Waeber B, Erne P, Saxenhofer H, Heynen G
Division of Hypertension, CHUV, Lausanne, Switzerland.
J Hypertens Suppl. 1994 Nov;12(8):S67-71.
To assess compliance with a drug regimen of two doses a day compared with one a day.
A prospective crossover study was set up in a general practice environment to compare compliance on a drug regimen of once a day versus twice a day. Data were collected by electronic monitoring in 113 patients with hypertension or angina pectoris. All patients were prescribed slow-release nifedipine twice a day during the first month and then crossed to a single daily dose of amlodipine for another month.
Compliance, defined as the proportion of days on which the correct dose was taken, improved in 30% of patients (95% confidence interval 19-41%; P < 0.001) when the patients were switched from twice a day to once a day, but at the same time there was a 15% increase (95% confidence interval 5-25%; P < 0.02) in the number of patients with one or more no-dose days. Approximately 8% of patients displayed low compliance, irrespective of the dose regimen. Actual dose intervals were used to estimate the extent and timing of periods with unsatisfactory drug activity for various hypothetical drug durations of action.
The apparent advantage of a single daily dose in terms of compliance appears to be clinically meaningful only when the duration of activity extends beyond the dose interval in all patients.
评估一天服用两剂药物方案与一天服用一剂药物方案的依从性。
在普通医疗环境中开展一项前瞻性交叉研究,以比较一天一次与一天两次药物方案的依从性。通过电子监测收集了113例高血压或心绞痛患者的数据。所有患者在第一个月每天服用两次缓释硝苯地平,然后在接下来的一个月改用氨氯地平每日单剂量服用。
依从性定义为服用正确剂量的天数比例,当患者从一天两次服药改为一天一次服药时,30%的患者依从性有所改善(95%置信区间19 - 41%;P < 0.001),但同时有一剂或多剂未服用天数的患者数量增加了15%(95%置信区间5 - 25%;P < 0.02)。无论剂量方案如何,约8%的患者表现出低依从性。使用实际剂量间隔来估计在各种假设的药物作用持续时间下药物活性不理想时期的范围和时间。
仅当所有患者的药物活性持续时间超过剂量间隔时,每日单剂量在依从性方面的明显优势在临床上才似乎有意义。