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益气固表丸治疗慢性阻塞性肺疾病频繁急性加重型（肺脾气虚证）的随机对照研究

A Randomized Controlled Study of the Yi Qi Gu Biao Pill in the Treatment of Frequent Exacerbator Phenotype in Chronic Obstructive Pulmonary Disease (Lung and Spleen Qi Deficiency Syndrome).

作者信息

Zhen Gao, Jing Jing, Dan Xu, Zheng Li, Fengsen Li, Qi Sun

机构信息

National Clinical Research Base of Traditional Chinese Medicine, Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University, Urumqi 830000, China.

出版信息

Evid Based Complement Alternat Med. 2017;2017:9130804. doi: 10.1155/2017/9130804. Epub 2017 Dec 4.

DOI:10.1155/2017/9130804
PMID:29348777
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5733762/
Abstract

OBJECTIVE

To evaluate the efficacy and safety of Yi Qi Gu Biao (YQGB) pill in treating frequent exacerbator phenotype in chronic obstructive pulmonary disease (lung and spleen qi deficiency syndrome) (FEPCOPD).

METHODS

This prospective, randomized, double-blind, controlled study assessed 112 cases (64 included) of FEPCOPD treated at the outpatient department in our hospital in January-August 2016. The patients were randomly divided into YQGB and placebo (Pb) and treated for three months. Lung function, CAT, mMRC, and TCM symptom scores (TCMs) were observed.

RESULTS

Compared with Pb, YQGB showed decreased wheezing symptom scores (WSs) and TCMs at one month and decreased CAT and TCMs at three months. From one to three months, CAT, cough, sputum, WSs, and TCMs in YQGB were lower than pretreatment values. But in Pb, CAT was lower than pretreatment values after one month; CAT, sputum, and TCMs were lower than pretreatment values after two months; CAT, cough, sputum, WSs, and TCMs were lower than pretreatment values after three months.

CONCLUSION

Yi Qi Gu Biao pill can improve wheezing, health status, and TCMs in FEPCOPD and also can shorten the durations of cough, sputum, and wheezing. This trial is registered in the Clinical Trials Registry of China: ChiCTR-IOR-15007542 (on 8 December 2015).

摘要

目的

评价益气固表丸治疗慢性阻塞性肺疾病（肺脾气虚证）频繁急性加重表型（FEPCOPD）的疗效及安全性。

方法

本前瞻性、随机、双盲、对照研究对2016年1月至8月在我院门诊治疗的112例FEPCOPD患者（纳入64例）进行评估。患者被随机分为益气固表丸组和安慰剂组，治疗3个月。观察肺功能、慢性阻塞性肺疾病评估测试（CAT）、改良英国医学研究委员会呼吸困难量表（mMRC）及中医症状评分（TCMs）。

结果

与安慰剂组相比，益气固表丸组在1个月时喘息症状评分（WSs）和TCMs降低，在3个月时CAT和TCMs降低。在1至3个月期间，益气固表丸组的CAT、咳嗽、咳痰、WSs和TCMs均低于治疗前值。但在安慰剂组中，1个月后CAT低于治疗前值；2个月后CAT、咳痰和TCMs低于治疗前值；3个月后CAT、咳嗽、咳痰、WSs和TCMs低于治疗前值。

结论

益气固表丸可改善FEPCOPD患者的喘息、健康状况及中医症状，还可缩短咳嗽、咳痰和喘息的持续时间。本试验已在中国临床试验注册中心注册：ChiCTR-IOR-15007542（2015年12月8日）。

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