三拗片治疗急性支气管炎(风寒袭肺证)的临床研究

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 7 d。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。

SanAo Tablet in treating acute bronchitis(wind-cold attacking the lung syndrome):A randomized controlled trial

AIM: To evaluate the efficacy and safety of SanAo Tablet in treating acute bronchitis 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 patients with acute bronchitis were randomly divided into two groups: a treatment group (120 patients) were treated with SanAo Tablet and TongXuanLiFei Oral Liquid Analogue, acontrol group (120 patients) were treated with TongXuanLiFei Oral Liquid and SanAo Tablet Analogue. 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 Syndrome, the treatment group showed a better clinical effect(P<0.05).SanAo tablet had significantly relieved the symptoms of cough and spitting sputum,compared with TongXuanLiFei Oral Liquid, SanAo tablet showed a better clinical effect(P<0.05).Onset time of cough and spitting sputum: there is no significant difference 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 effective and safe in treating wind-cold attacking the lung pattern of acute bronchitis.