千金口疮加味颗粒治疗阴虚火旺型复发性口腔溃疡的临床观察

Treatment of Recurrent Oral Ulceration( Yin Deficiency Fire Excess Type) by Qianjin Kouchuang Jiawei Granule: a Clinical Observation

目的观察千金口疮加味颗粒治疗阴虚火旺型复发性口腔溃疡的临床疗效。方法将120例中医辨证为阴虚火旺型的复发性口腔溃疡患者随机分为观察组和对照组,每组60例。观察组予千金口疮加味颗粒口服,对照组予口炎清颗粒治疗,用量均为每次20 g,每天2次,14天为1个疗程,连续治疗2个疗程。分别于治疗前、治疗后第3、7天评估两组患者症状体征积分(溃疡面积、渗出、充血、水肿、溃疡数目、烧灼感及疼痛程度),治疗后7天通过症状体征积分进行近期疗效判定,用药后12个月通过溃疡发作总间歇时间及总溃疡数进行远期疗效判定。结果与本组治疗前比较,两组治疗后3、7天各症状体征积分均明显改善(P<0.05);治疗3天后,与对照组比较,观察组在水肿、渗出、疼痛程度及烧灼感4项改善更明显(P<0.05,P<0.01);治疗7天后,观察组水肿、疼痛程度及烧灼感较对照组明显改善(P<0.05)。近期疗效:观察组总有效率为86.67%(52/60),对照组为83.33%(50/60),两组比较,差异无统计学意义(P>0.05)。远期疗效:观察组总有效率90.00%(54/60),明显高于对照组的81.67%(49/60),两组比较,差异有统计学意义(P<0.05)。治疗后12个月,与对照组比较,观察组总溃疡数减少,溃疡发作总间歇时间延长,差异均有统计学意义(P<0.05)。结论千金口疮加味颗粒治疗复发性口腔溃疡远期疗效优于口炎清颗粒。

Objective To observe the curative effect of Qianjin Kouchuang Jiawei Granule（ QKJG） on recurrent oral ulceration [yin deficiency fire excess type（ YDFET） ]. Methods Totally 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 longterm efficacy. Results Compared with before treatment in the same group,symptoms and signs were obviously improved at day 3and 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 experimentgroup 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）. Conclusion QKJG showed better long-term efficacy than that of KG in treating recurrent oral ulceration（ YDFET）.