Glycohemoglobin (HbA1c) is an important indicator for assessing long-term glycemic levels and diabetic complications of blood vessels in diabetic patients.However the test methods,reagents and technological capabilities in different laboratories are various,so there are significantly differences of the results in bias.In 2010 HbA1c was included in new guidelines from ADA for diagnosing diabetes,and recommended by WHO in 2011,which promoted the standardization process of HbA1c tests.In this article we analysed and reviewed main detection methods,the international advancement of standardization,current status of the establishment of HbA1c Reference system in China and its clinical application.

With the rapid development of life science and relevant technology of clinical laboratory medicine,it raised higher demands for current clinical biochemistry,which is to maximize the clinical efficacy and application value under the perfect quality management system.Based on the evidence-based medicine,considering the national conditions and the new situation of medical reform,comprehensive assessment the clinical performance of new technologies and new tests,to provide more objective and reliable evidence for practical application and to guide clinical decision making,is of great significance for the rational allocation and utilization of the limited medical resources.At the same time,promoting the development of personalized medicine process gradually,trying to change the passive medical model,focusing on the disease prediction,prevention and control,taking people as the foremost,optimizing the treatment plan,and strengthening the safety and efficacy of drugs,will become hot topics of clinical biochemistry.

Meshes or prostheses for hernia repair have been developing for half a century, while the best material is far away from being found.Although a few of disadvantages have been made up with products updating, new problems with usage have still arisen.In this review, development process of the repair materials for hernia was summarized and explored.

With the rapid development of life science and bioinformatics,clinical biochemistry is in a period of vigorous development under the new situation of medical reform.The work of mutual recognition of test results was carried out smoothly,new guidelines for clinical applications were introduced in succession,testing technology was gradually improved.Automation,molecularization and omics study has become three trends in the development of clinical biochemistry,leading clinical biochemistry's development in an all-round way.In this article we reviewed the main events of clinical biochemistry in 2012,and look forward to witnessing that laboratory medicine will play a more important role in the diagnosis and treatment of diseases in 2013.

ObjectiveTo explore the role and mechanism of NGAL in the process of hypoxia/ reoxygenation (H/R) injury in human renal tubular epithelial cell (HK-2).MethodsThe H/R model of HK-2 cells was established in vitro (oxygen concentration ＜ 0.1％ ).The expressions of NGAL in the cells of H/R group and control group were determined by WB and real-time RT-PCR.The cell models were treated with 50,100,200,400 and 1 000 ng/ml of recombinant NGAL respectively.Cell proliferation and apoptosis of the treated groups and control group were detected by the MTT assay and Annexin V-FITC/PI staining to determine the appropriate NGAL concentration.The cell cycle distributions in the H/R group,NGAL treated H/R group and control group were detected by flow cytometry,and the expressions of bax/bcl-2 and caspase-3 were measured by real-time RT-PCR.The experiments were triplicated to obtain the mean values.Results The protein expression of NGAL/actin in H/R group (5.875 ±0.081 ) was higher than that of the control group ( 1.513 ±0.032),the differences between the two groups had statistic significance (t =96.89,P ＜0.05). While the gene expressions of NGAL/actin in HL/R groups (12.32 ± 1.27 ) and control group ( 1.00 ±0.00) had statistical significance of difference ( t =15.40,P ＜ 0.05 ).In MTT assay,the absorption values of the H/R group and control group were 0.97 ± 0.03 and 0.56 ± 0.04,the differences had statistic significance( t =18.680,P ＜ 0.05 ).And the absorption value of cells treated with different concentrations of NGAL (50,100,200,400,1 000 ng/ml) were 0.56±0.04,0.53 ±0.03,0.56 ±0.04,0.53 ± 0.03,0.54 ± 0.02,respectively.There were no significant differences between the H/R group and NGAL treated groups ( F =0.978,P ＞ 0.05 ),but the differences of absorption values in the control group and other groups had statistical significance ( F =105.20,P ＜ 0.05 ).The ratios of early apoptotic cells ( Annexin V positive,PI negative) in the control group and the H/R group were ( 1.0 ±0.2) ％ and ( 27.6 ± 1.4 ) ％ respectively with a statistical significance of difference ( t =33.590,P ＜0.05 ).After the treatment of NGAL ( 50,100 ng/ml),the ratios were ( 27.8 ± 1.1 ) ％ and ( 26.4 ±1.3 ) ％ and there were no significant differences compared to the H/R group ( t =0.250,P ＞ 0.05 ).When the H/R model was treated with 200 ng/ml of NGAL,the ratio of early apoptotic cells dropped to ( 19.4 ± 0.6) ％,leading to a statistical significance of difference ( t =10.350,P ＜ 0.05 ).However,in the H/R model treated with high concentration of NGAL (400,1 000 ng/ml),the ratios were ( 19.3 ± 1.1 )％ and ( 18.9 ±0.5 ) ％,which had no significant differences compared to the cells treated with 200 ng/ml of NGAL (t =0.130,0.630; P ＞0.05).Thus the study chose 200 ng/ml as the appropriate treating concentration of NGAL.In the control group,H/R group and 200 ng/ml,NGAL treated HR group,PI values were (30.2 ±0.4)％,(22.1 ± 2.7 )％ and (23.2 ± 3.7 )％ respectively.There were no significant differences between the H/R group and NGAL treated group (t =0.510,P ＞0.05),but there was still statistical significance in difference among the control group and the treated groups ( F =8.28,P ＜ 0.05 ).The ratio of bax/bcl-2 and the expression of caspase-3 detected by real-time RT-PCR were 1.00 ± 0.00,1.00 ± 0.00 in the control group,5.83 ±0.33,8.13 ±0.20 in the H/R group and 2.52 ±0.07,1.89 ±0.02 in the NGAL treated H/R group.The bax/bcl-2 ( F =485.30,P ＜ 0.05 ) and caspase-3 ( F =3456.78,P ＜ 0.05 ) did have statistical significances of difference among the three groups.ConclusionsNGAL acts as a protective factor against hypoxia-reoxygenation injury by regulating pro-apoptotic genes.It provides a new idea and evidences for the treatment of AKI caused by ischemia-reperfusion injury.

Objective To evaluate the choices and surgical skills for tension-free femoral hernia repair under local anesthesia. Methods The clinical data of 109 nonincarcerated femoral hernia patients were summarized from December 2002 to December 2009. Patients were divided into 3 groups according the time period at which the surgery was performed. 85 patients from 2002 to 2008 were divided into 2 groups,45 cases treated with preperitoneal repair ( preperitoneal group), and the other 40 cases with mesh-plug repair (plug group). The 24 cases admitted from January 2009 to December 2009 received modified preperitoneal repair. Operation time, VAS, length of hospitalization, incidence of recurrence, foreign body feelings and seroma were compared among the three groups. Results All the 109 patients were repaired under local anesthesia, and there was no perioperative death. The statistical indicator value of incidence of recurrence, foreign body sensation and seroma in preperitoneal group was lower than plug group (P ＜0.05). The modified preperitoneal repair was better in operation time, VAS, length of hospitalization than preperitoneal group (P ＜ 0.05). Conclusions Modified preperitoneal repair under local anesthesia is the choice for treating femoral hernia without incarceration. Modified preperitoneal repair is faster, more minimally invasive and faster recovery.

Objective To explore the clinical efficacy of posterior component separation (PCS) with Sublay mesh repair for complex abdominal incisional hernia.Methods The retrospective cross-sectional study was conducted.The clinical data of 30 patients with complex abdominal incisional hernia who were admitted to the Beijing Chao-Yang Hospital of Capital Medical University from July 2016 to March 2017 were collected.Patients intraoperatively received PCS with Sublay mesh repair.Observation indicators:(1) intra-and post-operative situations:defect area of incisional hernia,operation time,volume of intraoperative blood loss,time of postoperative drainage-tube removal,postoperative complications and duration of postoperative hospital stay;(2) follow-up situation.Follow-up using outpatient examination and telephone interview was performed to detect recurrence of hernia and mesh-related complications up to July 2017.Outpatient examination was done once at postoperative month 1,3 and 6 and telephone interview was done at 1 year postoperatively.Measurement data with normal distribution were represented as x±s and measurement data with skewed distribution were described as M (range).Results (1) Intra-and post-operative situations:30 patients received successful PCS with Sublay mesh repair for complex abdominal incisional hernia.Defect area of incisional hernia,operation time,volume of intraoperative blood loss and time of postoperative drainage tube removal were respectively (222± 124)cm2,100 minutes (range,40-235 minutes),80 mL (range,50-200 mL) and 5 days (range,2-15 days).Of 7 patients with postoperative complications,3 were complicated with shallow surgical site infection,including 1 with wound healing by vacuum sealing drainage and 2 with delayed healing by debridement and drainage;2 with postoperative seroma were improved by aspiration and local pressurization after 1 months;1 with fat liquefaction of abdominal incision was improved by symptomatic treatment;1 with postoperative active hemorrhage was confirmed with arteriolar hemorrhage of muscular layer and then received hemostasis by ligation.Time of postoperative hospital stay of 30 patients was 15 days (range,10-57 days).(2) Follow-up situation:30 patients were followed up for (7± 3) months,without occurrences of hernia recurrence,intestinal fistula and mesh-related complications.Conclusion PCS with Sublay mesh repair for complex abdominal incisional hernia is safe and feasible,with good clinical efficacies.

Objective To investigate the application of combined detection of three serum markers,anti-cyclic citrullinated peptide antibody (anti-CCP),rheumatoid factor (RF),anti-keratin antibodies (AKA),for the diagnosis of rheumatoid arthritis.Methods This was a prospective study.Serum samples were randomly obtained from 137 RA patients,265 other autoinmmune diease patients,and 111 normal controls.All of the volunteers were outpatients or inpatients of Peking University Third Hospital from January 2011 to September 2013.Levels of AKA,anti-CCP antibody,RF were measured by indirect immunofluorescence,chemiluminescence,and immune turbidimetry,respectively.The values of 3 serum biomarkers and their varied combinations for RA diagnosis were systemically assessed.The results were compared using fourfold table chi-square (x2) test.Results When using one serum marker,anti-CCP had the highest accuracy (80.39％),Youden's index (YI) (0.51),and Kappa (κ) value (0.55) for the diagnosis of RA.While using three serum markers,anti-CCP + (AKA/RF),AKA /(anti-CCP + RF),anti-CCP/(AKA + RF) and (AKA + RF)/(anti-CCP + RF)/(AKA + anti-CCP) had the highest accuracy (80.94,80.94,80.66),YI (0.51,0.51,0.50),and κ value (0.55,0.56,0.54).Conclusion AntiCCP is the vital marker for RA diagnosis.Anti-CCP + (AKA/RF),AKA/(anti-CCP + RF),and (AKA +RF)/(anti-CCP + RF)/(AKA + anti-CCP) are the most ideal combinations for RA diagnosis.

Objective To establish an appropriate cut-off value of high sensitivity cardiac troponin T (hs-cTnT) and optimal combination measurement in the early diagnosis of acute myocardial infarction (AMI).Methods This research is a prospective study.342 patients admitted to emergency department with chest pain,43 patients with renal failure,40 patients with pneumonia and 18 premature with patent ductus arteriosus were involved from June 2012 to June 2013 in Peking University Third Hospital.The plasma hs-TnT,NT-proBNP,cardiac troponin Ⅰ (cTnI),CK-MB and copeptin were measured.The distribution of hs-cTnT among associated diseases was analyzed,the diagnostic performance of hs-cTnT and the role of combination hs-cTnT with NT-proBNP,CK-MB and copeptin were evaluated by receiver operating characteristic (ROC) curve.The statistical method was used to calculate the Sensitivity,specificity,negative predictive value and positive predictive value of hs-cTnT in the diagnosis of AMI.Results As compared to patients with STEMI(median 0.52 μg/L,range 0.037-7.610 μg/L),hs-cTnT was lower in the patients with Non-STEMI(median 0.127 5 μg/L,range 0.021-4.260 μg/L).However,the levels of hs-TnT in other diseases were also increased increased in varyng degrees (Chi-square =76.432,P ＜ 0.05)The areas under the curve (AUC) for hs-cTnT and cTnI in the diagnosis of AMI were 0.862 (95％ CI:0.729-0.928) and 0.748 (95％ CI0.666-0.818) respectively (Z =2.713,P ＜ 0.05).Taking 0.014μg/L and 0.035 μg/L as cut-off value of hs-TNT,the sensitivities were 100％ vs 95.1％,the specificities were 44.4％ vs 65.7％.The combination of hs-cTnT,NT-proBNP,CK-MB resulted in a increase in AUC (0.915,95％ CI:0.838-0.964) (Z =2.147,P ＜ 0.05) and the combination of hs-cTnT and copeptin resulted in a increase in AUC 0.921 (95％ CI:0.820-0.975) (Z =2.589,P ＜ 0.05).Conclusion With the cut-off value of 0.035 μg/L for diagnosis of AMI was appropriate,and the combination measurement can improve the accuracy of early diagnosis of AMI.

Objective To evaluate the correlation between RPA or the polymorphism of CYP 2C19 and the incidence of ischemic events and the influence on the clinical prognosis .Methods A case-control study was used.A total of 202 patients [male 66%,(63 ±11) years] with ACS on aspirin and clopidogrel treatment were recruited , whose RPA were measured by whole blood aggregometry ( WBA ) , and their CYP2C19 polymorphism were also tested .Their clinical ischemic events were recorded in the mean follow-up period of 16 months.The RPA cut-off values for antiplatelet low-responsiveness were defined by the receiver operator characteristic curve ( ROC); the relationships of clinical outcomes with RPA and CYP 2C19 were assessed by the Kaplan-Meier survival analysis.Results CYP2C19*2 (681G>A) present in 52.5% of recruited patients and*3 (636G>A) present in12.9%.RPA induced by adenosine diphosphate ( ADP) showed significant difference among CYP 2C19*2 or *3 heterozygotes, CYP2C19*2 or *3 homozygotes and noncarriers (χ2 =9.318, P=0.009);whereas, RPA induced by arachidonic acid (AA) (χ2 =2.441, P=0.295) and the incidence of ischemic events (χ2 =0.513, P=0.774) were not.During follow-up, 18 (9%) patients experienced clinical ischemic episodes , and their RPA were higher than patients without ischemic episodes [(8.6 ±4.8) Ωvs (5.2 ±3.7) Ω, P =0.013; (8.6 ±6.8) Ωvs (1.6 ±3.7) Ω, P <0.001].Moreover, employing 6.5 Ω(induced by ADP) and 2.5 Ω(induced by AA) as cutoff values,RPA showed optimal negative predictive values (97%, 96%) and poor positive predictive values (16%,29%).Survival analysis showed, statistically, patients with clopidogrel low-responsiveness had higher riskof ischemic episodes than patients with clopidogrel responsiveness (HR =2.86, χ2 =11.27,P =0.0008);however, patients with aspirin low responsiveness (HR =1.77, χ2 =1.74, P =0.19) or patients withCYP2C19*2 or *3 (HR =0.89, χ2 =0.12, P =0.73) did not.Conclusion Clopidogrel lowresponsiveness is associated with the occurrence of clinical ischemic events ; however, patients withCYP2C19 function reduced genetypes do not show higher risk of ischemic episodes though it presented slighlyhigher RPA.