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评估皮下注射阿达木单抗对 COVID-19 患者预后的影响:伊朗一项非随机临床试验研究。

Assessment of the Effect of Sub-Cutaneous Adalimumab on Prognosis of COVID-19 Patients: a Non-Randomized Pilot Clinical Trial Study in Iran.

出版信息

Clin Lab. 2023 Sep 1;69(9). doi: 10.7754/Clin.Lab.2023.230343.

Abstract

BACKGROUND

Adalimumab is an anti-inflammatory medicine used to treat a variety of disorders, although its effectiveness in improving the clinical status of COVID-19 patients is debatable. The goal was to evaluate the efficacy of adalimumab as an alternate treatment in COVID-19 patients.

METHODS

This non-randomized pilot clinical trial study included 18 patients with severe COVID-19 status hospitalized at the Afzalipour Hospital in Kerman from February 2022 to March 2022. Patients were divided into two groups: nine patients in the control group received dexamethasone, remdesivir, and heparin in addition to supportive therapies. The case group also included nine patients who received adalimumab injection (CinnoRA®, CinnaGen, Iran) in addition to the treatment administered to the control group.

RESULTS

Although the effect of adalimumab injection on clinical factors, including mechanical ventilation required, the number of days oxygen needed, the length of stay in the intensive care unit (ICU), and saturation of peripheral oxygen (SpO2) level and respiratory rate (RR), were not significantly different between groups, the intra-group SpO2 level before and after receiving oxygen was significantly different in the case group (p ≤ 0.001 and p = 0.002). In addition, laboratory tests for lactate dehydrogenase (LDH) and C-reactive protein (CRP) revealed no statistically significant differences between the two groups. Nonetheless, a positive intra-group effect of the medication was detected on these two parameters. No short-term side effects of drug injection were observed.

CONCLUSIONS

This study demonstrated the efficacy of adalimumab as an alternate medication for improving SpO2, LDH, and CRP levels in COVID-19 patients.

摘要

背景

阿达木单抗是一种抗炎药物,用于治疗多种疾病,尽管其在改善 COVID-19 患者临床状况方面的有效性存在争议。本研究旨在评估阿达木单抗作为 COVID-19 患者替代治疗的疗效。

方法

这是一项非随机的临床试验研究,纳入了 2022 年 2 月至 3 月期间在克尔曼省阿夫扎利普尔医院住院的 18 名重症 COVID-19 患者。患者分为两组:对照组 9 例患者除了支持治疗外,还接受地塞米松、瑞德西韦和肝素治疗;病例组也包括 9 例患者,他们除了接受对照组的治疗外,还接受阿达木单抗注射液(CinnoRA®,CinnaGen,伊朗)治疗。

结果

尽管阿达木单抗注射对包括机械通气需求、需要吸氧的天数、入住重症监护病房(ICU)的时间以及外周血氧饱和度(SpO2)和呼吸频率(RR)在内的临床因素的影响在两组之间没有显著差异,但病例组接受氧疗前后的 SpO2 水平有显著差异(p≤0.001 和 p=0.002)。此外,乳酸脱氢酶(LDH)和 C 反应蛋白(CRP)的实验室检测结果两组之间无统计学差异。然而,药物治疗对这两个参数有显著的组内效应。未观察到药物注射的短期副作用。

结论

本研究表明阿达木单抗作为 COVID-19 患者的替代药物,可有效改善 SpO2、LDH 和 CRP 水平。

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