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针对 SARS-CoV-2 的 COVID-19 疫苗和抗 SARS-CoV-2 单克隆抗体的真实世界疗效:对美国多元化大都市人群 COVID-19 观察性登记处的分析。

Real-world effectiveness of COVID-19 vaccines and anti-SARS-CoV-2 monoclonal antibodies against postacute sequelae of SARS-CoV-2: analysis of a COVID-19 observational registry for a diverse US metropolitan population.

机构信息

Department of Neurosurgery, Houston Methodist Research Institute, Houston, Texas, USA.

Houston Methodist Research Institute, Houston, Texas, USA.

出版信息

BMJ Open. 2023 Apr 5;13(4):e067611. doi: 10.1136/bmjopen-2022-067611.

Abstract

OBJECTIVES

We evaluated the effectiveness of COVID-19 vaccines and monoclonal antibodies (mAbs) against postacute sequelae of SARS-CoV-2 infection (PASC).

DESIGN AND SETTING

A retrospective cohort study using a COVID-19 specific, electronic medical record-based surveillance and outcomes registry from an eight-hospital tertiary hospital system in the Houston metropolitan area. Analyses were replicated across a global research network database.

PARTICIPANTS

We identified adult (≥18) patients with PASC. PASC was defined as experiencing constitutional (palpitations, malaise/fatigue, headache) or systemic (sleep disorder, shortness of breath, mood/anxiety disorders, cough and cognitive impairment) symptoms beyond the 28-day postinfection period.

STATISTICAL ANALYSIS

We fit multivariable logistic regression models and report estimated likelihood of PASC associated with vaccination or mAb treatment as adjusted ORs with 95% CIs.

RESULTS

Primary analyses included 53 239 subjects (54.9% female), of whom 5929, 11.1% (95% CI 10.9% to 11.4%), experienced PASC. Both vaccinated breakthrough cases (vs unvaccinated) and mAb-treated patients (vs untreated) had lower likelihoods for developing PASC, aOR (95% CI): 0.58 (0.52-0.66), and 0.77 (0.69-0.86), respectively. Vaccination was associated with decreased odds of developing all constitutional and systemic symptoms except for taste and smell changes. For all symptoms, vaccination was associated with lower likelihood of experiencing PASC compared with mAb treatment. Replication analysis found identical frequency of PASC (11.2%, 95% CI 11.1 to 11.3) and similar protective effects against PASC for the COVID-19 vaccine: 0.25 (0.21-0.30) and mAb treatment: 0.62 (0.59-0.66).

CONCLUSION

Although both COVID-19 vaccines and mAbs decreased the likelihood of PASC, vaccination remains the most effective tool for the prevention of long-term consequences of COVID-19.

摘要

目的

评估 COVID-19 疫苗和单克隆抗体(mAb)对 SARS-CoV-2 感染后后遗症(PASC)的效果。

设计和设置

这是一项使用基于电子病历的 COVID-19 特定监测和结果登记系统的回顾性队列研究,该系统来自休斯顿大都市区的八家医院三级医院系统。分析在全球研究网络数据库中进行了复制。

参与者

我们确定了患有 PASC 的成年(≥18 岁)患者。PASC 的定义为在感染后 28 天的恢复期之外出现全身(睡眠障碍、呼吸急促、情绪/焦虑障碍、咳嗽和认知障碍)或全身(心悸、不适/疲劳、头痛)症状。

统计学分析

我们拟合了多变量逻辑回归模型,并报告了与接种疫苗或 mAb 治疗相关的 PASC 的估计可能性,调整后的 OR 及其 95%CI。

结果

主要分析纳入了 53239 名受试者(54.9%为女性),其中 5929 名(11.1%(95%CI 10.9%至 11.4%))发生了 PASC。突破性接种疫苗病例(与未接种疫苗者相比)和 mAb 治疗患者(与未治疗者相比)发生 PASC 的可能性均较低,aOR(95%CI):0.58(0.52-0.66)和 0.77(0.69-0.86)。接种疫苗与除味觉和嗅觉改变外的所有全身和全身症状的发生几率降低有关。对于所有症状,与 mAb 治疗相比,接种疫苗与 PASC 的发生几率较低有关。复制分析发现 PASC 的频率相同(11.2%(95%CI 11.1%至 11.3%)),且 COVID-19 疫苗对 PASC 的保护作用相似:0.25(0.21-0.30)和 mAb 治疗:0.62(0.59-0.66)。

结论

尽管 COVID-19 疫苗和 mAb 均降低了 PASC 的可能性,但接种疫苗仍是预防 COVID-19 长期后果的最有效工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5bf/10083521/eef124b032a5/bmjopen-2022-067611f01.jpg

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