Coulter D M
National Toxicology Group, Medical School, Dunedin, New Zealand.
Br Med J (Clin Res Ed). 1988 Apr 16;296(6629):1086-8. doi: 10.1136/bmj.296.6629.1086.
Several notifications of eye pain and blurred vision associated with treatment with nifedipine were received by New Zealand's Intensive Medicines Monitoring Programme. A questionnaire survey of patients taking nifedipine was undertaken to test the importance of these associations, with disturbance of taste associated with captopril taken as a methodological control. Altogether 961 patients taking nifedipine and 368 taking captopril were sent a questionnaire that asked whether any eye problems and changes in the sense of taste had occurred while they were taking the drug and whether these had resolved after treatment was stopped. Compliance was high: of 922 and 343 questionnaires that were assumed to have been delivered to patients taking nifedipine and captopril, respectively, 770 (84%) and 295 (86%) were returned satisfactorily completed. The distribution of sex was comparable in the two groups; patients taking captopril were slightly younger. Eye symptoms were reported in both groups, but eye pain was significantly more common in patients taking nifedipine (107 (14%) compared with 26 (9%) patients taking captopril). This is a new finding and may be related to ocular vasodilatation. Theoretically, glaucoma is a possible adverse reaction. Loss of taste was significantly associated with captopril, but no other disturbances of taste showed significant associations. Loss of taste persisted in 27 out of 35 patients who continued to take captopril and in three out of eight patients when the drug was withdrawn. This study showed a method of assessing early signs of adverse drug reactions, which has been used once before and identified previously unrecognised reactions.
新西兰强化药物监测计划收到了几例与硝苯地平治疗相关的眼痛和视力模糊的报告。对服用硝苯地平的患者进行了问卷调查，以检验这些关联的重要性，并将与卡托普利相关的味觉障碍作为方法学对照。总共向961名服用硝苯地平的患者和368名服用卡托普利的患者发送了问卷，询问他们在服药期间是否出现任何眼部问题和味觉变化，以及停药后这些症状是否消失。问卷回收率很高：分别假定已送达服用硝苯地平患者和服用卡托普利患者的922份和343份问卷中，分别有770份（84%）和295份（86%）得到了令人满意的填答并返回。两组患者的性别分布相当；服用卡托普利的患者年龄稍小。两组均有眼部症状报告，但服用硝苯地平的患者眼痛明显更常见（107例（14%），而服用卡托普利的患者为26例（9%））。这是一个新发现，可能与眼部血管扩张有关。从理论上讲，青光眼是一种可能的不良反应。味觉丧失与卡托普利显著相关，但其他味觉障碍均未显示出显著关联。继续服用卡托普利的35名患者中有27名味觉丧失持续存在，停药的8名患者中有3名味觉丧失持续存在。这项研究展示了一种评估药物不良反应早期迹象的方法，该方法此前曾使用过一次，并识别出了先前未被认识到的反应。
