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目的：评价片仔癀外涂联合口服治疗复发性阿弗他溃疡的临床疗效及安全性。方法66例复发性阿弗他溃疡患者随机分为试验组31例和对照组35例，对照组溃疡部位外涂锡类散，每天3次；口服牛黄解毒片，每次3片，每天3次，直至溃疡愈合。试验组取片仔癀1g制成粉末并涂在溃疡表面，每天3次，口服片仔癀，每次0.5 g，q6 h，同时服用牛黄解毒片，每天3次，每次3片，直至溃疡愈合。观察2组患者的溃疡愈合时间，临床疗效及愈合后1月内复发情况。结果试验组总有效率为100％，显著高于对照组的80.0％（ P＜0.05）。试验组口腔溃疡平均愈合时间为（3.0±0.8） d，对照组愈合时间为（4.8±1.2） d，试验组愈合时间显著低于对照组（ P＜0.05）。2组患者随访1月，试验组复发8例，对照组复发19例，试验组复发风险显著低于对照组（ P＜0.05）。2组患者用药期间均未发现明显的不良反应。结论片仔癀外涂联合口服治疗复发性阿弗他溃疡可加速溃疡愈合，减少复发风险，且不增加不良反应的发生率。“,”Objective To evaluate the clinical efficacy and safety of Pianzaihuang in the treatment of recurrent aphthous ulcer .Methods A total of 66 cases with recurrent aphthous ulcer were randomly divided into treatment group ( n=31 ) and control group ( n=35 ) .Patients in control group were administered with the Xilei San , tid, and Niuhuang Jiedu Pian, tid, until the ulcer coalesced.Those in treatment group were treated with Pianzaihuang 1 g for external use and 0.5 g by oral adminis-tration, q6 h, plus Niuhuang Jiedu Pian , tid, until the ulcer coalesced. The data of healing time of ulcer , clinical efficacy and risk of recurrence were compared between the two groups .Results The total effective rate in experiment group was 100%, significantly higher than that in the control group ( 80.0%, P<0.05 ) .The mean ulcer healing time was ( 3.0 ±0.8 ) d and ( 4.8 ±1.2 ) d in two groups , which showed treatment group was significantly shorter ( P <0.05 ) .In one -month follow-up, there were 8 cases and 1 case reoccurred in treatment and control group , and the recurrence risk in the treatment group was signifi-cantly lower than that in the control group ( P<0.05 ) .Conclusion Panzaihuang can accelerate the healing of the recurrent aphthous ulcer , decrease the risk of recurrence without increase obvious adverse reaction .