Rudd P, Ahmed S, Zachary V, Barton C, Bonduelle D
Department of Medicine, Stanford University Medical Center 94305-5475.
Clin Pharmacol Ther. 1990 Dec;48(6):676-85. doi: 10.1038/clpt.1990.211.
To assess the value of improved monitoring of medication-taking behavior in a drug trial, we employed a modified pill vial with microcircuitry to record the precise times when the vials were opened. After a 3-week placebo washout period, 21 ambulatory subjects with mild hypertension (mean age, 57 years; 67% men; 76% white) randomly received isradipine or enalapril twice daily in a double-blind titration during 10 weeks. Both drugs achieved a 13% reduction in sitting diastolic blood pressure (p less than 0.01) with minimal symptomatic or laboratory toxicity. Although pill counts indicated near-perfect compliance (92% to 99% for both groups), the electronic monitor showed that fewer than half of all openings occurred at the prescribed interval of 12 +/- 2 hours. Modest overdispensing was documented in the 3 days before scheduled visits. The monitor confirmed that pill count misclassified compliance sufficiency in 22% of visits and permitted more discrete attribution for drug-associated adverse reactions and secondary resistance to treatment. We conclude that the electronic monitor reduces ambiguity about medication compliance and helps interpret both the biology and pharmacology of the trial.
为评估在药物试验中改进用药行为监测的价值，我们采用了一种带有微电路的改良药瓶来记录药瓶打开的精确时间。在为期3周的安慰剂洗脱期后，21名轻度高血压门诊患者（平均年龄57岁；67%为男性；76%为白人）在10周的双盲滴定过程中，随机接受每日两次的伊拉地平或依那普利治疗。两种药物均使坐位舒张压降低了13%（p<0.01），且症状或实验室毒性最小。尽管药丸计数显示依从性近乎完美（两组均为92%至99%），但电子监测器显示，所有打开药瓶的时间中，只有不到一半是在规定的12±2小时间隔内。在预定就诊前3天记录到有适度的过量配药情况。监测器证实，在22%的就诊中，药丸计数将依从性充足情况误分类，并且有助于更明确地归因于药物相关不良反应和继发性治疗抵抗。我们得出结论，电子监测器减少了用药依从性的模糊性，并有助于解释试验的生物学和药理学情况。
