Pothinamthong Pornchai, Janjumratsang Patcharin
The Institute of Dermatology, Ministry of Public Health, Bangkok, Thailand.
J Med Assoc Thai. 2012 Jul;95(7):933-40.
To compare the efficacy and safety between 0.1% Tacrolimus ointment twice a day and 0.05% clobetasol propionate.
Twenty-one Thai patients 18 to 60 years old with DLE lesions on both right and left sides of the body, without SLE, were included in the present study. Each patient was randomly allocated to determine the use of one side for twice-daily 0.1% topical tacrolimus ointment and the other side for once-daily 0.05% clobetasol propionate ointment for six weeks. Clinical outcomes were evaluated by modified cutaneous lupus erythematosus disease area and severity index (CLASI) and global assessment score for patient efficacy evaluation.
Disease activity score were significantly decreased from baseline in both groups but clobetasol had better efficacy (p < 0.05). No significant change in disease damage score between the two groups. Both drugs were well tolerated. Transient pruritus and burning sensation were found in the tacrolimus group. Telangiectasia and acneiform eruption were found in the clobetasol group.
The present study proved the efficacy of twice-daily tacrolimus and once-daily clobetasol treatment for DLE lesion. Clobetasol has significantly higher efficacy and tacrolimus may be an alternative treatment.
比较每天两次使用0.1%他克莫司软膏与每天一次使用0.05%丙酸氯倍他索的疗效和安全性。
本研究纳入了21名年龄在18至60岁之间、身体左右两侧均有盘状红斑狼疮（DLE）皮损且无系统性红斑狼疮（SLE）的泰国患者。每位患者被随机分配，一侧使用0.1%他克莫司软膏每日两次，另一侧使用0.05%丙酸氯倍他索软膏每日一次，为期六周。通过改良的皮肤红斑狼疮疾病面积和严重程度指数（CLASI）以及用于评估患者疗效的整体评估评分来评估临床结果。
两组的疾病活动评分均较基线显著降低，但丙酸氯倍他索的疗效更好（p < 0.05）。两组之间的疾病损伤评分无显著变化。两种药物耐受性均良好。他克莫司组出现短暂瘙痒和烧灼感。丙酸氯倍他索组出现毛细血管扩张和痤疮样皮疹。
本研究证实了每天两次使用他克莫司和每天一次使用丙酸氯倍他索治疗DLE皮损的疗效。丙酸氯倍他索的疗效显著更高，他克莫司可能是一种替代治疗方法。
