匹多莫德治疗复发性阿弗他溃疡的临床研究

Observation of the effect of pidotimod on recurrent aphthous ulcer

目的观察匹多莫德治疗复发性阿弗他溃疡(Recurrent aphthous ulcer,RAU)的临床疗效与不良反应。方法将2012年6月至2014年6月我院收治的120例RAU患者随机分为2组,A组60例患者早、晚餐后2 h服用匹多莫德口服液,7 m L/次,B组60例患者三餐后30 min口服维生素B2,0.5 mg/次。全身用药时间为8周,嘱患者在4、8、12、16、20、24周内复诊并记录各个阶段患者的情况,采集数据。两组观察期均为6个月。根据中华口腔医学会黏膜病专业委员会的"RAU疗效评价试行标准"进行疗效评价。结果两组患者在治疗期内的总间歇期均延长,A组由第4周的506 d延长到第24周的654 d,B组由第4周的314 d延长到第24周的448d;溃疡总数目均减少,A组由第4周的267个减少到第24周的159个,B组由第4周的345个减少到第24周的243个。治疗后4、8、12、16、20、24周,A组间歇期长于B组(P<0.05),溃疡数少于B组(P<0.05)。A组显效、有效例数多于B组(P<0.05)。A组有3例发生轻度不良反应,自行恢复,B组未观察到不良反应。结论匹多莫德治疗RAU具有较好的疗效,且不良反应轻,值得临床推广使用。

Objective To observe the effects and adverse reactions of pidotimod in the treatment of recurrent aphthous ulcer（ RAU）. Methods One hundred and twenty RAU patients were divided into 2 groups. Group A（ n =60） was treated with 0. 7 m L pidotimod twice daily at 2 h after breakfast and dinner,group B（ n = 60） received 0. 5mg Vit B2 orally three times daily at 30 min after 3 meals. The medication lasted for 8 weeks,The data of patients at 4,8,12,16,20,24 weeks after medication was collected by the follow-up. The efficacy was evaluated according to the trial standard of Chinese Stomatological Association. Results The total intermittent period of RAU in group A increased from 506 d to 654 d,and it increased from 314 d to 448 d in group B during 24 weeks of treatment; the total number of ulcer in group A decreased from 267 to 159,and it decreased from 345 to 243 in group B during 24 weeks of treatment. At 4,8,12,16,20,24 weeks after treatment,the intermittent period of RAU in group A was longer than that of group B respectively（ P〈0. 05） with less ulcer cases（ P〈0. 05）. The number of obvious effective cases and effective cases in group A was more than that of group B respectively（ P〈0. 05）. Three cases of minor adverse reaction was observed in group A. Conclusion Pidotimod is effective in the treatment of RAU without severe adverse reactions.