一清胶囊治疗热毒证的多中心、随机、双盲、对照试验  

A Mutli-center Randomized Double-blind Controlled Trial on the Function of Yiqing Capsule Treat Noxious Heat(Acpuei Pharyngitis,Acute Tonsillitis,Marginal Gingivitis,Recurrent Aphtha)

作　　者：丁红[1] 阎博华[1] 田理[1] 张蓉[1] 王德辉[2] 丁一[3] 林梅[3] 张瑞明[4] 周刚[5] 张瑞林[6] 宋宏杰[6] 梁国庆[7] 廖英男[7] 戚思国 李渠[8] 吴艳乔[3] 曾洁萍[1] 周宜[9] 黄晓燕 唐劲松 

机构地区：[1]四川省中医医院,四川成都610075 [2]复旦大学附属眼耳鼻喉科医院,上海200031 [3]四川大学华西口腔医院,四川成都610041 [4]四川大学华西医院,四川成都610041 [5]武汉大学口腔医院,湖北武汉430079 [6]成都市第二人民医院,四川成都610017 [7]自贡市第四人民医院,四川自贡643000 [8]达州市中心医院,四川达州635000 [9]成都中医药大学,四川成都610072 [10]成都康弘制药有限公司,四川成都610036

出　　处：《辽宁中医杂志》2011年第8期1486-1490,共5页Liaoning Journal of Traditional Chinese Medicine

基　　金：国家科技支撑计划(2007BAI40B06)

摘　　要：目的:对一清胶囊治疗热毒证(急性咽炎、急性扁桃体炎、边缘性牙龈炎、复发性口疮)的有效性和安全性进行再评价。方法:将热毒证(急性咽炎、急性扁桃体炎、边缘性牙龈炎、复发性口疮)的患者,随机分为两组。一清胶囊组375例,0.5g/粒,口服,2粒/次,3次/d。牛黄解毒胶囊189例,0.5/粒,口服,2粒/次,3次/d。疗程为急性咽炎、急性扁桃体炎连续用药5天,边缘性牙龈炎、复发性口疮连续用药7天。结果:本试验共筛查569例受试者,随机化564例。纳入FAS分析546例,其中试验组366例,对照组180例,纳入PPS分析507例,其中试验组339例,对照组168例。完成试验548例,未完成试验16例,其中试验组脱落7例,对照组脱落9例。结论:一清胶囊能有效治疗热毒证,与阳性对照药牛黄解毒胶囊相当。试验结果还显示一清胶囊能改善热毒证(急性咽炎、急性扁桃体炎、边缘性牙龈炎、复发性口疮)的主要症状,尤其能明显改善"牙龈肿痛",且改善"牙龈疼痛"明显优于牛黄解毒胶囊。本次试验未见明显毒副作用及严重不良事件,牛黄解毒胶囊腹泻11.89%发生率相比,一清胶囊腹泻发生率为1.60%。两组不良反应发生率比较差别有统计学意义(P<0.0001)。与牛黄解毒胶囊相比,一清胶囊具有更好的临床应用优势和更高的受益/风险比。Objective ： To revaluate the effect and safety of Yiqing capsule treat Noxious Heat （ Acpuei Pharyngitis, Acute Ton- sillitis, Marginal Gingivitis, Recurrent Aphtha） Methods ： The patients with Noxious Heat （ Acpuei Pharyngitis, Acute Tonsillitis, Marginal Gingivitis,Recurrent Aphtha） were included and randomized into the Yiqing capsule group（ Yiqing capsule,0.5g, po, tid. ） 375 patient,and Niuhuangjiedu capsule group（ Niuhuangjiedu capsule,0. 5g,po,tid. ） 189 patient. The period of treatment for Acpuei Pharyngitis and Acute Tonsillitis is 5d. ,The period of treatment for Marginal Gingivitis and Recurrent Aphtha is 7d. , Resttlts ：564 patients completed the trial, FAS is 546 （the trial group is 366, the control group is 180）, PP is 507 （the trial group is 339,the control group is 168 ）, 16 do not complete the trail （the trial group is 7, the control group is 9 ）, Conclusion：There was fairly between the two groups in relieving the symptoms i3f Noxious Heat（ Acpuei Pharyngitis ,Acute Tonsillitis ,Marginal Gingivitis, Recurrent Aphtha） especially in pain of gum. There was no serious adverse event and obvious toxi reaction. The incidence rate of diarrhea is 11.89% in control group and 1.60% in trial group（P 〈0. 0001 ）. The Yiqing capsule has a superiority compare with the Niuhuangjiedu capsule.

关 键 词：一清胶囊 牛黄解毒胶囊 热毒证 双盲随机对照试验 

分 类 号：R2-03[医药卫生—中医学]