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临床药师主导的干预措施对双相I型障碍患者治疗结局的影响:一项随机临床试验

Impact of Clinical Pharmacist-led Interventions on the Outcomes of Patients with Bipolar I Disorder: A Randomized Clinical Trial.

作者信息

Gorgzadeh Nazanin, Mohebbi Niayesh, Gholami Kheirollah, Amini Homayoun, Nejatisafa Ali-Akbar, Salamzadeh Jamshid

机构信息

Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

J Res Pharm Pract. 2025 Mar 11;13(3):78-84. doi: 10.4103/jrpp.jrpp_52_24. eCollection 2024 Jul-Sep.

Abstract

OBJECTIVE

Poor medication adherence, drug interactions, and adverse drug events occur frequently in patients with bipolar I disorder (BD-I), affecting their treatment outcomes. Due to limited research regarding the impact of pharmaceutical care (PC) services in the management of patients with BD-I, this study was designed to assess the role of clinical pharmacist-led interventions on outcomes of BD-I patients.

METHODS

A prospective randomized clinical trial was designed, and 59 patients were randomly assigned to the intervention group and 48 patients to the control group. Patients in the intervention group were provided with medication therapy management and follow-up services by the clinical pharmacist, whereas the control group only received routine care. Outcomes which were assessed at baseline (before discharge), 1 month, and 3 months after discharge were the Medication Appropriateness Index (MAI), Beck Depression Inventory-II (BDI-II), Young Mania Rating Scale, and World Health Organization Quality of Life, Brief version (WHOQOL-BREF).

FINDINGS

Endpoint mean changes in MAI scores from baseline were -5.25 ± 5.19 and 2.02 ± 3.98 points for the intervention and control groups, respectively ( < 0.001). Depressive symptoms, measured by the BDI-II, also showed significant improvement in the intervention group; the mean change from baseline to 2 follow-up assessment was -1.47 ± 7.73 in the intervention group and 1.66 ± 6.42 in the control group ( = 0.02). Furthermore, the mean change from baseline to 2 follow-up in the psychological health domain of the WHOQOL-BREF questionnaire was significantly higher in the intervention group (4.59 ± 17.79) compared with the control group (-3.90 ± 12.55) ( = 0.005).

CONCLUSION

Our findings reveal that clinical pharmacist-provided services could positively affect outcomes in BD-I patients.

摘要

目的

双相I型障碍(BD-I)患者中药物治疗依从性差、药物相互作用及药物不良事件频繁发生,影响其治疗效果。由于关于药学服务(PC)在BD-I患者管理中的影响的研究有限,本研究旨在评估临床药师主导的干预措施对BD-I患者治疗效果的作用。

方法

设计一项前瞻性随机临床试验,59例患者被随机分配至干预组,48例患者被分配至对照组。干预组患者由临床药师提供药物治疗管理和随访服务,而对照组仅接受常规护理。在基线期(出院前)、出院后1个月和3个月评估的结果指标为药物适宜性指数(MAI)、贝克抑郁量表第二版(BDI-II)、杨氏躁狂评定量表以及世界卫生组织生活质量简表(WHOQOL-BREF)。

结果

干预组和对照组MAI评分从基线期的终点平均变化分别为-5.25±5.19和2.02±3.98分(<0.001)。用BDI-II测量的抑郁症状在干预组也有显著改善;从基线期到2次随访评估的平均变化在干预组为-1.47±7.73,在对照组为1.66±6.42(P=0.02)。此外,与对照组(-3.90±12.55)相比,干预组WHOQOL-BREF问卷心理健康领域从基线期到2次随访的平均变化显著更高(4.59±17.79)(P=0.005)。

结论

我们的研究结果显示,临床药师提供的服务可对BD-I患者的治疗效果产生积极影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3aeb/12017403/4ed79d02228c/JRPP-13-78-g001.jpg

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