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目的:评价新型IUD元宫药铜220 IUD和元宫药铜365 IUD 12个月内的副反应和不良事件。方法:对1119例元宫药铜220 IUD和717例元宫药铜365 IUD使用者在置器后第3、6、12个月时进行随访,比较两种IUD队列12个月的副反应和不良事件。结果:①元宫药铜220 IUD队列有15.84%的妇女在置器后3个月内发生副反应,包括点滴出血,经期延长/经量增多和疼痛,显著高于元宫药铜365 IUD(5.86%),具有统计学意义(P<0.05);②元宫药铜220 IUD队列12个月不良事件发生率为4.75%,显著高于元宫药铜365 IUD(2.23%),具有统计学意义(P<0.05);③元宫药铜220 IUD副反应发生风险存在地区差异,在置器后的3个月内苏南地区使用者副反应发生风险显著高于苏北地区。结论:与元宫药铜220 IUD相比,元宫药铜365 IUD的副反应较小,不良事件发生率较低。
Objectives: To evaluate the side effects and adverse events within 12 months of the new IUD Uterine copper 220 IUD and Uterine copper 365 IUD. Methods: 1119 cases of Uterine copper 220 IUD and 717 cases of Uterine copper I 365 IUD were followed up at 3, 6 and 12 months after the device was set up. The side effects of 12 months of two IUD cohorts and Adverse events. Results: (1) 15.84% women in Yuan Gong Pharmacy 220 IUD cohort had side effects within 3 months after placement, including drip bleeding, prolonged menstrual flow, increased menstruation and pain, (P <0.05). ② The 12-month incidence of adverse events in Uterine Bronze 220 IUD cohort was 4.75%, which was significantly higher than that of Uterine Cancer copper IUD (2.23%), with statistical significance (P <0.05). (3) There was a regional difference in the risk of side effects of Uterine Pharmacopoeia 220 IUD. The risk of side-effects among users in southern Jiangsu was significantly higher than that in northern Jiangsu within three months after the device was set. Conclusion: Compared with the Yuan Gong Yao copper 220 IUD, Yuan Gong Yao copper 365 IUD has fewer side effects and a lower incidence of adverse events.