仁志止咳颗粒治疗咳嗽的临床疗效观察和安全性评价

Renzhi Granules Phosphate Solution for Cough:Observation of Curative Effect and Safety

目的观察仁志止咳颗粒治疗咳嗽的临床有效性并进行安全性评价。方法采用随机、双盲、多中心平行对照临床试验,将60例以干咳为主要症状的患者随机分成治疗组与对照组,治疗组给予仁志止咳颗粒加用盐酸左氧氟沙星注射液联合治疗,对照组单纯给予盐酸左氧氟沙星注射液治疗,疗程均为7d,观察2组治疗后咳嗽、咳痰和鼻塞症状的改善及不良反应情况。结果2组在治疗后咳嗽症状均较治疗前有显著性改善(P<0.05),但相间比较无显著性差异(P>0.05);治疗组与对照组显效率分别为36.84%、36.36%(P<0.05);有效率分别为84.21%、77.27%(P<0.05);第1秒用力呼气容积分别为(2966.433±352.28)ml、(1936.56±408.48)ml(P<0.05);用力肺活量分别为(3578.61±423.52)ml、(2996.37±778.58)ml(P<0.05),治疗组治疗前后比较具有明显的祛痰止咳作用(P<0.05);2组不良反应发生率分别为20%、25%,无显著性差异(P>0.05)。结论中西医结合治疗咳嗽的疗效显著,仁志止咳颗粒具有较好的祛痰止咳作用。

Objective To evaluate the efficacy and safety of Renzhi Granules phosphate solution for cough. Methods The study was a randomized, doubleblind, parallel contrast clinical trial, a total of 60 patients who were characterized chiefly by nonproductive cough in symptoms were randomly assigned to receive Renzhi Granules in combination with Ievofloxacin hydrochloride injection（ treatment group） or levofloxacin hydroctdoride injection alone（ control group）for seven days. The main outcome measures were improvement of the symptoms such as cough, expectoration, snuffles and adverse reactions. Results There were significant improvement in cough in both groups after treatment（P〈0.05）, but no significant difference were noted between 2 groups（P〉0. 05）. For treatment group and control group,the effectual rates were 36. 84% and 36. 36% （P 〈0.05） ;the effective rates were 84.21% and 77.27% （P〈0.05） ;the forced expiratory volume on second 1 were（2966.43±352.28） ml and （1936.56±408.48） ml（P〈0.05）, and the forced vital capacity （FVC） were （3578.61±423.52） ml and（2966.43±778.58）ml（P〈0.05）. Renzhi Granules was effective in eliminating phlegm（P〈0.05）. Incidences of adverse reactions were 20% and 25% in treatment group and control group respectively, and there was no significant statistical difference between 2 groups. Conclusion Combined treatment of traditional Chinese medicine and western medicine showed a satisfactory efficacy in the treatment of cough. Renzhi Granules is more effective in elinlhlatitlg phlegm and cough.