新型元宫药铜220 IUD、365 IUD上市后监测研究

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。

Post-marketing Surveillance of Two New Types of Copper-bearing Indomethacin-releasing Intrauterine Device

Objective: To evaluate the side effects and adverse events of Yuan-gong 220 and Yuan-gong 365 copper-bearing indomethacin-releasing intrauterine device (IUD) during twelve months. Methods: 1,119 women using Yuan-gong 220 IUD and 717 women taking Yuan-gong 365 IUD were followed at 3, 6, 12 months after IUD insertion. The side effects and adverse events were compared between the Yuan-gong 220 IUD cohort and the Yuan-gong 365 IUD cohort. Results: During the first 3 months, the incidence rate of side effects among Yuan-gong 220 IUD users was 15.84%, which was significantly higher than that in Yuan-gong 365 IUD users (5.86%), including spotting, prolonged bleeding and pain. During the observation period of 12 months, the overall rate of adverse events among Yuan-gong 220 IUD users was 4.75%, which was significantly higher than that in Yuan-gong 365 IUD users (2.23%). The risk of side effects for Yuan-gong 220 IUD varied with areas, those inhabited in southern area of Jiangsu were more possible to develop side effects. Conclusion: Compared with Yuan-gong 220 IUD, Yuan-gong 365 IUD brings fewer side effects and lower adverse events rate.