OBJECTIVE: Preliminary assessment of rabies virus neutralizing activity, safety and immunogenicity of a recombinant human rabies antibody (NM57) compared with human rabies immunoglobulin (HRIG) in Chinese healthy adults. METHODS: Subjects were randomly (1:1:1) allocated to Groups A (20 IU/kg NM57), B (40 IU/kg NM57), or C (20 IU/kg HRIG). One injection was given on the day of enrollment. Blood samples were collected on days -7 to 0 (pre-injection), 3, 7, 14, 28, and 42. Adverse events (AEs) and serious AEs (SAEs) were recorded over a period of 42 days after injection. RESULTS: All 60 subjects developed detectable rabies virus neutralizing antibodies (RVNAs) (> 0.05 IU/mL) on days 3, 7, 14, 28, and 42. The RVNA levels peaked on day 3 in all three groups, with a geometric mean concentration (GMC) of 0.2139 IU/mL in Group A, 0.3660 IU/mL in Group B, and 0.1994 IU/mL in Group C. At each follow-up point, the GMC in Group B was significantly higher than that in Groups A and C. The areas under the antibody concentration curve over 0-14 days and 0-42 days in Group B were significantly larger than those in Groups A and C. Fifteen AEs were reported. Except for one grade 2 myalgia in Group C, the other 14 were all grade 1. No SAEs were observed. CONCLUSION The rabies virus neutralizing activity of 40 IU/kg NM57 was superior to that of 20 IU/kg NM57 and 20 IU/kg HRIG, and the rabies virus neutralizing activity of 20 IU/kg NM57 and 20 IU/kg HRIG were similar. Safety was comparable between NM57 and HRIG.
Adult ; Antibodies, Neutralizing ; Antibodies, Viral ; Data Collection ; Humans ; Rabies/prevention & control* ; Rabies Vaccines/adverse effects* ; Rabies virus/genetics*

BACKGROUND: Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease. OBJECTIVE: This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m MAIN OUTCOME MEASURES: The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment. RESULTS: A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group. CONCLUSION: SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone. TRIAL REGISTRATION NUMBER NCT02063100 on ClinicalTrials.gov.

Objective To observe the effect of every-other-day fasting(EODF)on pathology and functional recovery of rats with spinal cord clip-compression injury,and to explore the related mechanism. Methods A total of 36 Sprague-Dawley rats were randomly assigned to groups A(sham operation),B(sham operation and EODF),C(spinal cord injury)and D(spinal cord injury and EODF)with nine rats in each group.The spinal cord injury rat model in T10was established by using medical aneurysm clip in latter two groups.The motor func-tion was assessed by Basso-Beattie-Bresnahan(BBB)score one day before and one day,two,four,six,eight,ten, twelve weeks after operation;and toluidine blue staining was performed for pathological observation at twelve weeks after operation.Another 180 Sprague-Dawley rats were randomly assigned in same way.The level of tu-mor necrosis factor-α(TNF-α)and interleukin-10(IL-10)were detected with ELISA six hours,twelve hours,one day,three days and seven days after operation. Results The BBB score reached lowest on the first day in groups C and D(P<0.05),and gradually increased with time,and were higher in group D than in group C eight weeks,ten weeks and twelve weeks after operation(P<0.05). The pathology in spinal cord was less in group D than in group C.Compared with group A,the level of serum TNF-α increased twelve hours after operation(P<0.05),peaked one day after operation,and returned back seven days after operation;the level of serum IL-10 increased at each time point after operation(P<0.05).Compared with group C,the level of serum TNF-α was lower in group D one day after operation(P<0.05);the level of se-rum IL-10 was not significantly different at each time point after operation(P>0.05). Conclusion Long-term EODF can promote the hind limb motor recovery in rats with spinal cord clip-compression inju-ry,and alleviate pathological damage.EODF might inhibit acute inflammatory reaction at acute stage of spinal cord injury,which may be correlated with its neuroprotective effect.

Objective To analyze the factors that might affect the recurrence after endoscopic resection of colorectal adenoma,we aim to provide a reference for the regular follow-up of colorectal adenoma after endoscopic resection.Methods In the Department of Gastroenterology,Huadong Hospital from Jan.,2013 to Dec.,2014,patients received endoscopic resection during hospital stay and postoperative follow-up colonoscopy.We collected their information of gender,age,smoking history,drinking history,hypertension,diabetes,fatty liver,cholecystectomy history,Helicobacter pylori (H.pylori) infection,related metabolic indicators,number of adenoma,size of adenoma,location of adenoma and pathology of adenoma.Multivariate and univariate analysis were performed by Logistic regression analysis to explore factors influencing the recurrence risk of colorectal adenoma.Results A total of 283 cases were enrolled.The recurrence rate of low-risk and high-risk adenoma was 39.3 ％ and 56.3 ％,respectively,and therate of all adenoma was 52.7％.Multivariate and univariate analysis both found that H.pylori infection (P＜0.001,OR:3.316 and 2.802,95％CI:1.869-5.884 and 1.660-4.728) and adenoma number (P＜0.001,OR:2.799 and 2.789,95％ CI:1.578-4.963 and 1.667-4.668) were risk factors for colorectal adenoma recurrence after endoscopic excision.Conclusions H.pylori infection and the number of base colorectal adenoma maybe associated with colorectal adenoma recurrence.

OBJECTIVETo study the dynamic accumulation regulation of dry substance and four coumarin constituents in root of Peucedanum praeruptorum, so to provide the basis for optimal harvest time.

METHODRoots of P. praeruptorum were collected periodically. The dry weight of the roots was measured and the content of four coumarins was determined by HPLC method.

RESULTThe dry substance accumulation of the root reached the maximum amount and the coumarin contents maintain stability at the end of the vegetative growth period. The coumarins of roots decline significantly in the reproductive growth period.

CONCLUSIONThe most optimum collecting time of root of P. praeruptorum cultivated in Ningguo county in Anhui province should be from December to next February.

Apiaceae ; chemistry ; growth & development ; metabolism ; Chromatography, High Pressure Liquid ; Coumarins ; analysis ; metabolism ; Plant Extracts ; analysis ; metabolism ; Plant Roots ; chemistry ; growth & development ; metabolism

OBJECTIVETo study the immunoregulatory effect of hepatitis B virus (HBV) e antigen (HBeAg) on peripheral blood monocytes (PBMCs).

METHODSPBMCs were isolated from patients with chronic hepatitis B (CHB; both HBeAg- and HBeAg+) and healthy controls, and cultured with recombinant HBeAg. The HBeAg-induced changes in expression of PD-1/PD-L1 were measured by flow cytometry of the cells and in secreted cytokines were measured by enzyme-linked immunosorbent assay of the supernatants. Comparisons between two groups were made by the independent-samples t-test; the relationship between PD-1/B7-H1 level and HBV DNA copy number was evaluated by Spearman's correlation analysis.

RESULTSExposure to HBeAg led to a significant decrease in CD3+CD4+ T lymphocyte-specific expression of IFNa for both the CHB patients' and healthy controls' samples (t = 2.382 and -4.190 respectively, P less than 0.01). For the HBeAg- CHB patients' and healthy controls' samples, the HBeAg exposure led to increased levels of secreted cytokines IL-6, IL-10 and TNFa (t = 2.504, 3.583 and 4.324, P less than 0.01 and t = 3.542, 6.246 and 5.273, P less than 0.01 respectively) and of CD14+ PBMC-specific expression of PD-L1 (t = 4.815 and 3.454, P less than 0.05 respectively). Compared to the HBeAg-negative CHB patients' and healthy controls' samples, the HBeAg+ CHB patients' samples had significantly lower CD3+CD4+ T cell-specific expression of IFNa (t = -3.177 and -4.541, P less than 0.01 respectively), but significantly higher levels of secreted IL-4 (t = 3.382 and 4.393, P less than 0.01 respectively), of CD3+ T cells-specific expression of PD-1/PD-L1 (t = 4.755, 2.942 and 4.518, 4.595, P less than 0.01 respectively), and of CD14+ T cells-specific expression of PD-L1 (t = 5.092 and 5.473, P less than 0.01 respectively). The CD3+ T cells-specific expression of PD-L1 was significantly higher in the samples from HBeAg- CHB patients than from the healthy controls (t = 3.214, P less than 0.01).

CONCLUSIONHBeAg was able to down-regulate the production of Th1-type cytokines (IFNgamma), and up-regulate the secretion of Th2-type cytokines (IL-6, IL-10) and the expression of PD-1/PD-L1on monocytes. These changes are conducive to the formation of immune tolerance to HBV. Therefore, HBeAg may play an important role in immune tolerance to chronic HBV infection.

Adult ; Case-Control Studies ; Cells, Cultured ; Female ; Hepatitis B e Antigens ; genetics ; immunology ; Hepatitis B, Chronic ; blood ; immunology ; Humans ; Interferon-gamma ; immunology ; Interleukin-10 ; immunology ; Interleukin-6 ; immunology ; Leukocytes, Mononuclear ; immunology ; metabolism ; Male ; Middle Aged ; Recombinant Proteins ; immunology ; Th1 Cells ; immunology ; Th1-Th2 Balance ; Th2 Cells ; immunology

Adolescent ; Brain Neoplasms ; metabolism ; pathology ; Diagnosis, Differential ; Female ; Humans ; Melanoma ; metabolism ; pathology ; Melanoma-Specific Antigens ; metabolism ; Neurilemmoma ; metabolism ; pathology ; S100 Proteins ; metabolism ; Vimentin ; metabolism

OBJECTIVETo establish experimental models for tumor neovascularization and to apply quantitative digital imaging analysis in the study.

METHODSAn endothelial tube formation model was established by human umbilical vein endothelial cells (HUVECs). A vasculogenic mimicry model was established by SGC-7901 gastric cancer cell line. Fertilized eggs were used to establish a chorioallantoic membrane angiogenesis model. Using gene transfection experiment, IRX1 tumor suppressor gene was chosen as a therapeutic target. Image Pro Plus (IPP) analysis software was used for digital vascular images analysis with parameters including points, lines, angles and integral absorbance (IA) for the tubular formation or vasculogenic mimicry.

RESULTSDigital image analysis by IPP showed that HUVEC tubular formation was significantly inhibited in IRX1 transfectant, compared with controls. The tubular numbers in three groups were 12.80 +/- 3.83, 29.00 +/- 5.34 and 28.20 +/- 4.32 (P<0.01). The connection points of tubules in three groups were 13.20 +/- 2.59, 25.00 +/- 2.24 and 24.60 +/- 3.21 (P<0.01). The tubular lengths of three groups were (821.5 +/- 12.5), (930.9 +/- 13.5) and (948.4 +/- 18.1) microm (P=0.022). The IA values of PAS stain in three groups were 3606 +/- 363, 14 200 +/- 1251 and 15 043 +/- 1220 (P<0.01). In chick chorioallantoic membrane model, the angular numbers of tubules in three groups were 6.41 +/- 2.60, 10.27 +/- 2.65 and 9.18 +/- 1.99 (P<0.01).

CONCLUSIONSThe endothelial tube formation model, vasculogenic mimicry model and chorioallantoic membrane angiogenesis model are useful for gene therapy and drug screening with targeting neoplastic vascularization. Professional image analysis software may greatly facilitate the quantitative analysis of tumor neovascularization.

Animals ; Cell Line, Tumor ; Cells, Cultured ; Chorioallantoic Membrane ; blood supply ; Diagnostic Imaging ; methods ; Homeodomain Proteins ; genetics ; metabolism ; physiology ; Human Umbilical Vein Endothelial Cells ; Humans ; Neovascularization, Pathologic ; Neovascularization, Physiologic ; Software ; Stomach Neoplasms ; genetics ; metabolism ; pathology ; Transcription Factors ; genetics ; metabolism ; physiology ; Transfection

OBJECTIVETo evaluate the value of valplast dentures in the temporary restoration of single missing anterior tooth.

METHODSTotally 76 patients who needed temporary restoration of single missing anterior tooth were involved and equally divided into two groups according to their own choices of procedures: group A, with valplast dentures as their temporary dentures and group B, with conventional removable partial dentures as their temporary dentures. Meanwhile,38 patients who had their single anterior teeth pulled out and did not need temporary dentures were enrolled as control group without any temporary restoration, and impressions were taken immediately before the temporary dentures were used (2 weeks after tooth extraction) and before the initiation of permanent restorations (97-100 days after tooth extraction).The heights of clinical crowns of the adjacent teeth were also recorded twice from plaster models made from the impressions.The height of labial gingiva recession was calculated as the difference between the two heights recorded.

RESULTSThe height differences of clinical crowns of the adjacent teeth was 0.5mm (range: 0.0-1.2mm) in group A, which was significantly larger than those in group B [0.0mm;(range: 0.0-0.6mm)](P<0.05) and in group C[0.0mm;(range: 0.0-0.4mm)](P<0.05).However, the difference was not significant between group B and group C (P>0.05).

CONCLUSIONApplication of valplast denture as temporary denture may cause labial gingival recession of the adjacent teeth, and therefore is not suitable for the restoration of single missing anterior tooth.

Adult ; Dental Restoration, Temporary ; instrumentation ; Dentures ; adverse effects ; Female ; Follow-Up Studies ; Gingival Recession ; etiology ; Humans ; Male ; Middle Aged ; Tooth Loss ; therapy ; Young Adult

OBJECTIVETo clone core promoter regions of iroquois homeobox gene 1 (IRX1) gene and evaluate the regulatory mechanism of IRX1 transcription.

METHODSUpstream sequence from transcriptional start site was predicted using bioinformatics methods. Serial deleted fragments from IRX1 promoter sequences were amplified by PCR and luciferase reporter plasmids were constructed. The luciferase intensity was analyzed after transferring reporters into GES-1 gastric mucosa cell line.

RESULTSThe promoter of IRX1 was predicted to be within 700 bp from the 5'-flanking region of IRX1 gene. Eight serial deleted luciferase reporter plasmids were constructed. The transcriptional activity of different fragments was expressed as following: p-416>p-584>p-715>p-350>p-687>p-320>p-188>p-92. Except p-320 and p-188, the transcriptional activity of other 6 fragments was higher than that of PGL3-basic plasmid. The transcriptional activity was the highest in p-416 and decreased sharply from p-320 to p-188.

CONCLUSIONSThe fragment p-416 shows the strongest promoter activity. The sequence from -320 bp to -188 bp is identified as core promoter region, which is focused as key sequence for further regulatory analysis, since some binding sites for important transcriptional factors such as Sp1 and TFII D are predicted.

Cell Line ; Cloning, Molecular ; Gastric Mucosa ; cytology ; Genes, Homeobox ; Homeodomain Proteins ; genetics ; Humans ; Promoter Regions, Genetic ; Transcription Factors ; genetics