竹沥颗粒与鲜竹沥液治疗小儿急性上呼吸道感染咳嗽、咯痰的临床观察

Efficacy of Succus Bambusae Granule vs.Succus Bambusae Liquid for Acute Infection of the Upper Respiratory Tract Associated with Cough and Expectoration in Children

目的:探讨竹沥颗粒与鲜竹沥液对急性上呼吸道感染患儿祛痰作用的临床疗效和安全性。方法:确诊的急性上呼吸道感染患儿260例,按随机对照试验设计分为2组,竹沥颗粒组(治疗组)131例,口服竹沥颗粒,每次4 g,每日3次;鲜竹沥液(对照组)130例,每次口服30 mL,每日3次,疗程均为7 d。结果:共242例患儿完成实验,疗效分析显示:(1)疗效:治疗组愈显率(痊愈+显效)为68.33%(82/120),对照组为69.67%(85/122),总有效率(痊愈+显效+有效)则分别为90.00%(108/120)、87.70%(107/122),2组比较差异无统计学意义(P>0.05)。(2)中医症候疗效:治疗组愈显率为73.33%(88/120),对照组为72.13%(88/122),总有效率分别为91.67%(110/120)8,8.52%(108/122),2组比较差异无统计学意义(P>0.05)。(3)主要症状、体征疗效:2组咳嗽评分下降值分别为3.04±0.08、1.96±0.07,消失时间分别为(4.8±0.8)(、6.3±0.9)d;咯痰症状评分下降值分别为3.46±0.06、2.1±0.07,消失时间分别为(4.2±0.6)(、6.0±0.7)d;痰液性质评分下降分别为3.56±0.08、2.22±0.06,2组比较差异有统计学意义(P<0.05)。另外,治疗组咳嗽、咯痰、痰液性质的愈显率分别为75.00%(90/120)、80.83%(97/120)8、2.50%(99/120),对照组则分别为49.18%(60/122)4、9.18%(60/122)、54.10%(66/122),2组比较差异均具有统计学意义(P<0.05)。2组均未发生明显不良反应。结论:竹沥颗粒治疗小儿急性上呼吸道感染有效且安全,颗粒剂型在改善咳嗽、咯痰、疗效及起效时间上更优。

OBJECTIVE：To evaluate the efficacy and safety of Succus Bambusae Granule vs.Succus Bambusae Liquid for acute infection of the upper respiratory tract associated with cough and expectoration in children.METHODS： In this randomized controlled trial（RCT）,260 children acute infection of the upper respiratory tract were assigned to receive Succus Bambusae Granule（n=131） at a dose of 4 g daily t.i.d for 7 days or Succus Bambusae Liquid（control group,n=130） at a dose of 30 mL daily t.i.d for 7 days.RESULTS： The RCT was completed in 242 cases.Regarding the curative efficacy,cure or excellent efficacy appeared in 68.33%（82/120） in the treatment group as compared with 69.67%（85/122） in the control group,and the total effective rate（cure rate plus excellently effective rate and effective rate） in the treatment group vs.the control group was 90.00%（108/120） vs.87.70%（107/122）（P0.05）.With regard to the efficacy for Chinese medicine syndrome,73.33%（88/120） in the treatment group vs.72.13%（88/122） in the control group showed cure or excellent efficacy,with total effective rate of 91.67%（110/120） vs.88.52%（108/122）,showing no significant differences between the two groups（P0.05）.In terms of efficacy for cardinal symptoms and signs,the scores for cough in the two groups reduced 3.04±0.08 and 1.96±0.07,respectively,and the time for extinction of cough was（4.8±0.8） days vs.（6.3±0.9） days;the scores for expectoration were reduced by 3.46±0.06 and 2.1±0.07,respectively,with the time to expectoration extinction of（4.2±0.6）days vs.（6.0±0.7）days;the scores for quality of sputum reduced 3.56±0.08 and 2.22±0.06,respectively,showing significant differences between the two groups（P0.05）.Moreover,the rates of cure or excellent efficacy in cough,expectoration and sputum quality in the treatment group were 75.00%（90/120）,80.83%（97/120） and 82.50%（99/120）,respectively,as compared with 49.18%（60/122）,49.18%（60/122） and 54.10%（66/122）,respectively in the control group,all showing significant differences（P0.05）.The adverse reactions were unremarkable in both groups.CONCLUSION： For patients with acute infection of the upper respiratory tract,Succus Bambusae Granule was proved to be an effective and safe therapy and it is superior to Succus Bambusae Liquid in terms of improvement of cough,expectoration,curative efficacy and time to onset.