Wallander M A, Dimenäs E, Svärdsudd K, Wiklund I
Research Laboratories, AB Hässle, Mölndal, Sweden.
Eur J Clin Pharmacol. 1991;41(3):187-96. doi: 10.1007/BF00315428.
251 patients from 23 primary health care centres were recruited to a clinical trial in which either felodipine or placebo was added to baseline metoprolol treatment. Three methods of symptom reporting were used in 191 patients, namely two previously documented self-administered questionnaires and an adverse event monitoring system (spontaneous reports to treating physician). Higher frequencies of symptoms were seen with the questionnaires compared to spontaneous reporting. However, the overlap between the methods was moderate and they were found to complement one another. The questionnaires were completed twice during the study and the adverse event monitoring system was applied on five occasions. The rate of application had consequences for the ability of each method to detect transient, dose-related symptoms, e.g. headache and dizziness. Regardless of method, the possibility of detecting dose-related symptoms was enhanced when symptoms were measured not only during active treatment but also during a run-in or other baseline period, and both phases were considered in the analyses.
来自23个初级卫生保健中心的251名患者被招募参加一项临床试验，在该试验中，非洛地平或安慰剂被添加到基线美托洛尔治疗中。191名患者使用了三种症状报告方法，即两种先前记录的自我管理问卷和一个不良事件监测系统（向治疗医生的自发报告）。与自发报告相比，问卷显示出更高的症状频率。然而，这些方法之间的重叠程度适中，并且发现它们相互补充。在研究期间，问卷填写了两次，不良事件监测系统应用了五次。应用率对每种方法检测短暂的、剂量相关症状（如头痛和头晕）的能力产生了影响。无论采用何种方法，当不仅在积极治疗期间而且在导入期或其他基线期测量症状，并在分析中考虑两个阶段时，检测剂量相关症状的可能性都会增加。
