摘要
目的:评价三拗片治疗急性支气管炎(风寒袭肺证)的疗效及安全性。方法:试验采用随机、双盲双模拟、阳性药平行对照、多中心、非劣性的临床试验方法,共纳入240例受试者,随机分为试验组(三拗片+通宣理肺口服液模拟剂)120例,对照组(通宣理肺口服液+三拗片模拟剂)120例,疗程7d。结果:试验组的临床愈显率、中医证候愈显率及咳嗽、咯痰等单项症状的愈显率均明显优于通宣理肺口服液组(P<0.05);二药对患者咳嗽、咯痰症状的起效时间无统计学差异(P>0.05);三拗片组中医证候总积分治疗后较治疗前降低幅度明显高于通宣理肺口服液组(P<0.05)。结论:三拗片治疗急性支气管炎(风寒袭肺证)安全有效。
AIM： To evaluate the efficacy and safety of SanAo Tablet in treating acute bronchi- tis with the syndrome of wind-cold attacking the lung. METHODS： A multicenter, randomized, double blind, double dummy, controlled trial, non-inferiority was conducted. A total of 240 pa- tients with acute bronchitis were randomly di- vided into two groups： a treatment group （120 patients） were treated with SanAo Tablet and TongXuanLiFei Oral Liquid Analogue, acontrolgroup （120 patients） were treated with TongXu- anLiFei Oral Liquid and SanAo Tablet Ana- logue. The therapeutic course of both groups was 7 days. RESULTS. For the clinical effective and curative rate, the treatment group obtained better effects than control group（P〈0.05）. For the effective and curative rate of TCM Syn- drome, the treatment group showed a better clinical effect（P〈0.05）. SanAo tablet had sig- nificantly relieved the symptoms of cough andspitting sputum,compared with TongXuanLiFei Oral Liquid, SanAo tablet showed a better clini- cal effect（P〈0.05）. Onset time of cough and spitting sputum： there is no significant differ- ence between two groups. The change amount of TCM syndrome total integral before and after treatment is higher in SanAo Tablet group than in TongXuanLiFei Oral Liquid group （P〈0.05）. CONCLUSION： SanAo Tablet is effectiveand safe in treating wind-cold attacking the lung pattern of acute bronchitis.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2014年第1期44-48,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
中国中医科学院第三批优势病项目(CACMS08Y0033)
国家中医药管理局全国名老中医药专家传承工作室建设项目--许建中工作室
关键词
三拗片
通宣理肺口服液
风寒袭肺证
急性支气管炎
随机对照试验
SanAo Tablet
TongXuanLiFei Oral Liquid
Pattern of wind-cold attacking the lung
Acute bronchitis
Randomized controlled trial
