竹沥颗粒和鲜竹沥液治疗小儿痰热咳嗽随机对照临床试验

A Randomized,Controlled Trial of Zhuli Granule and Liquid in Treat-Infection of the Upper Respiratory Tract with Cough and Expectoration

目的比较不同剂型的竹沥制剂(竹沥颗粒、鲜竹沥液)治疗急性支气管炎咳嗽、咳痰的功效及安全性差异。方法采用双盲双模拟方法,纳入240例急性支气管炎(痰热咳嗽)患儿,随机分为两组。竹沥颗粒组(治疗组)120例,口服竹沥颗粒+鲜竹沥液模拟剂;鲜竹沥液组(对照组)120例,口服鲜竹沥液+竹沥颗粒模拟剂。两组疗程均为7 d,主要症状随访至10 d,观察治疗前后症状、体征变化和有无不良反应,并进行血、尿、大便常规,肝肾功能及心电图检查。结果两组在急性支气管炎疗效、中医症候疗效上疗效相当。针对疾病主要症状咳嗽、咳痰的疗效,治疗组和对照组临床总有效率分别为96.61%和81.90%,咳嗽、咳痰消失时间分别为(5.4±0.8)d和(9.3±0.8)d,两组之间各项比较均有差异(P<0.05)。观察中未发现明显不良反应。结论竹沥固体制剂和液体制剂治疗急性支气管炎的疗效确切且相当;在主要症状咳嗽、咳痰改善方面,固体制剂优于液体制剂。

Objective To evaluate the efficacy and safety of Zhuli granule and Liquid in treatinfection of the upper respiratory tract with cough and expectoration. Methods The randomized controlled method was conducted. 240 patients were randomly divided into the treatment group and control group, both groups were all treated for 7 days. The accumulated scores of clinical symptoms and physical sign,adverse effect were recorded before and after the treatment. The safety indexes, such as routine tests of blood,urine and stool,hep- atic and renal function tests and electrocardiogram （ECG） were taken before and after the treatment. Results There is no difference effect of infection of the upper respiratory tract nor of Chinese medicine syndrome between the two groups.. But of the effect of cardinal symp- tom of cough and expectoration：efficacy rate and total efficacy rate of PPS were 96.61% ,81.90% in group A and B respectively, out time of cough and expectoration were （5.4±0. 8）d, （9.3±0.8）d respectively, there were significant difference between the two groups （P〈 0. 05）. No Obvious adverse effect was found in the trial. Conclusion Zhuli Granule and Liquid are effective and safe in treating infection of the upper respiratory tract, effect of cough and expectoration of Zhuli Granule were,without obvious adverse effect Zhuli Liquid.