口糜方治疗复发性阿弗他溃疡的近期和远期疗效观察

Short-term and long-term clinical evaluation of Koumi Formula in treating recurrent aphthous ulcer

目的:评价口糜方治疗复发性阿弗他溃疡(心脾积热、脾虚生热证)的近期和远期疗效以及安全性。方法:将110例复发性阿弗他溃疡患者随机分成治疗组和对照组,治疗组54例予口糜方治疗,对照组52例用肿痛安胶囊治疗,两组均服用1个月为1个疗程,分别进行药后7d的近期疗效和药后1年的远期疗效评价。结果:用药7d后与对照组比较,治疗组平均溃疡期明显缩短(P<0.01),疼痛指数减小(P<0.05);治疗组临床疗效显著,总有效率显著优于对照组(P<0.05);治疗组中医证候疗效临床痊愈率、总有效率显著优于对照组(P<0.01)。治疗组在治疗后1年未复发的痊愈率、显效率、总有效率显著优于对照组(P<0.01)。治疗组未发现不良反应。结论:口糜方治疗复发性阿弗他溃疡(心脾积热证、脾虚生热证)近期和远期疗效均显著,且安全性好,值得在临床上推广应用。

Objective： To evaluate the short-term and long-term curative effect and safety of Koumi Formula（KMF） in treating recurrent aphthous ulcer（RAU）（brimming heat of heart and spleen, heat due to spleen deficiency syndrome）. Methods： With the study method of randomized controlled trial, totally 110 RAU patients were randomly divided into the treatment group（54 cases） and the control group（52 cases）. Patients in the treatment group were treated with KMF, while those in the control group took Zhongtongan Capsule, 1 month as one therapeutic course. After 7 days of treatment, the short-term curative effect was evaluated, and the long-term curative effect was evaluated 1 year after treatment. Results： After 7 days of treatment with KMF, the average ulcer stage was significantly shortened（P0.01） and the pain index of ulcer significantly decreased（P0.05）. The clinical comprehensive curative effect was higher in the treatment group than that in control group（P0.05）, and the total effective rate of the treatment group was 100%. Meanwhile, the total effective rate of Chinese medical syndrome was 100% in the treatment group. The clinical cure rate was 18.5%. There were statistically significant differences between 2 groups in the total effective rate of the Chinese medical syndrome（P0.05）. The cure rate of the treatment group was 51.9%, the markedly effective rate was 40.7%, and the total effective rate was 100%, which was significantly better than that of the control group（P0.01）. No adverse reactions were found in the treatment group. Conclusion： KMF has obvious short-term and long-term curative effect in treating RAU（brimming heat of heart and spleen, heat due to spleen deficiency syndrome）, it is safe and worth of popularizing and applying in the clinic.