Abeyaratne Carmen, Lalic Samanta, Bell J Simon, Ilomäki Jenni
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria, 3052, Australia.
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.
Ther Adv Drug Saf. 2018 Apr;9(4):197-205. doi: 10.1177/2042098618760939. Epub 2018 Mar 25.
The rapid increase in prescribing and use of opioids for noncancer pain has coincided with an increase in opioid-related adverse drug events (ADEs). The objective of our study was to describe ADEs related to tapentadol and oxycodone/naloxone spontaneously reported to the Australian Therapeutic Goods Administration (TGA).
Public case detail reports for tapentadol (September 2013-March 2017) and oxycodone/naloxone (April 2011-March 2017) were sourced from the TGA. The total number of public case detail reports for tapentadol were 104 and 249 for oxycodone/naloxone. Demographic characteristics of patients, concomitant medications, causality assessment and outcome were described for each opioid according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class.
The most prevalent ADEs for tapentadol were nervous system disorders ( = 52, 50%), psychiatric ( = 34, 32.7%), gastrointestinal ( = 18, 17.3%), and general disorders and administration site conditions ( = 21, 20.2%). Sixteen (23.2%) of 69 nervous system disorders reaction terms were consistent with serotonin syndrome of which 14 (87.5%) involved documented coadministration with another serotonergic medication. The most prevalent ADEs for oxycodone/naloxone were psychiatric disorders ( = 78, 31.3%), gastrointestinal ( = 73, 29.3%), general disorders and administration site conditions ( = 87, 35%), and nervous system disorders ( = 62, 24.9%). There were 40 (16%) public case detail reports for oxycodone/naloxone with the MedDRA reaction terms 'drug withdrawal syndrome' and 'withdrawal syndrome'.
The profiles of spontaneous ADE reports for tapentadol and oxycodone/naloxone are largely consistent with their premarketing randomized controlled studies and profiles of opioids in general. Further research into the risk of serotonin syndrome with tapentadol use is warranted. The ADEs suggest clinicians should be cautious when switching patients to oxycodone/naloxone from other opioids.
用于非癌性疼痛的阿片类药物的处方量和使用量迅速增加，与此同时，阿片类药物相关的药物不良事件（ADEs）也有所增加。我们研究的目的是描述自发向澳大利亚治疗用品管理局（TGA）报告的与曲马多和羟考酮/纳洛酮相关的药物不良事件。
从TGA获取曲马多（2013年9月至2017年3月）和羟考酮/纳洛酮（2011年4月至2017年3月）的公开病例详细报告。曲马多的公开病例详细报告总数为104份，羟考酮/纳洛酮为249份。根据《监管活动医学词典》（MedDRA）系统器官分类，描述了每种阿片类药物的患者人口统计学特征、伴随用药、因果关系评估和结果。
曲马多最常见的药物不良事件是神经系统疾病（n = 52，50%）、精神疾病（n = 34，32.7%）、胃肠道疾病（n = 18，17.3%）以及全身疾病和给药部位情况（n = 21，20.2%）。69个神经系统疾病反应术语中有16个（23.2%）与5-羟色胺综合征一致，其中14个（87.5%）涉及与另一种5-羟色胺能药物的联合用药记录。羟考酮/纳洛酮最常见的药物不良事件是精神疾病（n = 78，31.3%）、胃肠道疾病（n = 73，29.3%）、全身疾病和给药部位情况（n = 87，35%）以及神经系统疾病（n = 62，24.9%）。羟考酮/纳洛酮有40份（16%）公开病例详细报告的MedDRA反应术语为“药物戒断综合征”和“戒断综合征”。
曲马多和羟考酮/纳洛酮的自发药物不良事件报告情况在很大程度上与其上市前随机对照研究以及一般阿片类药物的情况一致。有必要进一步研究使用曲马多导致5-羟色胺综合征的风险。这些药物不良事件表明，临床医生在将患者从其他阿片类药物转换为羟考酮/纳洛酮时应谨慎。
