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评价静脉注射免疫球蛋白(IVIg)对重症 COVID-19 病例治疗效果的影响:一项随机对照试验。

Evaluating the effects of Intravenous Immunoglobulin (IVIg) on the management of severe COVID-19 cases: A randomized controlled trial.

机构信息

Clinical Tuberculosis and Epidemiology Research Centre, National Research Institute for Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Int Immunopharmacol. 2021 Jan;90:107205. doi: 10.1016/j.intimp.2020.107205. Epub 2020 Nov 13.

Abstract

BACKGROUND

The newly discovered coronavirus has turned into coronavirus disease 2019 (COVID-19) pandemic and it rages at an unprecedented rate. Considering the findings of previous studies on the use of Intravenous Immunoglobulin (IVIg) for treating severe HN infection and the satisfying results for reducing viral load and mortality, this study aimed to investigate the potential usefulness of IVIg for the management of severe cases.

METHODS

In this randomized controlled trial, 84 patients were included: 52 in the IVIg group and 32 in the control group. The intervention group received IVIg at a dose of 400 mg/kg, IV, daily for three days. Both groups received hydroxychloroquine, lopinavir/ritonavir and supportive care. The demographic data, mortality rate, the need for mechanical ventilation, length of stay in hospital and in Intensive Care Unit (ICU), and imaging findings were recorded and compared in terms of the mentioned factors.

RESULTS

The mean time from admission to IVIg initiation was 3.84 ± 3.35 days. There was no significant difference between the two groups in terms of mortality rate (P-value = 0.8) and the need for mechanical ventilation (P-value = 0.39). The length of hospital stay was significantly lower for the control group than that of the intervention group (P-value = 0.003). There was a significant positive relationship between the time from hospital admission to IVIg initiation and the length of stay in the hospital and ICU among the survivors (P-value < 0.001 and =0.01, respectively).

CONCLUSIONS

Our findings did not support the use of IVIg in combination with hydroxychloroquine and lopinavir/ritonavir in treatment of severe COVID-19 cases.

摘要

背景

新发现的冠状病毒已演变为 2019 年冠状病毒病(COVID-19)大流行,其传播速度前所未有。考虑到先前关于静脉注射免疫球蛋白(IVIg)治疗严重 HN 感染的研究结果以及降低病毒载量和死亡率的令人满意的结果,本研究旨在探讨 IVIg 用于治疗重症病例的潜在用途。

方法

在这项随机对照试验中,纳入了 84 名患者:IVIg 组 52 例,对照组 32 例。干预组接受 400mg/kg 的 IVIg 治疗,每天一次,共三天。两组均接受羟氯喹、洛匹那韦/利托那韦和支持性治疗。记录并比较了人口统计学数据、死亡率、机械通气需求、住院和重症监护病房(ICU)的住院时间以及影像学发现,以评估这些因素。

结果

从入院到开始 IVIg 治疗的平均时间为 3.84±3.35 天。两组在死亡率(P 值=0.8)和机械通气需求(P 值=0.39)方面无显著差异。对照组的住院时间明显短于干预组(P 值=0.003)。在幸存者中,从入院到开始 IVIg 治疗的时间与住院和 ICU 住院时间之间存在显著的正相关关系(P 值均<0.001 和=0.01)。

结论

我们的研究结果不支持联合羟氯喹和洛匹那韦/利托那韦使用 IVIg 治疗严重 COVID-19 病例。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8709/7665876/0f3deec4812f/gr1_lrg.jpg

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