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| 冠心病稳定性心绞痛痰瘀互结证病例报告表的设计和研制 |
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敖玉涵1, 吴东宁2, 李涵3, 刘博通1, 周宇石1, 李峥4, 张明雪5
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1.辽宁中医药大学研究生学院, 沈阳 110032;2.中国中医科学院临床评价中心, 北京 100700;3.沈阳市卫生健康服务与行政执法中心, 沈阳 110000;4.辽宁中医药大学附属医院心内一科, 沈阳 110032;5.辽宁中医药大学附属医院心内二科, 沈阳 110032
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| 摘要: |
| 基于证候的“动态时空”特征及“病证结合，辨证论治”原则，结合目前数据采集工具研究现状，研制并设计稳定性心绞痛中医辨治方案的循证优化研究病例报告表（CRF）。形成的病例报告表以4次访视、2次随访为时间框架，包含基线指标、中医证候疗效指标、西医疗效指标、安全性指标、不良事件、合并用药表。为了获取标准化数据，以临床数据交换标准协会（CDISC）标准中的临床数据获取协调标准（CDASH）为指导，设计病例报告表。 |
| 关键词: 辨证论治 稳定性心绞痛 痰瘀互结 CDASH 病例报告表 |
| DOI：10.11656/j.issn.1672-1519.2021.03.11 |
| 分类号:R541.4 |
| 基金项目:国家重点研发计划项目（2017YFC1700400， 2017YFC1700401）；国家自然科学基金面上项目（81273698）；辽宁省特聘教授滚动支持项目（辽教函[2018]35号）。 |
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| Design and development of case report form of stable angina pectoris with blending of phlegm and blood stasis syndrome |
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AO Yuhan1, WU Dongning2, LI Han3, LIU Botong1, ZHOU Yushi1, LI Zheng4, ZHANG Mingxue5
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1.Graduate School, Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China;2.Clinical Evaluation Center, China Academy of Chinese Medical Sciences, Beijing 100700, China;3.Shenyang Health Service and Administrative Law Enforcement Center, Shenyang 110000, China;4.First Department of Cardiology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China;5.Second Department of Cardiology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China
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| Abstract: |
| Based on the "dynamic space-time" characteristics of syndromes and the principle of "combining disease with syndrome, syndrome differentiation and treatment", combined with the current research status of data collection tools, an evidence-based optimization study case report form (CRF) of traditional Chinese medicine (TCM) treatment scheme for stable angina pectoris was developed and designed. The formed case report form takes 4 visits and 2 follow-up as the time frame, including baseline index, TCM syndrome curative effect index, western medicine curative effect index, safety index, adverse events and drug combination table. In order to obtain standardized data, CRF was designed under the guidance of the Clinical Data Acquisition Standards Harmonization (CDASH) of the Clinical Data Interchange Standards Consortium (CDISC) standard. |
| Key words: syndrome differentiation and treatment stable angina pectoris blending of phlegm and blood stasis syndrome CDASH case report form |
