Efficacy and tolerability of antiasthma herbal medicine intervention in adult patients with moderate-severe allergic asthma
Efficacy and tolerability of antiasthma herbal medicine intervention in adult patients with moderate-severe allergic asthma
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DOI：
10.1016/j.jaci.2005.05.029
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发表时间：
2005-09-01
影响因子：
14.2
通讯作者：
Li, XM
中科院分区：
文献类型：
--
作者：
Wen, MC;Wei, CH;Li, XM
背景：中草药具有悠久的人类使用历史。抗哮喘草药干预(Ashmi)是一种新的中药配方，已被证明是一种有效的治疗过敏性哮喘的小鼠模型。目的：本研究旨在比较Ashmi治疗与泼尼松治疗的中重度持续性哮喘患者的有效性、安全性和免疫调节作用。方法：采用随机双盲试验，91例受试者接受随机对照试验。45例患者口服阿司米胶囊和泼尼松安慰剂(阿希米组)，46例患者口服泼尼松片和阿司米安慰剂胶囊(泼尼松组)，疗程4周。治疗前后分别进行肺活量测定、症状评分、不良反应及血清皮质醇、细胞因子和IgE水平的评估。结果：两组治疗后肺功能均有明显改善，表现为FEV1增加和呼气峰流速增加(P<；.001)。强的松组的改善稍大，但明显更大(P<；0.05)。两组的临床症状评分、β(2)-支气管扩张剂的使用和血清IgE水平均显著降低，且程度相似(P<；.001)。T(H)2细胞因子水平在两个治疗组均显著降低(P<；.001)，且强的松组更低(P<；.05)。强的松组的血清干扰素-γ和皮质醇水平显著降低(P<；.001)，而阿司米组显著升高(P<；.001)。两组均未观察到严重副作用。结论：平喘中药干预是治疗哮喘安全有效的替代药物。与泼尼松相比，阿司米对肾上腺功能无不良影响，对TO和T(H)2平衡有有利影响。
Background: Chinese herbal medicine has a long history of human use. A novel herbal formula, antiasthma herbal medicine intervention (ASHMI), has been shown to be an effective therapy in a murine model of allergic asthma.Objective: This study was undertaken to compare the efficacy, safety, and immunomodulatory effects of ASHMI treatment in patients with moderate-severe, persistent asthma with prednisone therapy.Methods: In a double-blind trial, 91 subjects underwent randomization. Forty-five subjects received oral ASHMI capsules and prednisone placebo tablets (ASHMI group) and 46 subjects received oral prednisone tablets and ASHMI placebo capsules (prednisone group) for 4 weeks. Spirometry measurements; symptom scores; side effects; and serum cortisol, cytokine, and IgE levels were evaluated before and after treatment.Results: Posttreatment lung function was significantly improved in both groups as shown by increased FEV1 and peak expiratory flow findings (P < .001). The improvement was slightly but significantly greater in the prednisone group (P < .05). Clinical symptom scores, use of beta(2)-bronchodilators, and serum IgE levels were reduced significantly, and to a similar degree in both groups (P < .001). T(H)2 cytokine levels were significantly reduced in both treated groups (P < .001) and were lower in the prednisone-treated group (P < .05). Serum IFN-gamma and cortisol levels were significantly decreased in the prednisone group (P < .001) but significantly increased in the ASHMI group (P < .001). No severe side effects were observed in either group.Conclusion: Antiasthma herbal medicine intervention appears to be a safe and effective alternative medicine for treating asthma. In contrast with prednisone, ASHMI had no adverse effect on adrenal function and had a beneficial effect on TO and T(H)2 balance.