Armstrong R B, Lesiewicz J, Harvey G, Lee L F, Spoehr K T, Zultak M
Roche Dermatologics, Nutley, NJ 07110.
Arch Dermatol. 1992 Mar;128(3):352-6.
Evaluation of the treatment of photodamaged skin requires adequate efficacy criteria. This study tested the ability of five independent dermatologists to distinguish the effect of topical treatment with isotretinoin cream (0.05% for 3 months, then 0.1% for 6 months) in 326 patients compared with vehicle for 9 months in 325 patients using high-quality, reproducible photographic slides. Panelists were blinded to the patient's identity, treatment group, and time of the photograph (baseline or end of treatment). A computer randomly projected the baseline photograph to one side of a split screen and the end-of-treatment photograph to the other.
Isotretinoin was significantly better than vehicle for overall appearance, fine wrinkles, and discrete pigmentation by multivariate analysis of the combined results for all panelists. Univariate analysis for each panelist also indicated statistically significant superiority of isotretinoin over vehicle for overall appearance (four panelists), fine wrinkles (five panelists), and discrete pigmentation (three panelists).
The clinical panel detected significantly better improvement in photodamaged-skin treated with isotretinoin than in such skin treated with vehicle. The panel provided an independent assessment of the effects of treatment uninfluenced by physical findings during treatment or information provided by the patients treated.
评估光损伤皮肤的治疗效果需要合适的疗效标准。本研究利用高质量、可重复的摄影幻灯片，测试了五名独立皮肤科医生区分326例患者使用异维甲酸乳膏（0.05%，3个月，然后0.1%，6个月）局部治疗效果与325例患者使用赋形剂治疗9个月效果的能力。小组成员对患者身份、治疗组和照片拍摄时间（基线或治疗结束时）不知情。计算机将基线照片随机投射到分屏的一侧，将治疗结束时的照片投射到另一侧。
通过对所有小组成员综合结果的多变量分析，异维甲酸在整体外观、细纹和散在色素沉着方面显著优于赋形剂。对每位小组成员的单变量分析也表明，异维甲酸在整体外观（四名小组成员）、细纹（五名小组成员）和散在色素沉着（三名小组成员）方面在统计学上显著优于赋形剂。
临床小组检测到，用异维甲酸治疗的光损伤皮肤比用赋形剂治疗的皮肤改善明显更好。该小组对治疗效果进行了独立评估，不受治疗期间体格检查结果或接受治疗患者提供信息的影响。
