段元元 吕健 王志飞 于丹丹 孙梦华

摘要 目的：系統评价喘可治注射液雾化吸入治疗支气管哮喘的疗效和安全性。方法：计算机检索Embase、Cochrane Library、CBM、CNKI、Medline、维普中文科技期刊全文数据库（VIP）和万方数据资源系统，筛选出喘可治注射液治疗支气管哮喘的随机对照试验，检索时限均为从建库至2019年4月。按照纳入和排除标准，由2名研究者独立进行文献筛选、资料提取，采用Cochrane系统评价手册进行质量评价，采用RveMan 5.3软件进行数据分析。结果：共纳入9个随机对照试验，包括842例支气管哮喘患者，其中观察组421例，对照组421例。Meta分析结果显示：1）有效性方面，喘可治注射液雾化吸入联合常规治疗干预支气管哮喘疗效在总有效率（RR=1.22，95% CI[1.15，1.29]，P<0.000 01）、肺功能FEV1实际值占预测值百分率改善（MD=6.03，95%CI[4.23，7.84]，P<0.000 01）、FEV1实际基础测试值（MD=0.44，95%CI[0.32，0.56]，P<0.000 01）、肺功能PEF实际值占预测值百分率（MD=6.03，95%CI[4.23，7.84]，P<0.000 01）、FEV1实际基础测试值（MD=0.58，95%CI[0.36，0.80]，P<0.000 01）方面优于单纯常规治疗;2）安全性方面，喘可治注射液雾化吸入联合常规治疗干预支气管哮喘的不良反应发生率与常规治疗比较差异无统计学意义（RR=0.59，95% CI[0.26，1.35]，P=0.21）。结论：基于现有临床证据，喘可治注射液雾化吸入联合常规治疗干预支气管哮喘疗效优于单纯的常规治疗。但由于纳入研究的方法学质量普遍较低，因此后续的临床研究还需要严格的方法学设计和质量控制，以期提供更高质量的证据。

关键词 喘可治注射液;支气管哮喘;系统评价;循证医学;Meta分析

Efficacy and Safety of Aerosol Inhalation of Chuankezhi Injection for

Bronchial Asthma：a Systematic Review and Meta-analysis

DUAN Yuanyuan1，2，LYU Jian1，WANG Zhifei1，YU Dandan1，SUN Menghua1

（1 Institute of Basic Medical Sciences，China Academy of Traditional Chinese Medicine，Beijing 100700，China;

2 Guang Anmen Hospital，China Academy of Traditional Chinese Medicine，Beijing 100091，China）

Abstract Objective：To systematically assess the effectiveness and safety of aerosol inhalation of Chuankezhi Injection for the treatment of bronchial asthma.Methods：Databases including Embase，Cochrane Library，SinoMed，CNKI and Wanfang Data were electronically searched in April 2019 for randomized controlled trials（ RCTs） on Chuankezhi Injection for the treatment of bronchial asthma.According to the inclusion and exclusion criteria，2 authors independently conducted literature screening and data extraction，and assessed the risk of bias of included studies.Then，meta-analysis was performed by RevMan 5.3 software.Results：A total of 9 RCTs were included with a total of 842 patients.Among them，there were 421 cases in the test group and 421 cases in the control group.Meta-analysis results showed：1） In terms of effectiveness，the total effective rate of Chuankezhi Injection aerosol inhalation combined with conventional treatment for bronchial asthma intervention （RR=1.22，95% CI [1.15，1.29]，P<0.000 01）.The actual value of lung function FEV1 accounted for the percentage improvement of the predicted value （MD=6.03，95% CI [4.23，7.84]，P<0.000 01）.The actual basic test value of FEV1 （MD = 0.44，95% CI [0.32，0.56]，P<0.000 01）.The actual PEF value of lung function as a percentage of the predicted value （MD = 6.03，95% CI [4.23，7.84]，P<0.000 01），the actual basic test value of FEV1 （MD = 0.58，95% CI [0.36，0.80]，P<0.000 01） is better than conventional treatment alone; 2） in terms of safety，the incidence of adverse reactions of Chuankezhi Injection combined with conventional treatment for bronchial asthma is not statistically significant compared with conventional treatment （RR=0.59，95% CI [0.26，1.35]，P=0.21）.Conclusion：Based on the existing clinical evidence，the effect of aerosol inhalation of Chuankezhi Injection combined with conventional treatment for bronchial asthma is better than conventional treatment alone.However，because the methodological quality of the included studies is generally low，follow-up clinical studies also require strict methodological design and quality control in order to provide higher-quality evidence.

Keywords Chuankezhi Injection; Bronchial asthma; Systematic review; Evidence-based medicine; Meta-analysis

中图分类号：R256.12文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.02.015

支气管哮喘在世界范围发病率较高，据有关数据调查显示，目前全球至少有3亿支气管哮喘患者，在中国这一数据达到3 000万[1]，并呈逐年升高趋势。支气管哮喘的主要临床表现为反复发作的喘息气短、胸闷、咳嗽等症状[2]，若不能给予快速且有效治疗，极易出现心肺功能失常甚至导致全身性并发感染，严重降低生命质量并威胁生命健康。目前临床常采用常规抗感染、吸氧、止咳平喘等疗法，治疗周期长、药物费用高，复发率高。中医将支气管哮喘归为哮病，病因为肺失宣肃，肺气上逆，以及肺肾两虚，肾失纳摄，治则扶正祛邪[3]。喘可治注射液由中药淫羊藿、巴戟天组成，具有温阳助肾、止咳平喘的作用，主治哮证属肾虚挟痰证。……