Objective To assess the efficacy and safety of insulin Lispro in type 1 or type 2 diabetic patients.Methods Forty diabetic patients were assigned to receive premeal insulin Lispro plus bedtime Neutral Protamine Hagedorn(NPH)insulin for 12 weeks.The following characters were compared between before and after treatment,including fasting plasma glucose(FPG),1 h and 2 h postprandial glucose(after a standardized meal),glycosylated hemoglobin(GHbA_1c)levels,total daily insulin dose and the number of hypoglycemic episodes.Results Thirty-nine subjects fulfilled the study.After 12 weeks of Lispro treatment,the levels of FPG and 1 h and 2 h postprandial glucose were decreased significantly,being 1.12 mmol/L,2.37 mmol/L and 1.92 mmol/L respectively;GHbA_1c was decreased by 1.45%(from 8.9% to 7.5%).The dose of insulin Lispro was not changed,compared with the dose of regular human insulin at baseline.The incidence of hypoglycemia was decreased from 19.5 every week at baseline to 9.8 every week with Lispro.Conclusion Insulin Lispro is an effective agent for good glucose control with fewer hypoglycemic episodes in diabetic patients.

Objective To evaluate the clinical performance of INNOVANCE D-Dimer,and provide information for clinical application.Methods 402 cases of sodium citrate anticoagulant blood were tested with INNOVANCE assay and PLUS assay on CA7000 analyzer to measure plasma D-Dimer levels.VIDAS-30 immunology analyzer was also used to validate the two assays.4 patients with elevated D-Dimer were monitored continuously during 5 days using INNOVANCE assay and PLUS assay respectively,then the consistency of trend between 2 assays was analyzed.Plasma specimens added with hemoglobin,bilimbin and triglyceride were used to verify the anti-interference capability of INNOVANCE D-Dimer assay.Results In 402 specimens,the result ranges of INNOVANCE D-Dimer and PLUS D-Dimer were [2.15 (0.33,8.63)]mg/L FEU and [325.50 (123.75,974.00)] μ,g/L DDU,respectively.The consistency between two assays was poor (Z =-17.375,P =0.000),especially the results in the range of PLUS D-Dimer (201-300) μg/L DDU and (301-400) μg/L DDU,the coincidence rates were only 25％ and 15％,respectively; the coincidence rate was up to 85％ during PLUS D-Dimer (500-600) μg/L DDU; the coincidence rate was close to 100％ when PLUS D-Dimer over 700 μg/L DDU.Totally 47 of 402 cases were unmatched between two assays.Verified by VIDAS 30,83.0％ (39/47) was false negative for PLUS assay,4.3％ (2/47) was false negative for INNOVANCE assay,12.7％ (6/47) was false positive for PLUS assay.There were 5 false positives and 39 false negative for PLUS assay,totally 45 cases; Two false negative for INNOVANCE assay.Four patients with elevated D-Dimer were monitored and the results showed similar trend between 2 assays.For INNOVANCE assay,the capacity of anti-interference to free bilirubin,unconjugated bilirubin,hemoglobin,and triglyceride was up to 217 μmol/L,337 μmol/L,41.04 g/L,18.35 mmol/L,respectively.Conclusions INNOVANCE assay can markedly reduce false negative results of D-Dimer compared with PLUS assay.INNOVANCE D-Dimer has good performance on anti-interference to jaundice,hemolysis and lipemia samples.

Objective To validate the four chronic kidney disease epidemiology collaboration (CKD-EPI) predictive equations based on serum creatinine (SCr) and cystatin C (Cys C) in Chinese CKD patients,and try to develop the GFR predictive equations for Chinese CKD patients.Methods254 CKD patients were randomly selected from four Grade ⅢA hospitals in different regions in China from September 2007 to December 2010.Clearance of dual plasma sampling 99mTc-DTPA was used to measure glomerular filtration rate (rGFR) in 254 CKD patients.The serum concentration of Cr and Cys C were measured.CKD-EPI SCr equation,Cys C equation,Cys C equation adjusted for age,sex and race,SCr/Cys C combinated equation adjusted for age,sex and race were used to estimate GRF ( labeled as eGFR1,eGFR2,eGFR3 and eGFR4,respectively).The correlation,bias and precision of eGFRs were compared with rGFR by Wilcoxon signed rank test,intraclass correlation coefficient (ICC) and Spearman correlation analysis.The deviation degree between rGFR and different eGFRs was compared via Bland-Altman graph.The accuracy within 15％,25％,30％ ( P15,P25,P30) and the staging correctness of eGFR against CKD at different stages was calculated.ResultsThe rGFR in 254 CKD participants was [ 48.07 (26.19 -92.97 )] ml · min -1·(1.73 m2) -1.The Spearman correlatiou coefficients (CC) of eGFR and rGFR varied within the range of 0.873 - 0.896 ( P =0.000 ).The intra-class CC ( ICC ) varied within the range of 0.920 - 0.942.The correlation of eGFR4 was the best.The absolute deviations of 4 eGFRs and deviation precision were eGFR4 ＜eGFR3 ＜ eGFR2 ＜ eGFR1.The 95％ confidence intervals for the regression line of 4 eGFRs shown by Bland-Altman graphs were 92.5,87.3,83.0 and 76.1 ml · min-1 · ( 1.73 m2 ) -1,respectively,with the best result of eGFR4.For P30,the correctness of 4 eGFRs were eGFR4 ＞ eGFR3 ＞ eGFR2 ＞ eGFR1,but no significant difference was found by Chi square test (x2 =6.448,P =0.092).The overall correctness rate in 4 eGFRs against CKD stages were 48.4％ -57.5％,with the highest consistency of eGFR4,but their staging correctnessratewerenotideal(Kappa values were 0.405,0.348,0.366 and 0.463,respectively).Conclusions Compared with CKD-EPI SCr equation,no advantage was found in CKD-EPI Cys C equation.The Cys C equation adjusted by age and sex shows a little advantages over CKD-EPI Cys C equation in bias,precision,correlation and accuracy.The CKD-EPI SCr/Cys C combinated equation adjusted by age,sex and race has advantage over other three equations not only in bias,precision,correlation and accuracy,but also in staging correctness.However,the validation of this equation is still not fairly ideal for Chinese CKD patients.Based on these findings,it is essential for the Chinese CKD patients to develop SCr/Cys C combined predictive equation which adjusted by age,sex or other factors.(Chin J Lab Med,2012,35:798-804)

Objective To establish a personalized musculoskeletal multi-body dynamics model of total knee replacement (TKR) by two software nmsBuilder and OpenSim, and verify this established model by using bouncy and medthrust gait patterns. Methods Based on skeletal data from a patient, the body, skeletal landmark clouds and muscular landmark clouds were established for automatically generating reference systems and muscles. The musculoskeletal model generated by nmsBuilder was introduced into OpenSim, and inverse kinematics, static optimization and knee joint force analysis were performed successively. Finally, the model was driven by bouncy gait and medthrust gait respectively, and the results were compared with experimental measurements. Results Except for the lateral joint contact forces, the predicted magnitude and trend of knee joint contact forces by the model had a good agreement with the experimental data, and the constructed skeletal muscle multi-body dynamics model could be used for knee joint research. Conclusions The established musculoskeletal multi-body dynamics model could predict the medial, lateral and total tibiofemoral joint contact forces simultaneously by inputting the marker positions and the ground reaction forces. The research ideas of this study can provide references for designing personalized knee prostheses for TKR patient.

Objective:To establish the clot waveform analysis (CWA) reference intervals of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Fbg) and thrombin time (TT) parameters CT, |Min1|, |Min2|, |Max2| and observe the changes in patients with coagulation factors deficiency.Methods:One hundered and twenty-five cases of apparent healthy person were enrolled to establish the CWA reference intervals of four coagulation parameters and 25 cases with coagulation factors were used to study the changes of CWA patients.Results:The CWA reference intervals of PT |Min1| (dT/dt), |Min2| (d 2T/dt 2), |Max2| (d 2T/dt 2) are3.14±1.22, 0.56±0.22 and 0.50±0.18; The CWA reference intervals of APTT |Min1| (dT/dt), |Min2| (d 2T/dt 2), |Max2| (d 2T/dt 2) are 4.75±1.71, 0.78±0.29 and 0.65±0.28; The CWA reference intervals of Fbg CT(s), |Min1| (dT/dt), |Max2|(d 2T/dt 2) are 7.01±1.96, 1.22±0.51 and 0.15±0.11; The CWA reference intervals of TT |Min1| (dT/dt), |Min2| (d 2T/dt 2), |Max2| (d 2T/dt 2) are 0.95±0.32, 0.14±0.05 and 0.07±0.03.These parameters of CWA in factor Ⅴ deficient patients were significantly reduced, the activity of coagulation factor Ⅶ was 0.42, |Min2| and |Max2| were significantly lower than that of normal people. The paramenters of CWA in factor Ⅶ deficient patients were significantly reduce. Conclusion:The CWA reference intervals of four CWA parameters helps judgment of coagulation factor deficiency.

Objective To report a pedigree with tyrosinemia type Ⅱ,and to analyze its causative mutations.Methods Clinical data were obtained from a 10-year-old male proband with tyrosinemia type Ⅱ,and analyzed retrospectively.Blood and urine samples were collected from 19 persons in 3 generations of the pedigree,and the amino acid level was detected in these samples.Genomic DNA was extracted from all of the 19 family members,and mutations in the tyrosine aminotransferase (TAT) gene were detected.Results The patient developed photophobia at 2 months after birth,and the symptom was gradually aggravated after that.At the age of 6 years,ocular pain and photophobia occurred.At the age of 8 years,linear keratotic plaques occurred on his fingertips and soles of both feet,with obvious tenderness.Ophthalmic examination showed no obvious abnormalities in corneal staining or ocular fundus.Skin examination showed multiple linear keratotic plaques on the fingers and soles of both feet.The serum tyrosine level was 825.64 μmol/L,and the level of p-hydroxyphenyllactic acid in urine was 161.4 μmol/L.Genetic testing showed 2 novel mutations,including c.236G ＞ A at position 236 in exon 2 of the TAT gene causing the substitution of glycine by glutamic acid (p.Gly79Glu),and c.1141G ＞ T at position 1141 in exon 10 of the TAT gene leading to the formation of a premature termination codon instead of glutamic acid (p.Glu381*).The proband was the only patient in the family.Some members in the patrilineal family carried the mutation c.1141G ＞ T (p.Glu381*),and some in the maternal family carried the mutation c.236G ＞ A (p.Gly79Glu).Conclusion This is the first case of tyrosinemia type Ⅱ reported in the domestic population,and 2 novel heterozygous mutations were identified in the TAT gene,which may lead to the occurrence of tyrosinemia type Ⅱ in the patient.