Progress in the epidemiology of COVID-19 infections in children and adolescents / 中国学校卫生

Abstract@#The COVID-19 pandemic has posed a series of complex challenges. COVID-19 in children and adolescents is generally less severe than in adults and the elderly; however, some children and adolescents may experience severe complications and adverse health effects even after mild or asymptomatic COVID-19 infections. The article focuses on gathering the epidemic characteristics, health impact, risk factors, prevention and control measures, and vaccination status of children and adolescents with COVID-19 infection to provide recommendations for protecting children and adolescents in the post COVID-19 era.

Correlation between the distribution of intracranial and extracranial aterial lesions and risk factors in Chinese patients with ischemic stroke :a multicenter registry study / 中华超声影像学杂志

Objective To investigate the distribution characteristics and risk factors of intracranial and extracranial aterial lesions in Chinese patients with ischemic stroke . Methods In this multi‐center study ,2 310 continuously inpatients with ischemic stroke diagnosed in 20 stroke screening and prevention project base hospitals from June 2015 to M ay 2016 were enrolled . Carotid ultrasonography and transcranial color‐coded sonography or transcranial Doppler were performed in all patients to confirm the presence of cerebral artery stenosis or occlusion . According to the distribution of lesions ,the subjects were divided into 2 groups :the simple intracranial artery stenosis group and the simple extracranial artery stenosis group . T he difference of risk factors between the two groups was compared . Results Of the 2 310 patients with ischemic stroke ,1 516 ( 65 .6% ) had simple intracranial artery stenosis and 794 ( 34 .4% ) had simple extracranial artery stenosis . T he incidence of anterior circulation artery stenosis was higher in the group of intracranial artery stenosis than that in the extracranial artery stenosis group ( 68 .1% vs 48 .7% , P ＜0 .001) . Posterior circulation artery stenosis and combined anterior with posterior circulation artery stenosis were more common in patients with extracranial artery stenosis group than those in intracranial artery stenosis group ( 36 .4% vs 22 .1% ,14 .9% vs 9 .8% ;all P ＜0 .001) . Univariate analysis of risk factors for stroke showed that patients with intracranial arterial stenosis had a higher prevelence of hypertension , diabetes ,obesity ,and family history of stroke ,and their systolic blood pressure ,diastolic blood pressure , body mass index ( BM I) ,fasting blood‐glucose ,glycosylated hemoglobin ,triacylglycerol ,total cholesterol , and low‐density lipoprotein cholesterol were significantly higher than those in the extracranial arterial stenosis group ( all P ＜ 0 .05 ) . T he proportion of elderly ( ≥ 65 years old ) ,male and smokers in the extracranial arterial stenosis group was significantly higher than that in the intracranial arterial stenosis group ( all P ＜0 .05) . Multivariate logistic regression analysis showed that elderly ( ≥65 years old) ,male , and smoking history were independent risk factors for extracranial arterial stenosis ( OR＝ 2 .012 ,1 .637 , 1 .325 ,respectively ;all P ＜0 .05) . While hypertension ,diabetes ,less physical activity ,and high BM I levels were independent risk factors for simple intracranial arterial disease ( OR ＝ 1 .301 ,1 .252 ,1 .248 ,1 .030 , respectively ;all P ＜0 .05) . Conclusions There are significant differences in the distribution characteristics and risk factors of intracranial and extracranial aterial lesions in patients with ischemic stroke in China .

Efficacy of preoperative concurrent radiotherapy and chemotherapy in middle and low rectal cancer / 中国生化药物杂志

Objective To investigate the efficacy of preoperative concurrent radiotherapy and chemotherapy in middle and low rectal cancer.Methods From October 2012 to September 2016,64 patients with middle and low rectal cancer underwent surgical treatment,were randomly divided into two groups,the treatment group 32 cases,the application of simultaneous preoperative radiotherapy and chemotherapy and surgery,control group of 46 patients,only the application of surgical treatment.After treatment,the efficacy,tumor decline,adverse reactions,serum CEA levels,the lower edge of the tumor to the anal distance,the longest diameter of the tumor and quality of life improvement were compared between two groups,and compared the local recurrence and survival of 2 groups in 3 and 5 years.Results The total effective rate of the treatment group was 78.13％,the rate of tumor decline was 87.5％,the improvement rate of quality of life 84.38％,the survival rate of 3 years and 5 years were 90.63％and 75％(19.14±8.52)ng/mL,the distance from the lower edge of the tumor to the anal margin was(7.88±2.07)cm,and the longest diameter of the tumor was(2.24±1.15)cm(P<0.05).The local recurrence rates were 6.25％and 15.63％in 3 years and 5 years,which were all lower than those in the control group(P<0.05).The side effects after radiotherapy and chemotherapy in the treatment group were(31.8％),nausea and vomiting(46.88％),radioactive pancreatitis(71.88％),neurotoxicity(3.13％),liver function abnormality(31.25％),leukopenia(25.00％),hemoglobin reduction),Diarrhea(87.5％),the vast majority of Ⅰ～Ⅱ degrees,the corresponding treatment were relieved.Conclusion The clinical curative effect of preoperative concurrent chemoradiation and radiotherapy of middle and low rectal cancer is significant,which has clinical value.

Age characteristics and distribution of cerivocerebral large artery lesions in inpatients with cerebral ischemia:an analysis of multi-center research results / 中国脑血管病杂志

Objective To investigate the differences of distribution characteristics and risk factors of large artery lesions in patients with ischemic cerebrovascular disease in different age groups in order to provide the basis for the prevention and treatment of stroke in different age groups.Methods From June 2015 to May 2016,a total of 10 711 consecutive inpatients with transient ischemic attack (TIA) and ischemic stroke from 20 centers nationwide were enrolled.Each 10 years was used as an age group from 40 years.All the patients were divided into 5 age groups.The differences of the different risk factors for cerebrovascular disease among the 5 groups were compared.All patients were separated by gender.The chi square test was used to compare the incidences of large artery stenosis of the intracranial and external and anterior and posterior circulation,and the number of vascular lesions in the same sex in different age groups.Results (1) The risk factors of elderly patients were mainly hypertension,diabetes mellitus,and atrial fibrillation (χ2=61.938,χ2=13.349,and χ2=55.940;all P<0.01).The smoking history,family history of cerebrovascular disease,and obesity were more frequent among the young and middle-aged people (χ2=131.505,χ2=7.298,and χ2=100.911,all P<0.01).(2) The linear trend chi square test results showed that the proportion of multivessel diseases in female and male extracranial arterial lesions increased gradually with the increase of age.(χ2=54.799,χ2=161.370,all P<0.01).The proportion of multivessel diseases in the intracranial artery in female decreased gradually (χ2=5.328,P=0.021),and that in male did not have obvious trend of change (χ2=0.289,P=0.591).(3) The linear trend chi square test results showed that the incidence of simple intracranial arterial stenosis in female and male intracranial arterial stenosis decreased gradually with the increase of age (χ2=20.090,χ2=42.351,all P<0.01),and the incidence of simple extracranial arterial stenosis increased gradually (χ2=40.311,χ2=90.698,all P<0.01).The incidence of both intracranial and extracranial artery stenoses increased gradually (χ2=12.077,χ2=45.887,all P<0.01).The incidence of simple posterior circulation vascular stenosis increased gradually in female (χ2=16.434,P<0.01),but that did not have obvious trend of change in male (χ2=1.701,P=0.192).The incidence of stenosis of both anterior and posterior arteries in female and male increased gradually (χ2=4.587,P=0.032;χ2=35.156,P<0.01).Conclusions The distribution of atherosclerotic lesions in ischemic cerebrovascular disease of the different age groups was different.No matter female or male patients,the majority of the young and middle-aged patients were intracranial artery lesions,and the elderly patients were mainly extracranial artery lesions.The majority of elderly women had posterior circulation artery lesions.Understanding the characteristics in patients with intracranial arterial lesion in different age groups will help to develop individualized stroke prevention and treatment strategies for the population of different age groups.

Correlation between serum lipid level and carotid artery stenosis in patients with ischemic cerebrovascular disease:a multi-center registry study / 中国脑血管病杂志

Objective To investigate the effect of serum lipid level on carotid artery stenosis in patients with ischemic cerebrovascular disease.Methods Using a multi-center cross-sectional study,10 711 consecutive inpatients with transient ischemic attack (TIA) or ischemic stroke diagnosed clearly in 20 stroke screening and prevention project base hospitals from June 2015 to May 2016 were enrolled.According to the results of carotid ultrasonography,1 560 patients with extracranial carotid artery stenosis rate≥50% screened were enrolled in the study.They were divided into a severe stenosis group (70%-99%) and a mild-moderate stenosis group (5.80 mmol/L (7.3%[43/586]vs.0.4%[4/974]) and LDL-C>3.12 mmol/L (26.3%[154/586]vs.10.0%[97/974]) in patients of the severe stenosis group were higher than those in the mild-moderate stenosis group (26.3%[154/586]vs.10.0%[97/974]).Conclusion The high LDL-C and TC levels may increase the incidence of severe carotid artery stenosis or occlusion.

Correlation between smoking and occurrence of intracranial artery stenosis by ultrasonography:an analysis of multi-center research results / 中国脑血管病杂志

Objective To analyze the correlation between smoking and occurrence of intracranial artery stenosis.Methods From June 2015 to May 2016,a total of 10 711 inpatients with transient ischemic attack (TIA) or ischemic stroke from 20 basel hospitals of nationwide were enrolled using a cross-sectional study,76 patients with unknown smoking and smoking cessation years were excluded.Finally,a total of 10 635 patients were enrolled.Transcranial color coded sonography and/or transcranial Doppler were used evaluate the intracranial artery stenosis lesions.The basic risk factors for cerebrovascular disease (age,sex,smoking and smoking years,whether smoking cessation and years,hypertension,diabetes,hyperlipidemia,atrial fibrillation,and family history of stroke) were recorded.According to the different smoking years,the smoking years were divided into five groups:non-smoking,smoking time ≤10-year,11 to 20-year,21 to 30-year,and >30-year groups for trend chi square test.According to the different smoking cessation years in the smokers,the smoking cessation years were divided into four groups:non-cessation,cessation time 1 to 10-year,11 to 20-year,and >20-year groups for trend chi square test.The effects of different smoking years and different smoking cessation years on the occurrence of intracranial arterial stenosis were analyzed.Results The incidence of intracranial artery stenosis in the smokers (40.4%[1 433/3 547]) was significantly higher than that in the non-smoking patients (29.4%[2 085/7 088]).There was significant difference (χ2=128.850,P<0.01),and the incidence of cerebral infarction in the smokers (91.6%[3 250/3 547]) was significantly higher than the non-smokers (85.0%[6 027/7 088]).There was significant difference (χ2=92.328,P<0.01).Smoking was an independent risk factor for intracranial artery stenosis (OR,1.603;95%CI 1.456-1.765;P<0.01).With the increase of smoking years,the detection rate of intracranial arterial stenosis increased gradually (trend χ2=115.437,P<0.01).Whether giving up smoking had no significant effect on the incidence of intracranial artery stenosis in patients with ≥20 years of smoking (trend χ2=1.043,P=0.307).Conclusions Smoking is an independent risk factor for affecting intracranial artery stenosis;the risk of disease increases with the number of smoking years.Long-term smokers (≥20 years) cannot reduce the effect on intracranial artery stenosis,even if they give up smoking.

Observation on curative effect of invigorating spleen qi, bushen fillixi combined with oxaliplatin+CF/5-FU on colorectal cancer / 中国生化药物杂志

Objective To investigate the therapeutic effect of Jianpi Yiqi, Bushen Fenjing combined with oxaliplatin+CF/5-FU on colorectal cancer.MethodsEighty patients with colorectal cancer who were treated in our hospital from January 2014 to December 2015 were randomly divided into observation group(40cases) and control group (40cases).The control group was given oxaliplatin+CF/5-FU treatment, the observation group in the control group based on the application of Spleen Qi, Bushen fill essence treatment, observed before and after treatment of two groups of serum tumor markers, clinical symptoms and living conditions, changes, record adverse reactions.ResultsThe observation effect of 82.50% was significantly higher than that of the control group (62.50%).The QOL score (37.8±5.6) was significantly higher than that of the control group (33.5±3.1) and the adverse reaction rate was 30.00% (P<0.05).The difference between the two groups was significant (P<0.05).ConclusionThe effect of invigorating spleen qi and tonifying siren solution combined with oxaliplatin+CF/5-FU on colorectal cancer can improve the clinical symptoms and improve the quality of life of patients.

Effects of pramipexole on serum cystatin C, antioxidant indexes and brain derived neurotrophic factor in Parkinson’s disease / 中国生化药物杂志

Objective To investigate the effects of pramipexole on serum cystatin C, antioxidant indexes and brain derived neurotrophic factor ( BDNF) in the treatment of patients with Parkinson’s disease.Methods Retrospective a total of 96 patients with Parkinson’s disease were collected and randomly divided into experimental group and control group with 48 cases in each group.Patients in the control group were treated by levodopa,patients in the experimental group were treated on the basis of the control group with pramipexole, movement and non-movement symptoms were assessed by unified Parkinson’ s disease rating scale ( UPDRS), the serum cystatin C, antioxidant indexes and brain derived neurotrophic factor levels were measured, and the clinical efficacy and adverse reactions were compared.Results The effective rate of the control group (68.75%) was lower than the experimental group (87.50%), with statistical significance (P<0.05); compared with the control group, the movement and non-movement symptoms of the experimental group reduced after treatment, after treatment the serum CRP, serum cystatin C decreased, serum BDNF increased, after treatment the glutathione (GSH), catalase (CAT), superoxide dismutase (SOD) and glutathione peroxidate (GPX) levels increased, with statistical significance (P<0.05).Conclusion Pramipexole in the treatment of patients with Parkinson’s disease could reduce serum cystatin C, improve the levels of BDNF and antioxidant capacity, the effect is remarkable.

Effect of rivaroxaban on HIF-α, P-selectin and TNF-αin patients with lower extremity venous thrombosis / 中国生化药物杂志

Objective To investigate the effect of rivaroxaban on HIF-α, P-selectin and TNF-αin patients with lower extremity venous thrombosis.Methods 41 cases from May 2014 to February 2015 were selected and randomly divided into two groups, 21 cases in the control group were treated by routine treatment, 20 cases in the experiment group were treated on the base of the control group with ivaroxaban.Serum HIF-α, P-selectin and TNF-αwere detected before and after the treatment.ResuIts Compared with the control group, the clinical effect were higher ( P0.05).HIF-α, P-selectin and TNF-αwere lower(P<0.05),HIF-αwas positively correlated with TNF-α(r =-0.468,P<0.05), and was not correlated with P-selectin, P-selectin was not associated with TNF-α.ConcIusion Rivaroxaban can effectively improve the lower limb venous thrombosis in patients with clinical symptoms, reduce serum HIF-α, P-selectin and TNF-αexpression, has better clinical curative effect, for clinical treatment of lower limb venous thrombosis has important significance.

Evaluation of value of indirect method in establishing reference intervals of CA72-4 / 中华检验医学杂志

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.

Harmonization of serum protein measurements with different immunoassays / 中华检验医学杂志

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.

Analysis of rejected specimens in the department of clinical laboratory medicine from 2007 to 2010 / 中华检验医学杂志

Objective To investigate how to control and decrease the number of rejected specimens in order to improve pre-analytical quality.Methods The 40 035 rejected blood specimens from 2007 to 2010 and the rejected body fluid specimens including 162 urine specimens and 167 feces specimens in 2010 in the Department of Clinical Laboratory Medicine,Zhongshan Hospital,Fudan University were analyzed retrospectively.Results were shown by the percentage of rejected specimens in which Pearson x2 test was used to assess the percentage of clotted specimens with different anticoagulant tubes.Results The percentage of rejected specimens collected by syringes with glass tubes or plastic tubes with anticoagulant artificially was 11.58％,which was higher than that of rejected specimens collected by vacuum blood collection system ( 1.33％ ).The percentage of rejected specimens from 2007 to 2010 collected by vacuum blood collection system was 13.29‰,1.49‰,0.76‰ and 0.52‰,respectively,which was decreased year by year.The three main reasons of rejected specimens were specimen clotted,insufficient specimen quantity and improper specimen type,respectively.Specimen clotted was more frequently in sodium citrate anticoagulant tube samples than others (x2 =202.3,P =0.000).The rejected specimens of body fluid specimens were mainly feces specimens without samples.The number of rejected feces specimens was significantly decreased from 2‰ above to 1.5‰ below with the implementations of transparent sample containers.Conclusion Appropriate improvement measures of rejected specimens with clinical communication should be taken by the clinical laboratory to reduce the number of rejected specimens and improve pre-analytical quality.

Biological variation in 32 clinical laboratory routine tests / 中华检验医学杂志

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.

Clinical application of high-sensitivity cardiac troponin T assay in the diagnosis of acute myocardial infarction / 中华检验医学杂志

Objective To evaluate the clinical application of hs-cTnT in diagnosis of AMI. Methods The detectable rates of hs-cTnT and con-cTnT from 147 AMI ( including 122 NSTEMI )patients on immediate admission were compared. The related biological markers including hs-cTnT, con-cTnT, CKMB mass and MYO were determined for all samples from 481 patients with chest pain on immediate admission and 4 h, 12 h ,20 h and 28 h after admission. The receiver operating characteristic curve was used to evaluate the sensitivity and specificity of all markers. The change rates of hs-cTnT within 4 hours from AMI group, non-AMI heart disease group, AMI related high risk disease group and control group were compared with serial detection. Results The detection rates of hs-cTnT for AMI and NSTEMI patients were 90. 3% and 91.0%, and both were significantly higher than the rates of con-cTnT, which were 61.9% and 60. 6% (x2 =23.08,18. 64,all P＜0. 01 ). Among different makers obtained from different collecting times,hs-cTnT had the highest detection rate. For admission cases, the area under curve of hs-cTnT, con-cTnT,CKMB mass and MYO were 0.935, 0.851, 0.827 and 0.769 respectively, and the differences have statistical significance(Z1 = 3. 13, Z2 = 4. 46, Z3 = 5.62, all P ＜ 0. 05 ). Besides, there was a significant difference between the change rate of hs-cTnT of AMI and other groups (x2=166.09,P＜0. 01).Conclusions In comparison with con-cTnT, hs-cTnT could provide reliable results for earlier diagnosis of AMI, and could also reduce misdiagnosis and missed diagnosis of NSTEMI. Combining single test of hs-cTnT with serial tests was superior to using cut-off value alone in diagnosis. Moreover, it could be helpful to distinguish non-AMI patients from true AMI patients due to the improved detection sensitivity. Because of its good diagnostic performance, hs-cTnT test may limit the application value of some other "early markers".

The analytical performance assessment of high-sensitivity cardiac troponin T reference intervals investigation / 中华检验医学杂志

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.

The analytical performance assessment and clinical practice of three sensitive cardiac troponin Ⅰ assays / 中华检验医学杂志

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.

Consistency of creatinine results in Shanghai and the preliminary clinical application of estimated glomerular filtration rate / 中华检验医学杂志

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.

Serum bone turnover markers reference intervals establishment in population of Shanghai / 中华检验医学杂志

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.

The preliminary study of target uncertainty during fractionated radiotherapy for esophageal cancer / 中华放射肿瘤学杂志

Objective To investigate the changes of target during fractionated radiotherapy for e-sophageal cancer, and to assess their impact on the implementation of radiotherapy. Methods Fourteen pa-tients with unresectable esophageal cancer were enrolled to receive full course conformal radiotherapy. CT scans were performed after every ten fractions. New targets (GTV) were delineated on repeated CT scans. Then the pretreatment radiotherapy plans were copied to the new targets to investigate the conformity between the new GTV and the plans. Results The majority of the GTVs decreased with the increasing fractions dur-ing radiotherapy. However, GTVs of 35.7% (5/14) patients increased by 2.0%-37.7% at the tenth frac-tion. The PTVs covered by 95% isodose curve at the time of pretreatment,tenth fraction,twentieth fraction and thirtieth fraction were 97.81%±1.53%, 91.95%±5.25%, 94.27%±4.23% and 94.03%±6.45%, respectively. Moreover, at tenth, twentieth and thirtieth fraction, there were 6,5, and 4 patients whose PTVs covered by 95% isodose curve were below 95%, respectively. Conclusions There are signifi-cant target changes during fractionated radiotherapy for esophageal cancer, which may result in uncertainties of radiotherapy implementation.

Uncertainty of target volume and organ at risk during fractional radiotherapy / 国际肿瘤学杂志

Anatomic structures and their relative position of the target and organs at risk surrounded will change more or less during fractional radiotherapy.These uncertainties will affect the practice of treatment planning correctly.The degree of these uncertainties can be investigated by imaging verification system during clinical practice.The possible reasons of these uncertainties may be tumor volume variations,organ motions orshape changes,patients weight or form changes and set-up errors.The development and practice of imageguided radiotherapy,dose guided radiotherapy and adaptive radiotherapy can offer rational approaches to over-come the uncertainties of the target and organ at risk surrounded during radiotherapy.