Moore N, Pierfitte C, Pehourcq F, Lagnaoui R, Bégaud B
Department of Pharmacology, Université Victor Segalen, Bordeaux, France.
Clin Pharmacol Ther. 2001 Jun;69(6):445-50. doi: 10.1067/mcp.2001.116147.
Exposure in pharmacoepidemiologic studies can rely on various sources such as medical records, patient questionnaires, or plasma samples, which do not always concur. This study endeavored to compare sources of information on current exposure to benzodiazepines in elderly subjects.
In a study in a hospital admissions department, 1136 elderly subjects included in a case-control study each completed a structured questionnaire. In addition, an inspection of the medical records of each subject was performed, as well as screening of a plasma sample (high-pressure liquid chromatography--diode array detector) for current exposure to benzodiazepines.
Benzodiazepines were found in the plasma of 33% of 1013 patients, in the records of 31% of patients, and in the questionnaires of 36% of 797 respondents. With use of the plasma results as a standard, questionnaires had 11% false positives and 28% false negatives; medical records had 14% false positives and 23% false negatives. The kappa for concordance between questionnaires and records was 0.63. Most of the errors were related to the unexpected presence in plasma of clorazepate, commonly used as a hypnotic agent.
Patient recall and medical records are not reliable measures of current exposure to benzodiazepines in elderly persons, although this unreliability may be more marked with certain drugs used as hypnotic agents.
药物流行病学研究中的暴露情况可依赖多种来源,如医疗记录、患者问卷或血浆样本,而这些来源并不总是一致的。本研究旨在比较老年受试者当前苯二氮䓬类药物暴露的信息来源。
在一家医院入院科室的一项研究中,纳入病例对照研究的1136名老年受试者每人都完成了一份结构化问卷。此外,对每位受试者的医疗记录进行了检查,并对血浆样本(高压液相色谱 - 二极管阵列检测器)进行筛查,以确定当前是否暴露于苯二氮䓬类药物。
在1013名患者中,33%的患者血浆中发现了苯二氮䓬类药物,31%的患者记录中有相关记载,797名受访者中有36%在问卷中提及。以血浆检测结果为标准,问卷有11%的假阳性和28%的假阴性;医疗记录有14%的假阳性和23%的假阴性。问卷与记录之间一致性的kappa值为0.63。大多数误差与血浆中意外出现的氯氮䓬有关,氯氮䓬常用作催眠剂。
患者回忆和医疗记录并非老年患者当前苯二氮䓬类药物暴露的可靠衡量指标,尽管这种不可靠性在某些用作催眠剂的药物中可能更为明显。