中药芪白颗粒治疗进展期白癜风的双盲随机对照研究  

A double-blind randomized controlled trial of Qibai Keli in treating vitiligo in progressive stage

作　　者：李剑 盛友渔 胡瑞铭 缪盈 周隽 傅雯雯 杨勤萍 徐金华 

机构地区：[1]复旦大学附属华山医院皮肤科,上海200040

出　　处：《临床皮肤科杂志》2018年第3期182-185,共4页Journal of Clinical Dermatology

基　　金：上海市科委中医重点项目资助(课题编号13401902600)资助项目

摘　　要：目的:评价华山医院自制制剂芪白颗粒治疗进展期白癜风的安全性和有效性。方法:采用随机、双盲、赋形剂平行对照的研究方法,将受试者按照1∶1的比例分配至芪白颗粒组(试验组)和安慰剂组(对照组)。共入组272例进展期白癜风患者,每组患者136例。试验组患者口服芪白颗粒,联合外用0.1%他克莫司软膏。对照组患者口服模拟冲剂,联合外用0.1%他克莫司软膏。受试者在接受治疗后的第4周、第8周、第12周各随访1次,记录活动性评分、中医症候评分、复色评分以及生活质量评分,治疗后第12周评价临床疗效及安全性。结果:芪白颗粒组能控制白癜风的发展,有效率84.56%,安慰剂组活动性评分有效率为44.85%,两者差异有统计学意义(P<0.05)。芪白颗粒组服药12周后中医症候改善的有效率为80.88%,明显高于安慰剂组的39.7%(P<0.05)。治疗12周后两组患者靶皮损均有不同程度的复色,芪白颗粒组复色率77.21%,安慰剂组复色率53.67%。结论:芪白颗粒对进展期白癜风有较好的控制作用,不良反应小,但中药起效相对较慢,治疗周期比较长。Objective： To evaluate the safety and efficacy of in-house-made Qibai Keli by Huashan hospital for the treatment of vitiligo in progressive stage. Methods： A randomized, double-blind, vehicle controlled trial was conducted. The subjects were assigned to the Qibai group（experimental group） and the placebo group（control group） with the ratio of 1 ：l. A total of 272 pa- tients with vitiligo in progressive stage were enrolled in this study. Patients were treated with either Qibai Keli or placebo 10 g twice daily. Both groups were also given topical 0.1% tacrolimus ointment twice daily. Patients were followed up at 4, 8 and 12 weeks. The activity scores, traditional Chinese medicine（TCM） symptom scores, repigmentation rates and quality of life scores were recorded. The clinical efficacy and safety were evaluated at the end of 12 weeks. Results： Qibai Keli prevented the progress of vitiligo with the effective rate of 84.56%（P〈0.05 vs. 44.85% for placebo）. After 12 weeks of treatment, the effective rates of TCM symptom improvement were 80.88% in Qibai Keli treated group vs. 39.7% in placebo group（P〈0.05）. Repigmen- ration rates were 77.21% in Qibai Keli treated group vs. 53.67% in placebo group（P〈0.05）. Both treatments could improve pa- tients＇ quality of life scores. Conclusion： Qibai Keli is effective and safe for treating vitiligo in progressive stage, but its onset of action is slow and requires a long term therapy.

关 键 词：白癜风 芪白颗粒 中医治疗 黑素细胞 随机对照试验 

分 类 号：R758.41[医药卫生—皮肤病学与性病学]