Wang Jia, Zhao Yuhang, Chen Zherui, Huang Rui
Personnel section, Traditional Chinese and Western Medicine Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Front Pharmacol. 2025 Jan 8;15:1451713. doi: 10.3389/fphar.2024.1451713. eCollection 2024.
There is a lack of studies investigating the safety of combination regimens specifically for cardiovascular and cerebrovascular diseases. This study aimed to evaluate the safety of combination drugs for cardiovascular and cerebrovascular diseases using real-world data.
We analyzed adverse drug reaction data received by the Hubei Adverse Drug Reaction Center from the first quarter of 2014 to the fourth quarter of 2022. The safety of combined drugs for cardiovascular and cerebrovascular diseases in different people was assessed using the association rule method and Ω shrinkage measurement.
A total of 53,038 reports were included in this study, revealing 9 signals of adverse reactions caused by combination drugs. The strongest signal found in this study was jaundice caused by the combination of amlodipine and atorvastatin (Ω 0.025:3.08, lift: 1116.69, conviction: 1.75). Additionally, the combination of aspirin with other drugs was associated with hemorrhaging in various organs. Female patients showed a cold signal when taking vitamin C and vitamin B6 together compared to male patients (Ω 0.025:0.89, lift: 7.15, conviction: 1.12). Patients under 60 years old had a palpitations signal when combining eritrea bei sha Tanzania and felodipine (Ω 0.025:0.41, lift: 14.65, conviction: 3.8), and an erythema signal when combining nifedipine (Ω 0.025:0.23, lift: 8.17, conviction: 1.077).
Among the 9 signals identified in this study, 4 were off-label adverse drug reactions that require further clinical research for exploration and confirmation, in order to provide more scientifically informed drug labeling. Five adverse events associated with aspirin-induced bleeding were identified. Notably, different adverse drug reactions were observed in different populations, suggesting the need for future studies to expedite the development of personalized medicine.
缺乏专门针对心脑血管疾病联合用药方案安全性的研究。本研究旨在利用真实世界数据评估心脑血管疾病联合用药的安全性。
我们分析了湖北省药品不良反应中心在2014年第一季度至2022年第四季度收到的药品不良反应数据。采用关联规则法和Ω收缩测量法评估不同人群中心脑血管疾病联合用药的安全性。
本研究共纳入53038份报告，发现联合用药引起的9个不良反应信号。本研究中发现的最强信号是氨氯地平和阿托伐他汀联合使用引起的黄疸（Ω 0.025:3.08，提升度：1116.69，确信度：1.75）。此外，阿司匹林与其他药物联合使用与各器官出血有关。与男性患者相比，女性患者同时服用维生素C和维生素B6时出现冷信号（Ω 0.025:0.89，提升度：7.15，确信度：1.12）。60岁以下患者在联合使用厄贝沙坦和非洛地平时出现心悸信号（Ω 0.025:0.41，提升度：14.65，确信度：3.8），在联合使用硝苯地平时出现红斑信号（Ω 0.025:0.23，提升度：8.17，确信度：1.077）。
在本研究确定的9个信号中，有4个是超说明书用药不良反应，需要进一步开展临床研究进行探索和确认，以便提供更具科学依据的药品标签。确定了5例与阿司匹林诱导出血相关的不良事件。值得注意的是，在不同人群中观察到不同的药品不良反应，这表明未来的研究需要加快个性化医疗的发展。
