蒲地蓝可炎宁牙膏治疗复发性阿弗他溃疡的临床研究  

Clinical study of treatment of recurrent aphthous ulcer with Pudilan Keyanning toothpaste

作　　者：许隽永[1] 赵玉萍[1] 刘青兰[1] 吴国英[1] 范媛[1] XU Juanyong ZHAO Yuping LIU Qinglan WU Guoying FAN Yuan.(Jiangsu Key Laboratory of Oral Diseases, Nanjing Medical University, Department of Oral Medicine, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing 210029, China)

机构地区：[1]南京医科大学口腔疾病研究江苏省重点实验室,南京医科大学附属口腔医院黏膜科病科,江苏南京210029

出　　处：《口腔医学》2016年第11期1023-1026,共4页Stomatology

基　　金：江苏高校优势学科建设工程资助项目(2014-37)

摘　　要：目的研究蒲地蓝可炎宁牙膏治疗复发性阿弗他溃疡的有效性和安全性。方法将轻型复发性阿弗他患者引用随机、双盲、平行对照的临床试验方法,分为试验组(40例)和对照组(入组40例,实际完成39例),分别应用蒲地蓝可炎宁牙膏和空白对照牙膏,2次/d,治疗6 d。比较2组溃疡愈合时间、靶溃疡的愈合率、疼痛指数变化、靶溃疡的面积和渗出、充血程度评分,并记录不良事件。结果用药6 d后,试验组和对照组的靶溃疡愈合率分别为95.00%、51.28%(P<0.05)。50%受试者溃疡愈合在试验组为5 d,对照组为6 d(P<0.05)。两组治疗第6天的疼痛指数评分、靶溃疡的面积、渗出和充血程度评分的比较均有统计学意义(P<0.05)。2组均未发生与牙膏有关的不良事件。结论蒲地蓝可炎宁牙膏治疗复发性阿弗他溃疡是安全有效的。Objective To study the effectiveness and security of Pudilan Keyanning toothpaste on the treatment of recurrent aphthous ulcer（ RAU）. Methods A randomized,double-blind,placebo-controlled clinical trial was applied in the treatment of RAU. 40 cases in the experimental group and the other 40 cases（ 39 cases finished） in the control group were administered with Pudilan Keyanning toothpaste and placebo respectively on the ulcer twice a day for 6 days. The effect was evaluated by ulcer healing ratio,ulcer healing time,change of pain indexes,ulcer area,exudates and hyperemia score of ulcer. Safety of the toothpaste was monitored by adverse even（ AE） observation. Results Treatment was completed,40 and 39 cases in the experimental and control groups respectively. The ulcer healing ratio of two groups was 95. 00% and 51. 28% respectively at day 6（ P〈0. 05）. DR（ Days） of 50% cases in the experimental and control groups were 5 and 6 respectively. Comparisons of pain indexes,area of ulcer,exudates and hyperemia score of ulcer at day 6 showed remarkable significance. No AE related to the toothpaste occurred in the two groups. Conclusions Pudilan Keyanning toothpaste is effective and safe in the treatment of RAU.

关 键 词：复发性阿弗他溃疡 蒲地蓝可炎宁牙膏 双盲试验 

分 类 号：R781.5[医药卫生—口腔医学]