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中药治疗儿童支气管哮喘的疗效评估:临床试验、免疫学检测及动物研究。台湾哮喘研究小组。

Evaluation of efficacy of traditional Chinese medicines in the treatment of childhood bronchial asthma: clinical trial, immunological tests and animal study. Taiwan Asthma Study Group.

作者信息

Hsieh K H

机构信息

Chang Gung Children's Hospital, Chang Gung Medical College, Taiwan, Republic of China.

出版信息

Pediatr Allergy Immunol. 1996 Aug;7(3):130-40. doi: 10.1111/j.1399-3038.1996.tb00120.x.

DOI:10.1111/j.1399-3038.1996.tb00120.x
PMID:9116877
Abstract

Traditional Chinese medicines (TCM) have been used to treat bronchial asthma for several centuries and a certain degree of clinical benefit has been observed; however, scientific substantiation is lacking. A multicenter, double-blind and placebo-controlled study was therefore conducted to evaluate the clinical efficacy in terms of symptom score, medication score, morning and evening PEFRs, and changes of immunoregulatory function, such as distribution of lymphocyte subsets and in vivo and in vitro production of lymphokines (IFN-gamma and IL-4) and inflammatory mediators (histamine, PGE2 and LTC4). Furthermore, the protective effect of TCM on the late asthmatic reaction (LAR) was evaluated by using asthmatic guinea pigs. Three hundred and three asthmatic children were classified by Chinese doctors, according to a standardized questionnaire designed on the basis of basic logic of Chinese medicine, into three groups of specific constitution (group A, B and C). Group A consisted of 32 herb A-treated patients and 34 placebo-treated; group B, 74 herb B-treated and 64 placebo-treated; and group C, 55 herb C-treated and 44 placebo-treated. The study period was six months. The results were: 1) Both treatment group and placebo group showed an improvement in all clinical parameters, thus demonstrating a placebo effect. However, the improvement was usually greater in the former than the latter, although only the difference in PEFR was significant; 2) Herb A could increase total T cell and decrease B cell; 3) Herb A and B enhanced production of PGE2 but not LTC4, IFN-gamma and IL-4; 4) There was a general tendency for in vivo and in vitro production of histamine to decrease at the end of study in both treatment group and placebo group; however, the decrease was significantly greater in the former than the latter; 5) In asthmatic guinea pigs, 10-day's pretreatment with Chinese herbs could reverse the decrease of sGaw, suppress eosinophilia in bronchoalveolar lavage fluid (BALF), prevent the eosinophil infiltration of airways, increase PGE2 production and decrease LTC4 production in serum and BALF. Thus, traditional Chinese medicines did show a certain degree of clinical efficacy. The decreased production of histamine and LTC4, increased production of PGE2 that were found in both asthmatic children and asthmatic guinea pigs, and prevention of occurrence of LAR by suppressing eosinophil infiltration of airways and preserving airway conductance that were observed in asthmatic guinea pigs after allergen challenge might be used to account partly for the effectiveness.

摘要

几个世纪以来,中药一直被用于治疗支气管哮喘,并且已观察到一定程度的临床疗效;然而,尚缺乏科学依据。因此,开展了一项多中心、双盲、安慰剂对照研究,以评估其在症状评分、用药评分、早晚呼气峰流速(PEFR)以及免疫调节功能变化方面的临床疗效,如淋巴细胞亚群分布、体内外细胞因子(干扰素-γ和白细胞介素-4)及炎症介质(组胺、前列腺素E2和白三烯C4)的产生。此外,通过使用哮喘豚鼠评估了中药对哮喘迟发反应(LAR)的保护作用。303名哮喘儿童由中医根据基于中医基本逻辑设计的标准化问卷分为三组特殊体质(A组、B组和C组)。A组包括32名接受草药A治疗的患者和34名接受安慰剂治疗的患者;B组,74名接受草药B治疗的患者和64名接受安慰剂治疗的患者;C组,55名接受草药C治疗的患者和44名接受安慰剂治疗的患者。研究期为6个月。结果如下:1)治疗组和安慰剂组在所有临床参数上均有改善,从而显示出安慰剂效应。然而,前者的改善通常大于后者,尽管只有PEFR的差异具有统计学意义;2)草药A可增加总T细胞并减少B细胞;3)草药A和B可增强前列腺素E2的产生,但不影响白三烯C4、干扰素-γ和白细胞介素-4的产生;4)在研究结束时,治疗组和安慰剂组体内外组胺的产生普遍呈下降趋势;然而,前者的下降幅度明显大于后者;5)在哮喘豚鼠中,用中药预处理10天可逆转气道比传导率(sGaw)的下降,抑制支气管肺泡灌洗液(BALF)中的嗜酸性粒细胞增多,防止气道嗜酸性粒细胞浸润,增加前列腺素E2的产生并减少血清和BALF中白三烯C4的产生。因此,中药确实显示出一定程度的临床疗效。在哮喘儿童和哮喘豚鼠中均发现组胺和白三烯C4产生减少、前列腺素E2产生增加,以及在变应原激发后哮喘豚鼠中观察到通过抑制气道嗜酸性粒细胞浸润和维持气道传导性来预防LAR的发生,这些可能部分解释了其有效性。

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