胸腺法新用于治疗新型冠状病毒肺炎重症和危重症患者的疗效和安全性研究

Study on the Efficacy and Safety of Thymalfasin for Treatment of Critically Novel Coronavirus Pneumonia Patients

摘要: 目的：评价胸腺法新用于治疗新型冠状病毒肺炎重症和危重症患者的疗效和安全性。方法：计划纳入30名新型冠状病毒肺炎重症和危重症患者，随机分配到试验组和对照组各15例。对照组执行国家卫健委发布的最新新型冠状病毒肺炎诊疗方案(简称“诊疗方案”)，试验组在执行诊疗方案的基础上，皮下注射胸腺法新1.6 mg/次，连续7天。比较治疗过程第1、3、7、14天及治愈出院后28天两组患者的细胞免疫学指标变化情况和不良事件发生率。结果：两组患者CD3+、CD4+、CD8+计数和CD4+/CD8+水平同期比较差异无统计学意义(P > 0.05)；免疫治疗组CD3+、CD4+、CD8+计数第7、14和治愈出院后第28天与基线比较差异有统计学意义(P < 0.05)；治疗过程中两组患者CD3+、CD4+、CD8+计数及指标处于正常范围的患者例数均有所增加，免疫治疗组的增加幅度大于常规治疗组(P < 0.05)；主要疗效指标和不良事件发生率两组比较差异无统计学意义(P > 0.05)。结论：本研究提示胸腺法新可能小幅提升细胞免疫抑制状态的新型冠状病毒肺炎重症和危重症患者的CD3+、CD4+、CD8+T淋巴细胞计数，没有足够证据显示其能够改善该类患者的预后。

Abstract: Objective: To evaluate the efficacy and safety of thymalfasin in the treatment of COVID-19 patients with severe and critical diseases. Methods: Thirty patients with severe and critical COVID-19 were enrolled and randomly assigned to the experimental group and the control group with 15 patients in each group. The control group was given the latest COVID-19 Diagnosis and Treatment Scheme (referred to as “Diagnosis and Treatment Scheme”) issued by the National Health Commission, while the experimental group was given subcutaneous injection of 1.6 mg/time for 7 consecutive days on the basis of the Diagnosis and Treatment Scheme. The changes of cellular immunological indexes and the incidence of adverse events were compared between the two groups on day 1, 3, 7, 14 of the treatment process and 28 days after discharge. Results: There was no significant difference in CD3+, CD4+, CD8+ count and CD4+/CD8+ level between 2 groups (P > 0.05). There were significant differences in CD3+, CD4+, CD8+ counts between the immunotherapy group and the baseline at the 7th, 14th day and the 28th day after discharge (P < 0.05). During treatment, the number of patients with CD3+, CD4+, CD8+ counts and indexes in the normal range increased in both groups, and the increase rate in the immunotherapy group was greater than that in the conventional treatment group (P < 0.05). There was no significant difference in the main efficacy indexes and the incidence of adverse events between the two groups (P > 0.05). Conclusion: The study suggested that thymalfasin may slightly increase the CD3+, CD4+, and CD8+T lymphocyte count in critical COVID-19 patients with cellular immunosuppression, but there is not enough evidence to show that it can improve the prognosis of these patients.