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富马酸替诺福韦艾拉酚胺对住院 COVID-19 患者结局的影响:一项前瞻性、区组平衡、开放标签、随机对照临床试验。

Effect of Tenofovir Alafenamide Fumarate on the outcomes of hospitalized COVID-19 patients: a prospective, block-balanced, open-label, randomized controlled trial.

机构信息

Alimentary Tract Research Center, Clinical Sciences Research Institute, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Department of Internal Medicine, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

出版信息

BMC Pharmacol Toxicol. 2024 Oct 17;25(1):78. doi: 10.1186/s40360-024-00781-3.

Abstract

BACKGROUND

The global effort to cure COVID-19 is still ongoing. Thus, a prospective, block-balanced, open-label, randomized controlled trial was conducted to evaluate how Tenofovir Alafenamide Fumarate affects hospitalized COVID-19 patients' outcomes.

METHODS

The intervention and control groups of 60 hospitalized COVID-19 patients were randomly allocated. Along with normal medication, the intervention group received 25 mg of tenofovir orally daily for seven days. The control group got normal therapy, including remdesivir and corticosteroids. ICU hospitalization duration, laboratory data, fever, dyspnea, arterial blood oxygen saturation with and without an oxygen face mask, mechanical ventilation, and mortality were the outcomes.

RESULTS

Sixty of 236 eligible patients between September 2020 and February 2021 were enrolled. The intervention group had a mean age (±SD) of 61.33 (±13.09) years and the control group 60.03 (±18.03). Sixteen (53.3%) intervention patients and 15 (50.0%) control patients were males. The intervention group had fewer mechanical ventilation and ICU days. Tenofovir Alafenamide Fumarate did not improve fever, dyspnea, oxygen saturation with or without a face mask or nasal cannula, or laboratory data including WBC, ESR, CRP, AST, ALT, AlkP, total and direct bilirubin, in COVID-19 patients.

CONCLUSION

According to this pilot trial, Tenofovir Alafenamide Fumarate, along with conventional treatment, significantly reduced mechanical ventilation and ICU stay in COVID-19 patients. Further thorough research is necessary to verify this conclusion.

摘要

背景

全球治愈 COVID-19 的努力仍在继续。因此,进行了一项前瞻性、区组平衡、开放标签、随机对照试验,以评估富马酸替诺福韦艾拉酚胺对住院 COVID-19 患者结局的影响。

方法

将 60 名住院 COVID-19 患者随机分为干预组和对照组。干预组除常规用药外,还每日口服 25mg 替诺福韦,共 7 天。对照组接受常规治疗,包括瑞德西韦和皮质类固醇。观察 ICU 住院时间、实验室数据、发热、呼吸困难、有无氧面罩时的动脉血氧饱和度、机械通气和死亡率等结局。

结果

2020 年 9 月至 2021 年 2 月期间,236 名符合条件的患者中,有 60 名患者入组。干预组的平均年龄(±SD)为 61.33(±13.09)岁,对照组为 60.03(±18.03)岁。16 名(53.3%)干预患者和 15 名(50.0%)对照患者为男性。干预组机械通气和 ICU 天数较少。富马酸替诺福韦艾拉酚胺并未改善 COVID-19 患者的发热、呼吸困难、有无氧面罩或鼻导管时的血氧饱和度或实验室数据,包括白细胞计数、红细胞沉降率、C 反应蛋白、天冬氨酸转氨酶、丙氨酸转氨酶、碱性磷酸酶、总胆红素和直接胆红素。

结论

根据这项初步试验,替诺福韦艾拉酚胺联合常规治疗可显著降低 COVID-19 患者的机械通气和 ICU 入住率。需要进一步的深入研究来验证这一结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2b52/11484439/6a7f22bf4592/40360_2024_781_Fig1_HTML.jpg

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