童喘清颗粒缓解儿童支气管哮喘慢性持续期症状及改善虚哮证候Ⅱ期临床试验

Effect of Tongchuanqing Granules on relief of the chronic persistent symptom of children with bronchial asthma and improvement of deficient asthma syndrome: A phase Ⅱclinical study

目的:探索童喘清颗粒对于儿童支气管哮喘慢性持续期的症状缓解作用和虚哮证候改善作用。方法:采用随机、双盲、安慰剂平行对照、多中心临床研究方法进行其Ⅱ期临床试验。结果:治疗4周后,两组哮喘控制水平比较,试验组118例,控制率75.42%,对照组117例,控制率51.28%,差异显著(P<0.01);两组治疗前后早晨呼吸峰流速(PEF)实测值变化,差异显著(P<0.01);两组中医证候疗效比较,试验组愈显率55.93%,对照组30.77%;两组等级疗效、总有效率比较,差异显著(P<0.01);FAS、PPS分析结论一致。结论:童喘清颗粒对于儿童支气管哮喘慢性持续期的疗效优于安慰剂,且未发现不良反应。

Objective： To explore the effect of Tongchuanqing Granules on the relaxation effect of chronic persistent symptom of children with bronchial asthma and improvement of the dei cient asthma syndrome. Methods： Randomized, double blind, parallel control of placebo and multi-center clinical trial were the research methods to perform phase Ⅱ clinical study. Results： After 4 weeks＇ treatment, there was signii cant dif erence between the treatment group and the control group in controlling the asthma symptom（P〈0.01）. One hundred and eighteen patients were selected as the treatment group, and the control rate was 75.42%, while 117 patients were selected as the control group, and the control rate was 51.28%. There was signii cant dif erence in morning PEF measured values compared after treatment with before（P〈0.01）. The efficacy rate on TCM syndrome of the treatment group was 55.93% and that of the control group was 30.77%. There were signii cant dif erences in curative effect grade and effective percentage（P〈0.01）. With no dif erence, the conclusion was drawn by the methods of FAS and PPS. Conclusion： The effect of Tongchuanqing Granules for children with bronchial asthma in chronic persistent period is better than the placebo, without the adverse reactions.