乙酰半胱氨酸对接受瑞德西韦治疗的COVID-19重症监护病房患者预防肝损伤的疗效和安全性。

Efficacy and safety of acetylcysteine for the prevention of liver injury in COVID-19 intensive care unit patients under treatment with remdesivir.

作者信息

Mousapour Pouria, Hamidi Farahani Ramin, Mosaed Reza, Asgari Ali, Hazrati Ebrahim

机构信息

Department of Anesthesiology and Intensive Care, AJA University of Medical Sciences, Tehran, Iran.

Department of Infectious Diseases, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.

出版信息

Gastroenterol Hepatol Bed Bench. 2022 Summer;15(3):241-248. doi: 10.22037/ghfbb.v15i3.2565.

DOI:10.22037/ghfbb.v15i3.2565

PMID:36311968

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9589135/

Abstract

AIM

The present double-blinded placebo-controlled randomized clinical trial evaluated prophylactic use of acetylcysteine for the prevention of liver injury in patients with severe COVID-19 pneumonia under treatment with remdesivir.

BACKGROUND

Liver injury is reportedly common in patients with severe COVID-19 pneumonia and can occur not only as a result of disease progression, but as an iatrogenic reaction to remdesivir.

METHODS

A total of 83 adult patients with severe COVID-19 pneumonia were randomly assigned in parallel groups to receive either acetylcysteine or placebo. All the patients received standard care according to institutional protocols, including remdesivir for a total of five days. One gram acetylcysteine was administered intravenously every 12 hours for 42 patients, and 41 patients received the same volume of 0.9% sodium chloride as placebo (Trial Registration: www.irct.ir identifier, IRCT20210726051995N1).

RESULTS

After 5 days, median aspartate transaminase (AST) and alanine transaminase (ALT) levels were significantly lower in the acetylcysteine than in the placebo group. Of those who received the placebo, 30 (73.2%), 4 (9.7%), and 3 (7.3%) patients had serum AST levels elevated between 1-2.5, 2.5-5, and over 5 times the upper limit of normal (ULN), respectively; while in the acetylcysteine group, 33 (78.6%) and 0 patients had AST levels between 1-2.5 and over 2.5 times ULN, respectively (-value=0.037). In the acetylcysteine group, 23 (54.8%), 1 (2.4%), and 1 (2.4%) patient had serum ALT levels elevated between 1-2.5, 2.5-5, and over 5 times ULN, respectively; in the placebo group, however, 24 (58.5%), 7 (17.1%), and 1 (2.4%) patient had serum ALT levels between 1-2.5, 2.5-5, and over 5 times ULN, respectively (-value=0.073).

CONCLUSION

Intravenous administration of acetylcysteine significantly prevents liver transaminases elevation and liver injury in seriously ill COVID-19 patients treated with remdesivir.

摘要

目的

本双盲安慰剂对照随机临床试验评估了在接受瑞德西韦治疗的重症COVID-19肺炎患者中预防性使用乙酰半胱氨酸预防肝损伤的效果。

背景

据报道，肝损伤在重症COVID-19肺炎患者中很常见，不仅可因疾病进展发生，还可作为对瑞德西韦的医源性反应出现。

方法

总共83例成年重症COVID-19肺炎患者被随机平行分组，分别接受乙酰半胱氨酸或安慰剂治疗。所有患者均按照机构方案接受标准治疗，包括使用瑞德西韦共5天。42例患者每12小时静脉注射1克乙酰半胱氨酸，41例患者接受相同体积的0.9%氯化钠作为安慰剂（试验注册号：www.irct.ir标识符，IRCT20210726051995N1）。

结果

5天后，乙酰半胱氨酸组的天冬氨酸转氨酶（AST）和丙氨酸转氨酶（ALT）水平中位数显著低于安慰剂组。接受安慰剂的患者中，分别有30例（73.2%）、4例（9.7%）和3例（7.3%）患者的血清AST水平升高至正常上限（ULN）的1 - 2.5倍、2.5 - 5倍和超过5倍；而在乙酰半胱氨酸组中，分别有33例（78.6%）和0例患者的AST水平在1 - 2.5倍和超过2.5倍ULN之间（P值 = 0.037）。在乙酰半胱氨酸组中，分别有23例（54.8%）、1例（2.4%）和1例（2.4%）患者的血清ALT水平升高至ULN的1 - 2.5倍、2.5 - 5倍和超过5倍；然而，在安慰剂组中，分别有24例（58.5%）、7例（17.1%）和1例（2.4%）患者的血清ALT水平在1 - 2.5倍、2.5 - 5倍和超过5倍ULN之间（P值 = 0.073）。