Shi Qi, Si Dongxu, Bao Haipeng, Yan Yue, Kong Yanhua, Li Chunlei, He Wenfeng, Damchaaperenlei Dashzeveg, Yu Mingxia, Li Youlin
The 2nd Department of Pulmonary Disease in TCM, The Key Unit of SATCM Pneumonopathy Chronic Cough and Dyspnea, Beijing Key Laboratory of Prevention and Treatment of Allergic Diseases with TCM (No. BZ0321), Center of Respiratory Medicine, China-Japan Friendship Hospital, National Clinical Research Center for Respiratory Diseases.
Beijing University of Chinese Medicine, Beijing.
Medicine (Baltimore). 2019 Aug;98(34):e16958. doi: 10.1097/MD.0000000000016958.
Asthma is a complex disease associated with many factors such as immunologic, environmental, genetic, and other factors. Common medicines used to treat asthma include β-agonist and glucocorticoid. However, in the long-term treatment, the effect of the above-mentioned drugs is not satisfactory, so many patients choose oral Chinese medicines instead of western medicines. The introduction of Chinese medicines therapies, a rapid proliferation of the literature on management of asthma in general, call for novel ways of evidence synthesis in this area. This systematic review is to systematically summarize and evaluate a large number of evidences for Chinese herbal interventions for asthma. Evaluate the efficacy and safety of Chinese medicines in the treatment of asthma and inform a decision aid for the clinical encounter between patients and clinicians. In addition, it helps to establish a future research agenda.
Five English databases (PubMed, Web of science, EBASE, Springer Cochrane Library, and WHO International Clinical Trials Registry Platform) and 4 Chinese databases (Wanfang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, and Chinese Biomedical Literature Database) will be searched normatively according to the rule of each database from the inception to the present. The literature screening, data extraction, and quality assessment will be conducted by 2 researchers independently. Data will be synthesized by either the fixed-effects or random-effects model according to a heterogeneity test. Asthma control test symptom score will be assessed as the primary outcome. The curative effect of single symptom and sign; Withdrawal and reduction of western medicines in a course of treatment, including: time, type, and quantity; Maintenance of western medicines after the course of treatment, including: type, quantity; Asthma Quality of Life Questionnaire; laboratory efficacy indexes as the secondary outcome. General physical examination; routine examination of blood, urine, and stool; electrocardiogram; liver and kidney function examination; possible adverse reactions and related detection indicators as the security indexes. Meta-analysis will be performed using RevMan5.3.5 software provided by the Cochrane Collaboration.
This study will provide high-quality synthesis based on current evidence of Chinese medicines treatment for asthma in several aspects, including asthma control score, side effects and laboratory examination such as lung-function test, serum total immunoglobulin, and so on.
The results of this study will provide updated evidence for whether Chinese medicines is an effective and safe intervention for asthma.
PROSPERO CRD42019136074.
哮喘是一种复杂的疾病，与免疫、环境、遗传等多种因素相关。用于治疗哮喘的常用药物包括β受体激动剂和糖皮质激素。然而，在长期治疗中，上述药物的效果并不理想，因此许多患者选择口服中药而非西药。随着中药疗法的引入，关于哮喘管理的文献迅速增多，这就需要该领域有新的证据综合方法。本系统评价旨在系统总结和评估大量关于中药干预哮喘的证据，评估中药治疗哮喘的疗效和安全性，并为患者与临床医生的临床诊疗提供决策辅助。此外，它有助于确立未来的研究议程。
将按照每个数据库的规则，从建库至当前对5个英文数据库（PubMed、Web of science、EBASE、Springer Cochrane Library和WHO国际临床试验注册平台）和4个中文数据库（万方数据库、中国科学期刊数据库、中国知网数据库和中国生物医学文献数据库）进行规范检索。文献筛选、数据提取和质量评估将由2名研究人员独立进行。根据异质性检验，采用固定效应模型或随机效应模型对数据进行综合分析。哮喘控制测试症状评分将作为主要结局进行评估。单个症状和体征的疗效；一个疗程内西药的撤减情况，包括：时间、种类和数量；疗程结束后西药的维持情况，包括：种类、数量；哮喘生活质量问卷；实验室疗效指标作为次要结局。一般体格检查；血、尿、便常规检查；心电图；肝肾功能检查；可能的不良反应及相关检测指标作为安全性指标。将使用Cochrane协作网提供的RevMan5.3.5软件进行Meta分析。
本研究将在哮喘控制评分、副作用以及肺功能测试、血清总免疫球蛋白等实验室检查等几个方面，基于目前中药治疗哮喘的证据提供高质量的综合分析。
本研究结果将为中药是否是哮喘的有效和安全干预措施提供最新证据。
PROSPERO注册号：PROSPERO CRD42019136074。
