置入新型MCu功能性宫内节育器1050例24个月临床报告

目的 :为了研究新型MCu功能性宫内节育器 (MCu IUD)的安全性、可接受性及临床效果。方法 :由 4个临床中心共放置MCu IUD10 5 0例 ,并随机抽样MCu IUD与TCu2 2 0C IUD各 10 9例 ,作临床效果对比观察。结果 :放置满 2 4个月时 ,随访率 >95 %。 10 5 0例使用MCu IUD者 2 4个月带器妊娠率为 0 2 9% ,脱落率为 0 ,续用率为 92 6 7%。放置MCu IUD与TCu2 2 0C IUD各 10 9例 ,观察 2 4个月 ,续用率分别为 93 5 8%和 81 6 5 % ;两组累积妊娠率分别为 0 92 %和2 75 % ;两组累积脱落率各为 0和 2 75 % ;两组因症取出率分别为 2 75 %和 9 17% ,差异均有显著性 ,P均 <0 0 5。副反应发生率MCu IUD组少于TCu2 2 0C IUD组 ,12个月时P <0 0 1,差异有非常显著性 ;2 4个月时差异无显著性。结论 :MCu IUD置、取方便 ,具有抗生育效果好、脱落率低、带器妊娠率低、副反应少、安全等特点 ,是当前应用效果比较理想的IUD。

A Clinical Study on 1050 Cases with Inserting MCu- IUD 24 Months

Objective: To investigate the clinical effect, acceptability, and safety of a new type of MCu intrauterine Device (MCu-IUD). Methods: A total of 1050 MCu-IUD were used in four clinical centers. 109 cases with MCu-IUD and 109 cases with TCu220C-IUD were randomly chosen from them for further investigated. Results: The follow-up rate after inserting MCu-IUD to 24 months was over 95%. Among 1050 women with 24 months of MCu-IUD, the pregnant rate, dropping out rate, and continuation rate were 0.29%, 0, and 92.67%, separatively. In those 218 women with 24 months of MCu-IUD or TCu220C-IUD, the continuation rate was, the cumulated pregnant rate, the cumulated dropping out rate, and the removal rate resulting from side effect was 93.57% vs 81.65%, 0.92% vs 2.75%, 0 vs 2.75%, and 2.75% vs 9.71%. There were significant differences between them (P<0.05). The side effect rate in MCu-IUD was lower than that of TCu220C-IUD within 12 months (P<0.01), but there was no difference between two groups after inserting 24 months. Conclusions: It's easy to insert and to remove out MCu-IUD, which has good contraceptive effect, less side effect, low pregnant rate and dropping out rate, and safety. We recommend MCu-IUD to be an ideal IUD.