WHO Collaborating Centre for Drug Information, Clinical Toxicology, National Poison Centre, Universiti Sains Malaysia (USM), Penang, Malaysia.
Hum Exp Toxicol. 2010 Mar;29(3):153-60. doi: 10.1177/0960327109359642. Epub 2010 Jan 13.
Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose. However, its use is not without adverse drug reactions (ADR) that might affect therapeutic outcome or lead to treatment delay.
The aim of this study was to investigate the type and incidence of ADR induced by IV-NAC in patients treated for acetaminophen overdose.
This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 4 years (1 January 2005 to 31 December 2008). The primary outcome of interest in this study was the occurrence of ADR during NAC administration. Pearson chi-square test or Fisher's exact test, student's t test, and Mann-Whitney U test were used in univariate analysis. SPSS 15 was used for data analysis.
Two hundred and fifty five patients were studied. Different types of ADR were observed in 119 (46.7%) cases. Of those patients, 83 (69.7%) had been treated with IV-NAC versus 36 (30.3%) who had not (p < .001). The following ADR were significantly associated with IV-NAC administration: vomiting (p = .001), flushing (p < .001), rash (p < .001), pruritus (p < .001), chest pain (p = .001), bronchospasm (p = .03), coughing (p = .01), headache (p = .001), dizziness (p < .001), convulsion (p = .03), and hypotension (p = .001). ADR were mild in 54 (43.2%), moderate in 17 (13.6%), and severe in 12 (9.6%) patients. There were no ADR in 42 (33.6%) patients. Comparative results of the characteristics of patients who reacted to IV-NAC and nonreactors showed that patients with ADR had no significant difference in age, gender, ethnicity, amount ingested, latency time, and acetaminophen level than nonreactors.
ADR to IV-NAC were common among patients with acetaminophen overdose, but mostly minor and all reported adverse reactions were easily managed.
静脉注射 N-乙酰半胱氨酸（IV-NAC）被广泛认为是治疗对乙酰氨基酚过量的首选解毒剂。然而，它的使用并非没有不良反应（ADR），这些不良反应可能会影响治疗效果或导致治疗延迟。
本研究旨在调查 IV-NAC 治疗对乙酰氨基酚过量患者的 ADR 类型和发生率。
这是一项回顾性研究，纳入了 4 年内（2005 年 1 月 1 日至 2008 年 12 月 31 日）因急性对乙酰氨基酚过量而住院的患者。本研究的主要观察终点是 NAC 给药期间发生的 ADR。采用 Pearson 卡方检验或 Fisher 确切概率法、学生 t 检验和 Mann-Whitney U 检验进行单因素分析。采用 SPSS 15 进行数据分析。
共纳入 255 例患者。119 例（46.7%）患者出现不同类型的 ADR。其中 83 例（69.7%）接受 IV-NAC 治疗，36 例（30.3%）未接受（p <.001）。以下 ADR 与 IV-NAC 给药显著相关：呕吐（p =.001）、潮红（p <.001）、皮疹（p <.001）、瘙痒（p <.001）、胸痛（p =.001）、支气管痉挛（p =.03）、咳嗽（p =.01）、头痛（p =.001）、头晕（p <.001）、抽搐（p =.03）和低血压（p =.001）。54 例（43.2%）患者的 ADR 为轻度，17 例（13.6%）为中度，12 例（9.6%）为重度。42 例（33.6%）患者无 ADR。对发生 IV-NAC 反应和无反应的患者的特征进行比较，结果显示，反应组与无反应组患者在年龄、性别、种族、摄入量、潜伏期和对乙酰氨基酚水平方面无显著差异。
对乙酰氨基酚过量患者中 IV-NAC 的 ADR 很常见，但大多为轻度，所有报告的不良反应均易于处理。
