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印度克什米尔地区对重症新型冠状病毒肺炎患者(无可检测到的中和抗体)采用恢复期血浆治疗的评估

Evaluation of Convalescent Plasma in the Management of Critically Ill COVID-19 Patients (with No Detectable Neutralizing Antibodies Nab) in Kashmir, India.

作者信息

Elkhalifa Ahmed M E, Nabi Showkat Ul, Shah Naveed Nazir, Dar Khurshid Ahmad, Quibtiya Syed, Bashir Showkeen Muzamil, Ali Sofi Imtiyaz, Taifa Syed, Hussain Iqra

机构信息

Department of Public Health, College of Health Sciences, Saudi Electronic University, Riyadh 11673, Saudi Arabia.

Department of Haematology, Faculty of Medical Laboratory Sciences, University of El Imam El Mahdi, Kosti 1158, Sudan.

出版信息

Healthcare (Basel). 2023 Jan 20;11(3):317. doi: 10.3390/healthcare11030317.

Abstract

BACKGROUND

For centuries, convalescent plasma (CP) has been recommended to treat a diverse set of viral diseases. Therefore, the present study was undertaken to evaluate the effectiveness of CP in critically ill COVID-19 patients.

METHODS AND MATERIALS

From 23 March 2021 to 29 December 2021, an open-label, prospective cohort, single-centre study was conducted at Chest Disease Hospital, Jammu and Kashmir, Srinagar. Patients with severe manifestation of coronavirus disease 2019 (COVID-19) under BST (best standard treatment) +CP were prospectively observed in order to evaluate effectiveness of CP therapy and historical control under BST were used as the control group Results: A total of 1667 patients were found positive for COVID-19. Of these, 873 (52.4%), 431 (28.8%), and 363 (21.8%) were moderately, severely, and critically ill, respectively. On 35th day post-infusion of CP, all-cause mortality was higher in the BST (best standard treatment) +CP group 12 (37.5%) compared to 127 (35%) in the BST group with an odds ratio (OR) of 1.4 and hazard ratio (HR) (95% CI: 1.08-1.79, = 0.06). Similarly, 7 (21.9) patients in the BST+CP group and 121 (33.3) patients in the BST group showed the transition from critically ill to moderate disease with subhazard ratio (s-HR 1.37) (95% CI: 1.03-2.9).

CONCLUSIONS

In the present study, we could not find any significant difference in the CP group and BST +CP in primary outcome of reducing all-cause mortality in critically ill patients with negligible Nabs levels. However, beneficial results were observed with use of CP in a limited number of secondary outcomes which includes days of hospitalization, negative conversion of SARS-CoV-2 on basis of RT-PCR on 7th day and 14th day, need for invasive mechanical ventilation on 14th day post-CP treatment, and resolution of shortness of breath.

摘要

背景

几个世纪以来,恢复期血浆(CP)一直被推荐用于治疗多种病毒性疾病。因此,本研究旨在评估CP对重症新型冠状病毒肺炎(COVID-19)患者的有效性。

方法和材料

2021年3月23日至2021年12月29日,在斯利那加查谟和克什米尔胸科医院进行了一项开放标签、前瞻性队列、单中心研究。对接受最佳标准治疗(BST)+CP的2019冠状病毒病(COVID-19)重症患者进行前瞻性观察,以评估CP治疗的有效性,并将接受BST的历史对照患者作为对照组。结果:共发现1667例COVID-19患者呈阳性。其中,873例(52.4%)、431例(28.8%)和363例(21.8%)分别为中度、重度和危重症患者。在输注CP后第35天,BST(最佳标准治疗)+CP组的全因死亡率高于BST组,分别为12例(37.5%)和127例(35%),优势比(OR)为1.4,风险比(HR)(95%CI:1.08-1.79,P = 0.06)。同样,BST+CP组7例(21.9%)患者和BST组121例(33.3%)患者从危重症转为中度疾病,亚风险比(s-HR 1.37)(95%CI:1.03-2.9)。

结论

在本研究中,我们发现在Nabs水平可忽略不计的重症患者中,CP组和BST +CP组在降低全因死亡率的主要结局方面没有显著差异。然而,在包括住院天数、第7天和第14天基于RT-PCR的SARS-CoV-2核酸转阴、CP治疗后第14天有创机械通气需求以及呼吸急促缓解等有限数量的次要结局中,使用CP观察到了有益结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e9d/9914564/a8173acfc34f/healthcare-11-00317-g001.jpg

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