氨来呫诺糊剂治疗复发性口腔溃疡临床研究

目的研究氨来呫诺糊剂的临床疗效和安全性。方法采用随机、双盲、安慰剂平行对照临床试验法，选择复发性口腔溃疡患者222例，随机分为试验组及对照组，分别给予5g：250mg的氨来呫诺糊剂或氨来呫诺糊剂基质4次／d，连续3d溃疡面涂布治疗。以用药前后患者口腔溃疡的平均溃疡期及疼痛指数作为疗效指标评价药物的疗效。结果试验组平均溃疡期为（5．91±1．64）d，对照组为（8．89±1．71）d（P〈0．05）；试验组临床有效率为85．0％，优于对照组35．2％（P〈0．05）。试验组不良反应发生率为2．78％，对照组为5．66％（P〉0．05），均为灼热、皮肤丘疹、口干等轻微不良反应。结论氨来呫诺糊剂能有效减轻复发性口腔溃疡的疼痛症状，明显缩短溃疡愈合期。

Clinical research of amlexanox paste in the treatment of recurrent aphthous ulcers

Objective To study the effect and safety of Amlexanox Paste. Methods A vehicle-controlled, randomized, double-blind, parallel group clinical trial of amlexanox was carried out in the treatment of recurrent aphthous ulcers（RAU）. Clinical trail involved 222 subjects. During the treatment period, which lasted for 3 days, patients received either placebo paste or amlexanox paste 4 times per day. Efficacy was assessed by pain index and duration of RAU. Results The duration of RAU in study and control group was （ 5.91 ± 1.64） days and （ 8.89 ± 1.71 ） days respectively （ P 〈 0. 05 ）. The total rate of clinical efficacy in study group and control group was 85.0% and 35.2% respectively （P 〈0. 05）. The rate of side effects in study group was 2. 78% and in control group was 5.66% （ P 〉 0. 05 ）. Conclusion Amlexanox is effective in alleviating the pain of RAU and significantly reduced the duration of RAU.