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通过处方事件监测研究地尔硫䓬和二氢吡啶类钙拮抗剂中与血管舒张相关的不良事件。

Vasodilation-related adverse events in diltiazem and dihydropyridine calcium antagonists studied by prescription-event monitoring.

作者信息

Kubota K, Pearce G L, Inman W H

出版信息

Eur J Clin Pharmacol. 1995;48(1):1-7. doi: 10.1007/BF00202163.

DOI:10.1007/BF00202163
PMID:7621840
Abstract

The incidence of vasodilation-related events (flushing, headache, dizziness and oedema) was determined in a total of 37,670 patients treated with diltiazem, nicardipine, isradipine or amlodipine and studied by Prescription-Event Monitoring between 1984 and 1991. Event rates are expressed as the percentage of patients who experienced these events during the six months after the first prescription. The rates for all these events with the newer vasoselective dihydropyridines (nicardipine, isradipine and amlodipine) were higher than those with diltiazem. Among the three dihydropyridines, there were large individual differences in the rates. With nicardipine, the frequency of each of the four vasodilation-related events were similar to one another (approximately 3%). With isradipine, the rates were also similar to one another but all were approximately twice those measured in the nicardipine study (approximately 6%). These differences may have been due to confounding factors such as the publicity about adverse drug reactions, the indication for use by individual patients or the doses actually being used at the time the event occurred. With amlodipine, in contrast, the rate for oedema was two to four times larger than the rates for flushing, headache or dizziness.

摘要

在1984年至1991年间,通过处方事件监测对总共37670名接受地尔硫䓬、尼卡地平、伊拉地平或氨氯地平治疗的患者进行了血管扩张相关事件(潮红、头痛、头晕和水肿)发生率的测定。事件发生率以首次处方后六个月内发生这些事件的患者百分比表示。所有这些新型血管选择性二氢吡啶类药物(尼卡地平、伊拉地平、氨氯地平)引发的事件发生率均高于地尔硫䓬。在这三种二氢吡啶类药物中,发生率存在较大个体差异。使用尼卡地平时,四种血管扩张相关事件的发生率彼此相似(约3%)。使用伊拉地平时,发生率也彼此相似,但均约为尼卡地平研究中测得发生率的两倍(约6%)。这些差异可能归因于混杂因素,如药物不良反应的宣传、个体患者的用药指征或事件发生时实际使用的剂量。相比之下,使用氨氯地平时,水肿发生率比潮红、头痛或头晕发生率高出两至四倍。

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