Efficacy and safety of modified Mai-Men-Dong-Tang for treatment of allergic asthma
Efficacy and safety of modified Mai-Men-Dong-Tang for treatment of allergic asthma
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DOI：
10.1111/j.1399-3038.2005.00230.x
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发表时间：
2005-02-01
影响因子：
4.4
通讯作者：
Chang, TT
中科院分区：
文献类型：
--
作者：
Hsu, CH;Lu, CM;Chang, TT
本研究的目的是评估中药配方加味麦门冬汤（mMMDT）治疗持续性轻至中度哮喘的疗效和安全性。在这项双盲、随机、安慰剂对照临床试验中，共有 100 名哮喘患者入组并分配到三个治疗组。在 4 个月的时间里，A 组和 B 组的患者接受了 80 毫克/公斤/天和 40 毫克/公斤/天的 mMMDT，而 C 组的患者则接受了安慰剂。功效变量包括 1 秒用力呼气量 (FEV1) 的变化、症状评分、血清总免疫球蛋白 E (IgE) 和尘螨特异性 IgE。安全性评估包括全血细胞计数、肝肾功能。相对于基线，与安慰剂治疗的类似物相比，A 组和 B 组的 FEV1 显着增加（均 p < 0.05）。此外，两个 mMMDT 治疗组的症状评分都有类似的改善。 A组治疗后血清总IgE呈下降趋势，但无统计学差异。此外，没有报告与药物相关的不良反应。研究期间，血液检查、肝肾功能均在正常范围内，随着时间的推移没有出现明显变化。总之，中草药配方 mMMDT 改善了我们的患者样本中的肺功能并缓解了哮喘症状。鉴于其有效性和安全性，我们认为 mMMDT 是治疗持续性轻至中度哮喘的可靠治疗方案。
The aim of this study was to evaluate the efficacy and safety of a Chinese herbal formula modified Mai-Men-Dong-Tang (mMMDT) for treatment of persistent, mild-to-moderate asthma. A total of 100 asthmatic patients were enrolled and assigned to three treatment groups in this double-blind, randomized, placebo-controlled clinical trial. Over a period of 4 months, patients in groups A and B received 80 and 40 mg/kg/day of mMMDT, while those in group C received a placebo. Efficacy variables included changes in forced expiratory volume in 1 s (FEV1), symptom score, serum total immunoglobulin E (IgE), and dust mite-specific IgE. Safety assessments included complete blood count, and liver and kidney function. Relative to baseline, significantly greater increases in FEV1 were demonstrated for both A and B groups in comparison with the placebo-treated analog (both p < 0.05). Further, similar improvements in symptom score were observed for both mMMDT treatment groups. The serum total IgE for group A showed a decreasing tendency after treatment but no statistical difference was noted. Furthermore, no drug-related adverse effects were reported. Blood test, and liver and kidney function were within normal range during the study, with no marked changes demonstrated over time. In conclusion, the Chinese herbal formula mMMDT provided improvements in lung function and relieved asthma symptoms in our sample of patients. Given its efficacy and safety, we consider mMMDT a credible treatment regimen for persistent, mild-to-moderate asthma.