Schwed A, Fallab C L, Burnier M, Waeber B, Kappenberger L, Burnand B, Darioli R
University Medical Outpatient Clinic, Lausanne, Switzerland.
J Clin Pharmacol. 1999 Apr;39(4):402-9. doi: 10.1177/00912709922007976.
Nonadherence to treatment is a common problem in the clinical management of hypercholesterolemic patients. This study was carried out with the aim of monitoring the daily compliance to a 6-month course of lipid-lowering therapy, using a microelectronic device, the Medication Event Monitoring System (MEMS), versus pill count. Forty men with primary hypercholesterolemia were prescribed fluvastatin 1 x 40 mg daily, provided in a MEMS package to record the date and time of each opening of the pillbox. Thirty-nine of 40 patients (98%) completed the study. Total cholesterol and LDL cholesterol levels decreased significantly (18% and 25%, p < 0.001) during the 6-month therapy period. A high mean rate of compliance was achieved by MEMS using the following three indexes--compliance to total prescribed dose (88.8% +/- 13.5%), compliance to prescribed days (82.4% +/- 19.5%), and compliance to prescribed time of day (81.86% +/- 19.5%)--and by pill count (93.4% +/- 9.5%). In addition, the MEMS provided some patterns of nonadherence to medication, undetectable by pill count alone, such as a drug holiday in 38% of cases, a drug omission for more than 7 consecutive days in 9% of cases, and, conversely, use of more than the one prescribed daily dose in 47% of cases. A significant correlation between the rate of compliance and the decrease in LDL cholesterol was observed only when the compliance was assessed by MEMS. The results indicate that MEMS is a useful tool for monitoring compliance in clinical practice and may possibly increase adherence to long-term lipid-lowering therapy.
在高胆固醇血症患者的临床管理中，治疗依从性差是一个常见问题。本研究旨在使用一种微电子设备——药物事件监测系统（MEMS），与药丸计数法相比，监测患者对为期6个月的降脂治疗的每日依从性。40名原发性高胆固醇血症男性患者被处方每日服用1次40毫克氟伐他汀，药物装在MEMS包装中，以记录药盒每次打开的日期和时间。40名患者中有39名（98%）完成了研究。在6个月的治疗期间，总胆固醇和低密度脂蛋白胆固醇水平显著下降（分别下降18%和25%，p<0.001）。通过MEMS使用以下三个指标——对总处方剂量的依从性（88.8%±13.5%）、对规定天数的依从性（82.4%±19.5%）和对规定每日时间的依从性（81.86%±19.5%）——以及药丸计数法（93.4%±9.5%），均实现了较高的平均依从率。此外，MEMS还发现了一些仅靠药丸计数无法检测到的用药不依从模式，例如38%的病例出现停药期，9%的病例连续7天以上漏服药物，相反，47%的病例用药量超过规定的每日剂量。仅当通过MEMS评估依从性时观察到依从率与低密度脂蛋白胆固醇下降之间存在显著相关性。结果表明，MEMS是临床实践中监测依从性的有用工具，可能会提高对长期降脂治疗的依从性。
