Borghi C, Pallavini G, Comi D, Grillo G, Lombardo M, Mantero O, Minetti L, Selvini A, Suppa G
Int J Clin Pharmacol Ther Toxicol. 1984 Jun;22(6):324-8.
In a double-blind, randomized, crossover, multicenter study performed in 227 hypertensive outpatients, two antihypertensive drugs, oxprenolol and chlorthalidone, were investigated to determine unwanted effects. Three main methodologic procedures were applied: the conventional evaluation of unwanted effects by the physician and involving the whole patient population, the checklist, and the free questionnaire. The latter two were assigned by randomization to the patients themselves. The study showed that unwanted effects seem to be frequently overreported when a checklist is used, whereas the free questionnaire gives more information about the symptoms of the disease than about the tolerance of the drug. The conventional method, when physicians are well-informed and sensitized to the problem, seems to provide more reliable information about unwanted effects of a drug.
在一项针对227名高血压门诊患者开展的双盲、随机、交叉、多中心研究中，对两种抗高血压药物氧烯洛尔和氯噻酮进行了研究，以确定其不良反应。采用了三种主要的方法学程序：医生对全体患者进行常规不良反应评估、使用清单法以及自由问卷法。后两种方法通过随机分配给患者本人。研究表明，使用清单法时，不良反应似乎经常被过度报告，而自由问卷法提供的关于疾病症状的信息比关于药物耐受性的信息更多。当医生充分了解并对该问题敏感时，传统方法似乎能提供关于药物不良反应更可靠的信息。
