Kelly-Pieper Kristin, Patil Sangita P, Busse Paula, Yang Nan, Sampson Hugh, Li Xiu-Min, Wisnivesky Juan P, Kattan Meyer
Division of Pediatric Pulmonary Medicine, Columbia University, New York, NY, USA.
J Altern Complement Med. 2009 Jul;15(7):735-43. doi: 10.1089/acm.2008.0543.
Complementary and alternative medicines are increasingly used for the treatment of asthma in Western countries. A novel three-herb antiasthma herbal medicine intervention (ASHMI; Sino-Lion Pharmaceutical Company; Shan Dong China) was demonstrated to be effective and safe in a murine model of asthma and in a preliminary clinical study in China.
The objective of this study was to evaluate the safety and tolerability of ASHMI in adult subjects with allergic asthma.
Randomized, double-blind, placebo-controlled, dose escalation, phase I trial aimed at developing a botanical drug under the United States Food and Drug Administration Investigational New Drug title.
Subjects received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 placebo subjects were treated at each dose level. Subjects continued to use their conventional asthma medications for the duration of the study.
Vital signs, physical examination, laboratory data, and electrocardiogram data were monitored throughout the study to assess occurrence of adverse events (AEs). Immunomodulatory studies were performed to evaluate the effect of ASHMI on cytokine, chemokine, and growth factor levels.
Twenty (20) nonsmoking, allergic subjects with asthma were included in the study. Eight (8) subjects (4 ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were observed during the study period. Vital signs, electrocardiogram findings, and laboratory results obtained at pre- and post-treatment visits remained within normal range. No abnormal immunologic alterations were detected.
In this phase I study, ASHMI appeared to be safe and well tolerated by subjects with asthma. These findings allowed initiation of a larger phase II study to assess the efficacy of ASHMI.
在西方国家，补充和替代医学越来越多地用于治疗哮喘。一种新型的三味草药抗哮喘草药干预剂（ASHMI；中国山东中狮制药公司）已在哮喘小鼠模型和中国的一项初步临床研究中证明是有效且安全的。
本研究的目的是评估ASHMI在成年过敏性哮喘患者中的安全性和耐受性。
随机、双盲、安慰剂对照、剂量递增的I期试验，旨在依据美国食品药品监督管理局的研究性新药标题开发一种植物药。
受试者接受三种剂量的ASHMI或安慰剂之一：600毫克（2粒胶囊）；1200毫克（4粒胶囊）；或1800毫克（6粒胶囊），每日两次，共1周。每个剂量水平治疗4名ASHMI受试者和2名安慰剂受试者。在研究期间，受试者继续使用其常规哮喘药物。
在整个研究过程中监测生命体征、体格检查、实验室数据和心电图数据，以评估不良事件（AE）的发生情况。进行免疫调节研究以评估ASHMI对细胞因子、趋化因子和生长因子水平的影响。
20名不吸烟的过敏性哮喘受试者纳入本研究。8名受试者（4名ASHMI受试者和4名安慰剂受试者）报告有轻度胃肠道症状。在研究期间未观察到3级AE。治疗前和治疗后访视时获得的生命体征、心电图结果和实验室结果均保持在正常范围内。未检测到异常免疫改变。
在这项I期研究中，ASHMI对哮喘受试者似乎是安全且耐受性良好的。这些发现使得能够开展一项更大规模的II期研究以评估ASHMI的疗效。
