CAJ | 학술논문

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14 d，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<0.0001）。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。
목적：평개0.05%정산록배타송유고（CB）치료습진적림상료효화안전성。방법：다중심、수궤쌍맹、부형제（기질）대조림상연구。중중도습진환자수궤납입0.05% CB시험조혹기질대조조，국부외용，매일2차，료정2주。진입시험후수시자매일전사일기，병우제7천화14천수방평개림상료효화안전성。결과：8개시험중심공입조수시자240례，시험조급대조조각120례；치료14 d，시험조습진면적급엄중정도지수（EASI）평균하강65.34%，대조조EASI평균하강38.84%，시험조명현우우대조조，차이유통계학의의（F=24.01，P<0.0001）。치료제7천급14천시，연구자총체평개（investigator’s global assessment, IGA）평분화기우IGA적치료성공솔、직관모의척법（VAS）소양증상자아평개등지표시험조균명현우우대조조，차이균유통계학의의（P<0.001）。안전성평개지표재시험조화대조조조간급조내치료전후비교차별균무통계학의의（P>0.05）。결론：0.05%CB괄용우치료중중도습진，기효쾌，료효화안전성량호。
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(65.34% vs. 38.83%, P<0.000 1). 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<0.000 1). No statistical differences in safety eval-uations 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.