小儿反复呼吸道感染中医治疗优化方案临床研究

Clinical research on optimization program of treating recurrent respiratory tract infection(RRTI) in children with Chinese medicine

目的:评价中医药防治小儿反复呼吸道感染优化方案的有效性和安全性。方法:采用分层区组随机、双盲、安慰剂平行对照、多中心临床试验、优效性检验设计。结果:试验组125例,临床痊愈率为66.40%;对照组124例,临床痊愈率为14.52%,两组疾病疗效优效性检验显示,试验组临床痊愈率高于对照组(P<0.01)。1年内上感、气管炎、肺炎发作次数的组间比较差异均有显著性统计学意义,试验组均低于对照组。随访12个月中医证候单项评分组间比较,除手足心热、低热外,组间比较差异均有显著性统计学意义。本次试验两组均未报道不良事件及不良反应的发生。结论:小儿反复呼吸道感染中医优化治疗方案临床有效优于安慰剂,可明显降低反复呼吸道感染次数,且临床应用未见不良反应发生。

Objective： To evaluate the effect and safety on the optimization program of preventing and treating recurrent respiratory tract infection（RRTI） in children with Chinese medicine.Methods： Adopted stratified block randomized,double-blind,parallel placebo-controlled,multi-center clinical trial,superiority design method.Results： The clinical cure rate of test group（125 cases） was 66.40%,which of control group（124 cases） was 14.52%.The superiority test of disease efficacy showed that the total cure rate of test group was higher than which of control group.The comparison between the two group on the flu,bronchitis,pneumonia＇s number was significant different statistically.That is to say,the test group was less than the control group.The comparison on individual symptom＇s score between the two group,except for dysphoria heat and low heat,the difference between groups was significant different statistically.Furthermore,there was no adverse event and adverse reaction on two groups.Conclusion： With being able to reduce the number of RRTI significantly and having no clinical adverse reaction,the optimization treatment on treating RRTI in children with Chinese medicine is effective,which is superior to the placebo.