环孢素治疗药物监测质控规则的比较与评价

Comparison and Evaluation of Quality Control Rule for TDM of Cyclosporine

目的通过不同质量控制方法的比较,确定本院实验室条件下环孢素治疗药物监测的质量控制规则,及时发现测定误差成因,确保血药浓度监测质量。方法对本院实验室2009年质控数据进行统计学分析,并使用不同的质控方法评价,根据临床检验质控设计评价方法选择最佳质控规则。结果 Levey-Jennings控制方法的结果均在控,累计和质量控制方法检出3次失控,Z-分数控制图法检出8次失控,修改的Westgard多规则控制方法达到了极高的误差检出率和较低的假失控概率。结论修改的Westgard多规则控制方法简便易行,误差检出率高,成本低,符合本院实验室的质量控制要求,提高了实验室测定数据的准确性,能为临床提供更加真实有效的数据。

Objective To explore the quality control rule for therapeutic drug mo nitoring（TDM） of cyclosporine（CsA） in the condition of our hospital laboratory by comparing the different quality control methods in order to timely discover t he causes of determination errors and to ensure the quality of drug concentratio n determination.Methods The quality control data of our laboratory in 2009 were statistically analyzed and evaluated by the different quality control methods.Th e optimal quality control rule was selected according to the evaluation method o f clinical laboratory quality design.Results All results from of the Levey-Jenn ings control method were under specified range;while 8 results from the control method of Z-score control chart were out of control,3 results from the control method of CUSUM were out of control.The control method of modified Westgard mult i-rules achieved a very high detection rate of error and lower probability of f alse loss of control.Conclusion The Z-scores of control chart method is highly feasible with high error detection rate and low cost,which is suitable for the q uality control in our laboratory,increases the accuracy of determining data in l aboratory and provides real and more effective data.