维药新药治疗稳定性心绞痛临床的研究指导的原则.docVIP

维药新药治疗稳定性心绞痛临床的研究指导的原则 　　 摘要：维医目前尚无符合维医药理论体系的维药新药临床研究指导原则。本研究针对稳定性心绞痛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及贡献度，建立以维医主症和次症条目及其症状量化表为证候要素的辨证分型标准，结合心绞痛症状、心电图变化、硝酸甘油停减率等指标，建立稳定性心绞痛病证结合疗效评价标准。在此基础上，按照国家新药审评的技术要求，制订维药新药治疗稳定性心绞痛的临床研究指导原则（草案）。 　　 关键词：稳定性心绞痛;维医药;诊断技术和方法;临床研究指导原则 　　 DOI：10.3969/j.issn.1005-5304.2015.02.042 　　 中图分类号：R259.414.2;R291.5 文献标识码：A 文章编号：1005-5304（2015）02-0133-04 　　Clinical Research Guidelines for the Treatment of Stable Angina with New Uyghur Medicine （Draft） Silafu Aibai1， Mainisha Maimaiti2， Maimaitihasimu2， WANG Ping-shan3， ZHANG Lei4， LI Gong-shu4， LIU Bing-lin4， LI Jin-feng3， TANG Jian-yuan4， LI Zhi-jian1， Abudujilili Abuduaini1 （1.Institute of Xinjiang Traditional Uyghur Medicine， Urumqi 830049， China;2.Xinjiang Uyghur Medicine Hospital， Urumqi 830049， China;3.Food and Drug Administration in Xinjiang Uyghur Autonomous Region， Urumqi 830002， China;4.Center for Drug Evaluation， State Food and Drug Administration， Beijing 100045， China） 　　 Abstract：Uyghur medicine has not yet had the clinical research guidelines consistent with Uyghur medicine theory for its new medicine. In this research， retrospective multi-center study on medical records of Uyghur medicine diagnosis and treatment program of stable angina was conducted. Data about demography， diagnostics， therapeutics， efficacy evaluation， and nursing were collated and analyzed. Uyghur medicine syndrome diagnosis indicators and their contribution to stable angina were identified， and Uyghur medicine syndrome differentiation criteria were established. Uyghur medicine established its primary and secondary disease syndrome and its symptoms quantization table entries for the syndrome elements of Uyghur medicine syndrome differentiation criteria. Then combined with symptoms of angina and ECG changes， nitroglycerin stop and decrement rate， evaluation criteria for the efficacy of disease symptom combination were established. On this basis， in accordance wi