OBJECTIVETo observe the curative effect of Qianjin Kouchuang Jiawei Granule (QKJG) on recurrent oral ulceration [yin deficiency fire excess type (YDFET)].

METHODSTotally 120 patients who suffered from recurrent oral ulceration (YDFET) were randomly assigned to two groups, the experiment group and the control group, 60 in each group. Patients in the experiment group took QKJG, 20 g each time, twice per day, while those in the control group took Kouyanqing Granule (KG) , 20 g each time, twice per day. Fourteen days consisted of one therapeutic course, two for all. Scores for patients' symptoms and signs (ulcer area, exudation, hyperaemia, edema, the number of ulceration, burning sensation, and pain degrees) were assessed before treatment, at day 3 and 7 after treatment. Short-term efficacy was assessed by visual analogue scale (VAS). The total paralysis time and the total number of ulceration at month 12 after treatment were taken as judgment for long-term efficacy. Results Compared with before treatment in the same group, symptoms and signs were obviously improved at day 3 and 7 after treatment in the two groups (P < 0.05). Compared with the control group at day 3 after treatment, the improvement of edema, exudation, pain degree, and burning sensation was more obvious in the experiment group (P < 0.05, P < 0.01). The improvement of edema, pain degree, and burning sensation at day 7 after treatment was more obvious in the experiment group than in the control group (P < 0.05). As for short-term efficacy, the total effective rate was 86.67% (52/60 cases) in the experiment group and 83.33% (50/60 cases) in the control group, with no statistical difference between the two groups (P > 0.05). As for long-term efficacy, the total effective rate was 90.00% (54/60 cases) in the experiment group, significantly higher than that of the control group with statistical difference [81.67% (49/60 cases), P < 0.05]. At month 12 after treatment, the total number of ulceration was reduced and the paralysis time of ulcer attack prolonged in the experiment group, with statistical difference when compared with the control group (P < 0.05).

CONCLUSIONQKJG showed better long-term efficacy than that of KG in treating recurrent oral ulceration (YDFET).