Blake P, Lewis J A
British Biotechnology Ltd, Abingdon, Oxford, United Kingdom.
J Clin Pharmacol. 1992 Jan;32(1):85-90. doi: 10.1002/j.1552-4604.1992.tb03793.x.
Since drug therapy of angina is likely to produce a similar degree of efficacy for most drugs in common use, treatment choice should additionally focus on other factors, notably adverse events, quality of life, and convenience. Improvements in these factors can also lead to better compliance and can aid the doctor by cutting down the number of patient visits required to optimize therapy. The authors have evaluated the patient's overall assessment of symptomatic relief and adverse experiences in a comparative manner by means of the two-period crossover design using the patient's declared treatment preference as the primary measurement. This encapsulates several factors in a single assessment that can be understood by both physician and patient. The authors carried out two such studies of epanolol (Visacor), a novel anti-anginal agent with both beta-1 selective antagonist activity and also beta-1 selective partial agonist activity. In one study (n = 608) the comparator was metoprolol, and in the other (n = 571) it was nifedipine. This article describes and evaluates the methodology of these studies. To assess preference optimally, each patient had to receive both treatments in short but clinically relevant treatment periods, with no washout. Re-entry into the second period, after withdrawal from the first, was permitted. Both studies showed advantages for epanolol, more marked in the case of nifedipine, arising from equivalent efficacy but fewer adverse events.(ABSTRACT TRUNCATED AT 250 WORDS)
由于对于大多数常用药物而言,心绞痛的药物治疗可能会产生相似程度的疗效,因此治疗选择应额外关注其他因素,尤其是不良事件、生活质量和便利性。这些因素的改善也可导致更好的依从性,并可通过减少优化治疗所需的患者就诊次数来帮助医生。作者采用两阶段交叉设计,以患者声明的治疗偏好作为主要衡量标准,以比较的方式评估了患者对症状缓解和不良经历的总体评价。这在一次评估中涵盖了几个医生和患者都能理解的因素。作者对依泮洛尔(Visacor)进行了两项此类研究,依泮洛尔是一种新型抗心绞痛药物,兼具β-1选择性拮抗剂活性和β-1选择性部分激动剂活性。在一项研究中(n = 608),对照药物是美托洛尔,在另一项研究中(n = 571),对照药物是硝苯地平。本文描述并评估了这些研究的方法。为了最佳地评估偏好,每位患者必须在短但具有临床相关性的治疗期内接受两种治疗,且无需洗脱期。允许在退出第一期后重新进入第二期。两项研究均显示依泮洛尔具有优势,在硝苯地平对照的情况下更为明显,这源于等效的疗效但不良事件较少。(摘要截取自250字)