阿片类药物主要用作全身麻醉诱导和维持的辅助药物,术后镇痛,治疗中度至重度癌痛和慢性疼痛。然而,这些药物对各器官器官的危害仍需进一步探讨。这项研究使用了美国FDA不良事件报告系统(FAERS)数据库来确定通常接受阿片类药物是否高于所有其他药物的基线风险。FAERS被问及阿片类药物吗啡的不良事件(AE),\"\"芬太尼,\"\"羟考酮,\"\"氢吗啡酮,\"\"舒芬太尼,从2004年第一季度(2004Q1)到2023年第二季度(2023Q2)的“瑞芬太尼”。不相称性信号分析通过计算报告比值比(ROR)进行,比例报告比率(PRR),贝叶斯置信度传播神经网络(BCPNN),和经验贝叶斯几何均值(EBGM)。具有心脏疾病的系统器官类别(SOCs)的不良事件,神经疾病,“和”呼吸,胸廓,然后筛查纵隔疾病。统计分析包括FAERS数据库中从2004Q1到2023Q2的12,819,518份报告,其中236,619份AEs报告为上述六种药物的“主要嫌疑人”,被选为“心脏疾病”,神经系统疾病,“和”呼吸,胸部和纵隔疾病。“这项研究中发现的一些不良事件与药物标签一致,比如心动过缓,呼吸抑制,和嗜睡。此外,一些意外和显著的急性药物不良反应(ADR),例如中毒性白质脑病和昏迷,可能发生。这项研究确定了阿片类药物潜在的新的和意外的ADR,为阿片类药物的安全性研究提供有价值的证据。
Opioids are mainly used as adjuncts to the induction and maintenance of general anesthesia, postoperative analgesia, and treating moderate to severe cancer pain and chronic pain. However, the hazards of these drugs to various organ organs still need to be further explored. This
study used the US FDA Adverse Event Reporting System (FAERS) database to determine whether commonly receiving opioids was higher than the baseline risk for all other medications. FAERS was asked about adverse events (AEs) for the opioids \"morphine,\" \"fentanyl,\" \"oxycodone,\" \"hydromorphone,\" \"sufentanil,\" and \"remifentanil\" from the first quarter of 2004 (2004Q1) through the second quarter of 2023 (2023Q2). Disproportionality signaling analysis was performed by calculating reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). AEs with system organ classes (SOCs) of \"cardiac disease,\" \"neurologic disease,\" and \"respiratory, thoracic, and mediastinal disease\" were then screened. The statistical analysis included 12,819,518 reports in the FAERS database from 2004Q1 to 2023Q2, of which 236,619 AEs were reported as \"primary suspect\" for the six drugs mentioned above, which were selected as \"cardiac disorders,\" \"nervous system disorders,\" and \"respiratory, thoracic and mediastinal disorders.\" Some AEs identified in this
study are consistent with the drug labeling, such as bradycardia, respiratory depression, and somnolence. In addition, some unexpected and significant acute adverse drug reactions (ADRs), such as toxic leukoencephalopathy and coma, may occur. This
study identified potential new and unexpected ADRs for opioids, providing valuable evidence for safety studies of opioids.