Rosenthal M, Bahous I
Bethesda Hospital, Basle, Switzerland.
Drugs Exp Clin Res. 1993;19(3):99-105.
In this clinical study the efficacy and the tolerability of a new topical formulation, DHEP plaster, have been evaluated. The plaster consists of an auto-adhesive medicated gauze pad of standard dimensions (10 x 15 cm) containing 180 mg DHEP. The reference drug was a well-known topical drug, diclofenac diethylammonium (DDA) emulgel at 1.16%. Treatments were applied to the affected area for 14 days: DHEP plaster b.i.d. and DDA emulgel q.i.d. A total of 190 patients, affected by various inflammatory diseases, participated in this clinical study. In both treatment groups (DHEP n = 96 patients, DDA n = 94 patients) a clear improvement in the disease and a rapid reduction in pain were observed. The statistical comparison between the two treatments showed a significant difference in favour of DHEP. However a comparison of the results, according to the different diagnoses, did not reveal any statistical significance. Both treatments were well tolerated, although five (DHEP n = 2, DDA n = 3) out of the 190 patients (2.6%) showed transient side effects (pruritus or erythema, both of light intensity).
在这项临床研究中，对一种新的局部用制剂——DHEP贴剂的疗效和耐受性进行了评估。该贴剂由标准尺寸（10×15厘米）的自粘性含药纱布垫组成，含有180毫克DHEP。对照药物是一种知名的局部用药，1.16%的双氯芬酸二乙胺（DDA）乳胶剂。治疗在患处应用14天：DHEP贴剂每日两次，DDA乳胶剂每日四次。共有190名患有各种炎症性疾病的患者参与了这项临床研究。在两个治疗组（DHEP组n = 96例患者，DDA组n = 94例患者）中，均观察到疾病明显改善且疼痛迅速减轻。两种治疗方法的统计学比较显示，结果有显著差异，DHEP更具优势。然而，根据不同诊断对结果进行比较，未发现任何统计学意义。两种治疗方法耐受性良好，尽管190名患者中有5名（DHEP组2名，DDA组3名，占2.6%）出现了短暂的副作用（瘙痒或红斑，均为轻度）。
