维药新药治疗高脂血症的临床研究指导原则(草案)  

Clinical Research Guidelines for Treatment of Hyperlipidemia 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 阿斯亚.吾甫尔 玉苏甫.买提努尔 莫合买提.乌斯曼 买尼沙.买买提 吐尔洪.阿西木 张宏 白连省 李金凤 李治建 阿布都吉力力.阿布都艾尼 李攻戍[4] 刘炳林[4] 裴小静[4] 周贝[4] Abuduwaili Abudukelimu;Silafu Aibai;WANG Ping-shan;Asiya Wufuer;Yusufu Maitinuer;Muhamaiti Wusiman;Mainisha Maimaiti;Tuerhong Aximu;ZHANG Hong;BAI Lian-sheng;LI Jin-feng;LI Zhi-jian;Abudujilili Abuduaini;LI Gong-shu;LIU Bing-lin;PEI Xiao-jing;ZHOU Bei(Xinjiang Uyghur Medicine Hospital, Urumqi 830049, China;Institute of Xinjiang Traditional Uyghur Medicine, Urumqi 830049,China;Xinjiang Uyghur Autonomous Region Food and Drug Administration, Urumqi 830002, China;Center for Drug Evaluation, CFDA, Beijing 100045, China)

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6期1-5,共5页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：新疆维吾尔自治区科技计划(201333101)

摘　　要：本研究在符合医学伦理的基础上,针对高脂血症维医诊疗方案进行多中心临床病例回顾性调查,收集人口学、诊断学、治疗学、疗效评价及护理学资料等信息,进行整理研究。归纳分析其主症和次症表现,将高脂血症分为异常血液质数量过盛的浓稠型、涩味黏液质型、石膏样黏液质型、燃烧的黑胆质型共4型,建立高脂血症维医辨证分型标准。根据实验室观察指标,结合维医主症和次症变化建立该病的病症结合疗效评定标准。在此基础上,按照国家新药审评的技术要求和程序,研究制定维药新药治疗高脂血症的临床研究指导原则(草案)。Based on medical ethics,retrospective multi-center study on medical records of Uyghur Medicinediagnosis and treatment program of hyperlipidemia was done and demographic,diagnostic,therapeutic,efficacyevaluation,nursing data and other information were collated.The main and secondary disease manifestations ofhyperlipidemia were analyzed inductively and hyperlipidemia were divided into4types in Uyghur Medicine field,which were surplus and sticky Kan type,Chuchumal Balgham type,Gaisiman Balgham type,and Koygan Savda type.Therefore,Uighur Medicine syndrome type standards of hyperlipidemia were established.Treatment efficacy wasevaluated with the combination of laboratory observation parameters and main and secondary disease manifestations.On this basis,in accordance with the technical requirements of the national medicine review,this study developedclinical research guidelines for the treatment of hyperlipidemia with new Uyghur Medicine(draft).

关 键 词：高脂血症 维医药 诊断技术和方法 临床研究指导原则 

分 类 号：R291.5[医药卫生—民族医学] R259.892.1[医药卫生—中医学]