中国药物警戒 ›› 2023, Vol. 20 ›› Issue (5): 544-552.
DOI: 10.19803/j.1672-8629.20220616

• 安全与合理用药 • 上一篇    下一篇

痰热清注射液雾化吸入治疗慢性阻塞性肺疾病Meta分析

王国华1, 黎晓蕾2△, 刘希萍2, 董毅智2, 臧琛1, 徐鸿1, 田纪祥1, 赵静2,*   

  1. 1中国中医科学院中药研究所,北京 100700;
    2中国中医科学院中医临床基础医学研究所,北京 100700
  • 收稿日期:2022-10-21 出版日期:2023-05-15 发布日期:2023-05-16
  • 通讯作者: *赵静,女,博士,研究员·博导,中西医结合防治传染病及中医药国际应用与推广。E-mail:hhzhaojing@126.com
  • 作者简介:王国华,男,博士,副研究员,中药创新药物研究及中药上市后评价。△为共同第一作者。
  • 基金资助:
    国家科技重大专项重大新药创制(2017ZX09-201002-006); 中国中医科学院科技创新工程项目(CI-2021A04304); 中国中医科学院科技创新工程项目(CI2021-A00704-4)

Aerosol inhalation of Tanreqing injection in the treatment of chronic obstructive pulmonary disease: a Meta-analysis

WANG Guohua1, LI Xiaolei2△, LIU Xiping2, DONG Yizhi2, ZANG Chen1, XU Hong1, TIAN Jixiang1, ZHAO Jing2,*   

  1. 1Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2022-10-21 Online:2023-05-15 Published:2023-05-16

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摘要： 目的 评价痰热清注射液（TRQ）雾化吸入治疗慢性阻塞性肺疾病（COPD）的有效性及安全性。方法 检索中国知网、万方数据、维普网、SinoMed、PubMed、Cochrane Library和Web of science数据库,纳入TRQ雾化吸入治疗COPD的随机对照试验（RCT）并对其进行资料提取。检索时间为数据库建库至2022年5月22日,采用Cochrane协作网“偏倚风险”评价工具对纳入研究进行方法学质量评价,应用Revman 5.4.1软件进行数据统计分析,采用哥本哈根临床试验中心开发的TSA软件进行试验序贯分析。结果 TRQ雾化吸入联合常规治疗能够提高COPD的治疗总有效率;在对动脉血氧分压（PaO2）的改善方面优于单用常规治疗及布地奈德或特布他林雾化吸入联合常规治疗;TRQ雾化吸入联合常规治疗对炎症因子肿瘤坏死因子α（TNF-α）的降低效果优于单用常规治疗。仅少数研究报告了TRQ雾化吸入治疗COPD的不良事件。结论 TRQ雾化吸入对于COPD具有一定疗效,但现有安全性证据较少,尚不足以对TRQ雾化吸入治疗COPD的安全性得出结论。后续研究应遵循国际公认的SPIRIT声明制定及注册,进行规范且样本充足的临床试验,并结合指南选取更加全面的指标,为临床提供更高质量的循证医学证据。

关键词: 痰热清注射液, 雾化吸入, 慢性阻塞性肺疾病, Meta分析

Abstract: Objective To evaluate the efficacy and safety of atomization inhalation of Tanreqing injection (TRQ) in the treatment of chronic obstructive pulmonary disease (COPD). Methods The databases of CNKI, Wanfang data, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were searched for literature on randomized controlled trials (RCT) of TRQ atomization inhalation in the treatment of COPD that was published between inception and May 22, 2022. The Cochrane Collaboration’s risk of bias evaluation tool was used to evaluate the methodological quality of the included studies. Revman 5.4.1 software was used for statistical analysis of the data, while TSA software developed by Copenhagen Clinical Trial Center was used for trial sequential analysis. Results Aerosol inhalation of TRQ combined with conventional treatments could not only improve the total effective rate of COPD treatment, but more significantly improve PaO2, than conventional treatments alone and budesonide or terbutaline atomized inhalation combined with conventional treatments. Aerosol inhalation of TRQ combined with conventional treatments could reduce inflammatory factor TNF-α more effectively than conventional treatments alone. Only a small number of studies have reported adverse events in the treatment of COPD with aerosol inhalation of TRQ. Conclusion Aerosol inhalation of TRQ is effective for the treatment of COPD to some extent, but the evidence available is not adequate enough to draw conclusions on the safety of this approach. Follow-up studies should be designed and registered in accordance with the internationally recognized SPIRIT Declaration, and standardized clinical trials with sufficient samples should be conducted. More comprehensive indicators should be selected in combination with the guidelines to provide high-quality evidence-based medical evidence for clinical practice.

Key words: Tanreqing injection, aerosol inhalation, chronic obstructive pulmonary disease, Meta analysis

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