关键词: 宫内节育器, 不良事件, 发生率

Abstract:

Objective To protect contraceptive safety，analyze the adverse events of commonly used intra⁃uterine devices（IUD）. Methods IUD adverse event reports were collected from 2011 to 2019 and populationinformation of using IUD database were linked to calculate the incidence rate of 10 common IUD adverse eventsand compare the risk. Results In the first year after IUD placement，the average incidence of adverse events of10 common IUD was 2.66%. With the prolongation of use time，the incidence of adverse events of IUD（exceptactive γ type）decreased gradually. However，the incidence of active γ type increased gradually. The cumulativeincidence of IUD in 3 and 5 years was 11.70% and 19.96% respectively，which was significantly higher thanthe average incidence. The relative risk（RR）was 1.69（95%CI：1.55 ~ 1.83）and 1.84（95%CI：1.72 ~ 1.98），respectively. The cumulative incidence of adverse events in 3 and 5 years of MLCu375 ranked the second place，8.30% and 12.33% respectively，and the incidence was also higher than the average incidence，RR was 1.20（95%CI：1.12 ~ 1.28）and 1.14（95%CI：1.07 ~ 1.21），respectively. Conclusion It is suggested that we should furtherstrengthen the monitoring of adverse events of contraceptives，improve the quantity and quality of reporting，andreduce the underreporting. The number of IUD varieties with high risk of adverse events shall be appropriatelyreduced. Regular follow⁃up and timely treatment shall be carried out after the IUD is placed，and the use of IUDwithin two years after the device is placed and near the placing period shall be focused，so as to reduce thewithdrawal of the cause of disease and promote the contraceptive safety.

Key words: intrauterine device（IUD）, adverse event（AE）, incidence