Development and Validation of a Risk Prediction Model for Tacrolimus Blood Concentration Failure
OBJECTIVE To analyze the influencing factors of tacrolimus(FK506)blood concentration non-attainment in renal transplant patients and construct a risk prediction column-line diagram model.METHODS Two hundred patients admitted to the hos-pital from June 2020 to June 2023 who were treated with FK506 after renal transplantation and whose blood concentration was monitored for 30 d were selected for the study,and according to the monitoring results,they were categorized into 126 cases in the group of meet-ing the standard(5-15 μg·L-1)and 74 cases in the group of failing to meet the standard(＜5 μg·L-1 or＞15 pg·L-1),and the clinical data were collected,and independent risk factors for failing to meet the standard of FK506 were screened and fit into a predic-tive model by single-factor and multifactorial logistic regression analysis.Clinical data of the two groups were collected,and the independ-ent risk factors for FK506 blood concentration non-compliance were screened by single-factor and multifactor logistic regression analyses,according to which,a prediction model for the risk of FK506 blood concentration non-compliance was constructed with a line graph and tested for goodness-of-fit.RESULTS Of the 1 200 FK506 concentration monitoring sessions in 200 patients within 30 d after surgery,the number of sessions in which the target concentration of 5-15 μg·L-1 was reached was 756,with an attainment rate of 63.0％.A total of 126 patients reached the target concentration(target group),and 74 patients did not reach the target concentration(non-target group).The proportion of patients with age＞60 years,male,intravenous,fasting blood glucose(FPG)＞7 mmol·L-1,total biliru-bin(TB)＞20 µmol·L-1,white blood cell count(WBC)≤4 x 109·L-1,and blood creatinine(Cr)＞133 μmol·L-1 was higher in the non-attainment group than in the attainment group,and the difference was statistically significant(P＜0.05).Multifactorial lo-gistic regression analysis was performed,and the results showed that age＞60 years,male,FPG＞7 mmol·L-1,TB＞20 μmol·L-1,and Cr＞133 μmol·L-1 were independent risk factors for substandard FK506 blood concentration in renal trans-plant patients(all P＜0.05).The AUC of the constructed column-line graph model reached 0.859(0.795-0.924),the model calibration curve validation C-index was 0.836,and the H-L deviation testX2=4.203,P=0.516,the calibration curve was basically the same as the ideal curve trend,with a good degree of precision and differentiation.DCA analysis showed that the column-line graph prediction model displayed a large range of threshold probabilities(0.05 to 0.95),which corresponded to the largest area of the red curve to the gray curve and the horizontal axis,indicating a better clinical utility value of the model.CONCLUSION Age＞60 years,male,FPG＞7 mmol·L-1,TB＞20 μmol·L-1,and Cr＞133 μmol·L-1 are the risk factors for substandard FK506 blood concentration in renal transplantation patients,and the column-line graph model constructed accordingly can effectively predict the degree of risk for substandard FK506 blood concentration in renal transplantation patients.
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