Medansky R S, Cuffie C A, Tanner D J
Schering-Plough Research Institute, Kenilworth, New Jersey, USA.
Clin Ther. 1997 Jul-Aug;19(4):701-9. doi: 10.1016/s0149-2918(97)80094-x.
This study compared the clinical efficacy and safety of the combination agent mometasone furoate 0.1%-salicylic acid 5% ointment with those of the single agent fluocinonide 0.05% ointment, each applied twice daily for 21 days, in the treatment of patients with moderate to severe plaque psoriasis. Forty adult patients were included in this single-center, randomized, double-masked, intraindividual, bilateral-paired comparative trial. Two similar, bilaterally symmetrical target lesions on the trunk, arms, or legs of each patient were selected for treatment and evaluation. One lesion was treated with mometasone furoate 0.1%-salicylic acid 5% ointment, and the other was treated with fluocinonide 0.05% ointment, both twice daily for 21 days. Treatment was randomly assigned to the right or left side of the body. Signs of psoriasis (ie, erythema, induration, and scaling) and overall clinical response were evaluated and scored on days 4, 8, 15, and 22 and compared against baseline. Patients were asked to evaluate the treatments for efficacy and acceptability at each visit. The primary efficacy parameter was the mean percentage of improvement in total sign scores for the target lesions. Safety was evaluated based on clinical observation and patients' reports. Beginning with day 15, statistically significant differences favoring mometasone furoate 0.1%-salicylic acid 5% ointment over fluocinonide 0.05% ointment were seen in individual and total sign scores, as well as in overall global clinical response. On day 15, 20 patients expressed a preference for one treatment over the other, and 20 patients made no distinction between the two. Of those who expressed a preference, significantly more patients believed mometasone furoate 0.1%-salicylic acid 5% ointment to be better than fluocinonide 0.05% ointment. On day 22, of 25 patients who expressed a preference, significantly more patients thought mometasone furoate 0.1%-salicylic acid 5% ointment was better than fluocinonide 0.05% ointment. No adverse events were recorded for either treatment group. The combination mometasone furoate 0.1%-salicylic acid 5% ointment was significantly more efficacious than and equally as safe as fluocinonide 0.05% ointment in the management of patients with plaque psoriasis and was preferred by a greater number of patients.
本研究比较了0.1%糠酸莫米松-5%水杨酸联合软膏与0.05%氟轻松单剂软膏治疗中度至重度斑块状银屑病患者的临床疗效和安全性,二者均每日外用两次,共21天。本单中心、随机、双盲、个体内、双侧配对比较试验纳入了40例成年患者。在每位患者的躯干、手臂或腿部选择两个相似的、双侧对称的目标皮损进行治疗和评估。一个皮损用0.1%糠酸莫米松-5%水杨酸软膏治疗,另一个皮损用0.05%氟轻松软膏治疗,均每日两次,共21天。治疗随机分配至身体的右侧或左侧。在第4、8、15和22天对银屑病体征(即红斑、硬结和鳞屑)和总体临床反应进行评估和评分,并与基线进行比较。每次就诊时要求患者评估治疗的疗效和可接受性。主要疗效参数为目标皮损总体征评分改善的平均百分比。基于临床观察和患者报告评估安全性。从第15天开始,在个体和总体征评分以及总体临床反应方面,0.1%糠酸莫米松-5%水杨酸软膏相对于0.05%氟轻松软膏有统计学显著差异。在第15天,20例患者表示更喜欢一种治疗方法,20例患者对两种方法无差异。在表示有偏好的患者中,明显更多的患者认为0.1%糠酸莫米松-5%水杨酸软膏比0.05%氟轻松软膏更好。在第22天,在25例表示有偏好的患者中,明显更多的患者认为0.1%糠酸莫米松-5%水杨酸软膏比0.05%氟轻松软膏更好。两个治疗组均未记录到不良事件。在斑块状银屑病患者的治疗中,0.1%糠酸莫米松-5%水杨酸联合软膏比0.05%氟轻松软膏疗效显著更高且安全性相当,并且更受更多患者青睐。