韩国口服抗病毒药物对 COVID-19 临床疗效的全国性目标试验模拟评估。

IF 3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Journal of Korean Medical Science Pub Date : 2024-11-04 DOI:10.3346/jkms.2024.39.e272
Kyungmin Huh, Youngji Jo, Gi Hwan Bae, Hyejin Joo, Munkhzul Radnaabaatar, Hyungmin Lee, Jungyeon Kim, Dong-Hwi Kim, Min-Gyu Yoo, Il Uk Jo, Poong Hoon Lee, Geun Woo Lee, Hee Sun Jung, Jaehun Jung
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引用次数: 0

摘要

背景:尽管在随机试验中证明了口服抗病毒药物对严重急性呼吸综合征冠状病毒2的有效性,但在广泛免疫和流行变异较轻的情况下,对其进行临床重新评估至关重要。本研究旨在评估口服抗病毒药物对冠状病毒病 2019(COVID-19)的疗效:这项回顾性队列研究利用目标试验仿真框架分析了2022年1月至12月期间60岁以上的COVID-19患者。数据来自韩国疾病预防控制机构和健康保险审查评估服务机构。研究涉及 957,036 名接受尼马瑞韦/利托那韦治疗的患者和 243,360 名接受莫仑吡拉韦治疗的患者,每组患者均与匹配的对照组进行了比较。主要结果是进展为需要高级呼吸支持的危重 COVID-19。次要结果包括进展为重症 COVID-19、需要补充氧气以及在 COVID-19 发生后 30 天内死亡。需要治疗的人数(NNT)来自绝对风险的降低:Nirmatrelvir/利托那韦显著降低了重度(调整后比值比 [aOR],0.823;95% 置信区间 [CI],0.803-0.843)、危重(aOR,0.560;95% CI,0.503-0.624)和致命 COVID-19 的风险(aOR,0.694;95% CI,0.647-0.744)。同样,molnupiravir 可降低重症(aOR,0.895;95% CI,0.856-0.937)、危重症(aOR,0.672;95% CI,0.559-0.807)和死亡病例(aOR,0.679;95% CI,0.592-0.779)的风险。nirmatrelvir/ritonavir的NNT分别为203.71(严重)、1230.12(危重)和691.50(死亡);molnupiravir的NNT分别为352.70(严重)、1398.62(危重)和862.98(死亡)。老年人、未接种疫苗者和大流行后期的有效性更高:结论:Nirmatrelvir/ritonavir和molnupiravir可有效预防COVID-19老年患者病情恶化。
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Nationwide Target Trial Emulation Evaluating the Clinical Effectiveness of Oral Antivirals for COVID-19 in Korea.

Background: Despite the proven effectiveness of oral antivirals against severe acute respiratory syndrome coronavirus 2 in randomized trials, their clinical reevaluation is vital in the context of widespread immunity and milder prevalent variants. This study aimed to assess the effectiveness of oral antivirals for coronavirus disease 2019 (COVID-19).

Methods: This retrospective cohort study utilized a target trial emulation framework to analyze patients with COVID-19 aged 60+ from January to December 2022. Data were obtained from the Korea Disease Control and Prevention Agency and Health Insurance Review and Assessment Service. The study involved 957,036 patients treated with nirmatrelvir/ritonavir and 243,360 treated with molnupiravir, each compared with the matched control groups. Primary outcome was progression to critical COVID-19 requiring advanced respiratory support. Secondary outcomes included progression to severe COVID-19, need for supplemental oxygen, and death within 30 days of the onset of COVID-19. Number needed to treat (NNT) derived from the absolute risk reduction.

Results: Nirmatrelvir/ritonavir was significantly associated with a reduced risk of severe (adjusted odds ratio [aOR], 0.823; 95% confidence interval [CI], 0.803-0.843), critical (aOR, 0.560; 95% CI, 0.503-0.624), and fatal COVID-19 (aOR, 0.694; 95% CI, 0.647-0.744). Similarly, molnupiravir reduced the risk of severe (aOR, 0.895; 95% CI, 0.856-0.937), critical (aOR, 0.672; 95% CI, 0.559-0.807), and fatal cases (aOR, 0.679; 95% CI, 0.592-0.779). NNTs for nirmatrelvir/ritonavir were 203.71 (severe), 1,230.12 (critical), and 691.50 (death); for molnupiravir, they were 352.70 (severe), 1,398.62 (critical), and 862.98 (death). Higher effectiveness was associated with older adults, unvaccinated individuals, and the late pandemic phase.

Conclusion: Nirmatrelvir/ritonavir and molnupiravir are effective in preventing progression to severe disease in elderly adults with COVID-19.

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来源期刊
Journal of Korean Medical Science
Journal of Korean Medical Science 医学-医学:内科
CiteScore
7.80
自引率
8.90%
发文量
320
审稿时长
3-6 weeks
期刊介绍: The Journal of Korean Medical Science (JKMS) is an international, peer-reviewed Open Access journal of medicine published weekly in English. The Journal’s publisher is the Korean Academy of Medical Sciences (KAMS), Korean Medical Association (KMA). JKMS aims to publish evidence-based, scientific research articles from various disciplines of the medical sciences. The Journal welcomes articles of general interest to medical researchers especially when they contain original information. Articles on the clinical evaluation of drugs and other therapies, epidemiologic studies of the general population, studies on pathogenic organisms and toxic materials, and the toxicities and adverse effects of therapeutics are welcome.
期刊最新文献
Genome-Wide Association Analysis of Rapid Decline in Lung Function: Analysis From the Korean Genome and Epidemiology Study. In This Issue on 04-November-2024. Nationwide Target Trial Emulation Evaluating the Clinical Effectiveness of Oral Antivirals for COVID-19 in Korea. Occupational Risk Factors for Skin Cancer: A Comprehensive Review. Reported Adverse Events and Associated Factors in Korean Coronavirus Disease 2019 Vaccinations.
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