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一项关于系统性酶和益生菌对缓解新冠后疲劳效果的随机对照试验。

A Randomized Controlled Trial of the Efficacy of Systemic Enzymes and Probiotics in the Resolution of Post-COVID Fatigue.

作者信息

Rathi Abhijit, Jadhav Swati B, Shah Neha

机构信息

Food Application and Development Laboratory, Advanced Enzymes Technologies Ltd., Louiswadi, Thane 400604, India.

Pulmonary Fibrosis Now, Chino, CA 91710, USA.

出版信息

Medicines (Basel). 2021 Aug 30;8(9):47. doi: 10.3390/medicines8090047.

Abstract

Muscle fatigue and cognitive disturbances persist in patients after recovery from acute COVID-19 disease. However, there are no specific treatments for post-COVID fatigue. Objective: To evaluate the efficacy and safety of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) in patients suffering from COVID-19 induced fatigue. A randomized, multicentric, double blind, placebo-controlled trial was conducted in 200 patients with a complaint of post-COVID fatigue. The test arm ( = 100) received the oral supplements for 14 days and the control arm ( = 100) received a placebo. Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. The supplemental treatment resulted in resolution of fatigue in a greater percentage of subjects in the test vs. the control arm (91% vs. 15%) on day 14. Subjects in the test arm showed a significantly greater reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm. The supplements were well tolerated with no adverse events reported. This study demonstrates that a 14 days supplementation of ImmunoSEB + ProbioSEB CSC3 resolves post-COVID-19 fatigue and can improve patients' functional status and quality of life.

摘要

急性新冠肺炎康复后的患者仍存在肌肉疲劳和认知障碍。然而,对于新冠后疲劳尚无特效治疗方法。目的:评估免疫酶复合物(ImmunoSEB)和益生菌复合物(ProbioSEB CSC3)这两种健康补充剂对新冠感染所致疲劳患者的疗效和安全性。对200例主诉新冠后疲劳的患者进行了一项随机、多中心、双盲、安慰剂对照试验。试验组(n = 100)接受口服补充剂14天,对照组(n = 100)接受安慰剂。在第1天至第14天的不同时间点,使用查尔德疲劳量表(CFQ - 11)比较治疗效果。在第14天,试验组中疲劳症状缓解的受试者比例高于对照组(91%对15%)。在所有时间点,试验组受试者的总疲劳评分以及身体和精神疲劳评分较对照组均有显著更大幅度的降低。这些补充剂耐受性良好,未报告不良事件。本研究表明,连续14天补充ImmunoSEB + ProbioSEB CSC3可缓解新冠后疲劳,并可改善患者的功能状态和生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c5b/8472462/39a6ae779a94/medicines-08-00047-g001.jpg

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