在农村地区进行妈富隆~口服避孕药的上市后监测

Post-marketing Surveillance of the DSG-containing Combined Oral Contraceptive Marvelon~ in Rural Areas

目的:评价中国农村妇女口服妈富隆避孕药12个月的副反应和续用率。方法:对江苏省5个县市870例妈富隆的农村妇女进行为期12个月的上市后监测。结果:①有24.02%的妇女发生副反应,12个月的前3位副反应是类早孕反应、点滴出血/突破性出血、黄褐斑;在服药的前3个月内,苏南地区的COC使用者副反应发生率比苏北地区高。②多数妇女体重改变不超过5kg(94.71%),约99%的妇女血压测量值、生化指标在正常范围内。③对象12个月续用率为83.14%,类早孕反应为最常见的医学终止原因;文化程度较高的COC使用者停用的风险率较低。结论:妈富隆口服避孕药在中国农村妇女中广泛使用12个月内,副反应发生较少,可接受性较好;建议加强对COC使用者的早期随访服务,重点做好文化程度较低的COC使用者的知情选择服务工作。

Objective：To evaluate the side effects, continuation rate of combined oral contraceptive （Marvelon） during twelve months. Methods： We conducted a 12-month post-marketing surveillance on oral contraceptive Marvelon among 870 healthy rural women in 5 different county of Jiangsu. Results： 24.02% of the women experienced side effects during the study period of 12 months, the three most frequent side effects were gastrointestinal disorder, bleeding/spotting, chloasma; the rate of side effects varied with areas during the first 3 months, those inhabited in southern area of Jiangsu were more possible to develop side effects. In the course of the post-marketing study, the vast majority of women did not experience major weight changes during treatment, i.e., loss or increase in weight of more than 5 kg. The blood pressure and biochemical indicators of almost 99% among these women were within the normal range. The gross cumulative continuation rate for 12 months was 83.14%, the most common medical reason for discontinuation of treatment was gastrointestinal disorder; lower educational level was found to be a risk factor for premature discontinuation. Conclusion： DSG-containing Marvelon brought fewer side effects and was well accepted when applied in Chinese rural women; we suggest that follow-up services should be stressed during the first 3 months, and more attention should be paid to let the users with lower educational level know the safety of Marvelon.