Schachner L, Eaglstein W, Kittles C, Mertz P
Department of Dermatology and Cutaneous Surgery, University of Miami School of Medicine, FL 33101.
J Am Acad Dermatol. 1990 Feb;22(2 Pt 1):253-60. doi: 10.1016/0190-9622(90)70034-f.
A double-blind, 12-week study was undertaken to determine the safety and efficacy of a formulation of 4% erythromycin plus 1.2% zinc acetate compared with its vehicle. The study was continued for 40 weeks after the 12-week double-blind phase by switching vehicle-treated patients to active treatment and continuing to give patients treated with active drug the same treatment. Seventy-three female patients started the study; 39 completed 1 full year of study. In the first 12 weeks statistically significant differences were noted in the efficacy of the erythromycin-zinc compared with vehicle for acne severity grades (global assessment) and for papule, pustule, and comedo counts. After crossover, the vehicle-treated group receiving active therapy duplicated the improvement of the group initially treated with erythromycin-zinc. No clinical problems with superinfection or secondary infection occurred during 1 year of treatment in 39 patients.
进行了一项为期12周的双盲研究,以确定4%红霉素加1.2%醋酸锌制剂相对于其赋形剂的安全性和有效性。在12周双盲期结束后,将接受赋形剂治疗的患者转为活性治疗,并继续给予接受活性药物治疗的患者相同治疗,研究持续了40周。73名女性患者开始了该研究;39名患者完成了整整一年的研究。在最初的12周内,与赋形剂相比,红霉素-锌制剂在痤疮严重程度分级(整体评估)以及丘疹、脓疱和粉刺计数方面的疗效存在统计学上的显著差异。交叉治疗后,接受活性治疗的赋形剂治疗组的改善情况与最初接受红霉素-锌治疗的组相同。39名患者在1年的治疗期间未出现超级感染或继发感染的临床问题。