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Objective:To study the efficacy of Shensong Yangxin capsule in the treatment of tachyarrhythmia and its effect on the hemorheology and cardiac function of patients.Methods:From June 2013 to June 2018, 86 patients with tachyarrhythmia who were treated in Taizhou Orthopedic Hospital were enrolled.The patients were divided into control group and observation group according to the random number table method, with 43 cases in each group.The patients in the control group were treated with amiodarone hydrochloride tablets, the patients in the observation group were treated with Shensong Yangxin capsule on the basis of the control group.After 8 weeks, the clinical efficacy, hemorheology and cardiac function of the two groups were compared and analyzed.Results:The total effective rate of the observation group was 93.02%(40/43), which was significantly higher than 76.74%(33/43) of the control group(χ 2=11.064, P<0.05). The plasma viscosity, fibrinogen and hematocrit in the observation group[(1.10±0.20)mPa·s, (1.69±0.36)g/L, (36.94±0.96)%] were lower than those in the control group[(1.51±0.38)mPa·s, (3.02±0.75)g/L, (45.15±1.06)%], the differences were statistically significant between the two groups( t=7.615, 9.463, 11.656, all P<0.05). After treatment, the LVDs and LVDd in the observation group[(39.02±4.68)mm, (53.16±6.42)mm] were significantly higher than those in the control group[(35.48±4.05)mm, (47.99±5.09)mm], the differences were statistically significant between the two groups( t=4.916, 5.064, all P<0.05). Conclusion:Shensong Yangxin capsule has significant therapeutic effect on patients with tachyarrhythmia, which can significantly improve the hemorheology and heart function of patients, and it is safe and worthy of promotion.
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Objective@#To verify the diagnostic value of adenosine deaminase (ADA) for tuberculous pleural effusion. @*Methods@#Forty-three cases with tuberculous pleural effusion and 163 cases with non-tuberculous pleural effusion were consecutively collected. The concentration of ADA in pleural effusion was determined by enzyme kinetics. The receiver operating characteristic (ROC) analysis curve was used to calculate the optimal cut-off value of ADA for diagnosing tuberculous pleural effusion based on the control groups with non-tuberculous pleural effusion. Meanwhile, the specificity and sensitivity of ADA level for diagnosis of tuberculous pleural effusion were compared with previous reports. @*Results@#The concentration of ADA in tuberculous pleural effusion (median 52.5 U/L) was significantly higher than that in non-tuberculous pleural effusion (median 9.8 and 10.6 U/L) (P＜0.05). With a cut-off level for ADA of 25 U/L, the diagnostic sensitivity and specificity was 88.0% and 91.0%, respectively. A system review analyzed data from 17 studies with QUADAS score ≥10 points and revealed the cut-off value of ADA to be （28.1±12.8） U/L (range 10.2 to 55.8 U/L) with a sensitivity of 89% (95%CI: 87% to 91%) and a specificity of 89% (95%CI: 88% to 91%). @*Conclusion@#The specificity and sensitivity of ADA for diagnosis of tuberculous pleural effusions should be up to over 85%, while the cut-off value of ADA from different literature reports were diverse.
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Objective@#To explore the feasibility and the value of CT enterography (CTE) in the quantitative evaluation of Crohn's disease (CD).@*Methods@#Retrospectively analyzed 49 patients diagnosed as CD by clinical, enteroscopy, pathology, and imaging from April 2016 to June 2017 in Zhongnan Hospital of Wuhan University. All patients underwent routine enteroscopy and standardized CTE. The interval between the two examinations was less than 2 weeks. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were measured at intervals. The ESR ranged from 2.0 to 97.0 mm/1 h, with an average of (30.6±26.5) mm/1 h, CRP from 0.3 to 143.3 mg/L, and a median of 27.7 mg/L. CD patients were classified into inactive, mild and moderate-severe according to Crohn's disease simplified endoscopic activity score(SES-CD) after enteroscopy. CTE evaluated the site of lesion, the thickness and enhanced patterns of the most severe lesions of the bowel wall, mural enhanced CT value in the portal vein phase, ΔCT value, stenosis, perienteric inflammation, mesenteric hypervascularity (comb sign), enlarged lymph nodes, abdominal abscesses, fistulas, etc. The Chi-square test was used to compare the differences of enhanced patterns among different groups. ANOVA (Analysis of Variance) was used to compare the differences in bowel wall thickness, plain CT values, mural enhanced CT value in the portal vein phase and ΔCT values among different groups. The correlation between CTE parameters and SES-CD or laboratory data was analyzed by Pearson (normal distribution data) or Spearman (skewed distribution data).@*Results@#SES-CD ranged from 1 to 15, with an average of 5.1±2.6. Among 49 cases, 13 were inactive, 19 were mild, and 17 were moderate-severe. There were 25 cases of intestinal obstruction or stenosis, including 24 cases in the active group and 1 case in the non-active group, and the difference was statistically significant (χ2=13.3, P<0.01). The short diameter of lymph nodes was more than 10 mm in 7 patients, all of them were active patients; 32 cases were mesenteric hypervascularity, manifested as "comb sign" , among them, 28 cases were active and 4 cases were non-active, and the difference was statistically significant (χ2=9.3, P<0.01). Perienteric inflammation was manifested in 30 cases, including 27 cases in the active group and 3 cases in the non-active group, and the difference was statistically significant (χ2=10.8, P<0.01). The enhanced patterns of thickened bowel wall in the non-active was dominated by C and D types, while A and B types was mainly in the active group, and the difference was statistically significant (P<0.05); There were significant differences in bowel wall thickness, mural enhanced CT value in the portal vein phase and ΔCT values between different groups (P<0.05), however, the difference of plain CT values between different groups was not significant (P>0.05). Bowel wall thickness, mural enhanced CT value in the portal vein phase and ΔCT values were all moderately correlated with SES-CD (r were 0.564, 0.585, 0.533, respectively; P all <0.01). Bowel wall thickness was positively correlated with ESR and CRP(r were 0.542, 0.452, respectively; P all <0.01). Mural enhanced CT value in the portal vein phase and ΔCT values were not correlated with ESR or CRP (P>0.05).@*Conclusion@#The bowel wall thickness, mural enhanced CT value in the portal vein phase and the ΔCT value can be used to accurately assess the activity of CD lesions.
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Objective To investigate the significance of carcinoembryonic antigen (CEA),carbohydrate antigen 19-9 (CA19-9),carbohydrate antigen 125 (CA125),neuron specific enolase (NSE),cytokeratin 19 fragment (CYFRA21-1) and squamous cell carcinoma antigen (SCC) for evaluation of first-line chemotherapeutic response and the prognostic value of these markers for prediction of overall survival (OS) in patients with advanced lung cancer.Methods Patients diagnosed with Ⅲ b/Ⅳ stage untreated,primary lung cancer and received first-line chemotherapy in Peking University Cancer Hospital & Institute from June 2013 to December 2014 were enrolled retrospectively into this study.The results of tumor markers before and after two cycles of chemotherapy and the clinical data of 181 eligible patients,including 133 males and 48 females with the average age of 58 years,were collected.The serum levels of six tumor markers were measured by electrochemiluminescence assay.Using RECISTv1.1 as standard,the sensitivity and specificity of tumor markers in classifying PR,SD,PD,were observed.The Kappa agreement test was used to evaluate the correlation between serum tumor markers and CT in evaluating chemotherapy response.The follow-up of OS was derived by telephone.Results The top three positive rates of biomarkers were CEA,CA125 and NSE in adenocarcinoma patients,CYFRA21-1,NSE and SCC in squamous carcinoma patients,NSE,CA125 and CYFRA21-1 in small cell lung cancer patients,respectively.In Kappa agreement test,the changes of serum levels of CEA and CA125,CYFRA21-1 and SCC,NSE were significantly correlated with CT for chemotherapy response evaluation in the mention above three kinds of carcinomas respectively (P ＜ 0.05).The sensitivity of tumor markers predicting PR was more than 90％,but the specificity was only 20％-58.3％,meanwhile,the specificity for SD and PD was high,but the sensitivity was low 0-66.7％).In the prognostic evaluation based on RECISTv1.1,there was no statistical significance for classifying PR,SD and PD in adenocarcinoma patients (median overall survival 17 months vs 22 months vs 14 months,P ＞0.05),but the OS of PR was longer than SD and PD in squamous and small cell lung carcinoma (median overall survival 28 months vs 22 months vs 4 months,12 months vs 8 months vs 8 months,P ＜ 0.05).Of these six tumor markers,only SCC was of statistical significance for classifying PR,SD and PD in squamous carcinoma (median overall survival 30 months vs 1 1 months vs 4 months,P ＜ 0.05).Conclusions Tumor marker has high sensitivity for predicting PR,but the value of tumor marker predicting SD and PD of advanced lung cancer was limited.The evaluation of patients would be comprehensive by combined use of tumor markers and CT.The changes of SCC after 2 cycles of chemotherapy are predictive of survival in squamous cell carcinoma patients.
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Colorectal Cancer (CRC) is a kind of molecular diversified neoplasm.For nonmetastatic early CRC patients who received surgery based systemic treatment,the 5 years survival rate is as high as 50％-80％.However,only chemotherapy is available for majority of metastatic advanced CRC patients.The effect of chemotherapy is disappointing.Numerous studies have demonstrated that some patients with metastatic advanced CRC can benefit from anti-EGFR and anti-VEGF monoclonal antibodies.Here,we give a brief overview about the clinical research of the detection of KRAS,BRAF,MSI and HER2in guiding treatment with targeted drugs in metastatic advanced CRC
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Objective To investigate the predictive value of baseline neutrophil-to-lymphocyte ratio (NLR) in the curative effect and prognosis of breast cancer patients treated with neoadjuvant chemotherapy.Methods The clinical data of 304 breast cancer patients received neoadjuvant chemotherapy in Beijing Cancer Hospital during 2010 were retrospectively analyzed.The correlations of baseline NLR with clinicopathological parameters of breast cancer patients were analyzed by Wilcox or Kruskal-Wallis tests,and the correlation of NLR with pathologic complete response (pCR) after neoadjuvant chemotherapy was analyzed by the binary logistic regression.The effect of clinic pathological parameters on the disease-free survival(DFS) of the patients was evaluated by the univariable and muhivariable Cox regression models.Results The medians of NLR in pCR + patients (n =62) and pCR-patients (n =242) were 1.76 and 1.72,respectively,and there was no significant difference between themn (P ＞ 0.05).Multivariate analysis indicated that the TNM stage (P ＜ 0.05) and pCR (P ＜ 0.05) were the independent risk factors influencing the prognosis of breast cancer patients.There was no significant correlation between NLR and 5-year DFS (HR=0.842,95％CI=0.566-1.255,P＞0.05).Condusion NLR lacks the predictive value in the curative effect and prognosis of breast cancer patients treated with neoadjuvant chemotherapy,while TNM stage and pCR are the independent risk factors influencing the prognosis of breast cancer patients.
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Objective To study the clinical effect of the treatment of cognitive dysfunction of acute cerebral infarction with ganglion glycosides.Methods 83 acute cerebral infarction patients with cognitive dysfunction were selected.83 patients were randomly divided into two groups:the conventional group (41 cases) and the intervention group (42 cases).The conventional group was given conventional control infection,anti platelet aggregation and control hemorrhage of digestive tract and routine rehabilitation training for the main therapy.The intervention group was given conventional treatment plus ganglioside 100mg + 0.9％ sodium chloride 250mL,1 time a day,treatment for 21 days.Observation index:(1) total effective rate;before and after treatment,the difference of MMSE score and Barthel index.Results The total effective rate of the intervention group was higher than that of the conventional group,there was statistically significant difference (95.24％ vs.75.61％,x2 =8.245,P ＜ 0.01);Before treatment,the MMSE score,Barthel index in the two groups had no significant differences (t =0.372,0.313;P =0.711,0.756).After treatment,the MMSE score,Barthel index of the intervention group improved more significantly compared with the conventional group,the differences were statistically significant(t =7.997,25.530,all P ＜ 0.01).Conclusion The clinical effect of ganglion glycosides in the treatment of acute cerebral infarction with cognitive impairment is accurate,it can effectively reduce the patients'cognitive dysfunction,improve the ability of daily life,it is worthy of promoting.
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Objective To investigate the effects of early continuous renal replacement thempy(CRRT)for hyperlipoidemia severe acute pancreatitis (HLSAP)patients.Methods 32 HLSAP patients were randomly divided into control group and CRRT treatment group.The levels of serum triglyceride(TG),serum and urine amylase,the APACHEⅡscore,the incidence of mechanical ventilation were compared between the two groups.Results The levels of serum TG was significantly lower in CRRT group than that in the control group in day 3(t =2.885,P =0.003). The APACHE II score,incidence rate of mechanical ventilation,the fatality rate were significantly lower in CRRT group than those in the control group in day 3(χ2 =4.572,t =4.912,χ2 =4.043;P =0.032,0.027,0.044).There were no significant differences between late group than that early group in age,gender,APACHE II score(all P >0.05).There were no significant differences between the two groups in the levels of amylase in serum and urine in day 3(all P >0.05).Conclusion Early CRRT therapy can eliminate the level of TG in HLSAP patients,may improve the prognosis of HLSAP patients.
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Objective To explore the effects of continuous renal replacement thempy ( CRRT) on efficacy in severe acute pancreatitis ( SAP) patients based on different time .Methods A total of 38 SAP patients were divided into two groups randomly:early group(CRRT within 48h) for 21 patients and late group(CRRT after 48h)for 17 pa-tients.the APACHE II score,the length of stay ICU and the mortality of 28d were compared between the two groups . Results The APACHE Ⅱscore was significantly higher in late group than that in early group in day 1 and 2 ( t=2.231,2.304,both P0.05);the hospitalizing days and mortality were significantly higher in late group than that in early group(t=2.156,χ2 =4.293,both P0.05).Conclusion Early CRRT can decrease both the hospi-talizing days and mortality in SAP patients .CRRT may provide more clinical benefits in the early phase (within 48h) of SAP.
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Acute kidney injury ( AKI) is a clinical syndrome associated with increased morbidity and mortality, and early recognition is critical .In an attempt to engage laypeople and non-experts,the term kidney attack has been introduced to refer to acute kidney injury (AKI),and AKI with functional loss and tubular damage can be diagnosed both with functional criteria ( CRIAKI, creatinine increase AKI ) and damage criteria ( NCRIAKI, non-creatinine increase AKI ) according to the most recent ADQI consensus .This comprehensive definition of Acute Kidney Syndromes may be a major advancement in terms of early referral , prevention of progression and therapeutic strategies for AKI .
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Objective To explore the influencing factors of gastrointestinal bleeding(GB) in secondary prevention patients with cerebral ischemic stroke(CIS).Methods A total of 616 patients were divided into bleeding group and control group according to the status (yes,no) of suffering GB during the 2years follow-up.Single factor analysis and Logistic regression analysis was used to explore the influencing factors of GB in CIS patients.Results The proportion of age≥65,a history of GB,gastric disease,renal insufficiency,sudden onset,NIHSS ≥12 and CIS ≥2 in the bleeding group was significantly higher than that in the control group (P ＜ 0.05) ; The proportion of combined with statins,proton pump inhibitors and gastric mucosal protective agent in the bleeding group was significantly lower than that in the control group (P ＜0.05) ; The Logistic regression analysis showed that age≥65,a history of GB,gastric disease,renal insufficiency,sudden onset,NIHSS≥12 and the times of CIS≥2 were risk factors of GB; however,combined with statins,proton pump inhibitors were protective factors.Conclusions Aging,a history of GB,gastric disease,sudden onset,higher NIHSS score and the times of CIS ≥ 2 were the risk factors of GB,combined with statins and proton pump inhibitors could reduce the risk of GB.
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Objective To compare the clinical effect of valsartan/amlodipine combination with valsartan only in primary hypertension patients.Methods After 4 weeks wash-out,90 patients (18-65 years) with primary hypertension were randomized to valsartan 160 mg/amlodipine 5 ng or valsartan 160 mg for 24 weeks according to a prospective study.Patients were checked every 4 weeks.At each visit clinical sitting blood pressure (SeDBP) were evaluated.weeks.The primary endpoint was to evaluate the improvement of SeDBP at the end of 24-week treatment.There were 83 patients(the combination therapy group n =43,monotherapy therapy group n =40) completed the 24h ambulatory blood pressure monitoring which was included in the final efficacy analysis.Results The randomized,single-blind treatment for 24 weeks.the mean value of SeDBP reduction,the reaching target blood pressure rate and total successful response rate to the treatment (a SeDBP ＜90 am Hg or a decrease of 10 mmHg or more from baseline) were (12.3 ±5.9)mmHg,64.9％ and 87.8％ in the combination therapy group,respectively,and were (7.9 ± 6.2) mmHg,34.8％ and 64.5％ in the monotherapy group,respectively.There were statistically significant difference between the combination therapy and the monotherapy groups in all the 3 indexs (P ＜ 0.01).The combination significantly reduced systolic blood pressure (SBP) and diastolic blood pressure (DBP) values throughout the 24h,the trough to peak ratios of DBP/SBP in the combination and valsartan alone were 82.8％/75.7％and 85.4％/78.8％ (P ＜ 0.05),respectively.Conclusion The combination therapy with valsartan/amlodipine was superior to valsartan monotherapy and was well tolerated in patients with essential hypertension and allowing a satisfactory BP control for 24 hours.
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Urinary excretion of albumin indicates kidney damage and is recognized as a risk factor for progression of kidney disease and cardiovascular disease,resulting a widespread clinical utilization of urine albumin measurement.Considerable inter-method difference has been reported for urine albumin,there are no available reference materials and no reference measurement procedures for urine albumin.This review discusses the clinical utilization of urine albumin in recent years,the principles of existing measurement systems and difference of results among systems,and the current status of work about reference materials and reference measurement procedures.
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Objective By investigating precision,linearity and accuracy of 9 commonly urine albumin assay systems (8 of immuno-turbidimetric assays and 1 of immuno-nephlometric assay),and comparing the concordance of measurement results,to elucidate the quality of the existing analytical systems.Methods Referring to Clinical and Laboratory Standards Institute (CLSI) EP15-A2,two mixed urines with U-Alb levels of 20 mg/L and 200 mg/L were made to validate precision; Referring to CLSI EP14-A2,fourty fresh urines were selected to evaluate matrix effect of saline diluted European Reference Materials (ERM) DA 470 and saline diluted urine,also to reflect the variation of measurement results among systems; Referring to EP6-A,saline diluted urines (10 levels) were made to validate linearity; Taking the theoretical concentration of precisely saline-diluted ERM-DA 470 as the target value,accuracy of each assay system was evaluated.Maximal allowable coefficient variation (CV) of ≤ 15％ was taken as the acceptable precision for each assay system,as rccommcnded by International Federation of Clinical Chemistry (IFCC)-and National Kidney Disease Education Program (NKDEP) ; maximum allowable bias of ≤25％ was taken as criteria for accuracy evaluation as used in Proficiency Test (PT) sponsored by College of American Pathologists (CAP).Results At level of micro-albuminuria(20-200 mg/L),all 9 systems total CVs were ≤ 15％ ; No matrix effect or interference were found in saline diluted ERM DA 470 and saline diluted urine.For A,B,E,F,G and I systems,validated linear regions were close to those stated in kit instruction;For C,D and H systems,the lower limits of validated linear region (18.7,3.6 and 12.0 mg/L,respectively) were higher than those stated in kits instruction (0,0.9 and 5.0 mg/L,respectively) ;For B and C systems,the lower limits of validated linear region were close to the upper limits of reference interval stated in kit instruction.When urine albumin was ≤ 12.6 mg/L,A,E,F,G and I systems showed good accuracy,absolute biases at all dilution were below 3 mg/L,D system showed higher positive bias (5.0-14.4 mg/L),B,C and H systems' biases were not evaluated because of high in-batch CV (the CV of B system≥ 18.1％,of C system ≥ 14.5％,of H system ≥ 39.1％); when U-Alb ranged in 25.2-201.0 mg/L,all 8 systems' relative biases were ≤25％,except D systems,which showed an un-acceptable positive bias (15.9％-44.3％).Good concordance among systems' results was present at level of microalbuminuria(20-200 mg/L),with CV among systems ＜ 15％ ;when urine albumin was ＜ 20 mg/L,CV among systems increased as allumin concentration decreased.The main contribution of variation came from B,C and H systems,which lower limits of linearity were relatively high.Conclusions At level of microalbuminuria(20-200 mg/L),except D system,the other 8 systems show good precision and accuracy;at low level of urine albumin(＜20 mg/L,especially ＜ 10 mg/L),precision and accuracy of some systems(B,C and H system) needs to be improved.
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Glycated hemoglobin is internationally recognized as the gold standard for assessment of long-term glycemic status in diabetic patients,but our determination of glycosylated hemoglobin standardization work is still at primary stage at present.Consistency and accuracy of glycated hemoglobin results are still needed to be solved.
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Objective Women with gestational diabetes mellitus (GDM) are at risk to develop Type 2 diabetes mellitus ( DM2).The aim of this study is to compare the effect of three diagnostic criteria on the prevalence of GDM.Methods 2864 pregnant women receiving obstetric care at 24 to 28 weeks of gestation at Peking University First Hospital,underwent the 75 g oral glucose tolerance test for routine GDM screening.The pregnancies were evaluated bythe American Diabetes Association (ADA 2004) Cuideline,the new criteria which was proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG 2010) based on the HAPO study,not by the criteria of American College of Obstetricians and Chinese Obstetrics and Gynecology (6th edition 2005).Venous plasma glucose was measured by the IDMS-traceable glucose oxidase method.Results The mean age of the women was 30 years.590 women were diagnosed with GDM using the IADPSG criteria.According to the IADPSG standard,GDM diagnostic rate reached 20.6％.The diagnostic rate of new criteria was increased by 307％ and 199％ compared with the Chinese Obstetrics and Gynaecology (6th edition) and the old ADA standard,respectively.If increasing the number of abnormal glucose values in the IADPS standard to 2 or more,the number of positive cases dropped to 227 people.The diagnostic rate of GDM plummeted to 7.93％,similar with that of the old ADA diagnostic criteria (6.8％).Conclusions The diagnosis rate of GDM was significantly higher using the IADPSG criteria,due to more stringent glucose abnormality recommended by the IADPSG.
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Chronic kidney disease (CKD) is a general term for heterogeneous disorders affecting kidney structure and function.It can be detected by routine laboratory tests.Acute kidney injury ( AKI),previously referred to as acute renal failure(ARF), represents a persistent problem in clinical medicine.Despite significant improvements in therapeutics,the mortality and morbidity associated with AKI remain high.A major reason for this is the lack of markers for early diagnosis of AKI.In this paper,we discuss recommendations for AKI and CKD laboratory assessment and management,and future challenges.( Chin J Lab Med,2012,35:773-779)
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Objective To compare the clinical effect of valsartan/amlodipine combination or irbesartan/hydrochlorothiazide(HCTZ)combination in very elderly hypertensives.Methods After a 4-week placebo period,94 hypertensives,aged 75-89 years were random given valsartan 160 mg/amlodipine 5 mg or irbesartan 300 mg/HCTZ 12.5 mg for 24 weeks according to a rospective study.After 4 weeks,amlodipine or HCTZ was doubled in non-responders.Patients were checked every 4 weeks.At each visit,sitting,lying and standing blood pressure(BP),systolic BP(SBP)and diastolic BP(DBP)were measured. At the end of placebo period and treatment period,electrolytes and uric acid were evaluated.Results Blood pressure was significantly decreased in both treatment groups,however,there was no statistical significance between two groups.BP changes from lying to standing position were significantly greater in the irbosartan/HCTZ group(-17.2/-9.1 mmHg)than that in the valsartan/amlodipine group(-10.1/-1.9 mmHg,t=2.14,P＜0.05 for SBP and t=3.11,P＜0.01 for DBP vs.irbesartan/HCTZ).Potassium significantly decreased and uric acid significantly increased(-0.4 mmol/L,t = 2.33,P＜ 0.05 and+29.7μ mol/L,t =2.54,P＜0.05 vs.baseline,respectively)only in the irbesartan/HCTZ group.Conclusions Both combinations had similarly effective in reducing clinical BP in very elderly hypertensives.However,valsartan/amlodipine offered some advantage and less pronounced BP orthostatic changes and absence of metabolic adverse effects.
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Objective To evaluate the accuracy of Cr measurement value from commonly used homogenous detection systems,to investigate the variation among different systems and the corresponding bias of eGFR.Methods According to the CLSI EP14-A2 protocol,commutability of LN24 was validated among 10 enzymatic assays and 1 picrate assay.LN24 included 6 vials of solution with Cr values assigned by IDMS at NIST,and concentrations of Cr for each vial were 68.1,126.9,185.7,244.5,303.2 and 361.9μmol/L LN24 was used to evaluate the accuracy of the included systems and the variation among them,and the assigned values were taken as the target values.eGFR were calculated by MDRD equation using IDMStraced picrate Cr and CKD-EPI equation using enzymatic Cr.Results Commutability was exist among the 11 systems for LN24 detection.Four systems showed bias ＜ 4.4 μmol/L at each level of LN24,two system showed bias ＞4.4 μmol/L at each level of LN24,one system showed a fixed negative bias( -4.2 ±0.7)μ mol/L,the other 4 systems showed diverse bias at different levels.Cr-bias-caused eGFR bias could reach 14.9 ml · min-1 · (1.73 m2) -1 at Cr level of 68.1 μmol/L SD among systems ascended with Cr level (2.6 -6.1 μmol/L) ;CV among systems descended with Cr level(4.0％ - 1.7％ ) ;After the 2 systems with obvious negative bias were removed,SD,CV among systems and eGFR bias decreased obviously.By measuring fresh serum,it was found that Cr bias among enzymatic systems was mostly ＜ 10 μmol/L;that between enzymatic assays and picrate assay was much diffused(from - 15 to 20 μmol/L).When Cr ＜ 100μmol/L,the eGFR difference between result of MDRD equation and that of CKD-EPI equation ranged from - 18 to 40 ml · min-1 (1.73 m2) -1.Conclusions Some enzymatic systems show good accuracy.Difference of Cr value is relatively fixed among enzymatic systems,and comparability can be reached through mathematic way.Un-acceptable difference between picrate assay and enzymatic assays still exists,thus comparability cannot be reached through mathematic way.At low Cr level,bias of Cr and using different equations may lead to significant bias of eGFR.We recommend that clinical laboratory should pay much attention to the accuracy and comparability at low level of Cr,and use uniform equation to calculate eGFR.
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Objective To evaluate the spot urine sample collection method and value of urinary albumin measurement in population survey. Methods Six hundred and fifty-nine Beijing residents were requested to collect 24 h urine for detection of UAER, as well as random spot urine samples and morning urine samples in the next day. Rapid semi-quantitative urinary albumin-specific dipstick and ACR were measured in each spot urine specimen. The 24 h UAER was measured as golden standard to generate ROC curves and evaluate the sensitivity, specificity and AUC of each method. Results The value of ACR in the morning spot urine samples and random spot urine samples were 9. 36(5. 12-33.29) mg/g and 11.29(6. 34-41.29) mg/g respectively and there was no significant difference between these two groups (t = - 1. 382,P＞0.05). The correlation was significant in the two groups (r = 0.932, P ＜ 0.01). The correlation coefficient between ACR in the morning spot urine samples and UAER was 0. 853 (P ＜ 0. 01). The correlation coefficient between ACR in the random spot urine samples and UAER was 0. 874 (P ＜0. 01).The sensitivity and specificity of ACR for diagnosis of albuminuria in the random urine samples were 77. 9% and 91.0%. The sensitivity and specificity of ACR for diagnosis of albuminuria in the morning urine samples were 78. 4% and 95.7%. Concerning the semi-quantitative urinary albumin-specific dipstick, sensitivity and specificity were 90. 3% and 41.1% , respectively. The specificity was much lower than that of ACR. The area under the ROC curves of ACR in the random urine specimens and the morning urine specimens was 0. 918 ±0. 012, 0. 929 ± 0. 015, respectively. There was no statistical difference between these two groups (χ2 =2. 13, P＞0. 05). The area under the ROC curves of semi-quantitative urinary albumin-specific dipstick in the random urine specimens was 0.661 ±0.021, lower than that of ACR (χ2 = 248.41, P＜0.01).Conclusion Measurement of ACR in random urine samples is a reasonable method with simplicity and accuracy for the detection of albuminuria in general population screening program.