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雷格丹维单抗对感染新冠病毒德尔塔变异株患者死亡率的影响:一项倾向评分匹配队列研究。

Effect of Regdanvimab on Mortality in Patients Infected with SARS-CoV-2 Delta Variants: A Propensity Score-Matched Cohort Study.

作者信息

Hwang Soyoon, Lee Nan Young, Nam Eunkyung, Kim Yu Kyung, Kim Shin-Woo, Chang Hyun-Ha, Kim Yoonjung, Bae Sohyun, Jeong Juhwan, Shin Jae-Ho, Jang Guehwan, Lee Changhee, Kwon Ki Tae

机构信息

Division of Infectious Diseases, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, 807, Hoguk-ro, Buk-gu, Daegu, Republic of Korea.

Department of Clinical Pathology, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.

出版信息

Infect Dis Ther. 2024 May;13(5):1037-1050. doi: 10.1007/s40121-024-00971-w. Epub 2024 Apr 12.

Abstract

INTRODUCTION

Regdanvimab, a monoclonal antibody pharmaceutical, is the first Korean drug approved for treating coronavirus disease 2019 (COVID-19). We analyzed the therapeutic efficacy of regdanvimab in patients with the COVID-19 delta variant infection.

METHODS

We retrospectively reviewed the electronic medical records of patients hospitalized at two Korean tertiary COVID-19 hospitals with COVID-19 delta variant infection between May 26, 2021, and January 30, 2022. To analyze the therapeutic efficacy of regdanvimab, the patients were divided into regdanvimab and non-regdanvimab groups and were 1:1 propensity-score (PS)-matched on age, severity at admission, and COVID-19 vaccination history.

RESULTS

Of 492 patients, 262 (53.3%) and 230 (46.7%) were in the regdanvimab and non-regdanvimab groups, respectively. After PS matching the groups on age, severity at admission, and COVID-19 vaccination history, each group comprised 189 patients. The 30-day hospital mortality rates (0.0% vs. 1.6%, p = 0.030), proportions of patients with exacerbated conditions to severe/critical/died (9.5% vs. 16.4%, p = 0.047), proportions who received oxygen therapy because of pneumonia exacerbation (7.4% vs. 16.4%, p = 0.007), and proportions with a daily National Early Warning Score ≥ 5 from hospital day 2 were significantly lower in the regdanvimab group.

CONCLUSIONS

We showed that regdanvimab reduced the exacerbation rates of conditions and mortality in patients with the COVID-19 delta variant infection. Thus, it is recommended to streamline the drug approval system during epidemics of new variant viruses to improve the availability and usage of therapeutics for patients. To facilitate this, relevant institutional support is required.

摘要

引言

雷格丹维单抗是一种单克隆抗体药物,是韩国首个获批用于治疗2019冠状病毒病(COVID-19)的药物。我们分析了雷格丹维单抗对感染COVID-19德尔塔变异株患者的治疗效果。

方法

我们回顾性分析了2021年5月26日至2022年1月30日期间在韩国两家三级COVID-19医院住院的感染COVID-19德尔塔变异株患者的电子病历。为了分析雷格丹维单抗的治疗效果,将患者分为雷格丹维单抗组和非雷格丹维单抗组,并根据年龄、入院时严重程度和COVID-19疫苗接种史进行1:1倾向评分(PS)匹配。

结果

492例患者中,雷格丹维单抗组和非雷格丹维单抗组分别有262例(53.3%)和230例(46.7%)。在根据年龄、入院时严重程度和COVID-19疫苗接种史对两组进行PS匹配后,每组各有189例患者。雷格丹维单抗组的30天医院死亡率(0.0%对1.6%,p = 0.030)、病情加重至重度/危重度/死亡的患者比例(9.5%对16.4%,p = 0.047)、因肺炎加重接受氧疗的患者比例(7.4%对16.4%,p = 0.007)以及从住院第2天起每日国家早期预警评分≥5的患者比例均显著较低。

结论

我们表明,雷格丹维单抗降低了感染COVID-19德尔塔变异株患者的病情加重率和死亡率。因此,建议在新变异病毒流行期间简化药物审批系统,以提高治疗药物对患者的可及性和使用率。为此,需要相关的机构支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0ed/11098974/599771d7b078/40121_2024_971_Fig1_HTML.jpg

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