维药新药治疗寻常痤疮的临床研究指导原则(草案)  

Clinical Research Guidelines for Treatment of Acne Vulgaris with New Uyghur Medicine(Draft)

作　　者：阿不都外力.阿不都克里木 斯拉甫.艾白 王平山 吐尔逊.乌甫尔 玉苏甫.买提努尔 莫合买提.乌斯曼 张宏 吐尔洪.阿西木 白连省 李金凤 古哈尔.麦合木特 阿布都吉力力.阿布都艾尼 李治建 李攻戍[4] 刘炳林[4] 裴小静[4] 周贝[4] 

机构地区：[1]新疆维吾尔自治区维吾尔医医院,新疆乌鲁木齐830049 [2]新疆维吾尔自治区维吾尔医药研究所,新疆乌鲁木齐830049 [3]新疆维吾尔自治区食品药品监督管理局,新疆乌鲁木齐830002 [4]国家食品药品监督管理总局药品审评中心,北京100045

出　　处：《中国中医药信息杂志》2017年第2期1-4,共4页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：新疆维吾尔自治区科技计划项目(201333101)

摘　　要：本研究针对寻常痤疮维医诊疗方案进行多中心临床病历回顾性调查,收集人口学、诊断学、治疗学、疗效评价、护理学资料等信息,进行整理研究。归纳分析其主症和次症表现,将寻常痤疮分为腐败血液质型痤疮、淡黄色胆液质型痤疮、涩味黏液质型痤疮共3型,以此建立寻常痤疮的维医辨证分型标准。同时分别于治疗前后对皮肤完整性及皮损形态进行评价,通过患者维医证候及生活质量的改善,观察患者内环境的变化,建立寻常痤疮的病证结合疗效判定标准。在此基础上,按照国家新药评审的技术要求和程序,研究制定维药新药治疗寻常痤疮的临床研究指导原则(草案)。In this article, retrospective multi-center study on medical records of Uyghur Medicine diagnosis and treatment program of acne vulgaris was done and demographic, diagnostic, therapeutic, efficacy evaluation and nursing data and other information were collated and analyzed. The main and secondary disease manifestations of acne vulgaris were analyzed inductively and acne vulgaris was divided into 3 types in Uyghur Medicine field, which are blood-type acne vulgaris, yellow bile-type acne vulgaris, and astringent mucus-type acne vulgaris. Uyghur Medicine syndrome type standards of acne vulgaris were established. At the same time, through evaluating skin integrity and morphology of lesions as well as changes in patients＇ symptoms and quality of life and observing changes in patients＇ internal environment respectively before and after treatment, disease and syndrome clinical criteria of acne vulgaris were established. On this basis, in accordance with the technical requirements of the national medicine review, this study developed clinical research guidelines for the treatment of acne vulgaris with new Uyghur Medicine.

关 键 词：寻常痤疮 维医药 临床研究指导原则 

分 类 号：R275.921.2[医药卫生—中西医结合]