Martin R M, Biswas P N, Freemantle S N, Pearce G L, Mann R D
Drug Safety Research Unit, University of Southampton.
Br J Clin Pharmacol. 1998 Nov;46(5):505-11. doi: 10.1046/j.1365-2125.1998.00817.x.
Little is known about the frequency with which suspected adverse drug reactions are seen by general practitioners after the prescription of newly marketed drugs. We investigated age and sex specific incidence rates of suspected adverse drug reactions recorded by general practitioners in England after the prescription of selected newly marketed drugs.
Information was collected from 48 national cohort studies of newly marketed drugs studied by prescription-event monitoring. Questionnaires were sent to prescribers asking for details of events and suspected adverse drug reactions recorded in the patients' notes occurring after the drugs were prescribed.
During the 48 cohort studies, a total of 513608 patients were investigated, of which 221781 (43.2%) were males and 285862 (55.7%) were females. The overall incidence of suspected adverse drug reactions in males was 12.9 per 10000 patient-months of exposure (95% confidence limits 12.3 to 13.5), and in females was 20.6 per 10000 patient-months of exposure (95% confidence limits 19.9 to 21.3). The overall age-standardised relative risk of an adverse drug reaction in females compared with males was 1.6 (1.5-1.7). This sex difference was significant in all age groups above 19 years of age, and was relatively consistent across all age groups (chi2 test for heterogeneity = 9.2, P=0.3). The highest rate of recording in males was in the 50-59 year age group, and in females was in the 30-39 year age group.
In general practice in England, suspected adverse drug reactions to newly marketed drugs are recorded more often in adults aged between 30 and 59 years of age and are 60% more common in women than in men. The sex difference occurs in all age groups over 19 years of age.
对于全科医生在开具新上市药物处方后所见到的疑似药物不良反应的发生频率，人们了解甚少。我们调查了英格兰全科医生在开具选定新上市药物处方后记录的特定年龄和性别的疑似药物不良反应发生率。
从48项通过处方事件监测研究新上市药物的全国队列研究中收集信息。向开处方者发送问卷，询问药物处方后患者病历中记录的事件及疑似药物不良反应的详细情况。
在48项队列研究中，共调查了513608名患者，其中男性221781名（43.2%），女性285862名（55.7%）。男性疑似药物不良反应的总体发生率为每10000患者月暴露量12.9例（95%置信区间12.3至13.5），女性为每10000患者月暴露量20.6例（95%置信区间19.9至21.3）。女性药物不良反应的总体年龄标准化相对风险与男性相比为1.6（1.5 - 1.7）。这种性别差异在19岁以上的所有年龄组中均显著，且在所有年龄组中相对一致（异质性卡方检验=9.2，P = 0.3）。男性记录率最高的年龄组为50 - 59岁，女性为30 - 39岁。
在英格兰的全科医疗中，新上市药物的疑似药物不良反应在30至59岁的成年人中记录更为频繁，且女性比男性常见60%。这种性别差异在19岁以上的所有年龄组中均存在。
