摘要
目的:验证蒡勃乳蛾消颗粒治疗小儿急性扁桃体炎(外感风热证)的有效性及安全性,从而为临床提供具有疏风清热、解毒利咽功效并保留中药汤剂特点的一种新制剂。
方法:运用随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法,将符合急性扁桃体炎(外感风热证)诊断标准的88例患儿分为试验组和对照组,试验组66例患儿服用蒡勃乳蛾消颗粒,对照组22例患儿服用小儿清咽颗粒,两组均以5天为1个疗程,服药1个疗程后,通过中医证候分级量化标准表,观察两组患儿治疗前后发热、咽喉肿痛等症状改善情况。
结果:试验组疾病治愈率为66.67%,显效率为90.91%,病证治愈率为68.18%,显效率为90.91%;对照组疾病治愈率为31.82%,显效率为63.64%,病证治愈率为36.36%,显效率为63.64%,疾病疗效P<0.05,病证疗效P<0.05,两组疾病疗效、病证疗效比较有显著性差异,试验组总疗效优于对照组。两组患儿在咽痛改善时间方面比较有显著性差异(P<0.05),试验组改善咽痛疗效优于对照组。退热时间方面,两组比较无显著性差异(P>0.05),两组退热疗效相当。试验组、对照组患儿均未出现不良反应。
结论:蒡勃乳峨消颗粒为治疗小儿急性扁桃体炎外感风热证安全有效的药物,在改善咽痛症状,疾病疗效、病证疗效方面比较优于对照组。
Objective:To verify efficacy and safety of Bangboruexiao granule due to acute tonsillitis in Children Caused by Exogenous wind-heat.
Methods:88patients that met the diagnostic criterion of the acute tonsillitis were equally divided into the experimental group (66patients) and the control group (22patients) in a random,double blinded double dummy,positive and parallel control way.The experimental group was taken Bangboruexiao granule,and the control group was taken Xiaoerqingyan granule,both groups were5days for a course of treatment. And then we observed the improvement situations of the sore throat,fever and the other symptoms in both groups before and after the treatment according to the quantitative criteria table of TCM syndrome classification.
Results:The effective rate of the experimental group is90.91%,while the rate of the control group is63.64%,the difference is remarkable (P<0.05),the effect of the experimental group is better.Compared with the control group,there was a significant difference (P<0.05) in the experimental group in improving the sore throat.Compared with the control group,there was no significant difference (P>0.05) in the experimental group in improving the fever.
Conclusion:Bangboruexiao granule is effective due to acute tonsillitis in Children Caused by Exogenous wind-heat.
引文
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