中药注射剂不良反应危险因素分析及药学干预

目的：尝试应用条件 logistic 回归多因素分析方法，识别和分析我医院中药注射剂（ Traditional Chinese Medical Injection，TCMI）不良反应（Adverse Drug Reaction，ADR）的主要危险因素，有针对性进行药学干预，从而降低我院中药注射剂 ADR 的发生率。方法选取126例使用中药注射剂的患者，发生 ADR 者和未发生 ADR 者各63例，采用1∶1病例－对照研究的方法，应用条件logistic回归多因素分析模型综合分析和识别出中药注射剂ADR的主要危险因素。根据分析出的主要危险因素进行药学干预，分析药学干预的临床效果。结果条件logistic回归多因素分析结果表明，在控制潜在混杂因素的影响后，配液后放置时长≥15min （ OR ＝9．475， P ＝0．004）、联合用药（OR＝20．574，P＝0．001）是中药注射剂产生 ADR 的主要危险因素；经药学干预的干预组的 ADR 发生率明显低于对照组（χ2＝7．179，P＝0．007）。结论配液后放置时长≥15min、联合用药为中药注射剂发生ADR的主要危险因素。针对性地对主要危险因素进行药学干预，能明显降低中药注射剂ADR的发生率。

Studies of the Risk Factors and PharmaceuticaI Intervention of ADR of TraditionaI Chinese MedicaI In-jections

OBJECTIVE Try to use the multivari-ate conditional logistic regression analysis method,to i-dentify and analysis of the major risk factors of TCMI ADR in our hospital,and reduce the incidence of TCMI ADR by targeted pharmaceutical intervention.METHODS 160casesofpatientsusingTCMIwereselected,there were 63 cases with ADR and 63 cases without ADR,1:1 case-control study method was used,the major risk fac-tors of TCMI ADR were analyzed and identified by logis-tic regression analysis.The clinical effect of pharmaceu-tical interventions were analyzed based on the major risk factors of ADR.RESULTS After controlling the af-fecting of potential confounding factors, the multivariate conditional logistic regression analysis showed that Place a long time after the dosing ≥15min( OR=9.475,P=0.004) and drug combination ( OR =20.574, P =0.001) were the major risk factors of TCMI ADR;the incidence of ADR in the intervention group was signifi-cantly lower than the control group (χ2 =7.179 , P =0.007).CONCLUSION Placing a long time after the dosing ≥15min and drug combination were the main risk factors of TCMI ADR.It can significantly reduce the incidence rate of TCMI ADR by targeted pharmaceutical intervention on the major risk factors.