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目的进一步观察新型MCu Ⅱ功能性宫内节育器(MCu Ⅱ IUD)的临床使用效果。方法随机放置MCu Ⅱ IUD和TCu220 cIUD各500例,放置后1、3、6、12、24个月进行随访观察。结果 24个月末的累积续用率依次为92.16%和89.89%;带器妊娠率为0.62%、0.84%;脱落率为0.41%、2.32%,差异有统计学意义(PO.05);观察中无损伤、感染及贫血发生。结论 MCu Ⅱ IUD设计合理、妊娠率低、脱落率低,副反应发生率低,值得推广使用,放置时需按说明书正规操作。
Objective To observe the clinical effect of new MCu Ⅱ IUD. Methods 500 cases of MCu Ⅱ IUD and TCu220 cIUD were randomly placed and observed at 1, 3, 6, 12 and 24 months after placement. Results The cumulative follow-up rates at the end of 24 months were 92.16% and 89.89% respectively. The pregnancy rate of the device was 0.62% and 0.84% respectively. The rate of exfoliation was 0.41% and 2.32%, respectively. The difference was statistically significant (P <0.05). The incidence of primary (side effects) MCu II IUD was lower than that of TCu220 cIUD at 5 follow-ups, mainly due to abnormal menstruation and lumbar pain and leucorrhea; the rates of side effects were 3.51% and 4.21% respectively, with no significant difference (P > O.05). No damage, infection and anemia were observed. Conclusion MCu Ⅱ IUD has reasonable design, low pregnancy rate, low exfoliation rate and low incidence of side effects. It is worth popularizing and should be operated according to the instructions when placed.