Tamur Shadi, Alyahya Bader, Alsani Faisal, Bahauddin Ammar Abdulraheem, Aljaid Maryam, Al-Malki Sultan, Alzahrani Ahmad, Khayat Abdullah, Shams Anwar, Chalut Dominic S
Department of Pediatrics, College of Medicine, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.
Department of Emergency Medicine, College of Medicine, King Saud University, Riyadh 11451, Saudi Arabia.
Pediatr Rep. 2024 Mar 20;16(1):232-242. doi: 10.3390/pediatric16010020.
Acetaminophen overdose is a common clinical condition, often leading to liver toxicity. Current treatments involve the three-infusion N-Acetylcysteine (NAC) regimen (FDA-labeled), which may be complex, time-consuming, and need to be changed. An alternative uses two infusions instead, which offers possible advantages regarding simplicity and administration errors. This study sought to compare the respective efficacies and safety outcomes when treating acute acetaminophen overdose among children and adolescents.
At Montreal Children's Hospital, a retrospective study was conducted comparing pre-2003 FDA-labelled three-infusion NAC therapy with a two-infusion regimen. Information was collected regarding patient demographics, NAC administration details, errors, rates of hepatotoxicity, and adverse reactions, and the statistical test Chi-square test was employed to obtain the results.
A total of 126 patients met the inclusion criteria. Of these patients, 65 received a two-infusion regimen, and 61 patients received the FDA-labeled regimen. The two-infusion group experienced significantly fewer administration errors (4 errors vs. 23 errors; < 0.001), while the rates of hepatotoxicity between them were similar. There were no instances of liver transplantation or mortality due to either regimen. Adverse reactions occurred equally frequently between both regimens with no discernible difference-the meantime to administer NAC was 9 h for the two-infusion regimen and 8.5 h for FDA-labeled regimen groups, respectively. Three cases of hepatitis were successfully treated with timely NAC therapy, and no liver transplantation or mortality occurred. Adverse reactions, including anaphylactoid reactions, were observed in both groups but were resolved when temporarily stopped and restarted at a slower infusion rate.
The two-infusion NAC regimen proved similar efficacy at protecting liver damage and improving patient outcomes compared to its FDA-labeled three-stage counterpart, with significantly fewer administration errors for this version of NAC treatment, suggesting potential advantages in terms of safety and simplicity. Future research should investigate larger cohorts and more variables to validate these results further and optimize the management of acetaminophen overdose cases; further investigation should focus on dosing strategies, personalized approaches, and long-term patient care in this context.
对乙酰氨基酚过量是一种常见的临床情况,常导致肝毒性。目前的治疗方法包括三次输注的N - 乙酰半胱氨酸(NAC)方案(美国食品药品监督管理局批准),该方案可能复杂、耗时且需要调整。另一种方法是改为两次输注,这在简单性和给药错误方面可能具有优势。本研究旨在比较治疗儿童和青少年急性对乙酰氨基酚过量时各自的疗效和安全性结果。
在蒙特利尔儿童医院进行了一项回顾性研究,比较2003年前美国食品药品监督管理局批准的三次输注NAC疗法与两次输注方案。收集了有关患者人口统计学、NAC给药细节、错误、肝毒性发生率和不良反应的信息,并采用卡方检验获得结果。
共有126名患者符合纳入标准。其中,65名患者接受了两次输注方案,61名患者接受了美国食品药品监督管理局批准的方案。两次输注组的给药错误明显更少(4次错误对23次错误;<0.001),而两组之间的肝毒性发生率相似。两种方案均未出现肝移植或死亡病例。两种方案的不良反应发生频率相同,无明显差异——两次输注方案给药NAC的平均时间为9小时,美国食品药品监督管理局批准方案组为8.5小时。3例肝炎患者通过及时的NAC治疗成功治愈,未发生肝移植或死亡。两组均观察到不良反应,包括类过敏反应,但在暂时停药并以较慢输注速度重新开始后得到缓解。
与美国食品药品监督管理局批准的三阶段方案相比,两次输注的NAC方案在保护肝脏损伤和改善患者结局方面显示出相似的疗效,且该版本的NAC治疗给药错误明显更少,表明在安全性和简单性方面具有潜在优势。未来的研究应调查更大的队列和更多变量,以进一步验证这些结果并优化对乙酰氨基酚过量病例的管理;在此背景下,进一步研究应侧重于给药策略、个性化方法和长期患者护理。