Diezel W, Michel G, Görtelmeyer R, Ostheimer K E
Dermatologische Klinik und Poliklinik, Universität Rostock, Frankfurt/Main, Fed. Rep. of Germany.
Arzneimittelforschung. 1993 Apr;43(4):491-6.
In a double-blind study, 198 patients experiencing recurrent herpes orofacialis were randomly assigned to treatment with either tromantadine hydrochloride (ViruMerz Serol, CAS 53783-83-8) or aciclovir. All patients performed an up to 5-day course of topical treatment beginning on average within 2 h after the first signs of recurrence. The herpes efflorescences and symptoms were assessed daily by the same physician for 14 days, except on weekends, and by the patients each day during the whole observation time. Rapid healing was achieved with both medications. Efficacy was assessed by rating the course of vesicle eruptions, duration until beginning of incrustation and the clinical course of the symptoms (burning, tension, pain). Equivalence between the medication groups was shown by comparative analysis of all evaluation criteria. The global efficacy and tolerability of both medications was rated by the physician as well as by the patients as "good" or "very good" in more than 80% of the cases. The results of this trial show equivalence of both medications in the treatment of recurrent herpes orofacialis, and confirm the good dermal tolerability of the drugs.
在一项双盲研究中，198例复发性口腔面部疱疹患者被随机分配接受盐酸曲金刚胺（ViruMerz Serol，CAS 53783 - 83 - 8）或阿昔洛韦治疗。所有患者均从复发的最初症状出现后平均2小时内开始进行为期5天的局部治疗。除周末外，同一位医生对疱疹皮疹和症状进行为期14天的每日评估，患者在整个观察期内每天进行自我评估。两种药物均实现了快速愈合。通过对水疱发作过程、结痂开始前的持续时间以及症状（灼痛、紧绷感、疼痛）的临床过程进行评分来评估疗效。通过对所有评估标准的比较分析显示了药物组之间的等效性。在超过80%的病例中，医生和患者对两种药物的总体疗效和耐受性评价为“良好”或“非常好”。该试验结果表明两种药物在治疗复发性口腔面部疱疹方面具有等效性，并证实了这些药物良好的皮肤耐受性。
