Objective To investigate the effect of two different detection methods of reagent kits on blood concentration of Tacrolimus in liver transplantation .Methods 81 cases of liver transplantation patients received Tacrolimus testing in Zhoushan Hospital from February 2013 to August 2016 were selected, fasting venous blood of upper limb were collected 12h after treatment, blood concentrations of Tacrolimus in whole blood samples were detected by Enzyme linked immunosorbent assay ( ELISA) kit and Enzyme enhanced immunoassay ( EMIT) kit respectively , the results of the two methods were observed and compared .Results The intra day and inter day precision and accuracy of ELISA method were good , RSD <5%, in the low concentration range , the precision of detection was slightly worse; the intraday and inter day precision and accuracy of ELISA method were good , RSD <5%, in the low concentration range , the precision of detection was slightly worse; the Tacrolimus blood concentration measured by ELISA (5.19 ±0.73) μg/L test kit was significantly lower than that measured by EMIT kit (8.29 ±1.14) μg/L, the difference was statistically significant (P<0.05); correlation coefficient of the detection results of two kinds of reagent kit was r =0.9176, the detection results were positively related; the determination results of ELISA kit ( 1.116 ±0.125 ) μg/L were obviously lower than that of EMIT kit (1.507 ±0.201) μg/L when Tacrolimus blood concentration <2g/L, with significant difference (P<0.05).Conclusion ELISA detection kit and EMIT kit can be used to monitor the blood concentration of Tacrolimus in liver transplantation patients , and the correlation was good, but the blood concentrations of Tacrolimus were significantly different between the two kits , need to establish their own of therapeutic window to judge,the test results can not be replaced with each other .

Objective To investigate the comparation of sodium valproate concentration in peripheral blood monitoring by fluorescence polarization immunoassay method(FPIA)and high performance liquid chromatography method(HPLC)in epilepsy children.Methods 87 cases of epilepsy children received Sodium valproate treatment in our hospital from February 2014 to June 2016 were selected,fasting venous blood of elbow vein were collected the next morning after last medication, blood concentrations of Sodium valproate in serum samples were detected by FPIA method and HPLC method respectively,the correlation and consistency of results of the two methods were observed and compared.Results The intra day and inter day RSD of Sodium valproate concentration in peripheral blood in epilepsy children detected by FPIA were <5%,the recovery rate was 90%-110%,the precision and accuracy were high;The intra day and inter day RSD of Sodium valproate concentration in peripheral blood in epilepsy children detected by HPLC were <5%,the recovery rate was 90%-110%,the precision and accuracy were high; the linear regression equation between determination value of HPLC method (X) and determination value of FPIA method (Y) was:Y=0.8355X+1.8231,correlation coefficient r=0.914,the detection results were positively related;the Sodium valproate blood concentration detected by FPIA was significantly lower than that detected by HPLC method, the difference was statistically significant (P<0.05);Bland-Altman deviation chart results show that determination of blood drug concentration by HPLC method was higher than that of FPIA method by 7.2μg/mL.Conclusion The precision and accuracy of sodium valproate concentration in peripheral blood monitoring by FPIA method and HPLC method were all high, and the correlation was good, but the detection results of the two methods were significantly different,the detection result of HPLC method was higher than that of FPIA method,need to choose and judge according to the clinical situation.

Objective: To investigate the methods for qualitative pathological assessment of dynamic changes in liver fibrosis/cirrhosis after antiviral therapy in patients with chronic hepatitis B (CHB), since antiviral therapy can partially reverse liver fibrosis and cirrhosis caused by hepatitis B and semi-quantitative, rather than qualitative, pathological assessment is often used for the research on liver fibrosis regression. Methods: Previously untreated CHB patients with liver fibrosis and cirrhosis were enrolled, and liver biopsy was performed before treatment and at 78 weeks after the antiviral therapy based on entecavir. The follow-up assessment was performed once every half a year. Based on the proportion of different types of fibrous septum, we put forward the new qualitative criteria called P-I-R classification (predominantly progressive, predominantly regressive, and indeterminate) for evaluating dynamic changes in liver fibrosis. This classification or Ishak fibrosis stage was used to evaluate the change in liver fibrosis after treatment and Ishak liver inflammation score was used to evaluate the change in liver inflammation after treatment. Results: A total of 112 CHB patients who underwent liver biopsy before and after treatment were enrolled, and among these patients, 71 with an Ishak stage of ≥3 and qualified results of live biopsy were included in the final analysis. Based on the P-I-R classification, 58% (41/71) were classified as predominantly progressive, 29% (21/71) were classified as indeterminate, and 13% (9/71) were classified as predominantly regressive; there were no significant differences between the three groups in alanine aminotransferase, aspartate aminotransferase, albumin, HBeAg positive rate, HBV DNA, and liver stiffness (P < 0.05). After treatment, the proportion of predominantly progressive, indeterminate, or predominantly regressive patients changed to 11% (8/71), 11% (8/71), and 78% (55/71), respectively. Among the 35 patients who had no change in Ishak stage after treatment, 72% (25/35) were classified as predominantly regressive and had certain reductions in the Laennec score, percentage of collagen area, and liver stiffness. Conclusion This new P-I-R classification can be used to assess the dynamic changes in liver fibrosis after antiviral therapy in CHB patients.