目的 观察补肺活血胶囊治疗新型冠状病毒（简称“新冠”）感染恢复期气虚兼血瘀证患者的临床疗效。方法 将160例新冠感染恢复期气虚兼血瘀证患者随机分为试验组和对照组，每组各80例。试验组患者口服补肺活血胶囊，3次/d，4粒/次；对照组患者口服补肺活血胶囊安慰剂，3次/d，4粒/次；两组疗程均为1个月。观察并比较两组治疗前后疲劳评定量表（fatigue assessment instrument，FAI）评分、中医证候积分、症状积分、T细胞亚群、D-二聚体、血常规、炎症指标、临床疗效及安全性指标。结果 治疗后，试验组FAI评分、中医证候积分、症状积分较治疗前和对照组明显降低（P＜0.05）；试验组除舌质暗紫症状积分，轻、中、重度患者其他症状积分较治疗前和对照组明显降低（P＜0.05）。治疗后，试验组T细胞CD4⁺、CD8⁺、CD4⁺/CD8⁺较治疗前和对照组明显升高（P＜0.05）；试验组中、重度组患者CD4⁺、CD8⁺、CD4⁺/CD8⁺均较治疗前和对照组明显升高（P＜0.05）。治疗后，试验组D-二聚体水平较治疗前和对照组明显降低（P＜0.05）；试验组中、重度患者D-二聚体较对照组明显降低（P＜0.05）。治疗后，试验组白细胞计数（white blood cell count，WBC）较治疗前和对照组明显降低（P＜0.05）；试验组中、重度患者WBC较治疗前和对照组明显降低（P＜0.05）。治疗后，试验组C-反应蛋白（C-reactive protein，CRP）较治疗前明显降低（P＜0.05）；试验组治疗后中、重度组的CRP较治疗前和对照组明显降低（P＜0.05），血沉在各组中较对照组差异均不具有统计学意义（P＞0.05）。结论 补肺活血胶囊可有效减轻新冠感染恢复期气虚兼血瘀证患者的疲劳症状、改善临床症状，促进肺部炎症、血常规指标改善，提高患者生活质量。

Objective To evaluate the clinical efficacy of Bufei Huoxue Capsules (补肺活血胶囊, BHC) in patients with qi deficiency and blood stasis syndrome during the recovery period of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Methods A total of 160 patients with qi deficiency and blood stasis syndrome during the recovery period of SARS-CoV-2 infection were randomly divided into an experimental group and a control group, with 80 cases in each group. The experimental group received oral administration of BHC, four capsules three times a day, for a duration of one month. The control group received a placebo of BHC, four capsules three times a day, for a duration of one month. The fatigue assessment inventory (FAI) score, TCM syndrome score, symptom score, T lymphocyte subsets, D-dimer, routine blood count, inflammation markers, clinical efficacy, and safety indicators were observed and compared before and after treatment in both groups. Results After treatment, FAI score, TCM syndrome score and symptom score of experimental group were significantly lower than those before treatment and control group (P < 0.05). In addition to tongue dark purple symptom scores, the scores of other symptoms in mild, moderate and severe patients in experimental group were significantly lower than before treatment and control group (P < 0.05). After treatment, T cell CD4⁺, CD8⁺, CD4⁺/CD8⁺ in experimental group were significantly higher than before treatment and control group (P < 0.05). CD4⁺, CD8⁺ and CD4⁺/CD8⁺ in moderate and severe groups were significantly higher than those before treatment and control group (P < 0.05). After treatment, the level of D-dimer in experimental group was significantly decreased compared with before treatment and control group (P < 0.05). The D-dimer of moderate and severe patients in experimental group was significantly lower than that in control group (P < 0.05). After treatment, white blood cell count (WBC) in experimental group was significantly decreased compared with before treatment and control group (P < 0.05). The WBC of moderate and severe patients in experimental group was significantly lower than that before treatment and control group (P < 0.05). After treatment, C-reactive protein (CRP) in the experimental group was significantly decreased compared with that before treatment (P < 0.05). After treatment, CRP in moderate and severe groups of experimental group was significantly decreased compared with that before treatment and control group (P < 0.05), and there was no statistical significance in erythrocyte sedimentation rate of all groups compared with control group (P > 0.05). Conclusion Bufei Huoxue Capsules can effectively relieve fatigue symptoms, improve clinical manifestations, promote the improvement of pulmonary inflammation and hematological indicators, and enhance the quality of life in patients with qi deficiency and blood stasis syndrome during the recovery period of SARS-CoV-2 infection.

国家重点研发项目（2016YFC1304102）；河南省中医药传承与创新人才工程（仲景工程）中医药学科领军人才项目