Straka R J, Fish J T, Benson S R, Suh J T
Department of Pharmacy Practice, College of Pharmacy, University of Minnesota, Minneapolis 55455, USA.
Pharmacotherapy. 1997 Jan-Feb;17(1):126-32.
To assess the accuracy of patient-kept diaries relative to electronic monitoring of compliance with isosorbide dinitrate prescribed 3 times/day for ischemic heart disease.
Unblinded, prospective, three-phase study.
Patients with coronary artery disease prescribed isosorbide dinitrate 3 times/day were asked to record the time of administration of each dose in a pocket diary while being monitored for compliance with a computerized Medication-Event Monitoring System (MEMS-4) vial that electronically recorded the date and time the vial was opened.
Sixty-eight stable outpatients with documented coronary artery disease who were prescribed isosorbide dinitrate 3 times/day were evaluated. Based on a prospectively chosen definition including a nitrate-free period, the mean (+/-SD) overall compliance rates were 71% (+/-30) versus 55% (+/-32) for the patient-kept diaries and the MEMS vials respectively (p = 0.001). The concordance between patient-kept diaries and MEMS data indicate that 67% of patients overestimate their compliance when using a self-recording tool. An average of 30% of diary entries were in error compared with the MEMS vial recordings.
Patient-kept diaries statistically overestimate actual compliance relative to that determined by MEMS devices. Given the prevalence of the use of diaries as the predominant tool on which researchers depend to document compliance with study drugs, our findings suggest that this practice should be reevaluated specifically when the time of the dose and documentation of administration are critical to qualifying the outcome of drug therapy. Such is the case with isosorbide dinitrate use in patients with ischemic heart disease. Furthermore, the overall poor compliance documented in this study suggests that the utility of isosorbide dinitrate prescribed 3 times/day be reevaluated as a clinically effective antianginal drug.
评估相对于电子监测，缺血性心脏病患者自行记录的硝酸异山梨酯每日3次用药依从性日记的准确性。
非盲、前瞻性、三阶段研究。
要求每日3次服用硝酸异山梨酯的冠心病患者在使用计算机化药物事件监测系统（MEMS-4）药瓶监测依从性时，在袖珍日记中记录每次服药时间，该系统可电子记录药瓶打开的日期和时间。
对68例记录在案的每日3次服用硝酸异山梨酯的稳定门诊冠心病患者进行了评估。根据预先选定的包括无硝酸盐期的定义，患者自行记录的日记和MEMS药瓶的平均（±标准差）总体依从率分别为71%（±30）和55%（±32）（p = 0.001）。患者自行记录的日记与MEMS数据之间的一致性表明，67%的患者在使用自我记录工具时高估了自己的依从性。与MEMS药瓶记录相比，平均30%的日记记录存在错误。
相对于MEMS设备确定的实际依从性，患者自行记录的日记在统计学上高估了依从性。鉴于日记作为研究人员用于记录研究药物依从性的主要工具的普遍使用情况，我们的研究结果表明，当服药时间和用药记录对确定药物治疗结果至关重要时，应特别重新评估这种做法。缺血性心脏病患者使用硝酸异山梨酯就是这种情况。此外，本研究记录的总体依从性较差表明，应重新评估每日3次服用硝酸异山梨酯作为临床有效抗心绞痛药物的效用。
