凝血功能分析的系统差异性对临床决策的影响探讨

目的通过研究临床标本凝血功能检验的系统差异及其对临床决策的影响程度,探索进行系统数据校正的可能性。方法以STAEvolution、CA7000和ACLAdvance凝血分析系统为研究对象,检测247例临床标本的凝血酶原时间(PT)、国际标准化比值(INR)、活化部分凝血活酶时间(APTT)和纤维蛋白原(FIB),通过完全随机区组方差分析和相关性分析,INR按量值水平分为<2、2～3和>3三组进行多个相关样本非参数检验,判断系统差异对抗凝治疗的影响。结果系统间PT、APTT和FIB的差异有统计学意义(F=32.570,P<0.01;F=134.076,P<0.01;F=99.873,P<0.01),STA-R和CA-7000测量PT(r=0.984,P<0.01)和APTT(r=0.944,P<0.01)相关性良好。使用系统特异的ISI时,INR的系统差异有统计学意义(χ2=7.583,P<0.05)。Clauss法FIB定量与演算法的差异有统计学意义(F=99.873,P<0.01),其中ACLAdvance与STA-R的相关性较好(r=0.909,P<0.01),在低浓度区间最接近。结论尽管系统间相关性良好,其差异仍不便用方程式简单校正,提高对试剂性能与溯源性要求,倡导系统特异性对于保证数据准确性至关重要。

Influence of systenmtic discrepancy in coagulation tests on clinical decision

Objective To investigate discrepancies of coagulation tmrameters in different systems ,and try tostandardize or calibrate these index. Methods 247 samples were collated from patients, to observe difference of PT/INR, APTT, and FIB tested in STA-R, CA7000 and ACL-Advanee, and then analyzed by Student-Newman-Keulstest. INR data was divided into 3 groups： 〈 2,2-3, and 〉 3 to make further analysis by nonparameter test.Results There were significant difference in PT,APTT and FIB（F=32.570,P〈0.01;F=134.076,P〈0.01;F=99. 873 ,P 〈0. 01 ）respectively. Both PT and AFYF from STA-R and CA-7000 system were correlated （ r =0. 984and 0. 944 ,all P 〈 0. 01 ）. Nonparameter test showed no difference （ X^2 = 7. 583, P 〈 0. 05 ） of INR in three levels,when system-specil3c ISI was used. FibHnogen measured by Clauss were different from that of PT -derived （ F =99. 873 ,P 〈 0. 01 ）. Moreover ACL Advance and STA-R showed good correlation （ r = 0. 909, P 〈 0. 01 ） in Fib,especially in low fibrinogen level. Conclusions It is difficult to minimize the difference merely by a correct formula,although good correlation lies between systems. We should continue to emphasize on the reagent quality andtraceability, and pay more attention on system specialty to keep accuracy of coagulation tests .