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中药口服膏剂治疗稳定期慢性阻塞性肺疾病的疗效与安全性:一项随机对照试验的系统评价与Meta分析

The Effects and Safety of Chinese Oral Herbal Paste on Stable Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

作者信息

Zeng Yan, Li Yu, Wei Hua, Xiong Chan, Liao Li, Miao Ti-Wei, Mao Bing, Fu Juan-Juan

机构信息

Department of Pneumology, Pidu District Hospital of Traditional Chinese Medicine, The Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Respiratory Group, Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.

出版信息

Evid Based Complement Alternat Med. 2020 Mar 10;2020:5867086. doi: 10.1155/2020/5867086. eCollection 2020.

DOI:10.1155/2020/5867086
PMID:32308709
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7086443/
Abstract

BACKGROUND

Chinese oral herbal paste has been widely used in the treatment of chronic obstructive pulmonary disease (COPD). However, the treatment effects of herbal paste were controversial and lack evidence to support its clinical use. This study aims to systematically assess the efficacy and safety of Chinese oral herbal paste for the treatment of stable COPD.

METHODS

PubMed, Web of Science, CENTRAL, EMBASE, CNKI, VIP, CBM, and WANFANG database in addition to two websites of clinical trial registry were searched from respective inception to August 2019. Only randomized controlled trials (RCTs) studying Chinese herbal paste for the treatment of stable COPD were included. Methodological quality was assessed based on Cochrane risk of bias and GRADE approach. Data were analyzed using RevMan 5.3.

RESULTS

A total of 19 RCTs with 1303 individuals compared Chinese oral herbal paste and Western medicine (WM) with WM alone were included for meta-analysis. The review showed compared with WM alone, the combination of herbal paste and WM reduced exacerbation frequency. Subgroup analyses showed that after two to three months of treatment, compared with WM alone, Chinese herbal paste plus WM significantly decreased the St George's Respiratory Questionnaire (SGRQ) scores, COPD assessment test (CAT) scores, and scores of traditional Chinese medicine (TCM) syndrome, and improved clinical effective rates, lung function, and 6-minute walk distance. No serious adverse events related to herbal paste were reported.

CONCLUSION

Current evidence showed that Chinese oral herbal paste may be an effective and well-tolerated adjuvant therapy for stable COPD. Considering the risks of bias and heterogeneity, more high-quality, well-designed RCTs are still needed.

摘要

背景

中药口服膏剂已广泛应用于慢性阻塞性肺疾病(COPD)的治疗。然而,膏剂的治疗效果存在争议,缺乏支持其临床应用的证据。本研究旨在系统评价中药口服膏剂治疗稳定期COPD的疗效和安全性。

方法

检索PubMed、Web of Science、CENTRAL、EMBASE、CNKI、VIP、CBM和万方数据库,以及两个临床试验注册网站,检索时间从各数据库建库至2019年8月。仅纳入研究中药膏剂治疗稳定期COPD的随机对照试验(RCT)。根据Cochrane偏倚风险和GRADE方法评估方法学质量。使用RevMan 5.3进行数据分析。

结果

共纳入19项RCT(1303例个体),比较了中药口服膏剂与单纯西药(WM)治疗稳定期COPD的疗效,进行荟萃分析。综述显示,与单纯西药相比,膏剂联合西药可降低急性加重频率。亚组分析显示,治疗两至三个月后,与单纯西药相比,中药膏剂联合西药可显著降低圣乔治呼吸问卷(SGRQ)评分、慢性阻塞性肺疾病评估测试(CAT)评分和中医证候评分,提高临床有效率、肺功能和6分钟步行距离。未报告与膏剂相关的严重不良事件。

结论

目前证据表明,中药口服膏剂可能是治疗稳定期COPD的一种有效且耐受性良好的辅助治疗方法。考虑到偏倚和异质性风险,仍需要更多高质量、设计良好的RCT。

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