Mensky G, van Blydenstein A, Damelin J, Omar S
Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Department of Pulmonology, Chris Hani Baragwanath Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
South Afr J Crit Care. 2024 Nov 25;40(3):e1897. doi: 10.7196/SAJCC.2024.v40i3.1897. eCollection 2024.
COVID-19 infection has a variable clinical presentation, with a small subgroup of patients developing severe disease, requiring intensive care with mechanical ventilation, with an increased mortality rate. South Africa (SA) has experienced multiple waves of this pandemic, spanning the pre-vaccine and vaccine periods. The method and initiation of treatment is a debated topic, changing according to evolving research and the literature. The present study investigated the use of high-dose intravenous immunoglobulin (IVIg) as a salvage therapy after initial medical treatment failure.
To compare disease progression among critically ill COVID-19 pneumonia patients receiving IVIg therapy with that in patients receiving standard of care (SoC), in respect of inflammation, organ dysfunction and oxygenation.
This was a single-centre, retrospective study of patients admitted to the intensive care unit (ICU) at Chris Hani Baragwanath Academic Hospital, Johannesburg, SA, during the pre-vaccine COVID-19 pandemic. Demographics, inflammatory markers (C-reactive protein (CRP)), organ function (Sequential Organ Failure Assessment (SOFA) score), oxygenation (ratio of partial pressure of oxygen in arterial blood to fraction of inspiratory oxygen (P/F ratio)), overall mortality and complications (nosocomial infections and thromboembolism) were recorded and compared.
We included 113 eligible patients in the study. The IVIg cohort had a significantly lower initial P/F ratio than the SoC cohort (p=0.01), but the change in P/F ratio was similar (p=0.54). Initial CRP and changes in CRP were similar in the two groups (p=0.38 and p=0.75, respectively), as were initial SOFA score and changes in SOFA score (p=0.18 and p=0.08, respectively) and vasopressor dose on day 0 and day 5 (p=0.97 and p=0.93, respectively). Duration of mechanical ventilation did not differ significantly between the IVIg group and the SoC group (p=0.13). There were no significant differences in measured complications between the two groups. On univariate analysis, the relative risk of death was 1.6 times higher (95% confidence interval (CI) 1.1 - 2.3) in the IVIg group; however, a logistical regression model demonstrated that only a higher P/F ratio (odds ratio (OR) 0.991; 95% CI 0.983 - 0.997) and higher mean airway pressure (OR 1.283; 95% CI 1.026 - 1.604) were significantly associated with ICU mortality.
Use of IVIg in our study was directed at an older population, with significantly worse oxygenation. We found no evidence of adverse effects of immunoglobulin therapy; however, we found no benefit either. Only the P/F ratio and mean airway pressure independently predicted ICU mortality.
During the COVID-19 pandemic, treatment protocols changed in response to the evolving literature. Hospitals were faced with choosing a treatment modality that they believed at the time had benefit. Chris Hani Baragwanath Hospital in Johannesburg, South Africa (SA), incorporated IVIg into its treatment protocols for patients with severe COVID pneumonia requiring ICU admission. This study retrospectively analysed the use of IVIg therapy in the hope of creating a more robust understanding of its safety and efficacy as a treatment option for SA patients in the future.
新型冠状病毒肺炎(COVID-19)感染的临床表现多样,一小部分患者会发展为重症疾病,需要重症监护及机械通气,死亡率较高。南非经历了多波疫情,涵盖了疫苗接种前和接种疫苗阶段。治疗方法和起始治疗时机是一个有争议的话题,会根据不断发展的研究和文献而变化。本研究调查了在初始治疗失败后使用大剂量静脉注射免疫球蛋白(IVIg)作为挽救治疗的情况。
比较接受IVIg治疗的重症COVID-19肺炎患者与接受标准治疗(SoC)的患者在炎症、器官功能障碍和氧合方面的疾病进展情况。
这是一项单中心回顾性研究,研究对象为南非约翰内斯堡克里斯·哈尼·巴拉干纳特学术医院重症监护病房(ICU)在疫苗接种前COVID-19大流行期间收治的患者。记录并比较了人口统计学数据、炎症标志物(C反应蛋白(CRP))、器官功能(序贯器官衰竭评估(SOFA)评分)、氧合情况(动脉血氧分压与吸入氧分数之比(P/F比值))、总体死亡率和并发症(医院感染和血栓栓塞)。
我们纳入了113例符合条件的患者进行研究。IVIg组的初始P/F比值显著低于SoC组(p = 0.01),但P/F比值的变化相似(p = 0.54)。两组的初始CRP及CRP变化相似(分别为p = 0.38和p = 0.75),初始SOFA评分及SOFA评分变化相似(分别为p = 0.18和p = 0.08),第0天和第5天的血管升压药剂量也相似(分别为p = 0.97和p = 0.93)。IVIg组和SoC组的机械通气时间无显著差异(p = 0.13)。两组间测量的并发症无显著差异。单因素分析显示,IVIg组的死亡相对风险高1.6倍(95%置信区间(CI)1.1 - 2.3);然而,逻辑回归模型显示,只有较高的P/F比值(比值比(OR)0.991;95%CI 0.983 - 0.997)和较高的平均气道压(OR 1.283;95%CI 1.026 - 1.604)与ICU死亡率显著相关。
我们研究中使用IVIg的对象为年龄较大、氧合情况明显较差的人群。我们没有发现免疫球蛋白治疗有不良反应的证据;然而,我们也没有发现其有益之处。只有P/F比值和平均气道压可独立预测ICU死亡率。
在COVID-19大流行期间,治疗方案根据不断发展的文献而改变。医院面临着选择他们当时认为有益的治疗方式。南非约翰内斯堡的克里斯·哈尼·巴拉干纳特医院将IVIg纳入了需要入住ICU的重症COVID肺炎患者的治疗方案中。本研究对IVIg治疗的使用情况进行了回顾性分析,以期未来能更全面地了解其作为南非患者治疗选择的安全性和有效性。