Current Status of Adverse Events Related with Opioid Analgesics in Japan: Assessment Based on Japanese Adverse Drug Event Report Database
Current Status of Adverse Events Related with Opioid Analgesics in Japan: Assessment Based on Japanese Adverse Drug Event Report Database
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DOI：
10.1248/bpb.b18-00997
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发表时间：
2019-05-01
影响因子：
2
通讯作者：
Takase, Hisamitsu
中科院分区：
文献类型：
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作者：
Suga, Yukio;Uchida, Mayako;Takase, Hisamitsu
阿片类镇痛药极大地促进了疼痛管理的进步。然而，尽管阿片类药物在日本已得到适当使用，但它们很少引起严重的不良事件，例如呼吸抑制。本研究旨在利用日本药物不良事件报告（JADER）数据库调查 2004 年至 2017 年间日本阿片类药物相关不良事件和死亡发生率的时间变化。我们利用从 JADER 网站提取的数据分析了以下几点：1）阿片类药物相关不良事件报告数量和比例的时间变化； 2) 每年消费量的吗啡、羟考酮和芬太尼相关不良事件报告数量的时间变化； 3) 阿片类药物相关不良事件报告结果为死亡的病例。我们的结果显示，尽管在调查期间每种阿片类药物的年消费量和共享成分发生了暂时变化，但阿片类药物相关不良事件的总体发生率没有显着变化。然而，自2010年以来，芬太尼相关不良事件及其结果“死亡”的数量和发生率有所增加，是包括吗啡和羟考酮相关不良事件在内的所有不良事件中最高的。芬太尼相关不良事件导致的“死亡”主要是由于呼吸抑制所致。这些研究结果表明，尽管日本医务人员可以通过适当的监测和管理来控制与阿片类药物相关的不良事件，但对于罕见但严重的芬太尼引起的不良事件仍应格外小心。
Opioid analgesics have greatly contributed to the advancement of pain management. However, although opioids have been appropriately used in Japan, they rarely induce serious adverse events, such as respiratory depression. The present study aimed to investigate the temporal changes in the occurrence of opioid-related adverse events and deaths between 2004 and 2017 in Japan using the Japanese Adverse Drug Event Report (JADER) database. We analyzed the following points using data extracted from JADER website: 1) temporal changes in the number and proportion of opioid-related adverse event reports; 2) temporal changes in the number of morphine-, oxycodone-, and fentanyl-related adverse event reports per annual consumption; and 3) cases in which the reported outcome following opioid-related adverse events was death. Our results showed no dramatic changes in the overall incidence of opioid-related adverse events, despite the temporal changes in the annual consumption and shared component of each opioid during the survey period. However, the number and rate of fentanyl-related adverse events and their outcome "death" increased since 2010, being the highest among all adverse event including those related to morphine and oxycodone. Outcome "death" by fentanyl-related adverse events was caused mainly due to respiratory depression. These findings suggest that, although opioid-related adverse events can be controlled through proper monitoring and management by medical personnel in Japan, extra caution should be continuously paid for the rare but serious fentanyl-induced adverse events.