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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 observe the clinical efficacy and safety of Yiqing Capsule in treating recurrent aphthous ulcer. Methods: A randomized, double-blind, parallel-control multicenter trial was designed. The patients with recurrent aphthous ulcer (light / herpes type) were enrolled in the study. The patients were randomly divided into experimental group (Yiqing soft capsule), positive drug control group (Niuhuangjiedu capsule) and placebo group. The course of treatment was 7 days, compared with 3 Group before and after treatment of drug efficacy and safety. Results: A total of 192 subjects were enrolled in this study. A total of 187 trials were completed, of which 93 were in the test group, 48 in the placebo group and 46 in the Niuhuang Jiedu Capsule group. 2.6% off rate. The effective rate of TCM syndromes (pain) was 86.02% in the experimental group, 79.17% in the placebo group and 84.44% in the Niuhuang Jiedu Capsule group. The effective rate of TCM syndromes was 90.32% in the experimental group, 79.17% in the placebo group and 91.11% in the positive drug group %. Adverse reactions in the three groups were 5.26%, 2.08% and 34.78%, respectively. Conclusion: The treatment of recurrent aphthous ulcer caused by Yiqing Capsule (heat toxin card) is equivalent to that of Niuhuang Jiedu Capsule, and has better safety.