他克莫司软膏治疗慢性手部湿疹临床观察

Clinical Trial of Chronic Hand Eczema with Topical Tarcrolimus Ointment

目的:评价外用0.1%他克莫司软膏治疗慢性手部湿疹的临床效果和安全性;方法:给予28例慢性手部湿疹患者外用0.1%他克莫司软膏,2/d,晚间行封包治疗(≥6h),共4周;于治疗前及治疗后1、2、4周和停药后2周各随访1次,疗效评估使用标准的手部湿疹评分(JHS)和临床严重性分级,并记录不良反应。结果:28例中26例完成临床试验。治疗后2周同治疗前相比JHS明显下降,直到研究结束其分值持续下降,最终12例(46.2%)完全治愈。临床分级也得到明显改善。药物相关性不良反应主要表现为用药部位烧灼感(15.4%)和瘙痒(11.5%),严重程度多为轻到中度,且均为一过性。结论:0.1%他克莫司软膏对治疗慢性手部湿疹具有良好的疗效,安全性较高。

Objective ： To investigate the clinical efficacy and safety of topical Tarcrolimus ointment 0.1% in patients suffering from chronic hand eczema. Methods ：28 patients were treated with topical Tarcrolimus ointment 0.1% twice daily;evening applications were immediate- ly followed by overnight occlusion（ ≥6 h）. Efficacy was evaluated by the use of a standardized hand eczema score and by clinical severity rating,conducted on all study visits（ baseline and weeks 1,2,4 and 6 ）. Meanwhile the adverse events were recorded. Results：26 of 28 cases completed the whole course of treatment. The hand eczema score declined significantly after 2 weeks of treatment when compared with baseline and further declined until the end of the study. Finally, 12 （46.2%） patients were clear of hand eczema. Clinical grading indicated improvement too. Local irritation adverse events such as burning sensation（ 15.4% ）and pruritus（ 11.5% ）were common but all these adverse events were transient. Conclusion ：Tarcrolimus ointment 0. 1% may be a safe and efective treatment option for the patients with chronic hand eczema.