口腔溃疡含片治疗复发性阿弗他溃疡Ⅲ期临床试验  

A phase Ⅲ clinical trial of oral ulcer buccal tablets in the treatment of recurrent aphthous ulcer

作　　者：刘敏 邢树国 王勤涛[2] 苗群爱[3] 董金凤[4] 

机构地区：[1]西安海欣制药有限公司,710075 [2]第四军医大学口腔医学院 [3]西安交通大学口腔医院 [4]陕西省人民医院

出　　处：《实用口腔医学杂志》2010年第5期664-667,共4页Journal of Practical Stomatology

摘　　要：目的:比较口腔溃疡含片和口腔溃疡散治疗复发性阿弗他溃疡的效果。方法:用多中心、随机、平行对照Ⅲ期临床试验,纳入患复发性阿弗他溃疡受试者试验组(含片组)312例,对照组(散剂组)104例。含片组用口腔溃疡含片,散剂组用口腔溃疡散,治疗6d。比较2组受试者的溃疡愈合时间、目标溃疡的逐日愈合率、疼痛指数变化、首次用药后疼痛缓解起始和维持时间、有效率。用药前、后进行血常规、血生化和心电图检查,记录不良事件。结果:试验组和对照组完成符合方案病例(PPS)分别为306例和100例。与散剂组相比,含片组中位溃疡愈合期较短(分别为6d和7d);目标溃疡的逐日愈合率较高(P<0.05),显效率与有效率之和较高(P<0.05),疼痛指数下降值较大(P<0.05),首次用药后疼痛缓解维持时间较长(P<0.05),与研究药物有关的不良事件发生率较低(P<0.05)。2组不良事件均为轻度。治疗前后各项实验室检查结果均无明显异常变化。结论:口腔溃疡含片在促进溃疡愈合、减轻疼痛、药效维持时间等方面优于口腔溃疡散。Objective：To compare the effect of oral ulcer buccal tablets with oral ulcer powder in the treatment of recurrent aphthous ulcer（RAU）.Methods：A multi-center randomized Phase Ⅲ clinical trial was conducted.312 cases of RAU were enrolled in the experimental group and 104 in the control.The patients in the experimental group were treated by oral ulcer buccal tablets and those in control by oral ulcer powder.The treatment was continued for 6 days,the effect was evaluated by median duration of RAU（MDR）,daily healing ratio（DHR）,decrease of pain index（DPI）,pain control time（PCT）and effecient ratio（ER）.Safety of the drugs was monitored by clinical lab examination and adverse event（AE）observation.Results：Treatment was completed in 306 experimental cases and 100 control cases respectively.In the experimental group MDR was shorter（6 vs 7 days）,DHR higher（P0.05）,DPI more（P0.05）,PCT longer（P0.05）,ER higher（P0.05）and drug related AE less（P0.05）.All AE were mild and lab examination showed no obvious abnormal changes.Conclusion：Oral ulcer buccal tablet is more effective in the treatment of RAU.

关 键 词：复发性阿弗他溃疡 口腔溃疡含片 口腔溃疡散 Ⅲ期临床试验 

分 类 号：R781.5[医药卫生—口腔医学]