Penn R G, Griffin J P
Br Med J (Clin Res Ed). 1982 May 15;284(6327):1440-2. doi: 10.1136/bmj.284.6327.1440.
A study was carried out comparing the reporting of adverse reactions to nitrofurantoin in Sweden, Holland, and the United Kingdom. The Swedish drug regulatory authorities receive more reports of adverse reactions to nitrofurantoin than to any other drug, and the annual reporting rate is increasing despite a steady fall in the prescription of nitrofurantoin. In the United Kingdom the total number of adverse reaction to nitrofurantoin reported to the Committee on Safety of Medicines has been steadily falling for many years, as has the number of prescription. Lung reactions and liver damage are more commonly reported in Sweden than in the UK, where gastrointestinal symptoms and peripheral neuropathy are more common. Such figures as were available in Holland showed an intermediate picture. The incidences of blood dyscrasias and allergic reactions are similar in the three countries. The causes for such differences are unresolved, but it is disturbing that the incidence and range of adverse reactions to such a common drug as nitrofurantoin reported to the national authorities can differ so much in countries that have close ethnic, dietary, and economic similarities. Thus great caution must be observed when data on adverse drug reactions from the country are extrapolated to another.
一项研究对瑞典、荷兰和英国关于呋喃妥因不良反应的报告情况进行了比较。瑞典药品监管当局收到的呋喃妥因不良反应报告比其他任何药物都多,尽管呋喃妥因的处方量在稳步下降,但年度报告率却在上升。在英国,多年来向药品安全委员会报告的呋喃妥因不良反应总数一直在稳步下降,处方量也是如此。肺部反应和肝损伤在瑞典比在英国更常被报告,而在英国,胃肠道症状和周围神经病变更为常见。荷兰现有的数据显示出一种中间情况。血液系统疾病和过敏反应在这三个国家的发生率相似。造成这种差异的原因尚未明确,但令人不安的是,在种族、饮食和经济相似的国家,向国家当局报告的像呋喃妥因这样常见药物的不良反应发生率和范围竟有如此大的差异。因此,当将一个国家的药物不良反应数据外推到另一个国家时,必须极其谨慎。