维药新药治疗骨质疏松症的临床研究指导原则(草案)  

Clinical Research Guidelines for Treatment of Osteoporosis 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 玉苏甫.买提努尔 莫合买提.乌斯曼 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;Yusufu Maitinuer;Muhamaiti Wusiman;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10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(201333101)

摘　　要：本研究针对骨质疏松症维吾尔医诊疗方案进行多中心临床病历回顾性调查,收集患者人口学、诊断学、治疗学、疗效评价、护理学等资料信息,进行整理研究,归纳分析其主症和次症表现,将骨质疏松症分为异常黑胆质型和异常黏液质型,建立骨质疏松症的维吾尔医辨证分型标准。从骨痛、骨密度、生存质量3个方面,并结合临床症状及维吾尔医证候改善情况进行疗效判定。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骨质疏松症的临床研究指导原则(草案)。In this study,retrospective multi-center study on medical records of Uyghur medicine diagnosis and treatment program of osteoporosis was done and demographic,diagnostic,therapeutic,efficacy evaluation and nursing data and other information were collected.The main and secondary disease manifestations of osteoporosis were analyzed inductively.Osteoporosis was divided into2types in Uyghur medicine field,which were abnormal Savda type and abnormal Balgham type.Uighur medicine syndrome type standards of osteoporosis were established.Treatment efficacy was evaluated according to bone pain,bone density,life quality,and improvement of clinical symptoms and Uyghur medical symptoms.On this basis,in accordance with the technical requirements of the national drug review,the study developed clinical research guidelines for the treatment of osteoporosis with new Uyghur medicine(draft).

关 键 词：骨质疏松症 维吾尔医药 临床研究指导原则 

分 类 号：R291.5[医药卫生—民族医学] R274.91[医药卫生—中医学]