氨来呫诺糊剂治疗复发性阿弗他繯竦牧俅惭芯?  

Treatment of recurrent aphthous ulcer with amlexanox paste

作　　者：吴军正  周威  王勤涛  王文梅  王宝彦 [3] 曹立萍 [3] 夏结来 [4] 温德升 

机构地区：[1]第四军医大学口腔医院国家药品临床研究基地,710032 [2]南京大学医学院附属口腔医院 [3]西安交通大学口腔医院 [4]第四军医大学卫生统计学教研室

出　　处：《实用口腔医学杂志》2005年第4期487-491,共5页Journal of Practical Stomatology

摘　　要：目的:研究50g/L的氨来呫诺糊剂治疗复发性阿弗他繯竦挠行院桶踩浴7椒?应用随机、双盲、平行对照的临床试验方法,试验组和对照组各纳入120例轻型复发性阿弗他受试者,分别应用50g/L氨来呫诺糊剂和空白基质糊剂,4次/d;应用5d。于初诊后第4天和第6天进行随访,采用视觉类比量表获取的疼痛指数评估其镇痛效果,并比较2组受试者的溃疡愈合时间,用药前、后进行血常规、血生化和心电图检查。结果:试验组和对照组完成病例分别为115例和113例(P>0.05)。初诊时2组的总体疼痛指数分别为18.12±7.18和18.09±7.15(P>0.05);第4天分别为7.56±6.87和10.00±7.07(P<0.01);第6天分别为2.14±4.70和3.84±5.75(P<0.01)。50%受试者溃疡愈合在试验组为5d,空白基质组为6d。与研究药物有关的不良事件在氨来呫诺组有10例(8.40%),在空白基质组中有9例(7.5%)(P>0.05)。全部不良事件均为轻度,未经处理即好转。2组受试者在治疗结束时血常规、血生化和心电图检查结果均为正常或异常但无临床意义。Objective:To study the effects of 50 g/L amlexanox paste in the treatment of recurrent aphthous ulcer (RAU). Methods:A randomized, double-blind trial method was applied in the treatment of RAU. 120 cases in the experimental group and another 120 cases in the control group were administered with 50 g/L amlexanox paste and placebo respectively on the ulcer 4 times a day for 5 days. Follow-up was conducted on day 4 and day 6 after the first visit of the patients. Pain control effect was evaluated with pain index (PI) expressed by visual analog scale. Healing time was used to compare the duration of RAU (DR) in the two groups. Results:Treatment was completed in 115 and 113 cases in the experimental and control groups respectively (P>0.05). On the day of the first visit total PI in experimental and control groups was 18.12±7.18 and 18.09±7.15 (P>0.05), on the 4th day 7.56±6.87 and 10.00±7.07 (P<0.01), on 6th day 2.14±4.70 and 3.84±5.75 (P<0.01), respectively. DR (days) of 50% cases in the in experimental and control groups was 5 and 6 respectively. Mild adverse drug reacion was observed in 10 cases(8.40%)in the experimental group and 9(7.5%)in the control (P>0.05). After therapy all the data of electrocardiogram, blood routine examination and blood biochemical test of the cases were without clinical significance. Conclusion:50 g/L amlexanox is effective and safe in the treatment of RAU.

关 键 词：复发性阿弗他溃疡 氨来咕诺 双盲试验 

分 类 号：R781.5[医药卫生—口腔医学]