Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial.
Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial.
复制标题
DOI：
10.34172/bi.2020.27
复制
发表时间：
2020
期刊：
影响因子：
--
通讯作者：
Chapman KR
中科院分区：
文献类型：
--
作者：
Ansarin K;Tolouian R;Ardalan M;Taghizadieh A;Varshochi M;Teimouri S;Vaezi T;Valizadeh H;Saleh P;Safiri S;Chapman KR
引言：溴己新是COVID-19的一种潜在治疗选择，但尚未获得随机临床试验的数据。本研究旨在评估溴己新在COVID-19患者重症监护室（ICU）入院、机械通气和死亡率方面的疗效。 方法：在伊朗西北部的大不里士进行开放标签随机临床试验研究。按1：1的比例随机分为溴己新组和对照组，每组39例，两组均采用常规治疗，治疗组在此基础上加用溴己新8 mg，每日3次口服。主要结局是ICU入院率、插管/机械通气率和死亡率降低。 结果：共有78例具有相似人口统计学和疾病特征的患者入组。与标准组相比，溴己新治疗组的ICU入院率（2/39 vs. 11/39，P = 0.006）、插管率（1/39 vs. 9/39，P = 0.007）和死亡率（0 vs. 5，P = 0.027）显著降低。没有患者因不良反应而退出研究。 结论：早期口服溴己新可减少COVID-19患者的ICU转移、插管和死亡率。这种负担得起的药物可以很容易地在任何地方管理，对公共卫生和世界经济产生巨大的积极影响。总之，强烈建议在更大规模和不同的医疗中心验证我们的结果。 试验注册：IRCT 202003117046797 N4; https://irct.ir/trial/46969。
Introduction: Bromhexine is a potential therapeutic option in COVID-19, but no data from a randomized clinical trial has been available. The present study aimed to evaluate the efficacy of bromhexine in intensive care unit (ICU) admission, mechanical ventilation, and mortality in patients with COVID-19. Methods: An open-label randomized clinical trial study was performed in Tabriz, North-West of Iran. They were randomized to either the treatment with the bromhexine group or the control group, in a 1:1 ratio with 39 patients in each arm. Standard therapy was used in both groups and those patients in the treatment group received oral bromhexine 8 mg three times a day additionally. The primary outcome was a decrease in the rate of ICU admissions, intubation/mechanical ventilation, and mortality. Results: A total of 78 patients with similar demographic and disease characteristics were enrolled. There was a significant reduction in ICU admissions (2 out of 39 vs. 11 out of 39, P = 0.006), intubation (1 out of 39 vs. 9 out of 39, P = 0.007) and death (0 vs. 5, P = 0.027) in the bromhexine treated group compared to the standard group. No patients were withdrawn from the study because of adverse effects. Conclusion: The early administration of oral bromhexine reduces the ICU transfer, intubation, and the mortality rate in patients with COVID-19. This affordable medication can easily be administered everywhere with a huge positive impact(s) on public health and the world economy. Altogether, the verification of our results on a larger scale and different medical centers is strongly recommended. Trial Registration: IRCT202003117046797N4; https://irct.ir/trial/46969.
登录
查看更多内容
影响因子：
8.8
作者：
Liu, Fang;Li, Lin;Zhou, Xiang
通讯作者：
Zhou, Xiang
影响因子：
168.9
作者：
Huang, Chaolin;Wang, Yeming;Cao, Bin
通讯作者：
Cao, Bin
影响因子：
39
作者：
Wu, Chaomin;Chen, Xiaoyan;Song, Yuanlin
通讯作者：
Song, Yuanlin
影响因子：
158.5
作者：
Ackermann, Maximilian;Verleden, Stijn E.;Jonigk, Danny
通讯作者：
Jonigk, Danny
影响因子：
28.2
作者：
Lucas JM;Heinlein C;Kim T;Hernandez SA;Malik MS;True LD;Morrissey C;Corey E;Montgomery B;Mostaghel E;Clegg N;Coleman I;Brown CM;Schneider EL;Craik C;Simon JA;Bedalov A;Nelson PS
通讯作者：
Nelson PS