Volume 97  ·  Issue 18  ·  2017

In 2016, the Chinese Medical Journal published a number of expert consensus and review articles on the testing and diagnosis reporting model^{[1,2,3,4,5,6,7,8,9,10]}That has aroused widespread attention in the industry. After a period of intense discussion, especially the development status of laboratory medicine, the vague understanding in the past gradually became clear, that is, how to strengthen effective communication with clinical practice and improve the knowledge service ability of laboratory medicine is the problem that must be solved in the development of laboratory industry. Through the establishment of the inspection and diagnosis report system, it is the key to improve the knowledge service connotation of the inspection industry and effectively improve the service level for clinical and patients. However, the leap from the data detection report to the inspection and diagnosis report to complete this inspection result needs to be based on the talent team capable of this job content.

Hepatitis B (hereinafter referred to as hepatitis B) is an infectious disease caused by hepatitis B virus (HBV). The susceptibility to hepatitis B virus varies greatly among different individuals, and the process of virus infection is complicated. Hepatitis B, especially chronic hepatitis B, has a variety of clinical manifestations. The laboratory diagnosis of hepatitis B is mainly clinical immunological detection, clinical molecular biological detection and clinical biochemical detection. Immunological detection includes colloidal gold immunochromatography, enzyme immunoassay and chemiluminescence immunoassay; Molecular biology methods include fluorescence quantitative PCR and gene sequencing; Clinical biochemical detection includes spectral analysis technology, electrochemical analysis, dry chemical analysis technology, electrophoresis technology, chromatography technology, etc.

Urinalysis is one of the commonly used clinical tests. Through routine urine test, special test, early renal injury test, renal function test and other tests, it is helpful for the screening, diagnosis and staging, differential diagnosis and curative effect observation of urinary system diseases, and it is of great significance for the screening or differential diagnosis of systemic diseases such as endocrine or metabolic abnormalities and jaundice. Routine urine examination includes physical examination, chemical examination and formable component examination. The combination of these three examinations has important guiding significance for screening, diagnosis and differential diagnosis of urinary system diseases.

Since November 2015, primary biliary cirrhosis has been officially renamed primary biliary cholangitis (PBC) internationally, and the abbreviated form remains unchanged. The reason for the name change is that the disease is a chronic intrahepatic cholestatic autoimmune liver disease mainly caused by inflammatory injury of small and medium-sized intrahepatic bile ducts. The progression of the disease is usually slow, and most patients do not develop liver cirrhosis. The old name may cause unnecessary mental burden on PBC patients. Therefore, renowned international experts in relevant fields jointly issued a statement to change the name of PBC^[1,2,3,4]。 The disease is more common in middle-aged and elderly women, usually with insidious onset, asymptomatic or non-specific symptoms such as fatigue and pruritus as the main clinical manifestations, and is easy to miss or misdiagnose. Serum anti-mitochondrial antibody (AMA) and alkaline phosphatase (ALP) and glutamyl transpeptidase (GGT) reflecting cholestasis are important for the diagnosis of PBC^[5]。 At present, the diagnostic criteria of PBC proposed at home and abroad are mainly based on the following three items: abnormal elevation of cholestatic enzyme; serum AMA or AMA-M2 antibody positive; Hepatic histology supports PBC. A diagnosis can be made if two of them are met. However, it should be noted in clinical practice that liver diseases caused by other common causes should be excluded before diagnosis of suspected PBC. Moreover, what may happen with laboratory test results is not all as simple as in the standards. Therefore, the test results need to be analyzed in detail.

Catheter-associated bloodstream infection (CRBSI) is a common clinical infection, which can develop into sepsis or even septic shock with poor prognosis. CRBSI is also the key object of hospital infection control. The incidence of CRBSI has returned to zero in medical institutions with the best infection control work in the world. Clinical microbiological diagnosis is the key to CRBSI diagnosis and the decisive basis for CRBSI diagnosis. It is an inevitable trend to improve the quality of laboratory medicine to formulate a scientific and complete laboratory diagnosis report model. In order to ensure the accuracy of CRBSI diagnosis and give full play to the role of laboratory medicine in the diagnosis, treatment and control of CRBSI, the Laboratory Physician Branch of Chinese Medical Physicians Association refers to the American CRBSI Guidelines^[1]American Society of Infectious Diseases (IDSA) /American Society of Microbiology (ASM) Clinical Microbiology Guidelines^[2]CDC Hospital Infection Diagnostic Criteria^[3]UK Health Protection Agency Guidelines (HPA)^[4]China Report Expert Consensus^[5,6]Combined with the latest progress of CRBSI at home and abroad and the current status of domestic clinical examination and diagnosis, the Expert Consensus on the Testing and Diagnosis Report Model of Catheter-related Bloodstream Infection was formulated.

The hormones produced by the thyroid gland regulate the body's metabolism and affect every cell, tissue and organ in the body^[1]。 Worldwide, thyroid disorders are very common and include abnormal thyroid function and morphological alterations. Functional abnormalities lead to hyperthyroidism and hypothyroidism, with morphological changes manifesting as goiter, nodules, and cancerous changes. The incidence of thyroid disease is increasing year by year, and the diagnosis, treatment and monitoring of thyroid disease are strongly dependent on laboratory tests. Therefore, it is very important to correctly select and understand the relevant laboratory tests for thyroid diseases^[2]。 Laboratory diagnosis report is a report issued by a qualified physician or authorized signatory that has guiding value for clinical diagnosis, differential diagnosis and treatment. Formulating a scientific laboratory diagnosis report model can improve the level of laboratory medicine and better serve clinical services^[3,4,5,6,7]。

To explore the Digital breast tomosynthesis technique (DBT) in breast cancer diagnosis accuracy.

Choose 263 cases of patients with breast lesions, using DBT combined FFDM (Full field digital mammography) independent FFDM, evaluate the diagnostic accuracy of breast cancer.

The ROC curve area (AUC) of two kinds of breast cancer diagnosis methods (DBT combined FFDM and independent FFDM) were 0.954±0.014 and 0.907±0.019, with significant difference (P=0.000 3). In premenopausal patients and breast density ACR3-4 cases, DBT combined FFDM diagnosis accuracy is higher than FFDM alone group, with significant difference (P<0.05).

DBT combined FFDM compared with independent FFDM, in a certain extent, improves the accuracy of the diagnosis of breast cancer.

To investigate the diagnostic accuracy of electrical impedance tomography (EIT) for benign and malignant breast diseases incomparison to conventional ultrasonography and mammography.

A total of 121 patients with 126 breast lesions who underwent mammography ultrasonography and EIT were enrolled in the study. All of these lessions were were confirmed by pathological biopsy. The accuracy, sensitivity, specificity, positive predictive value and negative predictive value of EIT, ultrasonography and mammography were calculated with histology as the gold standard.

The accuracy of EIT, ultrasonography and mammography were 75.4%, 81.7% and 76.1% respectively. The sensitivity was 76.8%, 94.6% and 74.4% respectively. The specificity was 74.3%, 71.4% and 77.6% respectively. The accuracy, sensitivity and specificity of EIT combined with ultrasound in diagnosis of breast lesions were 91.3%, 98.2% and 85.7%, respectively. The accuracy(χ²=4.896, P=0.027) and specificity(χ²=4.242, P=0.039) ere significantly higher on EIT compared to ultrasound.The accuracy, sensitivity and specificity of EIT combined with mammography were 95.5%, 97.4% and 93.9%, respectively, which were significantly higher than those of mammography (χ²=13.474, P<0.001; χ²=8.573, P=0.003; χ ²=5.333, P=0.021).

When together with ultrasound or mammography, electrical impedance tomography (EIT) could be a valuable complementary examination in the diagnosis of breast diseases. Furthermore, EIT could provide very useful additional information for metabolic assessment of mammary glands, which may be used for early screening of breast diseases.

To explore the expression and clinicopathological significance of Ser10 phosphorylated p27^kip1(P-p27Ser10) protein in human breast carcinoma tissue.

Tissue specimens were obtained from 111 cases with breast carcinoma from January 2004 to December 2005. And the expression of P-p27Ser10 protein for each specimen was detected by immunohistochemical (EnVision) analysis. Six representative paired samples of cancerous and paired adjacent normal tissues were collected and detected by Western blot. The relationships between the expression levels of P-p27Ser10 protein and its clinicopathological characteristics in primary breast carcinoma were retrospectively analyzed.The association of P-p27Ser10 and Jab1 protein was detected by co-immunoprecipitation method.

A high-level expression of P-p27Ser10 was present in cancerous tissues but not in paired adjacent normal tissues. The positive expression rate of P-p27Ser10 protein was as high as 88.3% (98/111) and 7.2% (8/111) in cancerous and paired adjacent normal tissues respectively (P<0.05). P-p27Ser10 expression was correlated with tumor size, lymph node metastasis and TNM stage (allP<0.05). P-p27Ser10 expression was significantly correlated with Ki-67 (r=0.582, P<0.05), and inversely correlated with p27 (r=-0.426, P<0.05). Co-immunoprecipitation revealed that the association of P-p27Ser10 and Jab1 protein was increased in breast carcinoma.

Over-expression of P-p27Ser10 protein might play an important role in the pathogenesis of breast carcinoma. P-p27Ser10 protein therefore represents a novel diagnostic marker and therapeutic target in patients with breast carcinoma.

To observe the expression of three microenvironment related prognostic factors, i. e. programmed death 1 (PD-1), forkhead box protein 3(FOXP3) and colony-stimulating factor 1 receptor(CSF-1R) protein in classical Hodgkin′s lymphoma (CHL) patients, and to explore the correlation between the protein expression and the prognosis of the patients.

A total of 45 cases of CHL patients, who had been admitted to the Tianjin Medical University Cancer Institute and Hospital and Chinese PLA General Hospital from February 2005 to August 2010 were analyzed, including clinical features, prognostic factors, and treatment regimens. CHL patients′ specimens were collected and the expression of PD-1, FOXP3, and CSF-1R proteins analyzed by immunohistochemical staining. Epstein-Barr virus encoded mRNA (EBER) was detected by in situ hybridization analysis. The relationship between the protein expression of PD-1, FOXP3 and CSF-1R and the patients′ outcome was analyzed with clinical and follow-up data. Survival analysis was performed by Kaplan-Meier method, the Cox proportional hazard model was used to perform multivariate analysis.

In this cohort of 45 CHL patients, PD-1 positive was found in 7 cases (15.6%), FOXP3 high expression in 23 cases (51.1%), CSF-1R positive in 18 cases (40.0%). In the univariate analysis, the expression of FOXP3 and CSF-1R, International Prognostic Index (IPI) score, Ann Arbor stage and EBER were related with the patients′ 5-year overall survival (OS); IPI score, the expression of FOXP3 and EBER were related with the patients′ 5-year progress-free survival (PFS). Multivariate analysis indicated that CSF-1R protein expression was the independent prognostic factor affecting the patients′ 5-year OS(HR: 8.918, P=0.020), and FOXP3 protein expression was the independent prognostic factor affecting the patients′ 5-year PFS (HR: 0.122, P<0.001). And EBV was an independent prognostic factor of PFS and OS in the CHL patients.

Microenvironment related prognostic factors FOXP3, CSF-1R and EBV may be independent prognostic factors of CHL and this study may provide novel strategies for targeted therapy of CHL.

To confirm the presence of erythropoietin receptor (EPOR) antibody in patients with immune-related pancytopenia (IRP) and to evaluate the significance of EPOR in IRP.

A total of 59 newly-diagnosed IRP patients, 62 patients with IRP in remission, 14 patients with aplastic anemia (AA), 15 patients with myelodysplastic syndromes (MDS) and 33 healthy controls were enrolled in this study from January 2013 to June 2015 in Tianjin Medical University General Hospital. The anti-EPOR antibody was detected by enzyme-linked immunosorbent assay(ELISA). The expression of EPOR mRNA was detected by quantitative real-time PCR (qRT-PCR). The correlation between the data and the clinical indicators of patients was analyzed.

The levels of anti-EPOR antibodies were higher in the newly-diagnosed IRP patients than in the remission IRP group, AA group, MDS group and controls(0.84±0.39 vs 0.46±0.25, 0.49±0.25, 0.50±0.25, 0.53±0.14, all P<0.05). The expression of EPOR- mRNA was up-regulated in the newly-diagnosed IRP group than in the remission IRP group and the controls. The positive rate of EPOR antibody was significantly elevated in the patients with low hemoglobin level (<100 g/L), positive GlycoA antibody, or low complement C3 (allP<0.05). Anti-EPOR antibody was significantly decreased in the IRP patients responding to immunosuppressive therapy.

Anti-EPOR autoantibody is present in patients with IRP. Detection of anti-EPOR antibody has important clinical value in the diagnosis, differential diagnosis and treatment effect evaluation of IRP.

To investigate the expression and clinical significance of long non-coding RNA colon cancer associated transcript-1 (CCAT1) in gastric cancer (GC), and to further explore the effect of CCAT1 on cell proliferation of GC.

The mRNA expressions of CCAT1 in GC tissues and matched adjacent normal tissues from 62 patients who received resection for gastric carcinoma between January 2013 and May 2015 in Nanjing Medical University Affiliated Wuxi Second Hospital and expressions in GC cell lines were assessed by quantitative real-time PCR (qRT-PCR). The clinical significance of CCAT1 expression was then analyzed. The expressions of CCAT1 in MGC-803 and SGC-7901 cells were inhibited by small interfering RNA (siRNA) transfection. The effect of CCAT1 on cell proliferation was studied by cell counting kit (CCK)-8 assay.

The expressions of CCAT1 mRNA in GC tissues were significantly higher than in the normal tissues (3.39±2.37 vs 1.28±0.74, P<0.05). Compared with immortalized human gastric epithelial cell line (GES-1), the expressions of CCAT1 mRNA were significantly higher in GC cell lines MGC-803 and SGC-7901 (3.07±0.69, 2.23±0.32 vs 1.01±0.12, bothP<0.05). Besides, the expression of CCAT1 varied significantly among patients with different TNM stage, depth of invasion, and lymph node metastasis (χ² =5.199, 5.395, 9.239, all P<0.05). The results of CCK-8 assay showed that down-regulation of CCAT1 in MGC-803 and SGC-7901 cells significantly inhibited the cell proliferation (bothP<0.05).

CCAT1 is up-regulated in GC and may be significantly correlated with the progression of GC. Decreased expression of CCAT1 can suppress the proliferation of GC cells. CCAT1 might be used as a novel target for GC early diagnosis and treatment.

To study the relationship between SORCS1 gene rs1416406 and efficiency of exenatide.

Between August 2010 and August 2012, a hundred and one newly diagnosed patients with type 2 diabetes mellitus (T2DM) were from CONFIDENCE study covering 25 university-affiliated hospitals in 13 provinces of China. All patients received exenatide treatment for 48 weeks. Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), body mass index (BMI), oral glucose tolerance test (OGTT) glucose and insulin levels were measured before and after therapy. β-cell function was assessed by fasting proinsulin/insulin (PI/I), disposition index (DI) and acute insulin response (AIR). SORCS1 gene rs1416406 was genotyped by improved multiple ligase detection reaction. The relationship between rs1416406 and the glucose-lowering effect as well as β-cell function improvement of exenatide was analyzed by multiple linear regression.

There were statistically significant differences of HbA1c, FPG, 2 h plasma glucose (2 h PG), β-cell function (PI/I, DI and AIR) and changes of PI/I in three genotypes (GG, GA, AA) of rs1416406 between baseline and 48-week therapy of exenatide (all P<0.05). No statistically significant difference was found in changes of HbA1c, FPG, 2 h PG, DI, AIR except for PI/I, after stratifying by genotypes of rs1416406. Multiple linear regression analysis showed rs1416406 was significantly associated with the PI/I change (P<0.05) after adjustment of age, sex, baseline BMI, HbA1c and PI/I.

SORCS1 gene rs1416406 was associated with the PI/I improvement induced by exenatide. Patients carrying GG genotype had greater reduction in PI/I after exenatide treatment as compared with those carrying allele A. The results suggests that the newly diagnosed T2DM patients with GG genotype might obtain more benefit from the early treatment of exenatide .

To analyze the risk factors and prognosis of bleeding in very old male patients with stage 5 chronic kidney disease (CKD).

The clinical data of 143 very old male patients with stage 5 CKD was retrospectively analyzed. According to the occurrence of bleeding, the patients were divided into two groups including the hemorrhage group and the non-hemorrhage group. The history of diseases, renal function, blood cell parameters and coagulation index were compared and analyzed between the two groups. The prognosis of patients with a period of 12 months was studied.

Among 143 patients, 67 cases (46.85%) suffered bleeding, and the other 76 patients (53.15%) were without bleeding. The age[(89±4) vs (87±5) years, P=0.02], pulmonary infection (32.84% vs 9.21%, P<0.001), activated partial thromboplastin time[(40.86±8.02) vs (38.41±5.72) s,P=0.036], fibrinogen[(4.09±0.75) vs (3.62±0.67) g/L, P<0.001], blood urea nitrogen (BUN)[(37.19±10.66) vs (32.86±8.97)mmol/L,P=0.009]were significantly increased in the hemorrhage group compared with the non-hemorrhage group. Multivariate logistic regression analysis showed that the incidence of pulmonary infection (OR=0.286, P=0.014), lower levels of mean platelet volume (OR=1.290, P=0.048), higher levels of fibrinogen (OR=0.444, P=0.004), BUN (OR=0.959, P=0.034) and systolic blood pressure (OR=0.970, P=0.013) were the independent risk factors of bleeding in the very old male patients with stage 5 CKD (P<0.05). All patients were followed up for 12 months. The proportion of all causes of death at the 3rd month, and bleeding events at the 3rd or 12th month, and recurrent major bleeding events at the 12th month were significantly higher in the hemorrhage group than those in the non-hemorrhage group.

Very old male patients with stage 5 CKD are prone to bleeding complications, and have more possibilities to bleed again. Pulmonary infection, average volume of blood platelet, fibrinogen, BUN, and systolic blood pressure were the independent risk factors of bleeding in these patients.

To investigate the current perception of disease among asthmatic patients in Chinese urban areas, and to address its association with asthma control.

This was a nationwide, multi-center, cross-sectional study covering 30 third-level, grade A hospitals in 30 provinces, municipalities and autonomous regions (not including Tibet) across Chinese mainland. The survey was carried out from October 2015 to May 2016. Asthmatic outpatients were selected to receive face-to-face questionnaire survey on asthma control including Asthma Control Test (ACT) score, classification of asthma control level[according to the Global Initiative for Asthma (GINA) 2015 classification system, as assessed by the physician completing the survey], perception of asthma (including question 1: nature of asthma as a disease; question 2: selection of first-line therapeutic agents to be regularly used daily for asthma; question 3: appropriate timing of the use of short-acting aerosols of β ₂ receptor agonists; and question 4: therapeutic goals for asthma).

A total of 3 875 asthmatic outpatients were included; among them, 69.0% (2 660/3 857) were aware that asthma is "an airway inflammatory disorder resulting from the combined effects of heredity and environment" ; 60.2% (2 321/3 857) considered "inhaled glucocorticoids or their compound preparations" to be the first-line therapeutic agents to be regularly used daily for patients with persistent chronic asthma; 85.7% (3 277/3 823) considered it appropriate to use short-acting aerosols of β ₂ receptor agonists "as needed in the event of disease aggravation or acute exacerbation" ; and 75.4% (2 761/3 661) were aware that asthma "can be adequately or completely controlled in the long term" . The ACT score[20 (16, 23) vs 19 (16, 22) points; Z=-3.928, P<0.001]and asthma control rate (29.92% vs 25.31%; χ²=8.616, P=0.003) were significantly higher, and the rate of uncontrolled asthma (19.92% vs 23.48%; χ ²=6.267, P=0.012) was significantly lower among the 2 660 (69.0%) patients correctly answering question 1 than among the 1 197 (31.0%) patients giving incorrect answer. The ACT score[21 (17, 23) vs 19 (15, 22) points; Z=-9.190, P<0.001] and asthma control rate (32.66% vs 22.20%; χ²=49.614, P<0.001) were significantly higher, and the rate of uncontrolled asthma (18.40% vs 25.00%; χ²=24.267, P<0.001) was significantly lower among the 2 321 (60.2%) patient correctly answering question 2 than among the 1 536 (39.8%) patients giving incorrect answer.

Compared to previous surveys, there has been improved perception of disease among asthmatic patients in Chinese urban areas. Correct perception of disease is favorable for improving asthma control level.

To explore the short-term effects of fine particulate matter (PM2.5) exposure on pulmonary function of healthy young adults in Beijing.

In this time series study, twenty-four healthy young adults who living around Guanyuan area were investigated in Beijing. The follow-up study was lasted for 12 days in total from Nov. 28, 2016 to Dec. 9, 2016, and pulmonary spirometry and inpulse oscillometry parameters were measured daily. Air pollution data (including PM2.5, etc.) and meteorological data (temperature, humidity, etc.) were monitored based on Guanyuan monitoring site. The short-term effects of PM2.5 on pulmonary ventilation function and airway resistance of healthy young adults were analyzed by using generalized estimating equation (GEE).

In our study period, average daily concentration of PM2.5 were 100.7 μg/m ³. The single pollutant model showed that there were negative dose-response associations between PM2.5 concentration and forced vital capacity (FVC) and forced expiratory volume in one second (FEV₁); and there were negatively correlated with daily mean level of PM2.5 lagged 0-1 days, and the strongest negative effect was in lag0. At lag0 day, each 10 μg/m ³ increase in PM2.5 concentration was associated with a significant decrease in FVC of 12.186 (95% CI: -15.573, -8.799) ml and in FEV₁ of 9.449 (95% CI: -13.265, -5.634) ml. Moreover, there were positive dose-response associations between PM2.5 concentration at lag0 to lag2 and peripheral resistance (Rp) , resonance frequency (Fres) and the fall in resistance between resistance at 5 Hz (R5) and resistance at 20 Hz (R20) (R_5-20). And the strongest negative effect was in lag0. Each 10 μg/m ³ increase in PM2.5 concentration was associated with a significant increase in Rp of 2.444 (95% CI: 0.889, 3.999) Pa·L^-1·s^-1 , Fres of 0.125 (95% CI: 0.082, 0.168) Hz and R_5-20 of 1.074 (95% CI: 0.444, 1.703) Pa·L^-1·s^-1 at lag0 day.

Short-term PM2.5 exposure has a negative and lagged effect on pulmonary function in healthy young adults.

Aplastic anemia (AA) is a bone marrow hematopoietic failure (BMF) caused by autoimmune destruction of hematopoietic stem/progenitor cells (HSPC). While immunosuppressive therapy (IST) and hematopoietic stem cell transplantation (HSCT) significantly improved the prognosis of AA, some patients progressed to clonal diseases, including paroxysmal nocturnal hemoglobinuria (PNH), myelodysplastic syndrome (MDS), and acute myeloid leukemia (AML)^[1,2]。 Recent studies using high-throughput sequencing technology have shown that some AA have clonal hematopoiesis, and the presence of these clones can be detected at the early stage of the disease even in pediatric patients and patients who do not eventually develop MDS/AML^[1,2]。 Clonal hematopoiesis does not necessarily mean the development of cancer or other disease, which can remain stable for a substantial period of time. Somatic mutations that occur in myeloid tumors also frequently occur in AA patients. Somatic mutations in AA patients may provide the basis for frequent clonal hematopoiesis, and then develop into MDS and AML. This part of AA with evidence of clonal hematopoiesis is completely different from AA without evidence of clonal hematopoiesis in both clonal indexes and treatment outcomes, and it is in line with the "clonal cytopenia (CCUS) of unknown significance" proposed by scholars in recent years. This article mainly reviews the recent progress of AA clonal hematopoiesis in recent years and the mechanism of its late development into clonal disease.