中国药物警戒 ›› 2025, Vol. 22 ›› Issue (2): 155-161.
DOI: 10.19803/j.1672-8629.20240011

• 中药/中成药减毒增效相关循证评价研究专栏 • 上一篇    下一篇

中成药治疗新型冠状病毒感染安全性和有效性的伞状评价

李波, 徐柳, 谢雨晴, 王艺颖, 董帅, 廉洁, 李国栋, 曹卉娟*   

  1. 北京中医药大学循证医学中心,北京 100029
  • 收稿日期:2024-01-04 出版日期:2025-02-17 发布日期:2025-02-17
  • 通讯作者: *曹卉娟,女,博士,教授·博导,循证中医药疗效评价。E-mail:huijuancao327@hotmail.com
  • 作者简介:李波,男,在读硕士,中西医结合循证医学。
  • 基金资助:
    国家重点研发计划(2023YFE0198400); 新疆自治区重点研发计划[2021B03003-2(C)]

Safety and Efficacy of Chinese Herbal Patent Medicines for COVID-19: an Umbrella Review

LI Bo, XU Liu, XIE Yuqing, WANG Yiying, DONG Shuai, LIAN Jie, LI Guodong, CAO Huijuan*   

  1. Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2024-01-04 Online:2025-02-17 Published:2025-02-17

摘要: 目的 总结评价中成药治疗新型冠状病毒肺炎(COVID-19)疗效及安全性的系统综述证据,对中成药作为干预手段治疗COVID-19的安全性和有效性进行评估,对相关证据的质量做出评价。方法 检索PubMed、Cochrane Library、Embase、Sinomed、中国知网、万方数据、维普网从建库至2023年6月15日的中成药治疗COVID-19的系统综述,并提取相关信息。使用Revman 5.3软件进行二次Meta分析,利用AMSTAR-II评估文章的方法学质量,采用GRADE分级方法对证据确定性进行评估,并将评估结果以气泡图的形式呈现。结果 最终纳入了13项系统评价,共计17 053例病例。Meta分析结果显示,与单独采用西药标准治疗相比,中成药联合西药标准治疗在多个结局指标体现出优势,主要包括全因死亡率[(RR=0.26,95%CI=(0.09~0.81),P=0.02,I 2= 0 %]、核酸转阴率[RR=1.12,95%CI=(1.01~1.23),P=0.03,I 2= 44%]、转重症率[RR=0.49,95%CI=(0.37~0.64),P<0.000 01,I 2= 0 %]、肺部影像学改善、临床症状消失率(包括发热、咳嗽、疲劳、气短)以及临床症状消失时间(特别是疲劳)。在不良反应发生率、缓解喉痛、腹泻方面2组没有明显区别。气泡图结果显示,极低等级的证据表明,热炎宁合剂、金花清感颗粒、连花清瘟颗粒、参黄颗粒、疏风解毒胶囊、连花清瘟胶囊、血必净注射液、连花清咳颗粒分别在提高核酸转阴率、降低转重症率、提高肺部影像学恢复率方面,可能有微弱到中等程度的效果。结论 综合分析表明,与常规西医治疗相比,中成药联合常规治疗在治疗COVID-19表现出更好的疗效。由于目前所收集到的证据质量相对较低,需要开展更多高质量的临床试验以进一步验证。

关键词: 中成药, 新型冠状病毒, 新型冠状病毒肺炎, 新型冠状病毒感染, 伞状评价, GRADE评价, Meta分析, 证据映射, 安全性, 有效性

Abstract: Objective To summarize the current systematic review evidence for evaluating the efficacy and safety of Chinese herbal patent medicines (CHPMs) for the treatment of novel coronavirus pneumonia, assess the safety and efficacy of CHPMs as an intervention for the treatment of COVID-19, and to evaluate the quality of related evidence. Methods PubMed, Cochrane, Embase, Sinomed, China National Knowledge Infrastructure (CNKI), Wanfang database, and VIP were searched for systematic reviews of CHPMs in the treatment of COVID-19 that were published from the inception to June 15, 2023. Revman 5.3 software was used to conduct a secondary meta-analysis, AMSTAR-II was adopted to assess the methodological quality of articles, and the GRADE system was employed to evaluate the level of evidence before the results of evaluation were presented in the form of a bubble chart. Results Finally, 13 systematic reviews involving a total of 17 053 cases were included. Meta-analysis results showed that CHPMs combined with STs with Western medicine enjoyed advantages over STs with Western medicine alone in multiple outcome indicators, including the all-cause mortality (RR=0.26, 95%CI=0.09~0.81,P=0.02, I 2= 0%), viral clearance rate (RR=1.12, 95%CI=1.01~1.23, P=0.03, I 2= 44 %), rate of conversion to severe cases (RR=0.49, 95%CI=0.37~0.64, P<0.000 01, I 2= 0%), improvement in pulmonary imaging, clinical symptom recovery rate (including fever, cough, fatigue and shortness of breath) and recovery time of clinical symptoms (especially fatigue). There was no significant difference between the two groups in terms of adverse events or therapeutic efficacy against sore throat and diarrhea. Bubble chart results showed that there was extremely low-level evidence suggesting the effectiveness of Reyaning compounds. Jinhuaqinggan granules, Lianhuaqingwen granules, Shenhuag granules, Shufeng Jiedu capsules, Lianhuaqingwen capsules, Xuebijing injection, and Lianhuaqingke granules could make a big difference to nucleic acid conversion to negative, the incidence of severe cases, and to the recovery rate of pulmonary imaging, respectively. Conclusion CHPMs combined with conventional STs show better efficacy in treating novel coronavirus pneumonia compared to ST alone. However, the overall quality of evidence in these studies is generally low, and high-quality clinical trials are needed to validate these findings.

Key words: Chinese Herbal Patent Medicines, SARS-CoV-2, COVID-19, Umbrella Review, GRADE Assessment, Meta-Analysis, Evidence Mapping, Safety, Efficacy

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