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评价口服 N-乙酰半胱氨酸在接受常规抗病毒和羟氯喹方案治疗的 COVID-19 患者中的疗效和安全性:一项随机对照临床试验。

Evaluation of the efficacy and safety of oral N-acetylcysteine in patients with COVID-19 receiving the routine antiviral and hydroxychloroquine protocol: A randomized controlled clinical trial.

机构信息

Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

Department of Internal Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

出版信息

Immun Inflamm Dis. 2023 Nov;11(11):e1083. doi: 10.1002/iid3.1083.

DOI:10.1002/iid3.1083
PMID:38018602
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10659758/
Abstract

BACKGROUND

The current absence of gold-standard or all-aspect favorable therapies for COVID-19 renders a focus on multipotential drugs proposed to prevent or treat this infection or ameliorate its signs and symptoms vitally important. The present well-designed randomized controlled trial (RCT) sought to evaluate the efficacy and safety of N-acetylcysteine (NAC) as adjuvant therapy for 60 hospitalized Iranian patients with COVID-19.

METHODS

Two 30-person diets, comprising 15 single diets of Kaletra (lopinavir/ritonavir) + hydroxychloroquine (HCQ) with/without NAC (600 mg TDS) and atazanavir/ritonavir + HCQ with/without NAC (600 mg TDS), were administered in the study.

RESULTS

At the end of the study, a further decrease in C-reactive protein was observed in the NAC group (P = 0.008), and no death occurred in the atazanavir/ritonavir + HCQ + NAC group, showing that the combination of these drugs may reduce mortality. The atazanavir/ritonavir + HCQ and atazanavir/ritonavir + NAC groups exhibited the highest O saturation at the end of the study and a significant rise in O saturation following intervention commencement, including NAC (P > 0.05). Accordingly, oral or intravenous NAC, if indicated, may enhance O saturation, blunt the inflammation trend (by reducing C-reactive protein), and lower mortality in hospitalized patients with COVID-19.

CONCLUSION

The NAC could be more effective as prophylactic or adjuvant therapy in stable non-severe cases of COVID-19 with a particularly positive role in the augmentation of O saturation and faster reduction of the CRP level and inflammation or could be effective for better controlling of COVID-19 or its therapy-related side effects.

摘要

背景

目前尚无 COVID-19 的金标准或全面有利疗法,因此关注拟用于预防或治疗这种感染或改善其体征和症状的多效药物至关重要。本设计良好的随机对照试验(RCT)旨在评估 N-乙酰半胱氨酸(NAC)作为辅助疗法对 60 名住院伊朗 COVID-19 患者的疗效和安全性。

方法

该研究共纳入 60 名患者,分为两组,每组 30 人,包括 15 名单独接受洛匹那韦/利托那韦(克力芝)+羟氯喹(HCQ)+NAC(600mg TDS)和阿扎那韦/利托那韦+HCQ+NAC(600mg TDS)治疗的患者。

结果

研究结束时,NAC 组 C 反应蛋白进一步下降(P=0.008),且阿扎那韦/利托那韦+HCQ+NAC 组无死亡病例,表明这些药物联合应用可能降低死亡率。在研究结束时,阿扎那韦/利托那韦+HCQ 组和阿扎那韦/利托那韦+NAC 组的 O 饱和度最高,并且在干预开始后 O 饱和度显著升高,包括 NAC(P>0.05)。因此,如果需要,口服或静脉内 NAC 可能会提高 O 饱和度,抑制炎症趋势(通过降低 C 反应蛋白),并降低 COVID-19 住院患者的死亡率。

结论

NAC 可能在 COVID-19 稳定非重症病例中作为预防或辅助治疗更有效,尤其是在提高 O 饱和度和更快降低 CRP 水平和炎症方面具有积极作用,或者对更好地控制 COVID-19 或其治疗相关副作用有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19e8/10659758/8171c88ff507/IID3-11-e1083-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19e8/10659758/dd126b4f6215/IID3-11-e1083-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19e8/10659758/8171c88ff507/IID3-11-e1083-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19e8/10659758/dd126b4f6215/IID3-11-e1083-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19e8/10659758/8171c88ff507/IID3-11-e1083-g003.jpg

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