【摘要】 目的:评价0.05%丁酸氯倍他松乳膏(CB)治疗湿疹的临床疗效和安全性。方法:多中心、随机双盲、赋形剂(基质)对照临床研究。中重度湿疹患者随机纳入0.05%CB试验组或基质对照组,局部外用,每日2次,疗程2周。进入试验后受试者每日填写日记,并于第7天和14天随访评价临床疗效和安全性。结果:8个试验中心共入组受试者240例,试验组及对照组各120例;治疗14d,试验组湿疹面积及严重程度指数(EASI)平均下降65.34%,对照组EASI平均下降38.84%,试验组明显优于对照组,差异有统计学意义(F=24.01,P<0.000 1)。治疗第7天及14天时,研究者总体评价(investigator’s global assessment,IGA)评分和基于IGA的治疗成功率、直观模拟尺法(VAS)瘙痒症状自我评价等指标试验组均明显优于对照组,差异均有统计学意义(P<0.001)。安全性评价指标在试验组和对照组组间及组内治疗前后比较差别均无统计学意义(P>0.05)。结论:0.05%CB适用于治疗中重度湿疹,起效快,疗效和安全性良好。更多还原

【Abstract】 Objective:To investigate clinical efficacy and safety of 0.05% clobetasone butyrate (CB) cream.Methods:This was a multicenter,double-blind,parallel group,randomized and controlled trial.Patients with moderate to severe eczema topically applied 0.05% CB cream or vehicle(base cream) twice daily for 14 days.Subjects maintained daily.Clinical efficacy and safety were assessed at Day 7 and Day 14 of follow up visits.Results:Two hundred and forty subjects(120 per group) satisfying study eligibility criteria were enrolled and randomized into two parallel groups.Mean EASI percentage reduction of observation group was greater than the control group at Day 14(6534% vs. 38.83%,P<0.0001).Treatment success rates based on IGA score in 0.05% CB cream group were significantly higher than the control group at Day 7 and Day 14(P<0.001).The 0.05% CB cream was also significantly superior to base cream at relieving pruritus(VAS self evaluation,P<0.0001).No statistical differences in safety evaluations were observed between the two groups and within each group before and after treatment Conclusions:0.05% CB cream is well tolerated and effective in the treatment of Chinese patients with moderate to severe eczema更多还原