Ayhan Yunus Emre, Bektay Muhammed Yunus, Gogas Yavuz Dilek, Sancar Mesut
Department of Clinical Pharmacy, Prof. Dr. Cemil Taşcıoğlu City Hospital, Istanbul, Türkiye.
Department of Clinical Pharmacy, Istanbul University-Cerrahpaşa Faculty of Pharmacy, Istanbul, Türkiye.
BMC Endocr Disord. 2025 Apr 8;25(1):94. doi: 10.1186/s12902-025-01914-3.
Hypothyroidism (HoT) treatment involves lifelong thyroxine replacement therapy and regular monitoring. The objective of this study was to assess the impact of clinical pharmacist (CP) intervention in managing drug-related problems (DRPs) on outcomes among patients with HoT receiving levothyroxine (LT4) therapy.
A randomized controlled trial involved patients with HoT attending a university hospital's endocrinology and metabolism outpatient clinic from March 2022 to September 2022. Participants were randomly assigned to control (CG) and intervention groups (IG). CP identified and classified DRPs based on Pharmaceutical Care Network Europe (PCNE) v9.1 criteria. The validated version of the Morisky-Green-Levine (MGL) 4-question scale was used to measure adherence. All patients included in the study were assessed during their first visit and again two months later at their second visit.
43 patients were assigned to the CG (n = 25) and IG (n = 18). Diabetes (21.6 vs. 20.5%) and hypertension (16.2% vs. 11.7%) were the most prevalent comorbidities in both the CG and IG, respectively. A total of 118 DRPs belonging to both groups were detected. In the IG group, the total number of DRPs significantly decreased from 66 to 24, and the total potential drug-drug interactions (pDDIs) decreased from 21 to 0 between the first and second visits (p < 0.001). CG and IG patients had no difference in adherence levels at the first and second visits (p > 0.05). A statistically significant increase in adherence to the time of taking the medication was observed between the first and second visits in IG (55.5% vs. 94.4%, p = 0.008).
This study highlights the frequent occurrence of DRPs and LT4 therapy adherence problems in patients with HoT. The findings suggest that the intervention of CPs, by increasing adherence to LT4 therapy and decreasing DRPs, could significantly contribute to improving patients' treatment outcomes.
This study protocol has been retrospectively registered at ClinicalTrials.gov (NCT06408909) at 06/05/2024.
甲状腺功能减退症（甲减）的治疗需要终身服用甲状腺素替代疗法并定期监测。本研究的目的是评估临床药师（CP）干预管理药物相关问题（DRP）对接受左甲状腺素（LT4）治疗的甲减患者治疗结局的影响。
一项随机对照试验纳入了2022年3月至2022年9月在某大学医院内分泌与代谢门诊就诊的甲减患者。参与者被随机分配至对照组（CG）和干预组（IG）。临床药师根据欧洲药物治疗护理网络（PCNE）v9.1标准识别并分类药物相关问题。采用经过验证的Morisky-Green-Levine（MGL）4问题量表来衡量依从性。所有纳入研究的患者在首次就诊时进行评估，并在两个月后的第二次就诊时再次评估。
43例患者被分配至CG组（n = 25）和IG组（n = 18）。糖尿病（21.6%对20.5%）和高血压（16.2%对11.7%）分别是CG组和IG组中最常见的合并症。两组共检测到118个药物相关问题。在IG组，首次就诊和第二次就诊之间，药物相关问题总数从66个显著降至24个，潜在药物相互作用（pDDI）总数从21个降至0个（p < 0.001）。CG组和IG组患者在首次和第二次就诊时的依从性水平无差异（p > 0.05）。IG组在首次和第二次就诊之间观察到服药时间依从性有统计学意义的提高（55.5%对94.4%，p = 0.008）。
本研究强调了甲减患者中药物相关问题和LT4治疗依从性问题的频繁发生。研究结果表明，临床药师的干预通过提高LT4治疗的依从性和减少药物相关问题，可显著有助于改善患者的治疗结局。
本研究方案已于2024年5月6日在ClinicalTrials.gov（NCT06408909）进行回顾性注册。
