Greer R O, Lindenmuth J E, Juarez T, Khandwala A
Division of Oral Pathology and Oncology, University of Colorado Health Sciences Center, School of Dentistry, Denver.
J Oral Maxillofac Surg. 1993 Mar;51(3):243-8; discussion 248-9. doi: 10.1016/s0278-2391(10)80164-8.
A double-blind trial of amlexanox (C16H14N2O4) was carried out in 32 patients with recurrent oral aphthous ulcerations. During the treatment period, which lasted for 3 days, patients received either placebo topical paste or 5% amlexanox paste. The paste was applied by the investigator twice per day for 3 days and once on the fourth day. Efficacy was assessed by the following parameters: 1) pain measured by the patients marking a 15-cm line between poles connoting no pain versus severe pain; 2) erythema evaluated by the investigator on a four-point scale ranging from none to strong; 3) size determined by investigator measurement of the perpendicular dimensions of the ulcer; and 4) an investigator's improvement scale consisting of six rank-ordered points from -1 for worsening of the ulcer with respect to previously described criteria to +4 when the ulcer had healed completely. All evaluations were based on a comparison with the day 1 visit of the patient. Outcomes for patients receiving the active ingredient were superior on all four criteria of effectiveness. Group differences for all criteria but pain reduction were statistically significant (P < .05). No side effects were reported. It was concluded that amlexanox is effective in reducing aphthous ulcer erythema, pain, and lesional size.
对32例复发性口腔溃疡患者进行了氨来呫诺（C16H14N2O4）双盲试验。在为期3天的治疗期间，患者分别接受安慰剂局部糊剂或5%氨来呫诺糊剂治疗。研究者每天两次涂抹糊剂，持续3天，第4天涂抹一次。通过以下参数评估疗效：1）患者在代表无痛至剧痛的两极之间标记一条15厘米长的线来测量疼痛；2）研究者以从无到强的四点量表评估红斑；3）研究者测量溃疡垂直尺寸来确定大小；4）研究者的改善量表，由六个排序点组成，从溃疡相对于先前描述标准恶化的-1到溃疡完全愈合的+4。所有评估均基于与患者第1天就诊情况的比较。接受活性成分治疗的患者在所有四个有效性标准上的结果均更优。除疼痛减轻外，所有标准的组间差异均具有统计学意义（P < 0.05）。未报告有副作用。得出的结论是，氨来呫诺在减轻口腔溃疡的红斑、疼痛和病变大小方面有效。
