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卡培他滨治疗患者的依从性与安全性研究。

Adherence and safety study in patients on treatment with capecitabine.

作者信息

Fernández-Ribeiro Francisca, Olivera-Fernández Rosario, Crespo-Diz Carlos

机构信息

Pharmacy Unit.Complejo Hospitalario Universitario de Pontevedra..

出版信息

Farm Hosp. 2017 Mar 1;41(2):204-221. doi: 10.7399/fh.2017.41.2.10596.

Abstract

BACKGROUND

The introduction of oral antineoplastic agents in therapeutics has caused a change in the treatment strategy against cancer. The objective of this study was to analyze the adherence in patients to treatment with capecitabine, their adverse events, and the overall health status of patients, as well as the relationship of these factors with adherence.

METHOD

An observational, prospective study at 7 months, in a cohort of patients on capecitabine treatment, including treatment initiations and continuations, regardless of diagnosis or indication. The data collected were: demographic variables (age, gender), diagnostic (breast cancer, colorectal cancer, gastric cancer, off-label), adherence (tablet count, Morisky test,Sackett test), safety (assessment of adverse events, clinical evaluation by the oncologist) and quality of life (performance status, SF-12 test).

DATA SOURCES

electronic clinical records (IANUS®), dispensing program for outpatients (SILICON®) and interviews with patients.

RESULTS

There were 111 evaluable patients, with a mean age of 66.7 years (range 32-86), ECOG PS 1 in 76.6%. Adherence level: 78.4% (81.7% in the initiation sub-group vs. 72.5% in the continuation sub-group). Adverse events: skin toxicity (33.33%), asthenia (25.22%), gastrointestinal toxicity (24.32%) and neurological toxicity (24.32%), mostly G1.Health status, SF-12 test: subjective evaluation as "good" in 33.30% of cases. Conclusions: The low level of adherence in the continuation sub-group can be associated with the duration of treatment, toxicities, clinical evolution, and perception of their health status. It is necessary to conduct individualized monitoring in this group of patients in order to obtain a favorable clinical response.

摘要

背景

口服抗肿瘤药物引入治疗领域后,癌症治疗策略发生了变化。本研究的目的是分析患者对卡培他滨治疗的依从性、不良事件、患者的整体健康状况,以及这些因素与依从性的关系。

方法

对一组接受卡培他滨治疗的患者进行为期7个月的观察性前瞻性研究,包括治疗开始和持续情况,无论诊断或适应症如何。收集的数据包括:人口统计学变量(年龄、性别)、诊断(乳腺癌、结直肠癌、胃癌、超适应症用药)、依从性(药片计数、Morisky测试、Sackett测试)、安全性(不良事件评估、肿瘤学家的临床评估)和生活质量(体能状态、SF-12测试)。

数据来源

电子临床记录(IANUS®)、门诊患者配药程序(SILICON®)以及对患者的访谈。

结果

有111例可评估患者,平均年龄66.7岁(范围32 - 86岁),76.6%的患者东部肿瘤协作组体能状态评分为1。依从性水平:78.4%(开始治疗亚组为81.7%,继续治疗亚组为72.5%)。不良事件:皮肤毒性(33.33%)、乏力(25.22%)、胃肠道毒性(24.32%)和神经毒性(24.32%),大多为1级。健康状况,SF-12测试:33.30%的病例主观评价为“良好”。结论:继续治疗亚组的低依从性可能与治疗持续时间、毒性、临床进展以及对自身健康状况的认知有关。有必要对这组患者进行个体化监测,以获得良好的临床反应。

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