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巴尼韦单抗在轻至中度 COVID-19 疾病中的应用:一项匹配队列设计。

Bamlanivimab use in mild-to-moderate COVID-19 disease: A matched cohort design.

机构信息

Pharmacy Practice, Creighton University, Omaha, Nebraska, USA.

Department of Clinical Research, Creighton University, Omaha, Nebraska, USA.

出版信息

Pharmacotherapy. 2021 Sep;41(9):743-747. doi: 10.1002/phar.2613. Epub 2021 Aug 12.

Abstract

STUDY OBJECTIVE

Our objective was to determine if bamlanivimab (LY-CoV555; BAM), a monoclonal antibody for mild-to-moderate Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Co-V-2, prevented emergency department (ED) visits, hospitalizations for SARS-CoV-2, or death within 60 days of a positive SARS-CoV-2 viral test.

DESIGN

Patient propensity matching was performed for BAM administration to get two discrete groups of patients; those who received BAM (N = 117) and those who did not (N = 117).

SETTING

Outpatients (N = 2107) eligible to receive BAM from November 1 to December 31, 2020, were identified.

PATIENTS

A total of 144 of 2107 patients with mild-to-moderate SARS-CoV-2 received BAM INTERVENTION: Eligible patients had mild-to-moderate SARS-CoV-2 disease, a positive SARS-CoV-2 test, and risk factor(s) for progression to severe SARS-CoV-2 infection. All patients were reviewed for subsequent ED visits, subsequent hospitalization, and death.

MEASUREMENTS AND MAIN RESULTS

Patients (N = 234) were matched, 117 in each group. Median (interquartile range) age was 72 (65-80) years. Forty-seven percent of patients were male. Twenty-one patients who received BAM were subsequently seen in the ED compared to 34 untreated patients (18.0% vs. 29.1%; p = 0.045). Fourteen BAM-treated patients were subsequently hospitalized post-BAM infusion compared to 27 untreated patients (12.0% vs. 23.1%; p = 0.025). Finally, there were no mortalities in the BAM group, however, eleven patients in the untreated group died (0.0% vs. 9.4%; p < 0.001). The number needed to treat (NNT) is 11 patients to prevent one mortality event.

CONCLUSIONS

BAM infusion for mild-to-moderate SARS-CoV-2 infection in outpatients significantly prevented subsequent ED visits, hospitalizations, and death from SARS-CoV-2.

摘要

研究目的

本研究旨在确定单克隆抗体巴姆洛维单抗(LY-CoV555;BAM)是否可预防轻症至中度严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)患者在感染 SARS-CoV-2 后 60 天内出现急诊就诊、因 SARS-CoV-2 住院或死亡。

设计

对 BAM 给药进行患者倾向匹配,以获得两组不同的患者:接受 BAM(N=117)和未接受 BAM(N=117)的患者。

地点

2020 年 11 月 1 日至 12 月 31 日,门诊(N=2107)中筛选出有资格接受 BAM 的患者。

患者

2107 例轻症至中度 SARS-CoV-2 患者中有 144 例接受了 BAM 干预:符合条件的患者有轻症至中度 SARS-CoV-2 疾病、SARS-CoV-2 检测阳性和进展为严重 SARS-CoV-2 感染的风险因素。所有患者均接受了后续急诊就诊、后续住院和死亡的评估。

测量和主要结果

患者(N=234)匹配,每组 117 例。中位(四分位间距)年龄为 72(65-80)岁。47%的患者为男性。117 例接受 BAM 的患者中有 21 例在接受 BAM 输注后随后在急诊就诊,而 117 例未接受 BAM 的患者中有 34 例(18.0% vs. 29.1%;p=0.045)。14 例接受 BAM 治疗的患者在接受 BAM 输注后随后住院,而 117 例未接受 BAM 治疗的患者中有 27 例(12.0% vs. 23.1%;p=0.025)。最后,BAM 组无死亡病例,但 117 例未接受 BAM 治疗的患者中有 11 例死亡(0.0% vs. 9.4%;p<0.001)。治疗人数(NNT)为 11 例可预防 1 例死亡事件。

结论

在门诊中,对轻症至中度 SARS-CoV-2 感染患者给予 BAM 输注可显著预防因 SARS-CoV-2 导致的后续急诊就诊、住院和死亡。

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