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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。
Objective: To further observe the stent with medical barium sulfate, MLCu375IUD similar appearance and MCu375IUD clinical efficacy and safety. Methods: A multicenter clinical study with MCu375IUD132 cases and MLCu375IUD128 cases was followed up. Results: The cumulative renewal rates of the two groups at the end of 24 months were 98.48% and 98.44% respectively, with no significant difference between the two groups (P <0.05). The side effects remained prolonged at the end of 24 months, (P> 0.05). No significant difference was found in the incidence of side effects between the two groups (P> 0.05). At the end of 3 months, 22 cases (16.9%) had MCU375 with IUD distance> 2cm, MLCu375 (P <0.01). There were 62 cases (42.5%) in the MCu375 group with IUD distance> 2 cm from the end of the palace at the end of 24 months, with a significant difference between the two groups (P <0.01) MLCu375 group 84 cases (57.5%), the difference between the two groups was significant (P <0.01). Conclusion: There is no significant difference in the validity of MCu375IUD and MLCu375IUD at the end of 24 months, but the support force of MCu375IUD containing barium sulfate is obviously higher than that of MLCu375IUD.