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一项评估临床药学干预对丙型肝炎患者治疗结果、健康相关生活质量和药物依从性影响的随机对照试验。

A Randomized Controlled Trial to Assess the  Impact of Clinical Pharmacy Interventions on Treatment Outcomes, Health Related Quality of Life and Medication Adherence Among Hepatitis C Patients.

作者信息

Ali Salamat, Ali Mashhood, Paudyal Vibhu, Rasheed Faisal, Ullah Shahan, Haque Sayeed, Ur-Rehman Tofeeq

机构信息

Department of Pharmacy, Quaid-i-Azam University, Islamabad, Pakistan.

Services Institute of Medical Sciences, Lahore, Pakistan.

出版信息

Patient Prefer Adherence. 2019 Dec 13;13:2089-2100. doi: 10.2147/PPA.S224937. eCollection 2019.

Abstract

PURPOSE

The role of specialized pharmacy services remains unexplored in clinical practice for hepatitis C patients in Pakistan. This study aimed to evaluate the impact of clinical pharmacy interventions on treatment outcomes, health-related quality of life (HRQoL), and medication adherence among hepatitis C patients.

METHODS

A randomized control trial was conducted at two tertiary-care teaching hospitals in Pakistan. Hepatitis C patients who attended the outpatient clinics between October 2015 and September 2018 were randomized to two groups [usual care (UC) and pharmaceutical care (PC)] in a 1:1 ratio, applying simple envelope method. The PC group received pharmaceutical care led by a clinical pharmacist. The care that patients received included education and counseling on medication compliance, labeling of medication packs, and monitoring of adverse drug events, led by a qualified clinical pharmacist during the 15- to 20-minute monthly sessions, while the UC group received standard care at hospital, which did not involve clinical pharmacist input. Outcome measures, such as sustained virological response, HRQoL, and adherence rate (pharmacy data) were assessed at enrolment and distinct time intervals: 4 weeks, 8 weeks, and end of treatment.

RESULTS

A total of 931 patients were included in the study (UC 466 and PC 465), with mean age 42.35±1.9 years. Sustained virological response at 12 weeks was achieved in 86.0% patients in the PC group, significantly (<0.001) higher than the UC (69.3%) group. Fewer patients (9.9%) in the PC group reported mobility problems, significantly fewer (<0.001) than the UC group (11.8%). Self-care, usual activity, pain, and depression were relieved significantly in the PC group compared to the UC group. The EuroQol visual analogue scale (baseline 56.1 of UC group versus 55.2 for PC group) was raised to 71.8 and 71.9 in the UC and PC groups, respectively. Medication adherence was significantly improved (<0.001) in the PC group (88.6%) when compared to the UC group (77.9%, 95% CI 88.9%-91.9%).

CONCLUSION

Pharmacist-led clinical pharmacy interventions as part of multidisciplinary care had a significant impact on improving cure rates, HRQoL, and medication adherence for hepatitis C patients. This study suggests that clinical pharmacists should be incorporated into the multidisciplinary health-care team for care of hepatitis C patients.

摘要

目的

在巴基斯坦,专科药房服务在丙型肝炎患者临床实践中的作用尚未得到探索。本研究旨在评估临床药学干预对丙型肝炎患者治疗结局、健康相关生活质量(HRQoL)和用药依从性的影响。

方法

在巴基斯坦的两家三级护理教学医院进行了一项随机对照试验。2015年10月至2018年9月期间到门诊就诊的丙型肝炎患者采用简单信封法以1:1的比例随机分为两组[常规护理(UC)组和药学护理(PC)组]。PC组接受由临床药师主导的药学护理。在每月15至20分钟的会诊期间,由合格的临床药师主导,患者接受的护理包括用药依从性教育和咨询、药包标签以及药物不良事件监测,而UC组在医院接受标准护理,不涉及临床药师的参与。在入组时以及不同时间间隔:4周、8周和治疗结束时,评估持续病毒学应答、HRQoL和依从率(药房数据)等结局指标。

结果

共有931名患者纳入研究(UC组466例,PC组465例),平均年龄42.35±1.9岁。PC组86.0%的患者在12周时实现了持续病毒学应答,显著高于UC组(69.3%)(<0.001)。PC组报告有行动问题的患者较少(9.9%),显著少于UC组(11.8%)(<0.001)。与UC组相比,PC组的自我护理、日常活动、疼痛和抑郁症状得到显著缓解。欧洲五维度健康量表视觉模拟评分(UC组基线为56.1,PC组为55.2)在UC组和PC组分别提高到71.8和71.9。与UC组(77.9%,95%CI 88.9%-91.9%)相比,PC组的用药依从性显著提高(<0.001)(88.6%)。

结论

作为多学科护理一部分的药师主导的临床药学干预对提高丙型肝炎患者的治愈率、HRQoL和用药依从性有显著影响。本研究表明,临床药师应纳入多学科医疗团队以护理丙型肝炎患者。

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