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目的考察高效液相色谱法(HPLC)与化学发光微粒子免疫分析法(CMIA)测定万古霉素血药浓度结果的相关性和差异性。方法用两种方法分别测定100例使用万古霉素患者的血药浓度,运用Bland-Altman分析、线性回归分析和配对t检验比较2种方法的测定结果。结果 Bland-Altman评价分析2种方法一致性较差,其中25例样本用2种方法测定结果相对偏差大(RE>15%)。通过病例分析,发现该25例样本患者都存在万古霉素疗程长、用药品种多(将近20种及以上)的现象。将另外75例样本(用药品种在10种及10种以下),以CMIA法测得的质量浓度为X,以HPLC法测得质量浓度为Y,得线性回归方程为Y=1.031X-0.456,两法测定值相关性良好(r=0.967 4)。2种方法测定结果比较差异无统计学意义(P=0.888 5,P>0.05)。结论因存在药物因素干扰,在用药品种过多的情况下,两种方法需要相互校正。
Objective To investigate the correlation and difference between the results of high performance liquid chromatography (HPLC) and chemiluminescence microparticle immunoassay (CMIA) in determining the plasma concentration of vancomycin. Methods Two methods were used to determine the plasma concentration of 100 patients with vancomycin. The results of two methods were compared by Bland-Altman analysis, linear regression analysis and paired t-test. Results The Bland-Altman evaluation showed that the two methods were inconsistent. Among them, the relative deviation of the two methods was relatively high (RE> 15%). Through the case analysis, found that patients with 25 cases of vancomycin have long course of treatment, drug variety (nearly 20 and above) phenomenon. The other 75 samples (drug varieties in 10 species and 10 species), the mass concentration measured by the CMIA method X, measured by HPLC mass concentration Y, the linear regression equation was Y = 1.031X-0.456, The correlation between the two methods was good (r = 0.967 4). There was no significant difference between the two methods (P = 0.888 5, P> 0.05). Conclusion Due to the interference of drug factors, the two methods need to be calibrated in the case of too many drugs.