Touskova Tereza, Vytrisalova Magda, Palicka Vladimir, Hendrychova Tereza, Fuksa Leos, Holcova Radka, Konopacova Jana, Kubena Ales Antonin
Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, Hradec Kralove, Czech Republic.
Osteocentre, Institute of Clinical Biochemistry and Diagnostics, Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Hradec Kralove, Czech Republic.
Patient Prefer Adherence. 2015 Dec 16;9:1771-9. doi: 10.2147/PPA.S88630. eCollection 2015.
All current recommendations include calcium and vitamin D (Ca-D) as an integrated part of osteoporosis treatment. The purpose of this pilot study was to analyze compliance with a fixed combination of Ca-D in women persistent with the treatment.
An observational study was carried out in three osteocenters in the Czech Republic. Women with osteoporosis ≥55 years of age concurrently treated with oral ibandronate were eligible. Compliance was evaluated in a period of 3 months by Medication Event Monitoring System (MEMS), tablet count, and self-report. Nonpersistence was defined as a MEMS-based gap in the use of Ca-D to be 30 days or more.
A total of 73 patients were monitored, of which 49 patients were analyzed (target population). Based on MEMS, mean overall compliance was 71%; good compliance (≥80%) was observed in 59% of the patients. As many as 71% of the patients took drug holidays (≥3 consecutive days without intake); overall compliance of these patients was 59% and was slightly lower on Fridays and weekends. Patients without drug holidays were fully compliant (did not omit individual doses). Compliance differed according to daily time at which the patients mostly used the Ca-D. Afternoon/evening takers showed a mean overall compliance of 82% while morning/night takers only 51% (P=0.049). Based on MEMS, tablet count, and self-report, compliance ≥75% was observed in 59%, 100%, and 87% of the patients, respectively. Outcomes obtained by the three methods were not associated with each other. Undesirable concurrent ingestion of Ca-D and ibandronate was present only twice.
Despite almost perfect self-reported and tablet count-based compliance, MEMS-based compliance was relatively poor. Consecutive supplementation-free days were common; more than two-thirds of the patients took at least one drug holiday. This pilot study showed drug holiday to be the most important type of noncompliance with Ca-D in those who are persistent with the treatment.
目前所有的建议都将钙和维生素D（Ca-D）作为骨质疏松症治疗的一个组成部分。这项初步研究的目的是分析坚持治疗的女性对固定复方Ca-D的依从性。
在捷克共和国的三个骨中心进行了一项观察性研究。年龄≥55岁且同时接受口服伊班膦酸盐治疗的骨质疏松症女性符合条件。通过药物事件监测系统（MEMS）、药片计数和自我报告对3个月期间的依从性进行评估。非持续性被定义为基于MEMS的Ca-D使用间隔为30天或更长时间。
共监测了73例患者，其中49例患者进行了分析（目标人群）。基于MEMS，总体平均依从性为71%；59%的患者依从性良好（≥80%）。多达71%的患者有停药期（连续≥3天未服药）；这些患者的总体依从性为59%，在周五和周末略低。没有停药期的患者完全依从（未遗漏单次剂量）。依从性因患者使用Ca-D的主要日常时间而异。下午/晚上服药者的总体平均依从性为82%，而上午/夜间服药者仅为51%（P=0.049）。基于MEMS、药片计数和自我报告，分别有59%、10%和87%的患者依从性≥75%。三种方法获得的结果彼此不相关。Ca-D和伊班膦酸盐同时摄入不良的情况仅出现过两次。
尽管基于自我报告和药片计数的依从性几乎完美，但基于MEMS的依从性相对较差。连续无补充剂的天数很常见；超过三分之二的患者至少有一次停药期。这项初步研究表明，停药期是坚持治疗的患者中Ca-D治疗不依从的最重要类型。
