维药新药治疗慢性胃炎临床探究指导原则(草案).docVIP

维药新药治疗慢性胃炎临床探究指导原则(草案) 　　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） 关键词：慢性胃炎；维医药；临床研究指导原则 DOI：10.3969/j.issn.1005-5304.2017.04.001 中图分类号：R291.5；R259.733 文献标识码：A 文章编号：1005-5304（2017）04-0001-04 Clinical Research Guidelines for Treatment of Chronic Gastritis with New Uyghur Medicine （Draft） Abuduwaili Abudukelimu1， Silafu Aibai2， WANG Ping-shan3， Yusufu Maitinuer1， Muhamaiti Wusiman3， Alifu Enti1， Guhaer Maihemute1， 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 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）. Key words： chronic gastritis； Uyghur Medicine； clinical research guidelines 慢性胃炎分?槲?缩性和非萎缩