/百妇女,2.42/百妇女,2.65/百妇女,各组间比较,差异无统计学意义(P>0.05)。结论:MCuⅡIUD避孕效果好,脱落率低,放置后副反应发生率低,是比较理想的IUD。
Objective: To investigate the clinical effect and safety of MCuⅡ functional intrauterine device (MCuⅡIUD). Methods: A multicenter randomized controlled study was conducted in different regions of China. 500 cases of MCuIIUD, MCuIUD and TCu220C IUD were placed in each region respectively and were followed up for 1 month, 3 months, 6 months and 12 months after placement. Results: The full pregnancy rate was 0.20 / 100 women in MCuⅡIUD group after 12 months of placement. There was no significant difference between the groups (P> 0.05). The cumulative shedding rate of MCuⅡIUD group was 0.20 / 100 women. There was no significant difference between MCu IUD group and MCu IUD group (P> 0.05). The difference was statistically significant (P <0.05) compared with TCu220CIUD group. The overall incidence of side effects after 4 follow-up was significantly different between MCuⅡIUD group, MCu IUD group and TCu220C IUD group (P <0.05), but there was no significant difference between MCuⅡUD group and MCu IUD group (P> 0.05); The main side effects of menstrual abnormalities, irregular bleeding, abdominal pain and vaginal discharge increased. There were no significant differences among the three groups (P> 0.05). The removal rate of the three groups were 2.21 per hundred women, 2.42 per hundred women and 2.65 per hundred women. Conclusion: MCu Ⅱ IUD has good contraceptive effect, low exfoliation rate and low incidence of side effects after placement, which is an ideal IUD.