5种口服中成药联合常规方案治疗稳定期慢性阻塞性肺疾病的网状Meta分析

Network Meta-analysis of five Oral Proprietary Chinese Medicines combined with Conventional Regimens in the treatment of stable Chronic Obstructive Pulmonary Disease

关键词:  口服中成药  稳定期慢性阻塞性肺疾病  随机对照试验  网状Meta分析

Key words:  Oral Proprietary Chinese Medicine  Stable Chronic Obstructive Pulmonary Disease  Randomized Controlled Trial  Network Meta-analysis

摘要:

目的:系统评价5种口服中成药用于治疗稳定期慢性阻塞性肺疾病的疗效和安全性。方法:计算机检索中国期刊全文数据库(CNKI)、万方、维普数据库(VIP)、中国生物医学数据库(CBM)电子数据库、The Cochrane Library、Embase、Pubmed等7个数据库收录的口服中成药用于治疗稳定期慢性阻塞性肺疾病的随机对照试验(RCT),检索时间均自建库至 2023 年 10 月 1 日,由两名评价员独立选择试验和评价质量,提取有效数据采用RevMan 5.3, Stata SE 14、 GeMTC 0.14.3 软件软件进行网状 Meta 分析。结果:共纳入 34 个临床对照试验研究,病例共 2385 例,其中对照组1228例,试验组1157例。网状 Meta分析结果显示①提高有效率方面,固肾定喘丸＞玉屏风胶囊(颗粒)＞金水宝胶囊＞百令胶囊＞苏黄止咳胶囊；②提高第一秒用力呼气容积(FEV1)方面,苏黄止咳胶囊＞固肾定喘丸＞百令胶囊＞玉屏风胶囊(颗粒)＞金水宝胶囊；③提高用力肺活量(FVC)方面,固肾定喘丸＞百令胶囊＞苏黄止咳胶囊＞玉屏风胶囊(颗粒)；④提高第一秒呼吸容积占用力肺活量百分比(FEV1/FVC)方面,百令胶囊＞苏黄止咳胶囊＞玉屏风胶囊(颗粒)＞金水宝胶囊＞固肾定喘丸；⑤降低急性发作次数方面,百令胶囊优于玉屏风胶囊(颗粒)；安全性方面,5 种口服中成药均未产生严重不良反应。结论:5种口服中成药用于治疗稳定期慢性阻塞性肺疾病效果明显,药品安全系数较高,不良反应轻微,但需更多设计严谨的高质量、大样本、多中心的随机对照试验加以验证。

Abstract:

Objective: To systematically evaluate the efficacy and safety of five oral Chinese patent medicines in the treatment of stable chronic obstructive pulmonary disease (COPD). Methods: Chinese Journal Full-text Database (CNKI), Wanfang Database, VIP Database, CBM electronic database and The Cochrane were searched by computer Randomized controlled trials (RCTS) of oral proprietary Chinese medicines in the treatment of stable COPD included in 7 databases including Library, Embase and Pubmed were retrieved from the self-built database to October 1, 2023. Two reviewers independently selected the trials and evaluated the quality. RevMan 5.3, Stata SE 14 and GeMTC 0.14.3 were used to extract valid data for network meta-analysis. Results: A total of 34 controlled clinical trials were included, including 2385 cases, including 1228 cases in the control group and 1157 cases in the experimental group. The results of network meta-analysis showed that ① in terms of improving the effective rate, Gushen Dingchuan pill > Yupingfeng capsule（granules）>Jinshuibao capsule >Bailing Capsules >Suhuangzhike capsule; ② In terms of improving forced expiratory volume in one second (FEV1), Suhuangzhike capsule > Gushen Dingchuan pill > Bailing Capsules > Yupingfeng capsule（granules）> Jinshuibao capsule; ③ In terms of improving forced vital capacity (FVC), Gushen Dingchuan pill > Bailing capsule > Suhuangzhike capsule > Yupingfeng capsule（granules）; ④ In terms of improving the percentage of respiratory volume in the first second to forced vital capacity (FEV1/FVC), Beling capsule > Suhuangzhike capsule > Yupingfeng capsule（granules）> Jinshuibao capsule > Gushen Dingchuan pill; (5) Bailing capsule was more effective than Yupingfeng capsule（granules） in reducing the frequency of acute attacks. In terms of safety, no serious adverse reactions occurred in the 5 oral proprietary Chinese medicines. Conclusion: The 5 oral Chinese patent medicines have obvious effect in the treatment of stable COPD, with high safety coefficient and mild adverse reactions. However, more high-quality, large-sample, multicenter randomized controlled trials with rigorous design are needed to verify.