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奈玛特韦/利托那韦与地塞米松在新冠肺炎住院患者中的真实世界有效性:一项前瞻性队列研究

Real-World Effectiveness of Nirmatrelvir/Ritonavir and Dexamethasone Among Hospitalized Patients with COVID-19: A Prospective Cohort Study.

作者信息

Liu Wei, Song Qingkun, Li Fang, Cao Yu, Han Ying, Wu Jiangping, Hu Zhongjie, Zhang Yonghong, Ma Yingmin

机构信息

Department of Pharmacy, Beijing Youan Hospital, Capital Medical University, Beijing, People's Republic of China.

Department of Clinical Epidemiology, Beijing Youan Hospital, Capital Medical University, Beijing, People's Republic of China.

出版信息

Infect Drug Resist. 2023 Aug 11;16:5223-5231. doi: 10.2147/IDR.S419373. eCollection 2023.

Abstract

PURPOSE

Anti-viral and anti-inflammatory therapies were effective in altering virus repletion and immune dysregulation in Coronavirus Disease 2019 (COVID-19) patients. This study aimed to explore the effect of combination therapy on disease progression in a real-world setting.

PATIENTS AND METHODS

A total of 836 patients confirmed with SARS-CoV-2 infection participated in the study from 15 November to 25 December 2022 at Beijing Youan Hospital, Capital Medical University. A prospective cohort study was implemented to investigate the prognostic effect of the combination therapy on virus shedding and clinical recovery.

RESULTS

About 78% of patients used nirmatrelvir/ritonavir (N/R, Paxlovid, Pfizer) negatively, 16% of patients were prescribed nirmatrelvir/ritonavir beyond five days of symptom onset, 4% of patients received N/R monotherapy within five days of symptom onset and 2% of patients received N/R combined with dexamethasone. Compared with untreated patients, N/R monotherapy reduced the median time to 10.0 days from 12.0 days according to the negative conversion of nucleic acid amplification test (NAAT), and combination therapy reduced the time to 7.0 days, and increased to a 1.99 (95% CI 0.92, 4.32) and 14.23-fold (95% CI 4.50, 44.95) probability of negative NAAT, respectively. N/R monotherapy reduced the clinical recovery time to 10.0 days from 13.0 days. Single-use and combined-use non-significantly increased the recovery probability by 61% and 69%, respectively. In mild and moderate patients, the HRs for clinical recovery increased to 1.69 (95% CI 0.73, 3.94) and 2.18 (95% CI 0.29, 16.62), respectively.

CONCLUSION

Combination therapy of N/R and dexamethasone increased negative conversion of NAAT and was associated with a non-significant improvement in clinical recovery. Further studies are warranted to confirm this efficacy.

摘要

目的

抗病毒和抗炎疗法在改变2019冠状病毒病(COVID-19)患者的病毒载量和免疫失调方面是有效的。本研究旨在探讨联合治疗在实际临床环境中对疾病进展的影响。

患者与方法

2022年11月15日至12月25日,共有836例确诊为SARS-CoV-2感染的患者在北京佑安医院、首都医科大学参与了本研究。实施了一项前瞻性队列研究,以调查联合治疗对病毒清除和临床恢复的预后影响。

结果

约78%的患者未使用奈玛特韦/利托那韦(N/R,帕罗韦德,辉瑞公司),16%的患者在症状出现超过5天后使用奈玛特韦/利托那韦,4%的患者在症状出现5天内接受N/R单药治疗,2%的患者接受N/R联合地塞米松治疗。与未治疗的患者相比,根据核酸扩增检测(NAAT)阴性转换,N/R单药治疗将中位数时间从12.0天缩短至10.0天,联合治疗将时间缩短至7.0天,NAAT阴性的概率分别提高到1.99倍(95%CI 0.92,4.32)和14.23倍(95%CI 4.50,44.95)。N/R单药治疗将临床恢复时间从13.0天缩短至10.0天。单用和联用分别将恢复概率非显著性提高了61%和69%。在轻度和中度患者中,临床恢复的风险比分别增至1.69(95%CI 0.73,3.94)和2.18(95%CI 0.29,16.62)。

结论

N/R与地塞米松联合治疗增加了NAAT阴性转换率,并与临床恢复的非显著性改善相关。需要进一步研究来证实这种疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6be4/10426452/41bf4ae9a7ae/IDR-16-5223-g0001.jpg

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