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维药新药治疗慢性胃炎的临床研究指导原则(草案)

Clinical Research Guidelines for Treatment of Chronic Gastritis with New Uyghur Medicine (Draft)

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【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·乌斯曼阿里甫·恩提古哈尔·麦合木特吐尔洪·阿西木张宏白连省李金凤李治建阿布都吉力力·阿布都艾尼李攻戍刘炳林裴小静周贝

【Author】 Abuduwaili Abudukelimu;Silafu Aibai;WANG Ping-shan;Yusufu Maitinuer;Muhamaiti Wusiman;Alifu Enti;Guhaer Maihemute;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;Institute of Xinjiang Traditional Uyghur Medicine;Xinjiang Uyghur Autonomous Region Food and Drug Administration;Center for Drug Evaluation,CFDA;

【机构】 新疆维吾尔自治区维吾尔医医院新疆维吾尔自治区维吾尔医药研究所新疆维吾尔自治区食品药品监督管理局国家食品药品监督管理总局药品审评中心

【摘要】 本研究针对慢性胃炎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、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,建立以维医主症和次症为证候要素的辨证分型标准,结合慢性胃炎的内镜检查和胃黏膜活组织学检查指标,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,研究制订维药新药治疗慢性胃炎的临床研究指导原则(草案)。

【Abstract】 In this study, retrospective multi-center study on medical records of Uyghur Medicine diagnosis and treatment program of chronic gastritis was done and demographic, diagnostic, therapeutic, efficacy evaluation and nursing data and other information were collated and analyzed. Diagnostic criteria were set to determine the elements of the symptoms of Uygur Medicine. Uygur Medicine syndrome differentiation standard was established with primary symptoms and secondary symptoms of Uygur Medicine as syndrome feature. Combined with endoscopy and gastric biopsy examination indicators of chronic gastritis, the efficacy evaluation of the disease was established. On this basis, in accordance with the technical requirements of the national medicine review, the study developed clinical research guidelines for the treatment of chronic gastritis with new Uyghur Medicine(draft).

【基金】 新疆维吾尔自治区科技计划(201333101)
  • 【文献出处】 中国中医药信息杂志 ,Chinese Journal of Information on Traditional Chinese Medicine , 编辑部邮箱 ,2017年04期
  • 【分类号】R29
  • 【被引频次】8
  • 【下载频次】221
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