摘要
目的通过安慰剂对照、双盲、随机、平行研究,应用二年时间观察814对COPD患者临床症状和对肺功能的改善效应,评价814对COPD患者临床症状和肺功能等的影响。方法选择COPD患者312例,通过双盲、随机分为两组:①814临床治疗组;②安慰剂对照组;所有患者仅在COPD急性加重期加用常规药物治疗(抗生素、止咳化痰药、平喘药物等)。临床观察时间为二年。结果 814治疗组比安慰剂对照组的症状改善比率较高,其中以咳嗽、咳痰、喘息、哮鸣音的改善较为显著(P<0.05)。814治疗组中,咳嗽缓解的总有效率为35％,咳痰为41％,喘息为16.7％;临床体征方面则以哮鸣音减少较为明显。COPD病情急性加重的发生次数:814治疗组中的COPD患者平均每年每个患者发生2.7±2.1次病情急性加重,而安慰剂对照组中平均每年每个患者发生4.8±1.9次病情急性加重,经统计学处理,两组间有显著性差异(P<0.05)。结论 814治疗后能缓解COPD肺功能下降趋势。814治疗后,COPD患者的临床表现有所改善,尤其能缓解咳嗽、咳痰及喘息等症状,并减少COPD急性加重的发作次数。
Objective To determine the therapeutic effects of Chinese herbal medicine of 814 in patients with chronic obstructive pulmonary diseases (COPD) .Methods The randomized, double blind, placebo controlled study was carried out in eligible COPD patients.312 COPD patients were randomly divided into two groups: the group - treated with Chinese herbal medicine 814 and the placebo group.Clinical symptoms and signs, lung function, exacerbations and health status were investigated in both groups during two years study. All patients received antibiotics, bronchodilators and mucolytics in any respiratory infections or exacerbations of the disease.The safety of 814 was assessed.Results Clinical symptoms and signs, such as cough, expectoration, short of breath and wheeze, were improved more in the 814 treated group than the placebo group.COPD exacerbation times were reduced in 814 treated group (2.7 ±2.1 per year) , compared with placebo group (4.8± 1.9 per year) .The difference between two group is significanf (P< 0.05) .The annual rate of decline in FEV1 was lower in 814 treated group than in placebo group. Conclusions Chinese herbal medicine 814 reduced the annual rate of decline in lung function in COPD patients.Clinical symptoms and signs of COPD patients were improved after treatment with 814.Patients on 814 therapy had fewer COPD exacerbations and a slower decline in health status.These improvements in clinical manifestation support the use of 814 in COPD patients.
出处
《医学研究通讯》
2002年第4期14-18,共5页
Bulletin of Medical Research
基金
国家"九五"重点科技基金
