补肾益气类中药复方对哮喘患者的抗炎作用
The Anti-Inflammatory Effects of Invigorating Kidney and Supplementing Qi Chinese Herbal Formulae in Asthma Patients.
作者信息
Kong Lingwen, Zhang Hongying, Cao Yuxue, Le Jingjing, Wu Jinfeng, Liu Baojun, Chen Meixia, Du Yijie, Wang Jia, Wang Genfa, Yi Tao, Zhou Xianmei, Wang Gang, Miao Qing, Li Suyun, Zhao Naiqing, Dong Jingcheng
机构信息
Institute of Integrated Traditional Chinese and Western Medicine, Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China.
Department of Integrated Traditional Chinese and Western Medicine, Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China.
出版信息
Evid Based Complement Alternat Med. 2017;2017:3754145. doi: 10.1155/2017/3754145. Epub 2017 Jun 27.
BACKGROUND
The theories of Shen-reinforcement and Qi-supplementation are important in asthma treatment based on traditional Chinese medicine theories. Early studies suggested that Invigorating Kidney and Supplementing Qi herbal formulae, Bu Shen Fang Chuan (BSFC) and Bu Shen Yi Qi (BSYQ), conveyed promising results in asthma treatment. However, the efficacy and safety of the formulae need to be further investigated by a randomized double-blind clinical trial.
METHODS
328 eligible patients were randomly sent to BSFC, BSYQ, and placebo group. The two formulae were received as add-on therapy. The primary endpoints were rate of asthma exacerbation and Hamilton Rating Scale for Depression (HAM-D) score. The secondary endpoints included HPA axis function and inflammatory cytokine production profile. All indexes were measured before and after treatment.
RESULTS
The primary endpoints were not improved in both groups; however, the depression levels of subgroup patients with HAM-D score > 5 were improved in BSFC group. HPA axis functions and inflammatory cytokines level were also improved by two formulae. The incidences of adverse events were similar among groups.
CONCLUSIONS
The two formulae had multiple advantage effects on neuroendocrine-immune system. They are worth used as a replacement therapy in asthma.
TRIAL REGISTRATION
This trial is registered with clinical trial number ChiCTR-PRC-09000529.
背景
补肾益气理论在中医治疗哮喘中具有重要意义。早期研究表明，补肾平喘方（BSFC）和补肺益气方（BSYQ）等补肾益气中药复方在哮喘治疗中显示出良好的效果。然而，这些复方的疗效和安全性需要通过随机双盲临床试验进一步研究。
方法
328例符合条件的患者被随机分为BSFC组、BSYQ组和安慰剂组。两种复方作为辅助治疗。主要终点为哮喘加重率和汉密尔顿抑郁量表（HAM-D）评分。次要终点包括下丘脑-垂体-肾上腺（HPA）轴功能和炎症细胞因子产生情况。所有指标在治疗前后进行测量。
结果
两组的主要终点均未改善；然而，BSFC组中HAM-D评分>5的亚组患者的抑郁水平有所改善。两种复方也改善了HPA轴功能和炎症细胞因子水平。各组不良事件的发生率相似。
结论
这两种复方对神经内分泌-免疫系统具有多种有益作用。它们值得作为哮喘的替代疗法使用。
试验注册
本试验已在临床试验注册中心注册，注册号为ChiCTR-PRC-09000529。
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