Objective To establish a HPLC method for quality control of Pei-bao capsule. Methods The content of lysine derivatized from 2,4-dinitoflruorobenzene was determined by HPLC, with chromatographic column being the agilent Zorbax SB-C18 column (250 mm×4.6 mm, 5 μm) , mobile phase being acetonirile-0.04mol/L, potassium dihydrogen phosphate (40 : 60), the flow rate being 1.0 ml/min, the column temperature being 30 ℃, and wavelength being 360 nm. Results It showed good linear coorelation when the concentration of Lysine hydrochloride being within 0.39～ 19.3μg/ml (γ =0.9999) , and the average sample recovery rate was 100.2%. Conclusion This method is simple, accurate, stable and reliable. It can be used for quality control of Pei-bao capsule.

Objective To investigate the applicative value of enhanced 3D multi-echo GRE T2*-weighted angiography(ESWAN) sequence phase values in evaluating brain gray nuclei iron content in idiopathic restless legs syndrome(RLS) patients, providing imaging basis in diagnosis and treatment of idiopathic RLS. Methods In our institute from June 2012 to September 2016,forty-five RLS patients were selected as the RLS group, and 45 healthy volunteers as the control group. ESWAN sequence was performed and serum ferritin values were obtained in all patients and volunteers. The raw data of ESWAN was postprocessed , where the phase maps were obtained. Phase analysis was performed on localized brain gray nuclei regions of interest (substantia nigra, red nucleus, dentate nucleus, thalamus, pallidum, putamen and caudate nucleus ) selected on phase maps. Differences between the 2 subject groups were evaluated using ANCOVA including age as a covariate. Results The phase values of the substantia nigra, thalamus, pallidum and putamen in the RLS group were (-0.087 ± 0.021), (-0.053 ± 0.012), (-0.161 ± 0.008), (-0.125 ± 0.019) radians , respectively. The phase values of the substantia nigra, thalamus, pallidum and putamen in the control group were (-0.127 ± 0.007), (-0.066 ± 0.007), (-0.166 ± 0.007), (-0.150 ± 0.010) radians, respectively. There were significant differences between the two groups (F=142.492, 37.988, 10.558, 60.725;P<0.05). Indicating reduced iron content in several regions of brain gray nuclei of the patients with RLS. Serum ferritin concentration between the RLS patients (157.02±95.78)μg/L and healthy controls (175.49 ± 38.65)μg/L was not significant (F=1.353,P>0.05). Conclusions Phase values can make a quantitative assessment of brain gray nuclei iron content in RLS patients, our results supported the hypothesis of reduced brain iron content in RLS patents , which may have an important role in the pathogenesis of the disorder. However, iron content change in some brain regions was not correlated with serum ferritin concentration changes.

Objective To analyze the distribution and antimicrobial resistance of bloodstream pathogens in surgical intensive care unit (SICU) and medical intensive care unit (MICU) of Fujian Provincial Hospital in the past four and half years for better use of antimicrobial drugs.Methods A retrospective analysis was carried out for the bloodstream pathogens isolated from SICU and MICU patients from January 2012 to June 2016.The clinical data and outcomes of patients were also reviewed.Results A total of 329 strains of isolates were recovered from blood samples in SICU,including gram-negative bacteria (53.5％),gram-positive bacteria (39.2％),and fungi (7.3％);258 strains were collected from MICU,including gram-negative bacteria (57.8％),gram-positive bacteria (36.0％),and fungi (6.2％).A.baumannii,K.pneumonia and E.coli were the top three gram-negative species in both SICU and MICU.The main gram-positive species were coagulase-negative Staphylococcus and Enterococcusfaecium.Overall,386 cases of bloodstream infections were diagnosed,including 226 cases in SICU (202 cases of single bacterial infection and 24 cases of multiple bacterial infection),and 160 cases in MICU (138 cases of single bacterial infection and 22 cases of multiple bacterial infection).A.baumannii isolates showed significantly higher rate of resistance to antibiotics in SICU than in MICU,while the K.pneumoniae and E.coli isolates in MICU showed higher resistance rates to cephalosporins,quinolones,penicillins and carbapenems than the corresponding isolates in SICU.The coagulase negative Staphylococcus and E.faecium isolates in MICU were associated with significantly higher resistance rates to quinolones and tigecycline than those strain in SICU.The bloodstream infections due to K.pneumoniae,E.coli and E.faecium were associated with higher mortality in MICU than in SICU,while the bloodstream infections due to A.baumannii were associated with higher mortality in SICU than in MICU.The total mortality rate of bloodstream infections was higher in MICU than in SICU.Conclusions SICU and MICU share similar profile of main bloodstream pathogens even though the disease spectrum was different between SICU and MICU.All the bloodstream pathogens isolated from MICU patients except A.baumannii showed significantly higher antimicrobial resistance rates than the isolates from SICU.The mortality rate associated with bloodstream infection was also higher in MICU patients than in SICU.

Objective To evaluate the value of 3D-PCASL in the pre-operation brain gliomas-grading.Methods 3D-PCASL images of 41 cases of gliomas comfirmed by pathology,including 20 cases of low-grade and 21 cases of high-grade were retrospectively analyzed. The cerebral blood flows of the solid region of tumor (TBF),1cm and 1 cm-2 cm brain tissue around the tumor,and contralateral normal brain CBF were obtained based on the region of interest (ROI),respectively.Results According to independent sample t-test,all had statisti-cally significant differences (P <0.001)between high and low-grade gliomas except the 1-2 cm region around the tumor.One-way ANO-VA displayed that all of them had its statistically significant between differences region (P <0.001)in high-grade gliomas,which had statisti-cally significant differences (P <0.001)except 1 cm and 1 -2 cm of peri-tumor in low-grade gliomas.ROC curve analysis of TBF/contralateral gray matter showed that the area under the curve was 0.96.When 2 was chosen as threshold of rCBF,there was the highest sensitivity (85.7%)and specificity (100%).The accurate rate of conventional MRI for gliomas dianosis was 76% and the ac-curate rate of conventional MRI with ASL was 93%,which was statistically significant difference (χ2 =6.61,P =0.01)between two methodson the chi-square test.Conclusion 3D-PCASL can improve the accuracy of diagnosis of different grade brain gliomas.Com-pared with others parameters,rCBF have a higher sensitivity and specificity.

OBJECTIVETo evaluate the diagnostic value of HGAL and LMO2 expression and compare with CD10 and bcl-6 in follicular lymphoma (FL).

METHODS63 cases of FL were collected from Guangdong General Hospital. The expression of HGAL, LMO2, CD10 and bcl-6 was assessed by immunohistochemistry.

RESULTSThe expression rates of HGAL, LMO2, CD10 and bcl-6 were 98.4% (62/63), 82.5% (52/63), 82.5% (52/63) and 87.3% (55/63), respectively. The expression rate of HGAL was higher than those of LMO2, CD10 and bcl-6, but the differences were not significant (P>0.05). There was no significant difference in HGAL, LMO2 and bcl-6 expression among FL1, FL2 and FL3 cases. The CD10 expression rate of FL1-3A cases was significantly higher than that of FL3B cases(P<0.01).

CONCLUSIONSHGAL and LMO2, especially HGAL, can be used in FL particularly high grade FL as useful germinal center marker.

Adaptor Proteins, Signal Transducing ; metabolism ; Biomarkers, Tumor ; metabolism ; Germinal Center ; Humans ; Immunohistochemistry ; LIM Domain Proteins ; metabolism ; Lymphoma, Follicular ; metabolism ; Neoplasm Proteins ; metabolism ; Neprilysin ; metabolism ; Proto-Oncogene Proteins ; metabolism ; Proto-Oncogene Proteins c-bcl-6 ; metabolism

Objective: To investigate the clinicopathological features, treatment and prognosis of duodenal-type follicular lymphoma. Methods: Four cases of duodenal-type follicular lymphoma diagnosed at Guangdong General Hospital from 2014 to 2015 with detailed clinical data were included. The histomorphology, immunophenotype, treatment and prognoses were analyzed. Results: The patients′ age ranged from 51 to 57 years (mean 54 years), and there were 2 males and 2 females. The involved sites were gastric fundus in one case, second portion of the duodenum in two cases and terminal ileum in one case. All patients presented with multiple mucosal granules or nodules at endoscopy. Microscopically, there were multiple mucosal neoplastic follicles, constituting grade 1-2 disease based on nodal follicular lymphoma grading system. The tumor cells were positive for CD20, CD10, bcl-6 and bcl-2. CD21 highlighted the follicular dendritic meshwork mainly at the periphery of the follicles. Proliferation index was low. Three patients received rituximab monotherapy for 4 cycles, leading to complete remission. One patient refused therapy and the disease progressed to systemic lymphoma 15 months after the initial diagnosis. Conclusions Duodenal-type follicular lymphoma is a special variant of follicular lymphoma with indolent clinical course. The tumor exhibits morphology of low grade follicular lymphoma with characteristic dendritic meshwork at the periphery of the follicles and a low proliferation index. Prognosis is excellent. Rituximab monotherapy is treatment of choice, but a small minority of patients may progress to systemic disease.

OBJECTIVETo study the clinical, pathologic, immunophenotype, molecular characteristics and prognosis of HIV-negative plasmablastic lymphoma (PBL).

METHODSTwelve cases of HIV-negative PBLs diagnosed between 2005 and 2014 in Guangdong General Hospital were identified according to WHO classification of tumors of haematopoietic and lymphoid tissues (2008). The clinicopathologic features and outcome were analyzed and the relevant literatures were reviewed.

RESULTSThe patients were predominantly male (11/12) with a median age of 55.5 years. The tumor cells showed the characteristic combination of immunoblastic/plasmablastic morphology, plasma cell phenotype and high proliferation, no expression of mature B cell markers. 7/10 of the cases were EBER positive. Two cases were positive for C-myc translocation. Four of twelve patients were died.

CONCLUSIONSPBL is a rare, aggressive B-cell lymphoma. HIV-negative PBL has lower rate of oral involvement and EBER expression than HIV-positive patients, the differential diagnosis is very challenging, and the prognosis is worse.

Diagnosis, Differential ; Female ; HIV Seronegativity ; Humans ; Immunophenotyping ; Lymphoma, B-Cell ; diagnosis ; Male ; Middle Aged ; Plasma Cells ; classification ; Plasmablastic Lymphoma ; diagnosis ; pathology ; Prognosis ; Translocation, Genetic

Objective: To evaluate the expression of βF1 and T cell receptor (TCR)γ in T lymphoblastic lymphoma/leukemia(T-LBL/ALL), and investigate the clinicopathological features. Methods: Fifty-one cases of T-LBL/ALL were collected at Guangdong General Hospital from 2010 to 2016, the expression of βF1 and TCRγ was assessed by immunohistochemistry. Results: There were 13 cases of children and adolescents, and 38 cases of adults. The expression rates of βF1 and TCRγ were 27.5%(14/51) and 15.7%(8/51) respectively. The proportion of adults in αβ T-LBL/ALL, TCR-silent T-LBL/ALL and γδ T-LBL/ALL was 7/14, 79.3%(23/29)and 8/8 respectively, and the difference was significant (P=0.023). There was no statistical difference in sex, LDH, bone marrow involvement and Ann arbor stage among these three groups(P>0.05). γδ T-LBL/ALLs included 6 cases of CD4^-/CD8^- phenotype, whereas αβ T-LBL/ALL included 7 cases of CD4⁺ /CD8⁺ phenotype. There was significant difference in CD4/CD8 expression among these three groups(P<0.01). Conclusions γδ T-LBL/ALL occurred only in adults, with predominantly CD4^-/CD8^- phenotype. αβ T-LBL/ALL occurred more common in children and adolescents, with predominantly CD4⁺ /CD8⁺ phenotype.

Objective:To investigate the kinetic metrics of 68Ga-fibroblast activation protein inhibitor (FAPI)-04 in pancreatic cancers and normal organs by using total-body PET dynamic imaging. Methods:From December 2020 to December 2021, 68Ga-FAPI-04 total-body PET/CT dynamic imaging were performed on 6 pancreatic cancer patients (3 males, 3 females, median age 55.5 years) in Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University. Images were respectively analyzed. Manual delineations of volume of interests (VOIs) on multiple normal organs and pathological lesions were performed and time-to-activity curves (TACs) were generated. A reversible two-tissue compartment model (2TCM) was fitted for each tissue TAC. Rate constants including K1, k2, k3 and k4, and the total volume of distribution ( Vt) were obtained and compared by tissue types. Wilcoxon rank sum test and Spearman correlation analysis were used for data analysis. Results:Kinetic metrics varied significantly among normal organs and pancreatic cancer lesions ( z values: 2.00-1 240.00, all P<0.05). The highest K1 among lesions was observed in primary tumor (0.30 min -1), which was observed in the spleen (1.42 min -1) among normal organs. The highest k2 among lesions was observed in peritoneal metastases (0.24 min -1), which was observed in the spleen (2.59 min -1) among normal organs. Primary tumor showed the highest k3 of 0.17 min -1 among lesions, and the pancreas had the highest k3 of 0.16 min -1 among normal organs. Primary tumor had the highest k4 of 0.03 min -1 among lesions, and the heart, lungs, parotid glands had high k4(0.06 min -1) among normal organs. Vt were higher in pathological lesions compared to normal organs, with the highest in primary tumor (13.78 ml/cm 3). There were correlations between Vt in lesions and SUV mean( rs=0.86, P<0.001) or SUV max ( rs=0.77, P<0.001). Conclusion:The rate constants including K1, k2, k3 and k4, and Vt of 68Ga-FAPI-04 vary among normal organs and lesions.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.