Mallion J M, Dutrey-Dupagne C, Vaur L, Genes N, Renault M, Elkik F, Baguet P, Boutelant S
CHU La Tronche, Médecine Interne et Cardiologie, Grenoble, France.
J Hypertens. 1996 Jan;14(1):137-44.
This study was designed to assess the compliance of hypertensive patients with a once-daily regimen of the angiotensin converting enzyme (ACE) inhibitor trandolapril and to evaluate the antihypertensive efficacy of the drug in relation to the time interval between taking the final dose and measuring the blood pressure (BP).
After a 2-week wash-out period, hypertensive patients, recruited by cardiologists, received trandolapril 2 mg once daily in the morning for 4 weeks.
In order to assess compliance, each patient's supply of trandolapril capsules was presented in a pillbox that incorporated in its lid a microprocessor that recorded the date and time of each occasion that it was opened. BP was measured using validated semi-automatic devices, at the end of both the wash-out and the treatment period.
A total of 590 patients entered the study. Compliance data were evaluable for 501 patients. Overall compliance, defined as the ratio of the number of openings recorded to the number of doses prescribed was less than 80, 80-100, and more than 100% in 17, 63 and 20% of patients, respectively. The average number (+/- SD) of missed doses was 4.5 +/- 8 (median 2). The average interval between successive openings was 25 h 07 min mean +/- 13 h (median 24 h). The average number of delayed doses (a delayed dose being defined as the box being opened 25-36 h after the previous occasion) was 5.6 +/- 3 (median 6). Patients living in the Paris area had more forgotten and delayed doses than those living in the provinces (7.9 versus 3.8 forgotten; P<0.0001 and 6.3 versus 5.5 delayed; P<0.005). Doses were forgotten and delayed more often during weekends than on weekdays. The greatest number of delayed doses occurred in those patients under 60 years of age (6.0 versus 5.2; P<0.01). Decreases in systolic blood pressure (SBP and diastolic blood pressure (DBP) were 20.3/12.8 mmHg, for patients whose final drug was taken on the same day as the BP measurement, and 18.9/11.2 mmHg for patients whose final dose was taken on the previous day.
Electronic compliance monitoring allows refined analysis of the behaviour of hypertensive patients. In this study doses were missed and delayed frequently during the first month of treatment, depending on the patient's lifestyle.
本研究旨在评估高血压患者对血管紧张素转换酶(ACE)抑制剂群多普利每日一次用药方案的依从性,并评估该药物在末次服药与测量血压(BP)之间的时间间隔方面的降压疗效。
在为期2周的洗脱期后,由心脏病专家招募的高血压患者每天早晨服用2毫克群多普利,持续4周。
为了评估依从性,给每位患者提供的群多普利胶囊放在一个药盒中,药盒盖子上装有一个微处理器,可记录每次打开药盒的日期和时间。在洗脱期和治疗期结束时,使用经过验证的半自动设备测量血压。
共有590名患者进入研究。501名患者的依从性数据可进行评估。总体依从性定义为记录的打开次数与规定剂量数之比,分别有17%、63%和20%的患者低于80%、80%-100%和高于100%。漏服剂量的平均数量(±标准差)为4.5±8(中位数为2)。连续两次打开药盒的平均间隔时间为25小时07分钟,平均±13小时(中位数为24小时)。延迟剂量(延迟剂量定义为药盒在上次打开后25-36小时被打开)的平均数量为5.6±3(中位数为6)。居住在巴黎地区的患者比居住在其他省份的患者有更多的漏服和延迟服药情况(漏服:7.9次对3.8次;P<0.0001;延迟:6.3次对5.5次;P<0.005)。周末漏服和延迟服药的情况比工作日更频繁。延迟剂量最多的是60岁以下的患者(6.0次对5.2次;P<0.01)。对于末次服药与血压测量在同一天的患者,收缩压(SBP)和舒张压(DBP)的下降分别为20.3/12.8 mmHg,对于末次服药在前一天的患者,下降为18.9/11.2 mmHg。
电子依从性监测有助于对高血压患者的行为进行精细分析。在本研究中,治疗的第一个月经常出现漏服和延迟服药的情况,这取决于患者的生活方式。