他克莫司软膏治疗慢性手部湿疹的临床研究

Clinical study of tacrolimus ointment in the treatment of chronic hand eczema

目的评价0．1％他克莫司软膏治疗成人慢性手部湿疹的疗效和安全性。方法86例慢性手部湿疹患者按就诊顺序进入试验组和对照组，分别接受0．1％他克莫司软膏（试验组）或丁酸氢化可的松乳膏（对照组）治疗；每日2次，疗程为4周；于治疗前及治疗后每周随访1次，疗效评估使用标准的手部湿疹评分系统（JHS），患者作视觉尺度VAS瘙痒症状测试及皮炎改善程度的自我评估，并记录不良反应。结果经过4周的治疗后，试验组和对照组的有效率分别为83．7％和46．5％，试验组的有效率高于对照组（P〈0．05）。治疗后，试验组的JHS明显下降，与患者自我评价符合，同对照组JHS相比，差异有统计学意义。试验组9例局部出现不同程度灼热、瘙痒等不适感，均于2—3d后消失；对照组3例出现一过性皮肤发红、刺痛，停药后消失。结论0．1％他克莫司软膏治疗慢性手部湿疹安全且效果良好。

Objective To evaluate the efficacy and safety of 0.1% tacrolimus ointment in the treatment of chronic hand eczema in patients. Methods A total of 86 patients with chronic hand eczema applied 0.1% tacrolimus ointment or hydrocortisone butyrate cream twice daily for 4 weeks. Eficacy was evaluated by the use of a standardized hand score（JHS）. Results The clinical efficacy rates of 0.1% tacrolimus and hydrocortisone butyrate group in patients were 83.7% and 46.5% ,0. 1% tacrolimus was significantly more effective than control group in patients with chronic hand eczema（ P 〈 0.05 ）. The hand eczema score in 0.1% tarcrolimus ointment group declined significantly compared with control group. The common but temporary side effects in tarcrolimus ointment group included skin itching and burning on the application site . Conclusions The results show that 0.1% tacrolimus ointment in the treatment of chronic hand eczema in patients is effective and safe.