蛇丹合剂治疗寻常痤疮临床疗效评价

Evaluation on Clinical Effect of Shedan Mixture on Acne Vulgaris

目的:观察蛇丹合剂临床疗效和安全性,探讨中药治疗痤疮及其评价的方法学。方法:采用随机、阳性药物对照,按盲法操作的方法客观评价疗效及安全性,采用DME方法,参照GCP临床研究规范进行中医药临床疗效评价和临床试验的方法学探讨。结果:184例随机分配至治疗组92例,对照组92例,治疗组采用蛇丹合剂,对照组口服清热暗疮片,疗程8周。治疗组痊愈5例(5.43%),显效5例,有效62例,总有效率78.26%;对照组痊愈1例,显效1例,有效41例,总有效率46.74%。两组总有效率差异显著(P=0.005)。治疗组1例发生不良事件且与治疗药物无关,对照组7例发生不良事件(P<0.05)。治疗组40例病人治疗前后进行安全性检测,结果表明,采用蛇丹合剂治疗8周,对血、尿常规,肝肾功能没有明显影响,安全性较好。结论:蛇丹合剂是治疗湿热蕴结型痤疮的安全有效的方剂,值得临床推广应用。

Objective ：To evaluate the effectivity and safety of Shedan Mixture on 184 aene patients and approach methodology of clinical trial and evaluation. Methods ： It is a randomized controlled clinical trial which evaluate the effectivity and safety of Shedan Mixture objectively. Using DME （design, measure, evaluation）method approach methodology of clinical trial and evaluation. Results ：184 patients were randomly divided to treatment group and control group. Total effective rate of two groups is 78. 26% ,46.74% respectively（ P = 0. 005）. Adverse effects occurs to 1 patient in treatment group but 7 in control group （ P 〈 0. 05）. 40 patients in treatment group were checked up on blood, urine and function of liver and kidney pretreatment and posttreatment, No abnormality correlated to Shedan Mixture were found. Conclusion ：Shendan Mixture is an effective and safety therapeutic method which is worthy of generalizing and utilizing.