一项关于使用中药制剂改善住院新冠肺炎患者预后的回顾性队列研究

A Retrospective Cohort Study on the Improvement of Prognosis of Hospitalized COVID-19 Patients Using Traditional Chinese Medicine Preparations

    摘要
  • 摘要:
    目的 在新型冠状病毒肺炎疫情期间及疫情持续阶段, 中药具有显著的生物活性和治疗效果。本研究旨在评估四种中药制剂对患者28 d死亡风险及实验室指标变化的疗效。
    方法 本研究纳入了2022年12月15日至2023年1月15日期间因COVID-19入住江苏省中医院的患者, 其中在入院后48 h内死亡或无法追踪预后结果的患者被排除在外。主要结局指标为入院后28 d的生存状态(死亡或存活)。次要结局指标包括实验室指标, 具体为淋巴细胞绝对计数、乳酸脱氢酶、肌酐及血尿素氮。主要分析采用二元logistic回归模型评估中药制剂对主要及次要结局的影响, 同时通过亚组分析和多重敏感性分析评估主要分析结果的异质性与稳健性。
    结果 1 816名符合条件的患者被纳入分析数据集, 其中573名患者接受标准治疗(对照组), 1 243名患者接受中医药制剂治疗(院内制剂组)。院内制剂组的28 d死亡率低于对照组(4.75% vs. 14.83%), 差异具有统计学意义(χ2=54.666, P < 0.001)。多元logistic回归分析显示, 与对照组相比, 院内制剂组的28 d死亡风险降低0.535倍(OR=0.46, 95%CI: 0.305~0.708, P < 0.001)。亚组分析表明, 服用中药制剂可降低28 d死亡风险。敏感性分析证实, 主要结局指标的主分析结果具有稳健性。次要结局方面, 院内制剂组患者出院时淋巴细胞绝对计数异常的风险降低0.284倍(OR=0.703, 95%CI: 0.515~0.961, P=0.027)。
    结论 与标准治疗相比, 服用抗感合剂、肺宁合剂、芪参固表颗粒及羌活祛湿清瘟合剂这四种院内制剂可降低住院COVID-19患者的28 d死亡风险。中医药疗法在COVID-19的治疗中可取得良好的治疗效果。

     

    Abstract:
    OBJECTIVE The emergence of evolving variants of Coronavirus disease 2019 (COVID-19) has fostered the need for change of newer and adaptive treatments for these infections. During the COVID-19 pandemic and persists, traditional Chinese medicine (TCM) herbs exhibit significant bioactivity and therapeutic effect. This study is aimed to evaluate the efficacy of four TCM preparations on 28-day mortality risk of patients and changes of the laboratory indicators.
    METHODS The retrospective cohort study included patients with COVID-19 who were admitted to the Jiangsu Province Hospital of Chinese Medicine from December 15, 2022 to January 15, 2023, and those died within 48 hours of admission or cannot be tracked for outcomes were excluded. The primary outcome was survival status in 28 days (death or survival) starting from the day of admission. The second outcomes were laboratory indicators, including absolute lymphocyte count, lactate dehydrogenase, creatinine, and blood urea nitrogen. Binary logistic regressions were used to estimate the effect of TCM preparations on the primary and secondary outcomes in main analysis. Meanwhile, heterogeneity and robustness of results from main analysis were assessed by subgroup analyses and multiple sensitivity analyses.
    RESULTS 1 816 eligible patients were included in analysis dataset, including 573 patients received standard care (control group) and 1 243 patients received TCM preparations (hospital preparation group). The 28-day mortality rate of hospital preparation group was lower than that of control group (4.75% vs. 14.83%), and the difference was statistically significant (χ2=54.666, P < 0.001). The risk of 28-day mortality was 0.535 times lower in the hospital preparation group as compared with the control group (OR=0.46, 95%CI: 0.305-0.708, P < 0.001) showed by multivariable binary logistic regressions. Subgroup analyses showed that taking TCM preparations reduced the 28-day mortality risk. Sensitivity analyses demonstrated that the results of the main analysis for primary outcomes were robust. For secondary outcomes, the risk of abnormal absolute lymphocyte counts at discharge in the hospital preparation group decreased by 0.284 times (OR=0.703, 95%CI: 0.515-0.961, P=0.027).
    CONCLUSION Compared with standard of care, taking four hospital preparations including Kanggan Heji, Feining Heji, Qishen Gubiao Keli, and Qianghuo Qushi Qingwen Heji decreased risk of 28-day mortality among hospitalized COVID-19 patients. TCM therapy achieves adequate therapeutic effects in COVID-19.

     

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