一清胶囊治疗(热毒证)复发性阿弗他溃疡的多中心临床研究  

A multi-center clinical trial of Yiqing capsule in the treatment of recurrent aphthous ulcer with noxious heat syndrome

作　　者：彭骊苏[1,2] 李敏[1,3] 周红梅[1] 周刚[4] 张蓉[5] 吴艳乔[6] 王凌晨[7] 廖英男[8] 林梅[1] 

机构地区：[1]四川大学口腔疾病研究国家重点实验室.四川大学华西口腔医院黏膜病科,成都610041 [2]天津医科大学口腔医院 [3]重庆医科大学附属口腔医院牙周黏膜科 [4]武汉大学口腔医院 [5]成都中医药大学附属医院 [6]四川大学华西公共卫生学院 [7]成都市第二人民医院 [8]自贡市第四人民医院

出　　处：《实用口腔医学杂志》2012年第6期766-770,共5页Journal of Practical Stomatology

基　　金：国家"十一五"科技支撑计划项目(编号:2007BAI40BO6)

摘　　要：目的:观察一清胶囊治疗(热毒证)复发性阿弗他溃疡的临床疗效及安全性。方法:采用随机双盲平行对照多中心临床试验设计。纳入复发性阿弗他溃疡患者(轻型/疱疹样型),随机分入试验组(一清软胶囊)、阳性药物对照组(牛黄解毒胶囊)和安慰剂组,疗程均为7 d,比较3组治疗前后药物疗效及安全性。结果:本试验共纳入192例受试者,完成试验187例,其中试验组93例,安慰剂组48例,牛黄解毒胶囊组46例。脱落率2.6%。中医主症(疼痛)有效率:试验组86.02%,安慰剂组79.17%,牛黄解毒胶囊组84.44%;中医证候疗效有效率:试验组90.32%,安慰剂组79.17%,阳性药对照组91.11%。3组不良反应率分别为5.26%,2.08%和34.78%。结论:一清胶囊治疗(热毒证)复发性阿弗他溃疡的疗效与牛黄解毒胶囊相当,且安全性更好。Objective： To study the effects and safety of Yiqing capsule in the treatment of recurrent aphthous ulcer（RAU） with noxious heat syndrome. Methods： A randomized controlled multi-center clinical trial was conduced, The patients with RAU （minor aphthous ulcer or herpetiform ulcers ） were randomly divided into trial group （ Yiqing capsule group ）, positive control group （ Ni- uhuangjiedu capsule group） and placebo group. Patients were treated for 7 days. The efficacy and safety of the drugs were analyzed. Results： 192 patients were included, 187 cases（93 in Yiqing capsule group, 48 in placebo group and 46 in Niuhuangjiedu capsule group） completely underwent the trial, the total drop-out rate was 2.6%. The effective rate of pain control was 86.02% in the trial group, 79.17% in the placebo group and 84.44% in the positive control respectively. The effective rate of traditional chinese medi- eine（TCM） syndrome was 90.32% in the trial group, 79.17% in the placebo group and 91.11% in the control group. The adverse reaction rates in the 3 groups were 5.26%, 2.08% and 34.78% respectively. Conclusion： Yiqing capsule is effective in the treatment of RAU with noxious heat syndrome with less adverse reation than Niuhuangjiedu capsule.

关 键 词：一清胶囊 牛黄解毒胶囊 复发性阿弗他溃疡 热毒证 多中心药物临床试验 

分 类 号：R781.5[医药卫生—口腔医学]