Objective:To develop an HPLC method for the determination of valacyclovir hydrochloride capsules. Methods: An Inertsil ODS (250 mm × 4. 6 mm,5μm) column was employed with methanol-0. 02 mol·L-1 potassium dihydrogen phosphate solution (20∶80) as the mobile phase, the flow rate was 1. 0 ml·min-1, the detection wavelength was at 251 nm, the column temperature was 30℃,and the sample size was 20μl. Results:The linear range of valacyclovir hydrochloride was 2-40μg·ml-1 , the correlation coeffi-cient was 0. 999 9 and the average recovery was 99. 8%(RSD=0. 16%,n=9). Conclusion:The analytical method is simple, accu-rate and special, which can be used in the content determination and quality control of valacyclovir hydrochloride capsules.

Objective To evaluate the effectiveness of discharge planning and home care for patients with peritoneal dialysis (PD).Methods A total of 60 PD patients were randomly divided into the intervention group and control group,30 cases in each group.Discharge planning and home care were carried out in the intervention group, while routine nursing and telephone follow -up service after discharge were implemented in the control group.The patientsˊscores of Zung Self -Rating Anxiety Scale(SAS),Self -Rating Depression Scale(SDS),Self management ability of patients undergoing peritoneal dialysis,complication rate and readmission rate were compared between the two groups at the next day admission,discharge,lth month and 3th after discharge.Results The scores of SAS and SDS in the intervention group were significantly lower than that in the control group at 3th month after discharge,the difference was statistically significant(tSDS =5.263,tSAS =3.812,P <0.05).The Self management ability of patients undergoing peritoneal dialysis was significantly higher than that of the control group at lth and 3th month after discharge,the difference was statistically significant (t =6.845,t =7.231,P <0.05).No significant difference in the re -admission rate (16.67%,6.67%)was found between the two groups (χ2 =0.387,P >0.05).The complication rate in the intervention group was significantly lower than in the control group at 3th month after discharge(χ2 =5.124,P <0.05).Conclusion Discharge planning and home care can effectively relieve depression and anxiety in patients with peritoneal dialysis and improve the abilities of daily life.It is worth promoting and applying in clinic.

ObjectivesTo evaluate the effect of combination of liraglutide,a glucagon-like peptide-1 analogue and pioglitazone,an insulin sensitizer,on diabetic db/db mice.MethodsThirty-five 8-week old male db/db mice were divided into control group (n = 8 ),pioglitazone group (n =9 ),liraglutide group (n =9) and combined therapeutic group (n =9),which was given normal saline 0.1 ml,2/d,pioglitazone 24 mg· kg-1 · d-1 (feed contained 0.02％ pioglitazone) + normal saline 0.1 ml,2/d,liraglutide 300 mg/kg,2/d,and pioglitazone 20 mg · kg-1 · d -1 ( feed contained 0.02％ pioglitazone) +liraglutide 300 mg/kg,2/d,respectively.Liraglutide were given at 8:00 and 16:00 via subcutaneous injection after having been diluted with sterilized normal saline.Effect on glucose,lipid metabolism and islet β-cell preservation were assessed after 4 weeks.Oneway ANOVA was adopted for statistical analysis.Results Combination therapy displayed promising anti-hyperglycemic[glycosylated hemoglobin Alc: (4.5 ± 0.6)％vs.(7.3 ±0.4)％,P ＜ 0.001].Glucose tolerance were improved assessed by area under curve(AUC) of glucose by intraperitoneal glucose tolerance test (IPGTT)[(1814 ±91 ) mmol · min · L-1 vs.(4042 ±183) mmol · min · L-1,P ＜0.001];insulin release response to glucose were also preserved as AUC of insulin by IPGTT was higher[( 1639 ±372) μg · min · L-1 vs.(834 ±201 )μg · min · L-1].Combination therapy also reduced circulated free fatty acids and TG[( 202.0 ± 20.4 ) μmol/L vs.( 272.5 ± 21.7 )μmol/L,(0.81 ± 0.28) mmol/L vs.( 1.35 ± 0.21 ) mmol/L],and increased plasma adiponectin [(16.7±2.0)mg/L vs.(10.2±1.8)mg/L].All P value ＜0.05.Islet immunohistochemistry showed that combination therapy significantly increased insulin positive area were[( 59.5 ± 1.5 ) ％ vs.( 22.4 ±1.5) ％]and ratio of Brdu positive β-cells was three folds than vehicle-treated mice[( 2.4 ± 0.5 ) ％ vs.(0.8 ±0.3)％],both greater than each single treatment.Combined therapy significantly improved islet β cell/α cell distribution,which led to islet recovery.ConclusionsCombined therapy improves glucose and lipid metabolism,preserves islet β-cell function and stimulates β-cell proliferation,greater than either liraglutide or pioglitazone treatment alone.

Objective To assess the analytical performance of three sensitive cardiac troponin Ⅰ assays and compare the clinical application to provide help in choosing the detection method for clinical laboratory. Methods A total of 474 serum samples were collected from apparently healthy subjects and a total of 112 serum samples were collected from patients presenting with symptoms suggestive of acute myocardial infarction. The functional sensitivities of three assays from Abbott, Beckman-Coulter and Ortho were determined ( CV = 10% ). The reference ranges have been established. The analytic performance was compared according to the assessment mode described by Apple. The relationship was compared among the different assays. The preliminary clinical application value for different detection methods has been evaluated and validated with self-established reference ranges. Results The functional sensitivities ( CV = 10% ) of the cTnI assays for Abbott, Beckman-Coulter and Ortho were 0. 030, 0. 04 and 0. 013 μg/L, respectively.The 99th percentiles of cTnI in healthy volunteers were 0. 021, 0. 02 and 0. 026 μg/L respectively. The analytical data of ROC curve showed that the area under curve (AUC) of the cTnI assays for Abbott,Beckman-Coulter and Ortho for diagnosis of AMI was 0. 852,0. 909 and 0. 910,respectively. There was no statistical difference between any two methods(Z1 = 1.18 ,Z2 = 1.21 ,Z3 =0. 026,all P ＞0. 05). There were good consistency between the 99th percentile obtained from our laboratory and suggested by manufacturers (Kappa value were 1. 000, 0. 730 and 0. 893 respectively, all P ＜ 0. 01 ). Conclusions The analytical performance of two cTnl assays is "clinical accepted" ,the other one is accepted according to guideline. All of them could detect cTnI in apparently healthy subjects. There exist differences among three assays, but their diagnostic characteristics for AMI are not significantly different.

Objective To assess the analytical performance of hs-cTnT and biological variations in healthy population as well as establish hs-cTnT reference intervals. Methods The serum samples from 100 acute myocardial infraction patients and 474 apparently healthy subjects were collected. The functional sensitivity,within- and between-run imprecision were determined. The hs-cTnT assay and con-cTnT assay were evaluated. The serum hs-cTnT levels were detected in apparently healthy subjects to establish reference intervals. Moreover,the long-term and short-term biological variations for hs-cTnT in healthy volunteers were assessed. Results The functional sensitivity of hs-cTnT was 0. 005 μg/L. The within- and between-run precision for lower level control(0. 014 μg/L) and higher level control(2. 500 μg/L) was 2. 97% vs 3. 64%and 0. 66% vs 1.01% ,respectively. The correlation between hs-cTnT assay and con-cTnT assay was good ( R2 =0. 972 ,P ＜0. 01 ). The 99th percentile in apparently healthy subjects was 0. 003 μg/L for women less than60 years, 0.008 μg/L for men less than 60 years, 0.015 μg/L for women above 60 years and 0. 021 μg/L for men above 60 years. The CVa, CVi, CVg and CVt of short-term biological variations in detecting hs-cTnT from 22 apparently healthy subjects were 3.8%, 4. 8%, 49.9% and 58.5%,respectively. The CVa,CVi ,CVg and CVt of long-term biological variations were 5. 3% ,6. 4% ,56. 6% and 68. 3% respectively. Conclusions The analytical performance of the hs-cTnT is better than con-cTnT assay,achieving acceptable level according to guideline. Our experimental result could provide the basis for the new high sensitivity cTnT assay in the diagnosis of acute myocardial infarction.

Objective To establish the reference interval for CA 72-4 in indirect method.Methods All results for CA72-4 that were stored in our laboratory information system of Zhongshan hospital between Jan.2010 and Dec.2012 were included in this study.Outliers were identified and omitted using Stem-and-Leaf&Box Plots in SPSS statistical software.The treated data was divided into several groups according to gender and age.Nonparametric rank sum test was used to observe the difference between male and female participants and Spearman correlation analysis was used to examine the correlation between CA 72-4 and age.Nonparametric reference intervals for CA 72-4 were estimated statistically in two gender sub-groups.Results After 139 cases excluded, there were 1 548 cases of male (Median 1.7, 0.4 to 18.9) and 773 cases of female ( Median 1.8, 0.2 to 18.9 ).There was a significant difference in serum CA 72-4 between male and female participants.No significant difference was found in serum CA 72-4 among age sub-groups.Indirect reference values for CA 72-4 of male and female were respectively 0 to 8.9 U/ml and 0 to 11.6 U/ml.Conclusion Indirect method to establish biological reference interval is a relatively simple and less expensive method under the high rapid development of the hospital information network .It can be used in the periodical review and establishing the reference intervals where the direct method can not be used.

Objective To analyze differences of serum proteins measurements by different methods in different systems and investigate whether the assigned serum valued by ERM-DA470k/IFCC can replace ERM-DA470k/IFCC in clinical measurements to promote the harmonization of serum proteins measurements.Methods Serum specimen was collected from 100 medical examination persons in Zhongshan Hospital (Jun 2012; age:27-73; 47 male and 53 female).Serum IgA,IgG,IgM,C3c,C4,TRF and PA of health persons,ERM-DA470k/IFCC and the assigned valued by ERM-DA470k/IFCC were measured by Hitachi 7600 (Roche and DiaSys reagents),Siemens BN Ⅱ (Siemens reagent) and Beckman IMMAGE (Beckman reagent),respectively.ERM-DA470k/IFCC was used as a calibrator to value the mixed serum.Serum proteins results obtained from the same methods were compared by T test and Wilcoxon test,and analysis of variance and Firendman test were used to compare results from different methods.The correlation of two groups was analyzed by linear regression.Results The differences of serum proteins results measured by two immunonephelometries,two immunoturbidimetries and all assays were statistically significant (P ＜0.05),respectively.The serum proteins results measured by two immunoturbidimetries showed good correlation (R2 were all above 0.97 except for C3c).In contrast,the serum proteins results measured by two immunonephelometries show poor correlation (R2 were all ranged from 0.90 to 0.94) except for IgM (above 0.96).The serum IgA,IgG and IgM results measured by different methods show good correlation (R2 were all above 0.95) Based on certified values of ERM-DA470k/IFCC,serum protein results measured by different methods could be harmonized,and got similar results from the assigned serum (P ＞ 0.05).Conclusions There is significant difference of serum proteins results detected by different methods.The ERM-DA470k/IFCC and certified serum can make serum protein results obtained from different methods harmonized.

Objective To set quality goals of conventional biochemical tests through the research of biological variation of the 32 routine items in Chinese population to provide the basis for Chinese clinical and laboratory standards.Methods According to the experimental designs and computing methods from foreign counterparts,the results of biological variation,individual indexes and quality goals were calculated through the serum detection of 22 subjects from clinical laboratory of Zhongshan Hospital in Shanghai (male 12,female 10,ages varying from 20 to 40 years old,median age 30) in short-term (five blood draws within one day at 8:00,10:00,12:00,14:00 and 16:00) and long-term (one blood draw at 8:00 in 6 weeks consecutively) and serum controls (mixed from healthy people).Results (1) Based on the results of shortterm and long-term biological variation in 32 routine itens,the individual indexes and quality goals were obtained.(2)The influence of diet on the biological variation of part of the test items could be observed,especially free fatty acid (the mean value of post-meal was less than pre-meal about 30％),and then followed by high-sensitivity C-reactive protein (the mean value of post-meal was lower than pre-meal about 20％) and triglyceride (the mean value of post-meal was higher than pre-meal about 10％).(3)There were some differences between the quality goals we accessed and the the indicators from Europe and CLIA.Conclusions (1)The results of apolipoprotein E and free fatty acid in this study made up for the inadequate of the European biology database.(2) Only a small part of the 32 routine items were affected by dietary factors.(3) Most quality goals obtained from this study generally consisted with Europe biology quality goals,but a few items existed different.(4)It's more practical and effective to use the results of biological variatiou than CLIA standards for setting up quality goals.

Objective To explore the consistency of the clinical serum creatinine results in Shanghai district and investigate the population distribution of apparently healthy people, modified MDRD formula adapted to Chinese population was used to estimate glomerular filtration rate and its distribution for further assessment of the clinical applicability of the eGFR.Methods A fresh pooled human serum sample with given IFCC's creatinine level from c.f.a.s.(calibration for automatic system) ,was used to calibrate the creatinine detecting systems of each participating hospital laboratory before every examination. Fourteen hospital laboratories successively conducted 6 experiments, and the test results were almost identical.They tested and studied the creatinine values of 6 837 ( male 3 289, female 2 132, children and teenagers 1 416)apparently healthy individuals, age from 0 to 99 years old, and estimated eGFR value of these apparently healthy individuals according to the documented eGFR formula [ eGFR = 175 × (Scr) -1.154 × (age) -0.203 ×0.742 (female) × 0.827 ] which was applied especially to Shanghai people.Results Before calibration,the inter-laboratory CVs of creatinine results varied from 3.1％ -9.1％, and after calibration, CVs decreased to less than 5％.A good consistency of the creatinine results was established among all these hospitals.The result of population distribution study of creatinine for men was 63.0-102.8 μmol/L,for women was 45.0-76.0 μmol/L, and for children and teenagers was 0-1 year old 11.0-77.0 μmol/L, 2 years old 15.5-33.3 μmol/L,3-5 years old 19.0-42.0 μmol/L, 6-19 years old 41.4-62.0 μmol/L.The Cr value were different between the male and femal [ male: ( 82.1 ± 10.9 ) μmol/L, femal: ( 59.4 ± 8.4 ) μmol/L, t =94.3 ,P <0.01 ＝ ;The eGFR value could decrease the sexual difference[ male: (79.1 ± 13.5) ml · ( min ·1.73 m2 ) -1, femal: (79.2 ± 13.6) ml · ( min · 1.73 m2 ) - 1, t = 0.266, P > 0.05 ].The difference of Cr and eGFR could not be eliminated between the groups divided by every 10 years(x2Cr =2 601 ,P <0.01 ;x2eGFR2= 1 105 ,P <0.01 ＝.Conclusions The pooled patients' sera could be used as calibrator for harmonizing of creatinine results among the laboratories. The reference rang of Cr should be differentiated by age and sex.Although eGFR can decrease the difference of sex, it cannot eliminate the difference of age.

Objective To establish the reference intervals of serum osteocalcin (OCN), C-terminal cross-linking telopeptide of type Ⅰ collagen (β-CTx) and total type Ⅰ procollagen N-terminal peptide (P1NP) by electrochemiluminescence assay. Methods According to the Clinical and Laboratory Standards Institute (CLSI) "CA8-A" document the appropriately healthy people, who were divided into three groups (men, premenopausal women, and postmenopausal women) by sex and pre- or postmenopausal status were screened. The levels of fasting serum of OCN,β-CTx, tPINP were detected by Roche Modular E170 electrochemical immunoassay. Results 393 appropriately healthy people consists of 112 men between the ages of 29 and 69 years, 148 premenopausal women between the ages of 29 and 69 years, 133 postmenopausal women between the ages of 29 and 69 years. The levels of serum OCN, β-CTx, tP1NP in men group were (15.33±4.76) μg/L, (413±189) ng/L, (42.15±17.14) μg/L, respectively. The levels of serum OCN, β-CTx, tP1NP in premenopausal women group were (12.99±4.53) μg/L, 265(30-820) ng/L, (36.43±14.23) μg/L, respectively. The levels of serum OCN, β-CTx, tP1NP in postmenopausal women group were (18.96±5.15) μg/L, (513±195) ng/L, 51.40 (8.98 -118.6)μg/L, respectively. Logarithmic transformation produced normal distributions for all markers but serum β-CTx of premenopausal women group and serum tPINP of postmenopausal women group. The 95% of the distribution intervals for serum OCN, β-CTx, tP1NP in men group was 6.00-24.66 μg/L, 43-783 ng/L, 9.06-76.24 μg/L, respectively. The 95% of the distribution intervals for serum OCN, β-CTx, tP1NP in premenopausal women group was 4.11-21.87 μg/L, 68-680 ng/L, 8.53-64.32 μg/L respectively. The 95% of the distribution intervals for serum OCN, β-CTx, tPl NP in postmenopausal women group were 8.87-29.05 βg/L, 131-900 ng/L, 21.32-112. 80 μg/L, respectively. Conclusions Compared with the reference intervals provided by manufacture, the reference intervals of three serum bone turnover markers established by our laboratory have great difference. Laboratory should pay attention to the reference intervals was cited.