药剂师主导的管理模式与慢性心力衰竭患者的药物依从性：一项随机临床试验。

Pharmacist-Led Management Model and Medication Adherence Among Patients With Chronic Heart Failure: A Randomized Clinical Trial.

作者信息

Wang Lingjiao, Zhao Yuanyuan, Han Liping, Zhang Huan, Chen Hejun, Liu Aixia, Yu Jing, Fu Ran, Duan Liguang, An Feiyue, Guo Zhimin, Lun Yang, Chen Chaoli, Cheng Fangfang, Song Chaohui, Gao Haixia, Zhou Chunhua

机构信息

Department of Clinical Pharmacy, The First Hospital of Hebei Medical University, Hebei, China.

Department of Clinical Psychology, Key Laboratory for Neuroimmunological Regulation and Mental Health of Hebei Province, Hebei, China.

出版信息

JAMA Netw Open. 2024 Dec 2;7(12):e2453976. doi: 10.1001/jamanetworkopen.2024.53976.

DOI:10.1001/jamanetworkopen.2024.53976

PMID:39705029

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11662253/

Abstract

IMPORTANCE

Poor medication adherence is associated with high morbidity and mortality among patients with chronic heart failure (CHF), which is particularly concerning in China.

OBJECTIVE

To assess the effect of a pharmacist-led management model incorporating a social media platform vs usual care on medication adherence in patients with CHF.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, multicenter randomized clinical trial was conducted from March 2021 to May 2023, with a follow-up duration of 52 weeks. The trial was conducted in the cardiology wards of 5 hospitals in China. Participants were 18 years or older, had a CHF diagnosis, and were receiving stable medication. They were randomly assigned to either the intervention group (pharmacist-led management) or the control group (usual care) in a 1:1 ratio using a computer-generated random number table with concealed allocation via opaque envelopes. Intention-to-treat data analysis was performed from June 2023 to July 2024.

INTERVENTION

The intervention group received a multimodal pharmaceutical intervention, including WeChat application-based communication and education, and a standardized follow-up visit from a pharmacist every month. The control group received the standardized follow-up visit from nurses every month.

MAIN OUTCOMES AND MEASURES

The primary outcome was the proportion of days covered (PDC) by heart failure medication at 52 weeks.

RESULTS

Among the 445 participants analyzed, 223 were assigned to the intervention group and 222 to the control group. These patients had a mean (SD) age of 63.2 (13.3) years and included 263 males (59.1%). A total of 333 patients (74.8%) had a New York Heart Association class III or IV heart failure, indicating severe limitations in physical activity. At 52 weeks, the intervention group had a significantly higher PDC for heart failure medication (8.1%; 95% CI, 5.5%-10.7%; P < .001) and a greater proportion of patients with PDC of 80% or greater (odds ratio, 0.34; 95% CI, 0.21-0.54; P < .001) compared with the control group.

CONCLUSIONS AND RELEVANCE

This randomized clinical trial found a modest improvement in medication adherence among patients with CHF who received the pharmacist-led management intervention vs usual care.

TRIAL REGISTRATION

Chinese Clinical Trial Registry Identifier: ChiCTR2000040232.

摘要

重要性

药物依从性差与慢性心力衰竭（CHF）患者的高发病率和死亡率相关，这在中国尤其令人担忧。

目的

评估结合社交媒体平台的药剂师主导管理模式与常规护理相比对CHF患者药物依从性的影响。

设计、设置和参与者：这项前瞻性、多中心随机临床试验于2021年3月至2023年5月进行，随访期为52周。该试验在中国5家医院的心脏病病房进行。参与者年龄在18岁及以上，被诊断为CHF，且正在接受稳定的药物治疗。使用计算机生成的随机数字表以1:1的比例将他们随机分配到干预组（药剂师主导管理）或对照组（常规护理），通过不透明信封进行隐藏分配。意向性分析于2023年6月至2024年7月进行。

干预措施

干预组接受多模式药物干预，包括基于微信应用的沟通和教育，以及药剂师每月进行的标准化随访。对照组每月接受护士的标准化随访。

主要结局和测量指标

主要结局是52周时心力衰竭药物的覆盖天数比例（PDC）。

结果

在分析的445名参与者中，223人被分配到干预组，222人被分配到对照组。这些患者的平均（标准差）年龄为63.2（13.3）岁，其中包括263名男性（59.1%）。共有333名患者（74.8%）患有纽约心脏协会III级或IV级心力衰竭，表明身体活动严重受限。在52周时，干预组心力衰竭药物的PDC显著更高（8.1%；95%CI，5.5%-10.7%；P < .001），且PDC达到80%或更高的患者比例更大（优势比，0.34；95%CI，0.21-0.54；P < .001），与对照组相比。