西米普明瑞韦/利托那韦和奈玛特韦/利托那韦治疗中度至重度新型冠状病毒肺炎的有效性和安全性
Effectiveness and Safety of Simnotrelvir/Ritonavir and Nirmatrelvir/Ritonavir in the Treatment of Moderate to Severe COVID-19.
作者信息
Chen Xin, Lin Xiao-Qing, Cheng Fang, Zheng Shi-Lin, Zhang Qiang, Wu Te, Jiang Xian-Gao, Shi Ji-Chan
机构信息
Department of Infectious Disease, Wenzhou Central Hospital, Dingli Clinical College of Wenzhou Medical University, Wenzhou Sixth People's Hospital, Zhejiang, China.
出版信息
Immun Inflamm Dis. 2025 Apr;13(4):e70174. doi: 10.1002/iid3.70174.
BACKGROUND AND AIM
Simnotrelvir/ritonavir and nirmatrelvir/ritonavir are major treatments for COVID-19, but their comparative efficacy and safety, especially in patients with moderate to severe COVID-19, remain unclear.
METHODS
This was a retrospective cohort study using electronic medical record data. From May 30, 2023, to October 8, 2023, 115 patients with moderate to severe COVID-19 were retrospectively collected from Wenzhou Central Hospital. They were treated with simnotrelvir/ritonavir or nirmatrelvir/ritonavir. The clinical effectiveness and adverse reactions were analyzed and compared between the two groups.
RESULTS
A total of 115 hospitalized patients were included in the study. They were 65 (56.5%) men and 50 (43.5%) women, with a mean age of 61 years. 58 (50.4%) were treated with simnotrelvir/ritonavir and 57 (49.6%) with nirmatrelvir/ritonavir. There was a similar rate of composite disease progression (10.3% vs. 7.0%, χ = 0.401, p = 0.527) and mortality (5.2% vs. 3.5%, χ = 0.191, p = 0.662) between the two groups. The progression rate from moderate COVID-19 to severe COVID-19 was not significantly different between the two groups (4.5% vs. 6.4%, χ = 0.148, p = 0.701). Median time for hospitalization was 7.0 (6.0, 8.0) days and 9.0 (8.0, 10.0) days (p = 0.338), and time for SARS-CoV-2 negative conversion was 6.0 (6.0, 7.0) days and 7.0 (6.0, 7.0) days (p = 0.934) in the simnotrelvir/ritonavir group and nirmatrelvir/ritonavir group, respectively. Among moderate patients, time for hospitalization was shorter in the simnotrelvir/ritonavir group [6.0 (6.0, 7.0) vs. 8.0 (8.0, 10.0) days, log-rank p = 0.004, HR = 1.838 (95% CI 1.199-2.815)]. And 5 (8.6%) had adverse drug reactions (ADRs) in the simnotrelvir/ritonavir group and 6 (10.5%) had ADRs in the nirmatrelvir/ritonavir group.
CONCLUSION
This is the first study comparing the effectiveness of simnotrelvir/ritonavir and nirmatrelvir/ritonavir in moderate and severe COVID-19 patients. Patients who received simnotrelvir/ritonavir exhibited shorter hospitalization. Disease progression, viral clearance times, and symptom resolution time were similar between the two groups.
背景与目的
西莫特瑞韦/利托那韦和奈玛特瑞韦/利托那韦是治疗新型冠状病毒肺炎（COVID-19）的主要药物，但它们的疗效和安全性比较，尤其是在中重度COVID-19患者中的情况，仍不明确。
方法
本研究为回顾性队列研究，使用电子病历数据。2023年5月30日至2023年10月8日，从温州中心医院回顾性收集了115例中重度COVID-19患者。他们接受了西莫特瑞韦/利托那韦或奈玛特瑞韦/利托那韦治疗。分析并比较了两组的临床疗效和不良反应。
结果
本研究共纳入115例住院患者。其中男性65例（56.5%），女性50例（43.5%），平均年龄61岁。58例（50.4%）接受西莫特瑞韦/利托那韦治疗，57例（49.6%）接受奈玛特瑞韦/利托那韦治疗。两组的综合疾病进展率（10.3%对7.0%，χ² = 0.401，p = 0.527）和死亡率（5.2%对3.5%，χ² = 0.191，p = 0.662）相似。两组中从轻度COVID-19进展为重度COVID-19的比例无显著差异（4.5%对6.4%，χ² = 0.148，p = 0.701）。西莫特瑞韦/利托那韦组和奈玛特瑞韦/利托那韦组的住院中位时间分别为7.0（6.0，8.0）天和9.0（8.0，10.0）天（p = 0.338），新型冠状病毒2（SARS-CoV-2）转阴时间分别为6.0（6.0，7.0）天和7.0（6.0，7.0）天（p = 0.934）。在轻度患者中，西莫特瑞韦/利托那韦组的住院时间较短[6.0（6.0，7.0）天对8.0（8.0，10.0）天，对数秩检验p = 0.004，风险比（HR）= 1.838（95%置信区间1.199 - 2.815）]。西莫特瑞韦/利托那韦组有5例（8.6%）出现药物不良反应（ADR），奈玛特瑞韦/利托那韦组有6例（10.5%）出现ADR。
结论
本研究首次比较了西莫特瑞韦/利托那韦和奈玛特瑞韦/利托那韦在中重度COVID-19患者中的疗效。接受西莫特瑞韦/利托那韦治疗的患者住院时间较短。两组的疾病进展、病毒清除时间和症状缓解时间相似。
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