重组全人源抗新型冠状病毒单克隆抗体注射液(F61注射液)治疗新型冠状病毒感染合并肾损伤患者的有效性和安全性:一项随机对照的探索性临床研究

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中文摘要：目的探究重组全人源抗新型冠状病毒单克隆抗体注射液(F61注射液)治疗新型冠状病毒感染(COVID-19)合并肾损伤患者的有效性和安全性。方法选取2023年1-2月在解放军总医院就诊的COVID-19合并肾损伤患者。将受试者随机分组，对照组采用常规抗新型冠状病毒(抗新冠)治疗，试验组采取常规抗新冠治疗联合F61注射液。给药后随访15 d，监测患者临床症状、实验室检查、心电图及胸部CT，分析F61注射液的有效性和安全性。结果共纳入12例受试者(试验组7例，对照组5例)，两组受试者均未出现临床进展或死亡病例。对照组新型冠状病毒核酸平均转阴时间为3。2 d，试验组为1。57 d(P=0。046);试验组用药后第3天及第5天的COVID-19相关目标症状评分均低于对照组(均P＜0。05)。根据临床分型和世界卫生组织(WHO)10分等级疾病进展量表，两组受试者病情均有好转，但差异无统计学意义(P＞0。05)。安全性方面，试验组未出现输液相关不良事件，两组受试者表现出不同程度血糖升高、尿葡萄糖升高、尿胆原升高、尿管型阳性及心律失常，但差异均无统计学意义(均P＞0。05)。结论 F61注射液在治疗COVID-19合并肾损伤患者时初步展现出安全性和临床获益，国产药物的临床可及性好，可为临床实践提供更多选择。

外文标题：Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study

外文摘要：Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P＜0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P＞0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P＞0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.

外文关键词：

F61 injectionsevere acute respiratory syndrome coronavirus 2renal damageefficacysafetyanti-severe acute respiratory syndrome coronavirus 2 monoclonal antibody injection

作者：

陈丁华、李超凡、牛越、张利、王涌、冯哲、朱晗玉、周建辉、董哲毅、段姝伟、王宏、黄梦杰、王远大、丛硕源、潘赛、周京、孙雪峰、蔡广研、李平、陈香美

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作者单位：

中国人民解放军总医院第一医学中心肾脏病医学部肾脏疾病全国重点实验室国家慢性肾病临床医学研究中心,北京 100853

关键词：

F61注射液新型冠状病毒肾损害有效性安全性抗新型冠状病毒单克隆抗体注射液

基金：

国家重点研发计划基金项目

项目编号：

2022YFC3602005

出版年：

2024

DOI：

10.12138/j.issn.1671-9638.20245379

中国感染控制杂志

中南大学

中国感染控制杂志

CSTPCD北大核心

影响因子：2.112

ISSN：1671-9638

年,卷(期)：2024.23(3)

参考文献量14