法莫替丁改善住院COVID-19患者预后的疗效:一项III期随机临床试验

H. Samimagham, Mehdi Hassani Azad, Maryam Haddad, M. Arabi, D. Hooshyar, Mitra KazemiJahromi
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引用次数: 3

摘要

作为首个随机临床试验,本研究评估了法莫替丁对COVID-19住院患者预后的改善作用。方法采用双平行臂、安慰剂对照、单盲、隐蔽分配的III期随机临床试验,共招募20例患者。患者口服法莫替丁160 mg,每日4次,直至出院日或最多服用14天。在基线(干预前)、干预后第14天或出院当天测量患者体温、呼吸速率、血氧饱和度、肺浸润、乳酸脱氢酶(LDH)水平和全血细胞计数(CBC)。在医院的住院时间和在ICU的住院时间也被测量为研究的次要结局。结果与对照组相比,法莫替丁治疗组患者LDH (P = 0.01)、平均WBC (P = 0.04)、住院时间(P = 0.04)均显著降低。与对照组相比,使用法莫替丁治疗组血氧饱和度显著升高(P = 0.01)。与对照组相比,口服法莫替丁组咳嗽的改善程度也更高(P = 0.02)。结论法莫替丁对COVID-19住院患者改善效果的首次临床试验,表明大剂量法莫替丁可改善患者临床体征,降低病情严重程度和住院时间。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Efficacy of Famotidine in improvement of outcomes in Hospitalized COVID-19 Patients: A phase III randomised clinical trial
IntroductionAs the first randomized clinical trial, this study evaluated the effect of Famotidine on the improvement of outcomes of hospitalized patients with COVID-19.MethodThis phase III randomized clinical trial was designed with two parallel arms, placebo-controlled, single-blind, and concealed allocation, and recruited 20 patients. Oral Famotidine 160 mg four times a day was given to patients until the discharge day or for a maximum of 14 days. Patients’ temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase (LDH) level and complete blood count (CBC) were measured at the baseline (before the intervention) and on day 14 after the intervention or on discharge day. Length of stay in the hospital and length of stay in the ICU were also measured as secondary outcomes of the study.ResultsThe results showed a significant decrease in LDH (P = 0.01), mean WBC (P = 0.04) and length of stay (P = 0.04) of patients with COVID-19 in the group treated with Famotidine compared to the control group. There was also a significant increase in oxygen saturation (P = 0.01) in the group treated with Famotidine compared to the control group. Cough improvement was also higher in the oral Famotidine group compared to the control group (P = 0.02).ConclusionThis was the first clinical trial on the effect of Famotidine on the improvement of hospitalized COVID-19 patients, which indicated that high-dose Famotidine improves patients’ clinical signs and reduces the severity of the disease and duration of hospitalization.
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