Zhou Lifeng, Harrison-Woolrych Mira, Coulter David M
Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.
Pharmacoepidemiol Drug Saf. 2003 Jul-Aug;12(5):371-7. doi: 10.1002/pds.875.
To demonstrate how the Intensive Medicines Monitoring Programme (IMMP) can be used to monitor adverse events associated with an intrauterine device, using the levonorgestrel-releasing intrauterine device (Mirena) as an example.
A long-term prospective observational cohort study using Prescription Event Monitoring (PEM) is currently being undertaken in women using Mirena in New Zealand. This report describes the method used and reports the early results for those women who used the device between March 1998 and March 2001. Adverse events were recorded by inserting doctors and general practitioners on registration forms and systematic follow-up questionnaires.
Between March 1998 and March 2001, the IMMP received 3519 registration forms for insertions in 3452 women. 'Difficult insertion' was the most frequently reported event (3.6% of all insertions). Approximately, 2% of the Mirena insertions were carried out under GA and there were three uterine perforations (0.9 per 1000 insertions) in the total cohort. To date, follow-up questionnaires have been processed for 495 patients. The response rate for these was 83%.
As adapted in the IMMP, PEM is an effective tool for the early post-marketing surveillance of an intrauterine device in real life clinical practice.
以左炔诺孕酮宫内节育器（曼月乐）为例，说明强化药物监测计划（IMMP）如何用于监测与宫内节育器相关的不良事件。
目前正在新西兰对使用曼月乐的女性进行一项采用处方事件监测（PEM）的长期前瞻性观察队列研究。本报告描述了所使用的方法，并报告了1998年3月至2001年3月期间使用该器械的女性的早期结果。不良事件由参与置入的医生和全科医生在登记表及系统的随访问卷上记录。
1998年3月至2001年3月期间，IMMP收到3452名女性置入器械的3519份登记表。“置入困难”是报告最频繁的事件（占所有置入的3.6%）。大约2%的曼月乐置入是在全身麻醉下进行的，整个队列中有3例子宫穿孔（每1000例置入0.9例）。迄今为止，已对495名患者的随访问卷进行了处理。这些问卷的回复率为83%。
如在IMMP中所应用的那样，PEM是在实际临床实践中对宫内节育器进行上市后早期监测的有效工具。
