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口服他莫昔芬的依从性:患者自我报告、药丸计数与微电子监测的比较

Adherence to oral tamoxifen: a comparison of patient self-report, pill counts, and microelectronic monitoring.

作者信息

Waterhouse D M, Calzone K A, Mele C, Brenner D E

机构信息

Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor.

出版信息

J Clin Oncol. 1993 Jun;11(6):1189-97. doi: 10.1200/JCO.1993.11.6.1189.

Abstract

PURPOSE

Recent innovations allow the integration of microelectronics into drug packaging, providing a continuous record of the interactions of the patient with the drug package. We hypothesized that adherence to oral tamoxifen, as measured by a pressure-activated microelectronic monitoring device, would be significantly discrepant from traditional measures of patient adherence, ie, patient self-report (SR) and pill counts (PCs).

PATIENTS AND METHODS

Twenty-six patients receiving oral tamoxifen therapy were assessed by patient SR, PCs, and Medication Event Monitoring System (MEMS; Aprex Corp, Fremont, CA) microelectronic monitoring. A microprocessor in the MEMS cap recorded each opening as a presumptive dose, listing the date, time, and duration of opening for later retrieval on a microcomputer. Patients were not informed that their adherence was to be monitored electronically or that PCs would be performed.

RESULTS

A total of 2,102 days (70.1 months) of tamoxifen therapy were monitored; patients were monitored for a mean of 2.92 months of tamoxifen therapy. SR adherence to oral tamoxifen was significantly higher than that suggested by either PCs (SR missed doses only v PC, P = .008) or MEMS adherence monitoring (SR missed doses only v MEMS missed doses only, P = .005; SR dosing-interval errors only v MEMS dosing-interval errors only, P < .0001; SR all dosing errors v MEMS all dosing errors, P < .0005). PC data also suggested significantly higher adherence rates than MEMS monitoring.

CONCLUSION

Microelectronic adherence monitoring provides both confirmatory and complimentary data regarding adherence behavior, while also allowing for the evaluation of patterns of nonadherence. Patient SRs and PCs likely overestimate the degree to which patients adhere to their tamoxifen regimen.

摘要

目的

近期的创新技术可将微电子技术集成到药物包装中,从而持续记录患者与药物包装的相互作用情况。我们推测,通过压力激活微电子监测设备测量的口服他莫昔芬的依从性,与传统的患者依从性测量方法(即患者自我报告(SR)和药丸计数(PC))会存在显著差异。

患者与方法

通过患者自我报告、药丸计数和药物事件监测系统(MEMS;Aprex公司,弗里蒙特,加利福尼亚州)微电子监测对26例接受口服他莫昔芬治疗的患者进行评估。MEMS瓶盖中的微处理器将每次打开记录为一次推定剂量,列出打开的日期、时间和持续时间,以便之后在微型计算机上检索。患者未被告知其依从性将通过电子方式监测,也未被告知将进行药丸计数。

结果

共监测了2102天(70.1个月)的他莫昔芬治疗;患者接受他莫昔芬治疗的平均监测时间为2.92个月。口服他莫昔芬的自我报告依从性显著高于药丸计数(仅自我报告漏服剂量与药丸计数相比,P = 0.008)或MEMS依从性监测(仅自我报告漏服剂量与仅MEMS漏服剂量相比,P = 0.005;仅自我报告给药间隔误差与仅MEMS给药间隔误差相比,P < 0.0001;自我报告所有给药误差与MEMS所有给药误差相比,P < 0.0005)所显示的依从性。药丸计数数据也显示出比MEMS监测更高的依从率。

结论

微电子依从性监测提供了关于依从行为的确认性和补充性数据,同时还能评估不依从模式。患者自我报告和药丸计数可能高估了患者坚持他莫昔芬治疗方案的程度。

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