基于ClinResearch心系不良事件分析印证中医脏腑相关性理论

吴东宁，何丽云，王鑫，艾艳柯，文天才

1.沈阳市和平区前进中医门诊部，辽宁沈阳110001；2.中国中医科学院中医临床基础医学研究所，北京100700

基于ClinResearch心系不良事件分析印证中医脏腑相关性理论

吴东宁1，何丽云2，王鑫2，艾艳柯2，文天才2

1.沈阳市和平区前进中医门诊部，辽宁沈阳110001；2.中国中医科学院中医临床基础医学研究所，北京100700

目的从不良事件数据分析与挖掘角度研究中医脏腑相关性理论，并探讨其可行性。方法以ClinResearch电子数据管理系统目前在研及存储的研究数据为基础，以统计学方法分析、挖掘心系不良事件的特征。结果ClinResearc电子数据管理系统中的心系不良事件的特征较好的印证了中医“心与小肠相表里”“心肺为君臣相傅之官”等脏腑相关性理论。结论从不良事件数据分析与挖掘角度研究中医脏腑相关性理论具有可行性及意义，但尚局限于不良事件的低报告率、研究及管理水平等因素，下一步可以提高不良事件报告率及从不同角度回溯不良事件发生的方法，增加数据量、提高其数据质量以进行进一步的统计及挖掘。

ClinResearch；心系不良事件；脏腑相关性理论

［Abstract］Objective To research the zang-fu related theory in Chinese traditional medicine by analyzing the adverse event data and studying its feasibility.Methods The features of heart-system adverse events were analyzed and mined by the statistical method on the basis of the understudied and stored research data in the ClinResearch electronic data management system.Results The heart-system adverse events in the ClinResearch electronic data management system better confirmed the zang-fu related Chinese traditional medicine theories of“heart and small intestine being interior-exteriorly related”and“heart-lung being the viscus likened to a prime minister of the heart”.Conclusion The research of zang-fu related theory in Chinese traditional medicine from the perspectives of adverse event data analysis and mining has feasibility and significance，and we can further improve the report rate of adverse events and recall the occurrence method of adverse events from different perspectives，increase the data amount and improve the data quality for further statistics and mining due to the low report rate of adverse events，research and management levels.

［Key words］ClinResearch；the heart of adverse events；Zang and Fu Relativity Theories

中医临床评价研究已成为中医研究的重要方向及方法，且为中医学进步提供了积极有效的循证医学证据，但“我国临床试验，尤其是中医药临床试验中，不良事件的记录率较低［1］”且“从申办者到研究者，都存在概念的不清楚和意识的薄弱，没能真正理解不良事件记录的重要性和意义所在［1］”导致不良事件管理难度较大等现状，不仅影响研究的科学性和可信度，更影响对不良事件数据本身的分析和挖掘。……