Zindani Gameel N, Streetman Darcie D, Streetman Daniel S, Nasr Samya Z
University of Michigan School of Public Health, University of Michigan Health System, Ann Arbor, MI, USA.
J Adolesc Health. 2006 Jan;38(1):13-7. doi: 10.1016/j.jadohealth.2004.09.013.
The purpose of this study was to monitor medication adherence in cystic fibrosis (CF) patients and its correlation with disease severity and patient age.
Children less than 12 years of age (group 1) and adolescents 12 years of age and older (group 2) were recruited from the University of Michigan CF Center. The study duration was 3 months. A total of 22 patients per group were enrolled. Adherence to ADEKs, an oral multivitamin, and dornase alfa, a nebulized mucolytic medication, was monitored. Adherence to ADEKs was monitored by using the Medication Event Monitoring System (MEMS) SmartCaps (APREX, AARDx, Inc., Union City, California). Dornase alfa adherence rate was monitored by counting empty medication vials.
Thirty-three patients completed the study, 15 patients in group 1 and 18 patients in group 2. The overall mean adherence rates for ADEKs and dornase alfa were (+/- SD) 63.6% +/- 24.0% and 66.5% +/- 31.2%, respectively. The median ADEKs and dornase alfa adherence rate for group 1 was 84.6% and 79.1%, respectively (p = .08); and for group 2 was 56.7% vs. 78.4%, respectively (p = .07). There was a trend toward significance, suggesting that the adherence rate for ADEKs was higher than for dornase alfa (p = .08) in group 1. Group 2 showed a trend toward adherence to dornase alfa than to ADEKs (p = .07). There was a trend for ADEKs adherence between groups 1 and 2 (p = .09), but not for dornase alfa (p = .93).
Parental supervision and disease severity are likely to play a major role in adherence to medical management. Partnership with patients and families about the treatment plan might be important for improving adherence rate. The MEMS SmartCaps is an electronic monitoring technology that should be used to measure drug adherence objectively both in further larger clinical trials and in the outpatient setting.
本研究旨在监测囊性纤维化（CF）患者的药物依从性及其与疾病严重程度和患者年龄的相关性。
从密歇根大学CF中心招募12岁以下儿童（第1组）和12岁及以上青少年（第2组）。研究持续时间为3个月。每组共纳入22例患者。监测对ADEKs（一种口服多种维生素）和多黏菌素B雾化黏液溶解剂的依从性。通过使用药物事件监测系统（MEMS）智能帽（APREX，AARDx公司，加利福尼亚州联合市）监测对ADEKs的依从性。通过计算空药瓶数量监测多黏菌素B的依从率。
33例患者完成了研究，第1组15例，第2组18例。ADEKs和多黏菌素B的总体平均依从率分别为（±标准差）63.6%±24.0%和66.5%±31.2%。第1组ADEKs和多黏菌素B的中位依从率分别为84.6%和79.1%（p = 0.08）；第2组分别为56.7%和78.4%（p = 0.07）。有显著趋势，表明第1组中ADEKs的依从率高于多黏菌素B（p = 0.08）。第2组显示出对多黏菌素B的依从性趋势高于对ADEKs的依从性（p = 0.07）。第1组和第2组之间ADEKs的依从性有趋势（p = 0.09），但多黏菌素B没有（p = 0.93）。
家长监督和疾病严重程度可能在医疗管理依从性中起主要作用。与患者及其家庭就治疗计划建立合作关系可能对提高依从率很重要。MEMS智能帽是一种电子监测技术，应在进一步更大规模的临床试验和门诊环境中用于客观测量药物依从性。
