含硫酸钡MCu375 IUD的临床效果多中心研究

目的:进一步观察支架含医用硫酸钡,外型与MLCu375IUD相似的MCu375IUD临床使用效果和安全性。方法:对放置MCu375IUD132例和MLCu375IUD128例的多中心临床研究对象进行随访观察。结果:24个月末两组的累积续用率分别为98·48%和98·44%,两组间差异无显著性意义(P<0·05);24个月末副反应仍以经期延长、月经量增多为主,组间副反应发生率差异无显著性意义(P>0·05);随访3个月末时IUD距宫底距离>2cm者MCu375组22例(16·9%),MLCu375组39例(30·7%),两组间差异有显著性意义(P<0·01);至24个月末时IUD距宫底距离>2cm者MCu375组62例(42·5%),MLCu375组84例(57·5%),两组间差异有显著性意义(P<0·01)。结论:MCu375IUD与MLCu375IUD24个月末的有效性无明显差别,但含硫酸钡的MCu375IUD的支撑力明显高于MLCu375IUD。

Study on the Effective and the Safety of MCu375 Enringed BaSO4 IUD

Objective: To compare the effectiveness and the safety of MCu375(Ba) with Mlcu375. Methods:To following up the 132 women with MCu375(Ba)and the 128 women with Mlcu375 in multiple centers for 24 months for clinical comparing study. Results: The cumulative continuation rate was 98.48% and 98.44% at the end of the 24th month, there was no significant difference in the two groups(P>0.05). The hypermenorrhea and menostaxis still were the main side-effect at the end of 24th month,and the incidence rate was approximate and there was no significant difference(P>0.05). The distance between the fundus of uterus and IUD which was >2 cm were 22 cases (16.9%) in the MCu375 group,39 cases (30.7%)in the Mlcu375 group at the end of the 3rd month, respectively, and there was significant difference between the two groups(P<0.01); which were 62 cases(42.5%) in the MCu375 group and 84 cases (57.5%)in the MLcu375 group at the end of the 24th month,respectively, and there was significant difference between the two groups(P<0.01). Conclusion:The effectiveness shows no significant difference between the MCu375 group and Mlcu375 group at the end of the 24th month,however, the sustaining force of MCu375 enringed BaSO4 in the uterus appears to be more stronger than MLcu375.