Yan Miao, Xie Min, Zhu Sainan, Li Haixia, Li Shuangling
Department of Critical Care Medicine, Peking University First Hospital, Beijing 100034, China.
Department of Biostatistics, Peking University First Hospital, Beijing 100034, China.
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2023 Nov;35(11):1150-1156. doi: 10.3760/cma.j.cn121430-20230718-00523.
To describe negative conversion and rebound of patients with severe and critical acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection after treatment with Nirmatrelvir/Ritonavir, and to analyze related factors associating with failure of SARS-CoV-2 negative conversion and relapse and prognosis.
A single center retrospective cohort study was conducted. Patients aged ≥ 16 years old who were diagnosed with severe or critical SARS-CoV-2 infection and took Nirmatrelvir/Ritonavir for 5 days in Peking University First Hospital from December 7, 2022 to January 27, 2023, were included. General characteristics and clinical data were collected from electronic medical record system. The Kaplan-Meier curve of SARS-CoV-2 negative conversion was drawn. Factors with P < 0.10 were incorporated into multivariate Logistic regression model to analyze the relationship between the factors and persistent nucleic acid positive and rebound.
A total of 31 severe and 37 critical SARS-CoV-2 infection patients were included. The median duration from initiation of Nirmatrelvir/Ritonavir to negative conversion of SARS-CoV-2 for both was 6.0 days, and the negative conversion rate on day 15 was 93.5% and 86.5%, respectively. SARS-CoV-2 rebound was observed in 7 patients (11.3%), among whom were 1 severe patient and 6 critical patients. The above 7 patients with SARS-CoV-2 rebound and 6 patients with failure of SARS-CoV-2 negative conversion were compared with 55 patients with persistent negative conversion. Factors with P < 0.10, including the lowest lymphocyte count (LYM), the highest D-dimer, the highest procalcitonin (PCT), the lowest Ct value, cardiovascular diseases other than hypertension and coronary heart disease, were incorporated into multivariate Logistic regression analysis. The decreased LYM [odds ratio (OR) = 0.146, 95% confidence interval (95%CI) was 0.031-0.689, P = 0.015] and the increased PCT (OR = 2.008, 95%CI was 1.042-3.868, P = 0.037) were revealed to be independent risk factors of the failure of SARS-CoV-2 negative conversion or rebound. The proportion of mechanical ventilation and invasive ventilation were significantly higher in patients with persistent SARS-CoV-2 infection or rebound than those in patients with SARS-CoV-2 negative conversion (84.6% vs. 38.2%, 69.2% vs. 25.5%, both P < 0.01), but no significant difference in mechanical ventilation and invasive ventilation duration was observed. Compared with the patients with SARS-CoV-2 negative conversion, more patients with persistent SARS-CoV-2 infection or rebound were admitted to intensive care unit (ICU, 76.9% vs. 50.9%), and length of ICU stay in patients with persistent SARS-CoV-2 infection or rebound tended to be longer [days: 13.0 (10.3, 24.3) vs. 11.0 (5.3, 23.0), P > 0.05].
The decreased LYM and increased PCT are independent risk factors for the failure of SARS-CoV-2 negative conversion or rebound in patients with severe and critical SARS-CoV-2 infection. Attention should be paid to these patients for their poor prognosis.
描述新型冠状病毒2(SARS-CoV-2)感染重症和危重症患者经奈玛特韦/利托那韦治疗后的病毒转阴及复阳情况,并分析与SARS-CoV-2转阴失败、复发及预后相关的因素。
进行一项单中心回顾性队列研究。纳入2022年12月7日至2023年1月27日在北京大学第一医院确诊为SARS-CoV-2感染重症或危重症且服用奈玛特韦/利托那韦5天的≥16岁患者。从电子病历系统收集一般特征和临床资料。绘制SARS-CoV-2转阴的Kaplan-Meier曲线。将P<0.10的因素纳入多因素Logistic回归模型,分析这些因素与核酸持续阳性及复阳的关系。
共纳入31例SARS-CoV-2感染重症患者和37例危重症患者。两者从开始使用奈玛特韦/利托那韦至SARS-CoV-2转阴的中位时间均为6.0天,第15天的转阴率分别为93.5%和86.5%。观察到7例患者(11.3%)出现SARS-CoV-2复阳,其中重症患者1例,危重症患者6例。将上述7例SARS-CoV-2复阳患者和6例SARS-CoV-2转阴失败患者与55例持续转阴患者进行比较。将P<0.10的因素,包括最低淋巴细胞计数(LYM)、最高D-二聚体、最高降钙素原(PCT)、最低Ct值、除高血压和冠心病外的心血管疾病,纳入多因素Logistic回归分析。结果显示,LYM降低[比值比(OR)=0.146,95%置信区间(95%CI)为0.031-0.689,P=0.015]和PCT升高(OR=2.008,95%CI为1.042-3.868,P=0.037)是SARS-CoV-2转阴失败或复阳的独立危险因素。SARS-CoV-2持续感染或复阳患者的机械通气和有创通气比例显著高于SARS-CoV-2转阴患者(84.6%对38.2%,69.2%对25.5%,P均<0.01),但机械通气和有创通气持续时间无显著差异。与SARS-CoV-2转阴患者相比,SARS-CoV-2持续感染或复阳患者入住重症监护病房(ICU)的比例更高(76.9%对50.9%),且SARS-CoV-2持续感染或复阳患者的ICU住院时间倾向于更长[天数:13.0(10.3,24.3)对11.0(5.3,23.0),P>0.05]。
LYM降低和PCT升高是SARS-CoV-2感染重症和危重症患者SARS-CoV-2转阴失败或复阳的独立危险因素。应关注这些患者预后较差的情况。