基于灰色理论的中药注射剂不良反应因素分析

Study of ADRs of Traditional Chinese Medical Injections Based on the Gray System Theory

目的:将灰色关联分析法应用于中药注射剂不良反应成因研究,通过实例分析,旨在以定量的方式反映中药注射剂ADR影响因素与ADR的关联程度,并筛选出关键因素和危险元素,为临床合理用药提供有效参考,为现有研究提供新思路。方法:灰色关联分析法、实例分析法。结果:得到了中药注射剂不良反应成因的灰色关联分析模式,并应用于双黄连注射剂实例分析中,得出"是否初次用药"、"有无过敏史"、"配液类型"、"患者性别"是影响双黄连注射剂ADR的关键因素;"非初次用药"、"有过敏史"、"与GS配液"、"男性"、"配液501 ml～"、"年龄0～24岁"、"注射液"、"剂量21 ml～或2.5～4.2 g"、"原患其他疾病"、"与抗菌药联用"为ADR危险主元素。结论:灰色关联分析法应用于中药注射剂ADR成因研究是可行的。

Objective： To quantitatively understand the correlation between traditional Chinese medicine injection （TCMI） ADR factors and ADRs in the clinical application process, and select the key ADR factors and key dements by means of the application of the gray correlation analysis used in TCMI ADR causes analysis to finally provide new ideas for existing TCMI ADR causes analysis and meaningful references for rational clinical medication. Method：The gray correlation analysis and example analysis were used. Result： The application mode of the gray correlation analysis in TCMI ADR causes analysis was obtained and used in the Shuang Huanglian injection example analysis to obtain the following key factors ： ＂whether the initial medication be administered＂, ＂any allergic history＂, ＂liquid type＂, and ＂patient sex＂. And ＂not initial medication＂, ＂allergic history＂, ＂GS＂, ＂male＂, ＂liquid volume 501ml-＂, ＂age 0-24＂, ＂liquid injection＂, ＂dose 21mlor 2.5-4.2 g＂, ＂other original illness＂, and ＂combination with antibiotics＂ were dangerous elements in the application of Shuang Huanglian injection. Conclusion： It is effective to use the gray correlation analysis to study traditional Chinese medicine injection （TCMI） ADR factors.