摘要
目的观察加味野马追胶囊对急性支气管炎、慢性支气管炎急性发作(痰热郁肺证)的临床疗效。方法采用多中心、随机、双盲、平行对照的临床研究设计,将60例患者按盲法编码分组,治疗观察结束后揭盲显示,实际观察52例,其中试验组26例,对照组26例(脱落8例,试验组4例,对照组4例,脱落率<20%)。试验组口服加味野马追胶囊(每粒0.3 g);对照组口服克咳胶囊(每粒0.3 g),疗程均为7 d,观察两组患者治疗前后症状积分的变化情况。结果试验组总有效率96.15%,对照组总有效率88.46%,两组总有效率差异无统计学意义(P>0.05)。各组治疗后症状积分(治疗第4日和第7日)较治疗前的差异均有显著统计学意义(P<0.05)。同时第3次访视(治疗7 d)时,两组间症状积分出现明显差异(P<0.05)。两组在治疗过程中均未见任何不良反应。结论加味野马追胶囊能有效地改善急性支气管炎、慢性支气管炎急性发作(痰热郁肺证)的临床症状,其疗效优于克咳胶囊,且安全性好。
Objective： To observe the clinical efficacy of modified Yemazhui capsule in treating acute bronchitis ＆ acute exacerbation of chronic bronchitis with the syndrome type of phlegm-heat obstructing lung. Methods： According to the clinical study design with the principle of multi-center randomized trial, double-blind trial and parallel control,60 patients who met the diagnostic criteria and inclusion criteria were divided into groups by blinding code. After treatment, the result showed that there were 52 effective actual observation cases, with 26 patients in test group and 26 patients in control group （8 cases of dropouts and withdrawals,4 cases in test group and 4 in control group,expulsion rate 〈 20%）. The test group was treated with modified Yemazhui capsule （0.3 g per capsule） ,3 times a day,0.6g a time. While the control group was treated with Keke capsule （0.3 g per cap- sule） ,3 times a day,0.6g a time. Both groups had a therapeutic course of 7 days. After the treatment,the changes of symptom scores were compared. Results： The efficiency rate of main symptoms in test group was 96.15%, which was not significantly better than 88.46% of the control group （P 〉 0.05）. The symptom scores of the two groups （on the 4th day and 7th day of treatment） were significantly improved than before （P〈 0.05）. The test group was significantly better than the control group on the symptom scores at the 3rd visit （after 7 days of treatment） （P〈 0.05）. There were no adverse reactions in the two groups. Conclusion： Modified Yemazhui capsule can effectively improve clinical symptoms of acute bronchitis ＆ acute exacerbation of chronic bronchitis with the syndrome type of phlegm-heat obstructing lung. Its efficacy is better than that of Keke capsule, and the security is good, thus worthy of being studied and further promoted.
出处
《中国中医急症》
2016年第12期2229-2231,共3页
Journal of Emergency in Traditional Chinese Medicine
基金
江苏省科技基础设施建设计划专项(BM2009903)
第二批江苏省名老中医药专家传承工作室建设项目
关键词
加味野马追胶囊
克咳胶囊
急性支气管炎
慢性支气管炎急性发作
痰热郁肺证
临床研究
Modified Yemazhui capsule
Keke capsule
Acute bronchitis
Acute exacerbation of chronic bron-chitis
Syndrome type of phlegm-heat obstructing lung
Clinical observation
