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-cine(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 treat-rnment of RAU with noxious heat syndrome with less adverse reation than Niuhuangjiedu capsule.%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),随机分人试验组(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.
展开▼
