在特拉马多尔/乙氨基单片药组合疗法后出现低血的风险:基于OMOP-CDM数据库的现实研究
Yu Jeong Lee1, Jinmi Kim2, Youngmi Han3
1Department of Pharmacy, Pusan National University Hospital, Pusan, Republic of Korea.
Drugs in R&D
|July 28, 2023
概括
与单独使用乙氨基相比,与特拉马多尔/乙氨基 (TA) 联合治疗增加了低血的风险. 延长释放的特拉马多尔/乙氨基显示,低血症的发生率高于即时释放配方.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 内部医学 内部医学
背景情况:
- 特拉马多尔与低血症有关,但证据是矛盾的.
- 对于使用特拉马多尔/乙氨基 (TA) 联合治疗时出现低血的风险尚不清楚.
- 这项研究调查了TA使用与低血症风险之间的关联.
研究的目的:
- 为了确定特拉马多尔/乙氨基 (TA) 治疗是否会增加低血的风险,与单独使用乙氨基 (AA) 相比.
- 为了比较延长释放 (TA-ER) 和立即释放 (TA-IR) 的特拉马多尔配方之间的低血症风险.
主要方法:
- 从2011年到2020年对30999名患者的医院数据 (OMOP-CDM) 的分析.
- 定义新发的低血症为血清<135mEq/L. 在药物开始后的10天内.
- 使用原始和1:1倾向分数匹配模型来计算发生率比率.
主要成果:
- 低血症发生在TA组的8.4%,而AA组的4.2%.
- 倾向性得分匹配模型显示,TA组的低血症发病率高出1.57倍 (每1000个PD为6.8),与AA组相比 (每1000个PD为4.3).
- 无论是原始模型还是匹配模型,都表明TA-ER亚组的低血症发病率明显高于TA-IR亚组.
结论:
- 特拉马多尔/乙氨基 (TA) 治疗与单独使用乙氨基 (AA) 相比,低血的发生频率更高.
- 延长释放的特拉马多尔/乙氨基 (TA-ER) 与立即释放 (TA-IR) 相比,具有较高的低血症风险.
- 谨慎的特拉马多尔处方和密切监测电解质水平是必不可少的.
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