儿童清咽解热口服液联合阿奇霉素颗粒治疗小儿急性咽炎肺胃实热证的临床效果

Clinical Efficacy of Ertong Qingyan Jiere Oral Liquid Combined with Azithromycin Granules in Treating Infantile Acute Pharyngitis with Lung-stomach Excess-heat Syndrome

目的:评价儿童清咽解热口服液联合阿奇霉素颗粒治疗小儿急性咽炎肺胃实热证的有效性和安全性。方法:采用随机、双盲、阳性药和安慰剂平行对照、与阿奇霉素联合治疗、多中心临床研究的方法。计划纳入240例,考虑细菌感染的患儿,按照2∶1∶1的比例随机分至观察组、阳性对照组和安慰剂组,在服用阿奇霉素颗粒的基础上,分别服用儿童清咽解热口服液、蒲地蓝消炎口服液和两者的模拟剂。疗程为5 d。观察咽痛疗效、疾病疗效、中医证候疗效及其他症状体征消失率。结果:观察组、阳性对照组和安慰剂组的咽痛疗效的愈显率分别为90.27%、81.82%、60.71%,3组比较差异有统计学意义(P<0.05),观察组优于安慰剂组,且非劣于阳性对照组。在疾病疗效愈显率和中医证候疗效愈显率方面,3组比较差异有统计学意义(P<0.05),观察组优于安慰剂组,且非劣于阳性对照组。咳嗽、口臭、小便黄、大便干单项症状的消失率,3组比较差异均有统计学意义。其中,咳嗽、小便黄、大便干的消失率,观察组优于阳性对照组和安慰剂组。3组均未报告不良反应,不良事件发生率的组间比较,差异无统计学意义(P>0.05)。结论儿童清咽解热口服液联合阿奇霉素颗粒在治疗小儿急性咽炎(肺胃实热证)咽痛症状方面,其疗效不劣于蒲地蓝消炎口服液联合阿奇霉素颗粒,且优于单用阿奇霉素颗粒,安全性良好。

Objective： To evaluate the efficacy and safety of Ertong Qingyan Jiere Oral Liquid in treatment of infantile acute pharyngitis with Lung-stomach excess-heat syndrome. Methods： This study was a multi-center clinical research with the methods of randomized,double-blind,parallel controlled. A total of 240 cases of children with bacterial infection were enrolled and divided into experimental group,positive control group and placebo group in the rate of 2∶ 1∶ 1. All patients took Azithromycin Granules as basic treatment,while the experimental group took Ertong Qingyan Jiere Oral Liquid,positive control group took Pudilan Xiaoyan oral liquid,placebo group took the simulant of them. Treatment course lasted for 5 days. The curative effects of throat pain,efficacy of disease and Traditional Chinese Medicine（ TCM） Syndrome were observed. Results： Effectiveness evaluation. The markedly effective rate of sore throat in the experimental,positive control and placebo groups were 90. 27% 、81. 82% 、60. 71% respectively.There were significant differences between the 3 groups（ P 0. 05）. Experimental group was better than the placebo group,and non-inferior to positive control group. There were significant differences between the 3 groups in the markedly effective rate of disease efficacy and TCM syndrome efficacy（ P 0. 05）. Experimental group was better than the placebo group,and non-inferior to control group. There were significant differences between the 3 groups in the disappearance rate of symptoms of cough,ozostomia,yellow urine,dry stool. For the disappearance rate of cough,yellow urine,dry stool,experimental group was better than other two groups. Safety evaluation. There were not reports about adverse events in 3 groups,and no significant differences in the incidence of adverse events between groups（ P 0. 05）. Conclusion： Ertong Qingyan Jiere Oral Liquid combined with azithromycin granule was non-inferior to Pudilan Xiaoyan oral liquid combined with azithromycin granules in lightening the throat pain of children with acute pharyngitis（ lung-stomach excess-heat syndrome）,and was superior to azithromycin granules alone with good safety.