Objective We aimed to describe the application value of continuous glucose monitoring system in patients with advanced gestational diabetes mellitus (GDM). Methods Pregant women in the medium and late pregant phases (24～35 weeks) underwent GDM screen test from January 2006 to April 2007. They first received 50 g glucose challenge test and 100g OGTT was performed 3 days later when the blood glucose was higher than or equal to 7.8mmol/L. According to the diagnostic criteria from American Diabetes Mellitus (ADA) 47 women were diagnosed to possess GDM and they were further divided into the test group (25 cases) and the control group (22 cases). The test group received 72 hours continuous glucose monitoring (CGMS). The control group adopted peripheral blood glucose monitoring using blood from the fingertip, 7 times per day. Results There were no records of consciousness hypoglycemic symptoms and hypoglycemia during monitoring. The CGMS data suggested that the record of the percent of high blood glucose was (17.5±3.1)%, percent of low blood glucose was (2.4±0.9)%, which were higher than those of the control group, which were (14.3±2.2)% and 0. Conclusions We recommend pregant women with GDM to undergo CGMS while using peripheral blood glucose monitoring with blood from the fingertip. It could systemicly evaluate the real control condition of blood glucose and ensure the safety of both mothers and babies.

AIM: To investigate the effect of aminoguanidine (AG) on plasma and renal levels of angiogenesis Ⅱ (AngⅡ), and to identify the relationship of AGEs with AngⅡ in STZ-induced diabetic rats. METHODS: Wistar rats were randomly assigned to three groups. Diabetes was induced, rats were then received AG in treatment group. At the end of 12th week, urine albumin excretion rate (UAER) and calculate creatinine clearance (Ccr) were detected. Periodic acid-Schiff reagent was used to evaluate renal pathology. Plasma and renal AngⅡ were analyzed by radioimmunoassay and immunohistochemistry, respectively. RESULTS: AG treatment significantly prevented the increase in UAER (P<0.01), renal pathology (P<0.01), and level of renal AngⅡ (P<0.01). However, plasma concentration of AngⅡ was higher than that in diabetic rats without AG treatment (P<0.01). CONCLUSION: AG down-regulates renal Ang Ⅱ level, probably by reducing the formation of AGEs, which may be one of the renoprotective factors in diabetic nephropathy. More proofs are needed to identify the result that plasma AngⅡ concentration increases in DMA group.

ObjectiveTo establish the time-resolved fluoroimmunoassay (TRFIA) method for the detection of serum galectin-3 and investigate the clinical value of serum galectin-3 for the diagnosis of pancreas cancer.MethodsMonoclonal anti-human galectin - 3 antibody and biotinylated polyclonal antibody were used to establish the sandwich TRFIA for detection of serum galectin-3.The optimal experimental condition was studied.Serum levels of galectin-3,CEA and CA19-9 in the patients with pancreatic cancer,benign pancreatic mass,pancreatitis,and healthy controls were measured.The diagnostic value of serum galectin-3,CEA and CA19-9 for pancreas cancer was studied.ResultsThe linearity of the TRFIA for detection of serum galectin3 tanged between 0 to 100 μg/L.The within-run CV and between-run CV were ≤6.45％ and ≤8.68％,respectively,and the average recovery was 106.6％.The level of serum galectin-3 was 4.93 ( 0.85 ～ 23.80) μg/L in pancreatic cancer group,which were significantly higher than those in benign pancreatic mass [2.83 ( 2.17 ～ 4.06) μg/L ],pancreatitis [ 2.62 (0.55 ～ 9.76 ) μg/L ],and healthy controls group [ 1.88 ( 0.59 ～ 3.94) μg/L] (P ＜0.05).By using 3.77 μg/L as the cut-off point,the smsitivity,specificity for the diagnosis of pancreatic cancer was 75.5％ and 90.9％.The levels of Gal 3 and CEA,CA19-9 was not correlated ( r =0.1321,P =0.3761 ; r =0.0920,P =0.5384).Combined determination of galactin-3 and CEA,CA19-9 levels could increase the diagnostic sensitivity to 92％.ConclusionsTRFIA method for the detection of galactin-3 is sensitive and stable.Galectin-3 could be a potentially novel serum tumor marker of pancreatic cancer.

Objective To evaluate the matrix effect of processed materials in serum total glycerol measurement and to assess the accuracy of routine test systems.Methods With an isotope dilution liquid chromatography tandem mass spectrometry method as the comparative method，matrix effects of 28 processed materials on 8 routine test systems were evaluated ccording to the NCCLS EP 14 protocol.The processed materials and 20 flesh patient specimens were analyzed with both the comparative method and each of the evaluated methods and results obtained with the two methods were plotted.Two-tailed 95% prediction intervals for the mean of the flesh patient specimen were computed and results on the processed aterials were compared with these intervals for evaluation of matrix effect.Results with the two methods on fresh samples were also compared for assessment of the accuracy of the routine test systems.Results Some of the processed samples showed matrix effects on some of the routine test systems.The observed matrix effects were system-specific and aused either positive or negative biases.Calibration biases were also observed on some test systems.Conclusion Matrix effect and calibration bias have been observed in serum total glycerol measurements.Continued efforts are needed for improving the accuracy of serum total glycerol measurements.

Objective To evaluate the matrix effects in serum urea measurements of external quality assessment(EQA)materials and commercial reference materials(calibrators or controls)on enzymatic methods and to verify the trueness of the enzymatic methods.Methods The Clinical and Laboratory Stadards Institute(CLSI)EP 14-A2 protocol was used for the evaluation of matrix effect.An isotope dilution gas chromatography mass spectrometry method was used as the comparative method.Twenty five fresh patient serum samples,15 EQA materials and 13 calibrators or controls were analyzed with 7 enzymatic methods (evaluated methods)and the comparative method and results were processed according to the protocol. The trueness of the evaluated methods were also assessed by comparing the fresh sample results obtained with the evaluated and comparative methods.Results Eight of 15 EQA materials and 3 of 13 calibrators or controls showed no matrix effects on all the 7 routine methods.One processed sample showed matrix effect on all the routine methods.Method dependent matrix effects of other materials were observed on other materials.Calibration biases were also observed on some enzymatic methods.Conclusions Matrix effects and calibration bias have been observed in serum urea measurements.Continued efforts are needed for improving the accuracy and the comparability of serum urea measurements.

Objective To develop a candidate reference method for the measurement of serum glucose based on isotope dilution liquid chromatography tandem mass spectrometry(ID-LC/MS/MS)Methods An internal standard [~(13)C_6]glucose was added to serum samples and equilibrated with endogenous glucose.Serum proteins were removed by a precipitation with anhydrous ethanol.Serum glucose and the internal standard were then reacted with 1-phenyl-3-methyl-5-pyrazolone and the formed derivatives were analyzed by liquid chromatography tandem mass spectrometry with multiple reaction monitoring(MRM).The method was calibrated with bracketing calibrators and serum glucose concentrations were calculated by comparing the peak area ratios of samples with that of the calibrators.Results The within-run,between-run and total coefficients of variation averaged 0.36%,0.47%and 0.61%,respectively.The analytical recoveries ranged from 99.0% to 100.9%.Results of analyzing the certified reference material SRM 965a showed an average biases of-0.20%.Conclusions An ID-LC/MS/MS method for measuring serum glucose has been developed.The method is highly precise and accurate and may be used as a candidate reference method.

Objective To exlore the influence of internal quality control and external quality control assessment(EQA) resulting from applicability of control samples in measurement of whole blood viscosity (WBV) through the analysis and comparison of applicability of 1 non-Newtonian fluid internal quality control sample in 3 viscometers. Methods Viscometer B, C and D were used to measure WBV of 30 blood samples in parallel under the shear rate(SR) of 1 s-1,30 s~(-1) and 200 s~(-1), then the blood SR-WBV curves of 3 viscometers were drawn according to the results. At the same time, viscometers B, C and D were used respectively to determine the WBV of control A 10 times in one day, then the control A SR-WBV curves were mapped. Three viscometers were used to measure the manufactory control samples and control A 5 times in one day for 4 days. Four groups of daily values of manufactory control samples and control A of each instrument were used to carry out F test to calculate whether 4 daily values are difference. Finally, the control A was dispensed in 49 laboratories nationwide chosen for measurement. On the basis of viscometer used, 20 laboratories were classified as group B, 20 laboratories were classified as group C and 9 laboratories were classified as group D. Then the data under SR of 1 s~(-1) were analyzed to calculate the coefficient of variation (CV) in the group. Results There was significant difference among the WBV of blood samples measured by the viscometers B, C and D. The results under SR of 1 s~(-1) declined in turn, and they were highest under SR of 30 s~(-1) followed by the values of viscometer D and B and they were (8.14±0.75), highest under SR of 30 s-1 followed by the values of viscometer B and D, and they were (7.35±0.07), daily values of manufactory control and control A of each instruments in four groups were compared. Under SR of 1 s~(-1), there was no difference between daily values of manufactory control and control A in viscometer B (F = 2.63, 1.37, P > 0.05), and there was no difference of daily values of manufactory control among viscometer C and D (F = 0.33,3. 14, P > 0.05), but significant daily difference existed when control A was tested by viscometer C and D (F = 5.76, 8.00, P < 0.05). Under SR of 30 s~(-1), there was no difference of daily values of manufactory control among 3 viscometers(F =0.31, 0.18, 2.26, P >0.05), and there was no difference of daily values of control A among 3 viscometers' (F = 1.03, 1.83, 2.40, P > 0.05); Under SR of 200 s~(-1), there was no difference of daily values of manufactory control among 3 viscometers (F =2.59, 0.68, 2.96, P > 0.05), and there was no difference of daily values of control A among 3 viscometers (F=2.31, 3.01, 2.28, P>0.05). When control A was tested under SR of 1 s~(-1) in 49 laboratories nationwide, the WBV values in groups of viscometer B, C and D were (18.47±1.30), (11.17±2.38), viscometer D and C were 63.75% and 21.3%. Conclusions Control A could fully mimic the properties of whole blood steadily on viscometer B, but partially mimic viscometer C and D, so the control A is most appropriate for viscometer B. Because current non-Newtonian fluid internal quality control could mimic rheological properties of whole blood under specifically conditions, laboratories should evaluate the consistent degree between control and whole blood, only the candidates which can mimic the properties of whole blood approximately could be chosen as quality control of WBV. When third-party control is chosen to be samples of EQA, its applicability should be in consideration. Pretest should be performed adequately to define applicability of third-party control, so as to reduce the difference among laboratories due to applicability of control and reflect detection quality of laboratories exactly.

Objective To develop a candidate reference method for the measurement of creatinine in human serum based on isotope dilution liquid chromatography tandem mass spectrometry (ID-LC/MS/MS). Methods An isotopically labeled internal standard [<'2>H<,3>] creatinine was added to the serum sample and equilibrated with the endogenous creatinine. The samples were treated with anhydrous ethanol to remove proteins by precipitation. After being washed with chloroform for further clean-up, the samples were analyzed by LC/MS/MS. Serum creatinine was quantified by a bracketing calibration. Results The within-run, between-run and total coefficients of variation ranged from 0.52% to 0.61%, 0.11% to 0.59% and 0.61% to 0.83%, and the averages were 0.57%, 0.43% and 0.73%, respectively. The analytical recoveries ranged from 99.09% to 101.13% with an average of 100.3%.The results of analyzing the certified reference material SRM 909b (Level Ⅰ and Ⅱ) and SRM 967b showed biases of less than 0.4%. Conclusions An ID-LC/MS/MS method for measuring serum creatinine has been developed. The method is highly precise and accurate and may be used as a candidate reference method for serum creatinine measurements.

Objective To develop a candidate reference method for the measurement of urea in human serum based on isotope dilution/gas chromatography/mass spectrometry.Methods [13C,15N2]Urea used as internal standard Was added to the serum sample and equilibrated with endogenous nonlabeled urea.The serum samples were treated with anhydrous ethanol to emove proteins by precipitation.The serum urea and labeled urea were converted into a trimethylsilyl derivative of 2-hydroxypyrimidine and analyzed by gas chromatography/mass spectrometry system with selected ion monitoring.The concentration of serum ureaWas calculated by the theory of bracketing method.Results The average value of within-run oefficient of vailation(CV),between-run CV and total CV of the procedure were 0.38%(ranged from 0.12%to 0.47%),O.62%(ranged form 0.49% to 0.87%)and 0.73%(ranged from 0.51% to 0.93%).Respectively.The analytical recoveries ranged from 99.37% to 100.95%.The resuhs of analyzing the certified refefence material SRM909b(Level Ⅰand Ⅱ)showed a bias less than 0.2%.Conclusion The procedure for measuring urea in serum is a highly accurate and precise method and can be used as a candidate reference method for serum urea assays.

Objective:To explore the application advantages of hospital-community linkage network blood glucose management model for elderly type 2 diabetes patients in community in order to supply reference for improve patients′ qualitye of life.Methods:This study was a randomized controlled study. A total of 84 elderly patients in Huangpu Community Hospital of Guangzhou from February to September 2022 were selected and divided into control group and intervention group by a table of random numbers. The control group adopted the hospital community linkage management model, and the intervention group followed the network management mode on the basis of the routine management. After 6 months of intervention, we compared the level of fasting blood glucose, blood glucose two hours after meal and glycosylated hemoglobin, and the scores of the Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Specificity Quality of Life Scale(DSQL) between the two groups to illustrate the application advantages.Results:There were no significant differences in blood glucose two hours after meal, fasting blood glucose and glycosylated hemoglobin between the intervention and control groups (all P>0.05). After 6 months of intervention, the blood glucose two hours after meal, fasting blood glucose and glycosylated hemoglobin of the intervention group were (9.25 ± 2.87) mmol/L, (6.07 ± 0.69) mmol/L and (7.04 ± 1.59) %, respectively, which were lower than those of the control group (11.04 ± 3.75) mmol/L, (6.57 ± 0.95) mmol/L and (8.02 ± 2.25)%. The differences were statistically significant ( t = 2.45, 2.76, 2.30, all P<0.05). After 6 months of intervention, the scores of SDSCA scale and DSQL scale were (34.21 ± 10.43) and (135.64 ± 10.71) points, which were higher than (29.12 ± 7.36) and (145.85 ± 10.33) points in the control group, and the differences were statistically significant ( t = 2.58, 4.44, both P<0.05). Conclusions:The hospital-community linkage network management model can improve the blood glucose level of elderly patients with type 2 diabetes mellitus in the community and has a positive effect on improving self-management behavior ability and improving quality of life.