竹沥胶囊与沐舒坦祛痰作用的临床研究

目的比较口服竹沥胶囊与沐舒坦祛痰作用的临床疗效和安全性。方法随机将160例急、慢性支气管炎的患者,分为竹沥胶囊组（治疗组）83例,口服竹沥胶囊,0.5g/次,3粒/次,3次/d;沐舒坦组（对照组）77例,口服氨溴索片,30mg次,3次/d。两组疗程均为10d。结果①临床综合疗效：治疗组和对照组的临床控制率分别为54.2%,54.5%,总有效率分别为89.1%,89.6%;②祛痰单项指标：治疗组痰液性质、痰量、咳痰难易程度的消失率分别为60.2%,65.1%,55.4%;平均消失天数分别为8.0±2.6,9.1±2.2,9.1±2.8,对照组消失率则分别为59.7%,64.9%,61.0%;平均消失天数分别为8.3±2.7,9.2±2.4,8.4±2.8,两组单项指标症状评分均显著下降,单项指标均无显著性差异（P〉0.05）;③治疗组与对照组的不良反应发生率分别为4.8%和11.7%（P〉0.05）。结论口服竹沥胶囊对急、慢性支气管炎祛痰作用与沐舒坦基本等效,进一步的临床疗效和安全性尚须作更为严格的大规模、多中心、双盲临床试验。

Clinical study on zhuli capsule and ambroxol in treating bronchitis with expectoration

Objective To evaluate the efficacy and safety of zhuli capsule and ambroxol in treating bronchitis with expectoration. Methods Therandomized controlled method was conducted. 160 patients were randomly divided into the treatment group （n = 83, treated with zhuli capsule, 3 pills/d bid）, and control group （n = 120, treated with ambroxol, 3 tablets/d, tid）, both groups were all treated for 10 days. The accumulated scores of clinical symptoms and physical sign, adverse effect were recorded before and after the treatment. Results There were 160 patients who entered to the intention-to-treat （ITT） analysis： ①Compositive clinical effect： rate of clinical control in two groups were 54.2% , 54.5% ; and the total efficacy rate were 89.1% , 89.6% respectively; ②Single effect of expectorant： rate of disappearance of properties of sputum, amount of sputum, easy extend of expectoration were 60.2% ,65.1% ,55.4% respectively in treatment group, and the mean days of disappearance were 8.0 ± 2.6, 9.1 ± 2.2, 9.1 ± 2.8. At the mean time , these in control groups were 59.7% ,64.9% ,61.0% , 8.3 ± 2.7, 9.2 ±2.4, 8.4 ± 2.8 respectively. There were no difference in these endpoints between the two groups ; ③ The rate of adverse effect was 4.8% in treatment group, 11.7% in control group. There was also no difference （P 〉0.05）. Conclusion Zhuli capsule is effective and safe in treating bronchitis with expectoration, and the clinical effect of zhuli capsule is similar to ambroxol, without obvious adverse effect.