免疫调节剂对 COVID-19 重症和危重病人的非凡生存效益:孟加拉国临床试验的结果。

Md Azizul Islam, Masudul A Mazumder, Neelima Akhter, Akm Faizul Huq, Mamun Al-Mahtab, Md Sakirul I Khan, Sheikh Mf Akbar
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引用次数: 0

摘要

背景:冠状病毒病(COVID)-19 几乎摧毁了世界上所有国家的医疗保健系统和社会机构。然而,遏制 COVID-19 新病例的疫苗尚未问世。此外,目前可用的抗病毒药物和其他标准护理(SOC)管理策略也无法令人满意地控制与 COVID-19 相关的死亡率,在过去 9 个月中,死亡率已突破 100 万大关。这些事实表明,迫切需要开发新的、新型的和不断发展的治疗策略来治疗 COVID-19:这项队列研究是在孟加拉国的真实情况下进行的一项临床试验,在严重和危重的 COVID-19 患者中应用了两种免疫调节剂:本研究共招募了 199 名确诊的 COVID-19 患者。所有患者均为重症危重 COVID-19 患者,在孟加拉国达卡联合军事医院(CMH)重症监护室(ICU)住院治疗。所有患者的鼻拭子聚合酶链反应(PCR)结果均为 SARS-CoV-2 阳性,并伴有重症肺炎、多器官功能障碍和凝血功能障碍。肺部受累的中位比例为 65%。平均血氧饱和度为 83%。患者接受了两种免疫调节剂(托珠单抗和贝伐珠单抗)的不同组合治疗,以便更广泛地了解免疫调节剂在COVID-19治疗中的安全性和有效性:在199名患者中,122人存活,77人死亡。单剂量托西珠单抗可使71.5%的患者存活(102例COVID-19患者中的73例)。另一方面,接受贝伐珠单抗治疗的患者生存率显著提高(92%):研究表明,COVID-19 患者应尽早开始积极治疗,因为中度 COVID 患者可能会发展为更严重的疾病,造成严重后果。在这批严重和危重的 COVID-19 患者中,记录了两种免疫调节剂的安全性。为了正确使用这些免疫调节剂,有必要进行至少两组对照、盲法和大规模前瞻性研究:Islam MA, Mazumder MA, Akhter N, et al:孟加拉国临床试验的结果。Euroasian J Hepato-Gastroenterol 2020;10(2):68-75.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Extraordinary Survival Benefits of Severe and Critical Patients with COVID-19 by Immune Modulators: The Outcome of a Clinical Trial in Bangladesh.

Background: Coronavirus disease (COVID)-19 has devasted the healthcare delivery system as well as social establishments of almost all countries of the world. However, vaccines for containing new cases of COVID-19 are yet to be realized. Also, presently available antiviral drugs and other standard of care (SOC) management strategies could not satisfactorily control COVID-19-related mortality, which has crossed the one million mark during the last 9 months. These facts present an emergent need for developing new, novel, and evolving therapeutic strategies for the management of COVID-19.

Aim and objective: This cohort study represents a clinical trial in real-life situations in Bangladesh where two immune modulators were applied in patients with severe and critical COVID-19 patients.

Materials and methods: A total of 199 confirmed patients of COVID-19 were enrolled in this study. All of them had severe and critical COVID-19 and they were hospitalized at the intensive care unit (ICU) of the Combined Military Hospital (CMH), Dhaka, Bangladesh. All patients were positive for SARS-CoV-2 by polymerase chain reaction (PCR) of the nasal swab and they were endowed with severe pneumonia, multiple organ dysfunctions, and coagulopathy. The median percentage of lung involvement was 65%. The mean oxygen saturation was 83%. The patients received two immune modulators (tocilizumab and bevacizumab) in different combinations to retrieve broader insights about the safety and efficacy of immune modulators in COVID-19 management.

Results: Out of the total 199 patients, 122 survived and 77 expired. A single dose of tocilizumab resulted in the survival of 71.5% (73 of 102 COVID-19 patients). On the other hand, a dramatic survival benefit was found in patients receiving bevacizumab (92%).

Conclusion: The study indicates that active treatment should be started as early as possible for COVID-19 patients as moderate COVID-patients may progress to more severe illnesses with grave consequences. The safety of two immune modulators has been recorded in this cohort of severe and critical COVID-19 patients. In order to have a proper use of these immune modulators, there is a need to accomplish controlled, blinded, and large-scale prospective studies with at least two arms.

How to cite this article: Islam MA, Mazumder MA, Akhter N, et al. Extraordinary Survival Benefits of Severe and Critical Patients with COVID-19 by Immune Modulators: The Outcome of a Clinical Trial in Bangladesh. Euroasian J Hepato-Gastroenterol 2020;10(2):68-75.

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