作　　者： (屈双擎）; (赵丽丽）; (蔡艳丽）; (于思杰）; (王琳琳）; (瞿幸）;

机构地区： 北京中医药大学东直门医院皮肤科

出　　处： 《中华中医药杂志》 2017年第8期3858-3860,共3页

摘　　要： 目的:评价复方苦参止痒软膏治疗亚急性、慢性湿疹的临床疗效及安全性。方法:本研究采用双盲、安慰剂、随机对照临床研究方法。将纳入的亚急性、慢性湿疹患者随机分为治疗组和安慰剂组,观察治疗前后患者皮损形态、皮损面积、瘙痒症状及其对谷丙转氨酶、血肌酐及尿素氮、血尿常规和心电图等安全性指标的影响。结果:本研究共纳入有效病例140例,每组70例,两组治疗后在总有效率、愈显率及缓解瘙痒、减少皮损面积、改善皮损形态方面有显著性差异(P<0.05)。两组治疗前后均未见安全性指标显著异常病例,未见药物相关不良事件。结论:复方苦参止痒软膏治疗亚急性、慢性湿疹有较好疗效,安全性满意。 Objective: To evaluate the clinical efficacy and safety of Compound Radix Sophorae Flavescentis Itchingrelieve Ointment(CRIO) in treating subacute or chronic eczema. Methods: A randomized, double-blind, placebo-controlled clinical trial approach was applied in this study. Patients with subacute or chronic eczema were randomly divided into CRIO group and placebo group. Appearance and area of skin lesions, symptoms of itching and safety index including ALT, blood Cr and BUN, blood routine, urine routine and electrocardiogram were observed before and after treatment. Results: A total of 140 available patients were included, and 70 in each group. There were significant differences in total effective, curative-obvious-effective rate, itching relief, area of skin lesions, and DLQI scores between groups(P<0.05). No abnormal safety index and agent-related adverse event were observed in each group by the end of the trail. Conclusion: CRIO is safe, more effective in the treatment of subacute or chromic eczema.

关 键 词： 复方苦参止痒软膏 湿疹 中医外治法