Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial
Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial
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DOI：
10.1016/s0140-6736(13)62062-0
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发表时间：
2014-02-22
期刊：
影响因子：
168.9
通讯作者：
Gray, Alasdair
中科院分区：
文献类型：
--
作者：
Bateman, D. Nicholas;Dear, James W.;Gray, Alasdair
背景扑热息痛中毒在世界范围内很常见。它是用静脉注射乙酰半胱氨酸治疗，但标准方案是复杂的，并与频繁的不良反应有关的浓度，这可能会导致治疗中断。我们的目的是确定是否可以减少不良反应，无论是一个较短的修改乙酰半胱氨酸时间表，止吐预处理，或both.Methods我们进行了一项双盲，随机析因研究，在英国三家医院，2010年9月6日，2012年12月31日之间。我们将急性扑热息痛过量的患者随机分配至标准静脉注射乙酰半胱氨酸方案（持续时间20.25小时）或更短（12小时）的改良方案，伴或不伴静脉注射昂丹司琼预处理（4 mg）。通过输注5%葡萄糖（乙酰半胱氨酸给药期间）或生理盐水（用于止吐预处理）实现掩蔽。通过互联网进行随机化，包括预后因素的最小化程序。主要结局为2 h时无呕吐、干呕或需要补救性止吐治疗。预先设定的次要结局包括丙氨酸氨基转移酶活性比入院值增加50%以上。该试验在ClinicalTrials.gov注册（标识符NCT 01050270）。结果在222名接受随机分组的患者中，217名在乙酰半胱氨酸治疗开始后2小时可评估。108例患者中有39例在2小时后出现呕吐、干呕或需要补救止吐治疗，而109例患者中有71例在2小时后出现呕吐、干呕或需要补救止吐治疗（校正比值比0.26，97.5%CI 0.13- 0.52; p
Background Paracetamol poisoning is common worldwide. It is treated with intravenous acetylcysteine, but the standard regimen is complex and associated with frequent adverse effects related to concentration, which can cause treatment interruption. We aimed to ascertain whether adverse effects could be reduced with either a shorter modified acetylcysteine schedule, antiemetic pretreatment, or both.Methods We undertook a double-blind, randomised factorial study at three UK hospitals, between Sept 6, 2010, and Dec 31, 2012. We randomly allocated patients with acute paracetamol overdose to either the standard intravenous acetylcysteine regimen (duration 20.25 h) or a shorter (12 h) modified protocol, with or without intravenous ondansetron pretreatment (4 mg). Masking was achieved by infusion of 5% dextrose (during acetylcysteine delivery) or saline (for antiemetic pretreatment). Randomisation was done via the internet and included a minimisation procedure by prognostic factors. The primary outcome was absence of vomiting, retching, or need for rescue antiemetic treatment at 2 h. Prespecified secondary outcomes included a greater than 50% increase in alanine aminotransferase activity over the admission value. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov (identifier NCT01050270).Findings Of 222 patients who underwent randomisation, 217 were assessable 2 h after the start of acetylcysteine treatment. Vomiting, retching, or need for rescue antiemetic treatment at 2 h was reported in 39 of 108 patients assigned to the shorter modified protocol compared with 71 of 109 allocated to the standard acetylcysteine regimen (adjusted odds ratio 0.26, 97.5% CI 0.13- 0.52; p