中国药物警戒 ›› 2025, Vol. 22 ›› Issue (8): 914-919.
DOI: 10.19803/j.1672-8629.20240919

• 安全与合理用药 • 上一篇    下一篇

清气化痰丸治疗慢性阻塞性肺疾病急性加重的系统评价

史琪1,2, 王建新2, 王桂杰2,3, 陆悦阳1,2, 主佳旭2,3, 高蕊2*   

  1. 1北京中医药大学研究生院,北京 100029;
    2中国中医科学院西苑医院国家药物临床试验机构,北京 100091;
    3中国中医科学院研究生院,北京 100700
  • 收稿日期:2024-11-26 出版日期:2025-08-15 发布日期:2025-08-13
  • 通讯作者: *高蕊,女,博士,主任医师,中药临床药理学研究。E-mail: ruigao@126.com
  • 作者简介:史琪,女,在读硕士,中药临床药理学研究。
  • 基金资助:
    国家重点研发计划（2021YFF0901404）; 国家中医药管理局中医药科学技术研究专项（GZY-KJS-2021-019）; 中国中医科学院科技创新工程重大攻关项目（CI2021A04701）; 中国中医科学院科技创新工程-中药临床药理学培育项目（CI2021A04708）

Adjuvant Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Qingqi Huatan Pills: a Systematic Review

SHI Qi1,2, WANG Jianxin2, WANG Guijie2,3, LU Yueyang1,2, ZHU Jiaxu2,3, GAO Rui2*   

  1. 1Graduate School of Beijing University of Chinese Medicine, Beijing 100029, China;
    2National Drug Clinical Trial Institution, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;
    3Graduate School of China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2024-11-26 Online:2025-08-15 Published:2025-08-13

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摘要： 目的 系统评价清气化痰丸治疗慢性阻塞性肺疾病急性加重（AECOPD）的有效性和安全性。方法 检索SinoMed、PubMed、Cochrane Library、Web of Science、中国知网、万方数据和维普网数据库,检索时间为数据库建库至2024年9月26日,筛选纳入清气化痰丸治疗AECOPD的随机对照试验（RCTs）,提取文献资料后依据Cochrane协作偏倚风险评估工具2.0版（ROB 2.0）进行文献质量评估。随后利用Revman5.4.1及Stata18.0对数据进行统计分析。结果 共纳入8项研究,632例受试者,ROB 2.0评估结果为4项研究是低风险（Low Risk）、4项研究有些顾虑（Some Concerns）。Meta分析结果显示：试验组的临床疗效[RR=1.28,95%CI(1.18,1.39),P<0.000 01]、FEV1%[MD=7.29,95%CI(5.68,8.90),P<0.000 01]、FEV1/FVC[MD=6.10,95%CI(4.81,7.38),P<0.000 01]、PaO2[MD=7.10,95%CI(6.04,8.16),P<0.000 01]高于对照组,差异具有统计学意义;试验组PaCO2[MD=-5.54,95%CI(-6.39,-4.69),P<0.000 01]、中医证候积分[MD=-5.79,95%CI(-6.39,-5.18),P<0.000 01]低于对照组,差异具有统计学意义。安全性方面,有5项研究报告不良事件,试验组[RR=0.61,95%CI(0.26,1.44),P=0.26]相比于对照组差异无统计学意义。结论 清气化痰丸辅助治疗AECOPD可改善喘息症状、肺功能及动脉血气指标,安全性良好,但考虑到纳入研究在数量、质量方面存在一定局限性,该结论仍需更多高质量RCTs进一步验证。

关键词: 清气化痰丸, Meta分析, 慢性阻塞性肺疾病急性加重期, 随机对照试验

Abstract: Objective To evaluate the efficacy and safety of Qingqi Huatan pills in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods Such databases as SinoMed, PubMed, Cochrane Library, Web of Science, CNKI, Wanfang Data and VIP were searched for randomized controlled trials (RCTs) on Qingqi Huatan pills used in the treatment of AECOPD that were published from the inception to September 26, 2024. The quality of the literature included was evaluated using the Cochrane Collaboration’s Risk of Bias 2.0(ROB 2.0) before Revman5.4.1 and Stata18.0 software were used for statistical analysis of the data. Results Eight trials involving 632 patients were included. ROB 2.0 results showed that four of these studies reported low risk, and the rest expressed concerns.The results of Meta-analysis showed that the clinical efficacy in the experimental group [RR=1.28,95%CI(1.18,1.39), P<0.000 01], FEV1%[MD=7.29, 95%CI(5.68, 8.90), P<0.000 01], FEV1/FVC[MD=6.10, 95%CI(4.81,7.38), P<0.000 01], PaO2[MD=7.29, 95%CI(5.68, 8.90), P<0.000 01] was significantly higher than in the control group. The TCM syndrome scores of the experimental group [MD=-5.79, 95%CI(-6.39, -5.18), P<0.000 01], PaCO2[MD=-5.54, 95%CI(-6.39, -4.69), P<0.000 01] were lower than those of the control group, and the difference was statistically significant. In terms of safety, five studies reported adverse events, but there was no significant difference between the experimental group and the control group [RR=0.61, 95%CI(0.26, 1.44), P=0.26]. Conclusion Qingqi Huatan pills as an adjuvant therapy for AECOPD patients can improve the wheezing symptom, pulmonary function and arterial blood gas parameters. They are safe clinically. However, this conclusion needs to be verified by more high-quality randomized controlled trials given the limitations related to the quantity and quality of the included studies.

Key words: Qingqi Huatan Pills, Meta-Analysis, Acute Exacerbation of Chronic Obstructive Pulmonary Disease(AECOPD), Randomized Controlled Trials

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