Lee Hyun-Young, Ban Ga-Young, Jeong Chang-Gyu, Lee Ji-Ho, Park Seung-Hee, Kim Sang-Hee, Lee Young-Hee, Ye Young-Min
Department of Statistics, Clinical Trial Center, Ajou University Medical Center, Korea.
Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Korea.
Pharmacoepidemiol Drug Saf. 2017 Mar;26(3):256-264. doi: 10.1002/pds.4159. Epub 2017 Jan 13.
Researchers recently suggested intravenous paracetamol as a potential cause of hypotension. We aimed to investigate risk factors of paracetamol- and propacetamol-associated adverse drug reactions (ADRs) in Korean individuals.
All adverse hypotension cases, regardless of suspected drug, and all ADRs associated with paracetamol and propacetamol use were collected from the Korea Adverse Event Reporting System database between 2011 and 2014. The seriousness, causality, and type of ADR were classified.
Of 4,771 cases of adverse hypotension, 403 (8.4%) were reported to be related to propacetamol. This was comparable to the rate of hypotension associated with fentanyl (454, 9.5%), the major suspected drug of hypotension. Paracetamol-associated hypotension accounted for merely 1.2% (55 cases) of all hypotension cases. Among ADRs associated with propacetamol use, hypotension was the most common (37.1%), whereas cutaneous reactions were the primary paracetamol-associated ADR. Propacetamol/paracetamol-associated hypotension was frequently recorded in older patients (≥54 years) (53.9 ± 25.8 vs. 42.8 ± 21.7, P < 0.001) and taking more concomitant drugs (1.9 ± 5.0 vs. 1.1 ± 3.2, P < 0.001). Also, compared with other ADRs associated by propacetamol/paracetamol, hypotension was more commonly assessed as a serious outcome (27.3% vs. 11.4%, P < 0.001). Regarding concomitant medications, the risk for hypotension associated with propacetamol was significantly increased in patients simultaneously taking antibacterials (J01), cold preparations (R05), drugs for acid related disorders (A02), blood substitutes (B05), or antithrombotics (B01).
Propacetamol was found to be a major suspected drug of pharmacologically associated hypotension in Korea. Older and male patients taking medications in combination with propacetamol/paracetamol should undergo monitoring of their blood pressure. Copyright © 2017 John Wiley & Sons, Ltd.
研究人员最近提出静脉注射对乙酰氨基酚可能是导致低血压的原因。我们旨在调查韩国人群中对乙酰氨基酚和丙帕他莫相关药物不良反应（ADR）的危险因素。
从韩国不良事件报告系统数据库中收集2011年至2014年间所有不良低血压病例（无论可疑药物是什么）以及所有与使用对乙酰氨基酚和丙帕他莫相关的ADR。对ADR的严重程度、因果关系和类型进行分类。
在4771例不良低血压病例中，有403例（8.4%）报告与丙帕他莫有关。这与与芬太尼相关的低血压发生率（454例，9.5%）相当，芬太尼是低血压的主要可疑药物。对乙酰氨基酚相关的低血压仅占所有低血压病例的1.2%（55例）。在与丙帕他莫使用相关的ADR中，低血压最为常见（37.1%），而皮肤反应是与对乙酰氨基酚相关的主要ADR。丙帕他莫/对乙酰氨基酚相关的低血压在老年患者（≥54岁）中经常出现（53.9±25.8对42.8±21.7，P<0.001），且服用更多合并用药（1.9±5.0对1.1±3.2，P<0.001）。此外，与丙帕他莫/对乙酰氨基酚相关的其他ADR相比，低血压更常被评估为严重后果（27.3%对11.4%，P<0.001）。关于合并用药，同时服用抗菌药物（J01）、感冒药（R05）、治疗酸相关疾病的药物（A02）、血液代用品（B05）或抗血栓药物（B01）的患者，与丙帕他莫相关的低血压风险显著增加。
在韩国，丙帕他莫被发现是药物相关性低血压的主要可疑药物。服用丙帕他莫/对乙酰氨基酚合并用药的老年男性患者应监测其血压。版权所有©2017约翰威立父子有限公司。
