康复新液和重组牛碱性成纤维细胞生长因子外用溶液治疗顽固性轻型复发性阿弗他溃疡的疗效比较

Kangfuxin Liquid versus Beifuji Solution in the treatment of refractory minor recurrent aphthous ulcer

目的复发性阿弗他溃疡(RAU)病因及发病机制尚不完全明确,至今仍缺乏有效的根治方法。文中旨在比较康复新液和重组牛碱性成纤维细胞生长因子外用溶液治疗顽固性轻型复发性阿弗他溃疡(Mi RAU)的短期疗效。方法选择2016年3月至2018年6月南京大学医学院附属口腔医院口腔黏膜病科门诊诊断为顽固性Mi RAU的150例患者进行前瞻性研究。随机分为5组:康复新液组(康复新液)、生长因子组(重组牛碱性成纤维细胞生长因子外用溶液)、吞服盐水组(吞服等渗盐水)、喷涂盐水组(喷涂等渗盐水)、空白对照组(不接受治疗),每组30例。记录第1、3、5、7天溃疡面积、疼痛指数及首次用药后的止痛起效时间、止痛维持时间、平均溃疡期等。结果第3、5、7天,康复新液组溃疡面积明显小于吞服盐水组、空白对照组(P<0.05);生长因子组明显小于喷涂盐水组、空白对照组(P<0.05)。第3、5天,生长因子组疼痛指数[(3.35±1.23)、(2.32±1.80)]明显小于喷涂盐水组[(5.08±1.83)、(3.53±1.50)]、空白对照组[(5.50±1.69)、(3.79±1.34)],康复新液组[(4.21±1.47)、(2.97±1.69)]明显小于吞服盐水组[(5.29±1.73)、(3.74±1.42)]、空白对照组(P<0.05);第3天,生长因子组明显小于康复新液组(P<0.05)。康复新液组平均溃疡期较生长因子组改善更加明显(P<0.05)。康复新液组止痛起效时间较生长因子组明显延长,止痛维持时间明显缩短(P<0.05)。结论康复新液和重组牛碱性成纤维细胞生长因子外用溶液治疗RAU均有较好的短期临床疗效,康复新液患者的平均溃疡期改善更加明显,而重组牛碱性成纤维细胞生长因子外用溶液止痛起效快,维持时间长。

Objective The etiology and pathogenesis of recurrent aphtha ulcer(RAU)are not yet sufficiently clear and there has been no cure for it hitherto.This study aimed to compare the short-term effect of Kangfuxin Liquid(KFX)versus that of Beifuji Solution(BFJ,a topical solution of the recombinant bovine alkaline fibroblast growth factor)on refractory minor RAU(RMiRAU).Methods This prospective study included 150 cases of RMiRAU treated in Nanjing Hospital of Stomatology between March 2016 and June 2018.The patients were randomized into five groups of equal number:KFX,BFJ,oral control(oral isotonic saline),topical control(topical isotonic saline),and blank control(not treated).We measured the ulcer area and obtained the pain index at 1,3,5 and 7 days of treatment.We also recorded the onset time and duration of analgesia as well as the course of ulcer after initial medication.Results At 3,5,and 7 days after treatment,the ulcer areas in the KFX group,significantly smaller than in the oral control and blank control groups,and also smaller in the BFJ than in the topical control and blank control groups(P<0.05).At 3 and 5 days,the pain indexes were(3.35±1.23)and(2.32±1.80)in the BFJ group,significantly lower than(5.08±1.83)and(3.53±1.50)in the topical control and(5.50±1.69)and(3.79±1.34)in the blank control group(P<0.05),and lower in the KFX than in the oral control([5.29±1.73]and[3.74±1.42])and blank control groups(P<0.05);On day 3,the pain index of the BFJ group is much smaller than the KFX liquid group(P<0.05).The course of ulcer after initial medication was remarkably shorter,the onset of analgesia significantly later,and duration of analgesia markedly shorter in the KFX than in the BFJ group(all P<0.05).Conclusion Both KFX and BFJ have a good short clinical effect on RAU.KFX has advantage in decreasingulcer duration;BFJ has fast onset time and long maintenance time.