维药新药治疗普通感冒的临床研究指导原则(草案)

CJI (Traditional Chinese Medicine) - - 中国中医药信息杂志 -

阿不都外力•阿不都克里木1,斯拉甫•艾白 2,王平山3,乌布力哈斯木1,玉苏甫•买提努尔 1,莫合买提•乌斯曼3,买尼沙•买买提1,吐尔洪•阿西木 1,张宏 3,白连省 3,李金凤 3,李治建2,阿布都吉力力•阿布都艾尼2,李攻戍 4,刘炳林 4,裴小静 4,周贝 4

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摘要:本研究针对普通感冒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,进行整理分析,确定其维医证候要素的诊断指标,建立以维医主证和次证条目及症状诊断表为证候要素的辨证分型标准,结合普通感冒症状,建立该病的疗效评价标准。在此基础上,按照国家新药审评的技术要求,制定维药新药治疗普通感冒的临床研究指导原则(草案)。关键词:普通感冒;维医药;诊断技术和方法;临床研究指导原则

DOI:10.3969/j.issn.1005-5304.2017.05.001

中图分类号:R291.5;R259.116 文献标识码:A 文章编号:1005-5304(2017)05-0001-04

Clinical Research Guidelines for Treatment of Common Cold with New Uyghur Medicine (Draft)

Abuduwaili Abudukelimu1, Silafu Aibai2, WANG Ping-shan3, Wubulihasimu1, Yusufu Maitinuer1, Muhamaiti Wusiman3, Mainisha Maimaiti1, Tuerhong Aximu1, ZHANG Hong3, BAI Lian-sheng3, LI Jin-feng3, LI Zhi-jian2, Abudujilili Abuduaini2, LI Gong-shu4, LIU Bing-lin4, PEI Xiao-jing4, ZHOU Bei4 (1. Xinjiang Uyghur Medicine Hospital, Urumqi 830049, China; 2. Institute of Xinjiang Traditional Uyghur Medicine, Urumqi 830049, China; 3. Xinjiang Uyghur Autonomous Region Food and Drug Administration, Urumqi 830002, China; 4. Center for Drug Evaluation, CFDA, Beijing 100045, China)

Abstract: In this study, retrospective multi-center study on medical records of Uyghur Medicine diagnosis and treatment program of common cold was done and demographic, diagnostic, therapeutic, efficacy evaluation and nursing data and other information were collected, sorted out and analyzed to determine the diagnostic cretiria of Uygur Medicine syndrome factors. Syndrome differentiation standard with the syndrome factors of the enrties of main syndromes and sub-syndromes and symptomatic diagnosis chart was established. Combined with the symptoms of common cold, the efficacy evaluation standards were established. On this basis, in accordance with the technical requirements of the national new medicine review, the study developed clinical research guidelines for the treatment of common cold with new Uyghur Medicine (draft).

Key words: common cold; Uyghur Medicine; diagnostic techniques and methods; clinical research guidelines

普通感冒是常见病、多发病,由于发病频率高,呈急性病变过程,给患者带来生活及工作的诸多不便,加之抗生素在治疗过程中的滥用,也带来一定的

基金项目:新疆维吾尔自治区科技计划项目(201333101)

通讯作者:斯拉甫•艾白,E-mail:aibai@263.net 社会问题。维吾尔药治疗感冒有着悠久的历史和丰富的经验,有良好的疗效及较高的安全性,在研究治疗感冒的维药新药时要充分体现维医药治疗感冒的特点、优势,以科学、客观地评价受试药物。本病属维医“祖卡木”“乃子来”范畴,维医认为,体内外因素使人体生成的气质发生异常变化,体液之间的相辅

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