Objective To determine the effects of different excipients ( amino acids, carbohydrates and nonionic surfactants) on thermal stability of the IgG1 monoclonal antibody, and to examine the interactions between the excipients and the protein.Methods Differential scanning calorimetry ( DSC) was used to study thermal stability of the protein in different solutions and got information on the solubility of the unfolded forms of the protein.Isothermal titration calorimetry ( ITC) was used to examine the binding interactions between the excipients and the protein.ResuIts Negatively charged amino acids could significantly reduce the denaturation temperature (Tm) of IgG1( Tm >9 ℃), and other excipients didn’t have a major effect ( Tm <1℃).Excipients shared different impacts on thermal stability of the IgG1 monoclonal antibody under different pH, and negatively charged amino acids result in a much lower Tm at pH 5 than at pH 7.The ITC binding isotherms of different excipients (including polysorbate 20 and 80) and IgG1 were almost straight lines, while there was strong binding interaction between polysorbate 20 or 80 and Human Serum Albumin (HSA).ConcIusion The results suggest that there is no binding interaction between these studied excipients and the IgG1 monoclonal antibody; instead electrostatic interactions seem to play a leading role between the excipients and the IgG1 monoclonal antibody.

Objective To investigate the TcpA gene sequence and analyze the characteristics of O 139 epidemic strains.Methods PCR was performed to detect the O 139 VC in the bacteria sample.The positive sample was sequenced and analysed.Results PCR products of one strain in the positive sample were sequenced.The gene sequences showed 100% nucleotide homology to O 139 strains adn Eltor strains 96.0%.Conclusion The present study indicates that O 139 VC and O1EVC in Pingxing area are genetically nearest in genetic relation.The study has significance in the diagnose and treatment of Vibrio cholerae in Pingxiang area.

Objective To investigate the correlation of ankle-brachial index(ABI),pulsatility index(PI),resistent index(RI)and vibration perception thresholds(VPT)in type 2 diabetic patients(T2DM).Methods A total of 664 type 2 diabetic patients with 1 328 legs(362 men and 302 women)were divided into three groups based on the ABI test: group A(ABI

Objective To investigate an evaluation program for external quality assessment ( EQA) of quality indicators ( QIs) and develop a software .Methods According to GB/T 27043-2012 ( ISO/IEC 17043:2010,IDT) mode 3, 28 provincial centers for clinical Laboratories were organized by National Center for Clinical Laboratories to launch an investigation on “QIs in clinical laboratory” with the use of Clinet-EQA online .Participants were asked to collect data of April 2014 and report related results online .Mean, median, the 5 th, 25 th, 75 th and 95 th percentiles of defectpercentages for biochemistry , immunology, blood and body fluid and microbiology were calculated , respectively .Sigma values were also calculated . Meanwhile , 25 th of sigma value and 75 th of defect percentages were chosen as preliminary quality specifications for each QI so that laboratories can evaluate related process quality .Results Take incorrect sample type rates for example , 4 771 laboratories were involved in this study .Among four subjects , incorrect sample type rates were lowest (0.01%, 6σ) for immunology tests, followed by blood and body fluids tests (0.06%, 4.7σ) and biochemistry tests (0.06%, 4.7σ), and were highest for microbiology tests (0.33%, 4.2σ).Evaluation reports will besent back to participants so that they can understand national , provincial , and their own sigma levels well .Preliminary quality specifications of incorrect sample type for biochemistry, immunology, blood and body fluid, and microbiology tests were 0.08% (4.6σ), 0.03%(5σ), 0.09%(4.6σ) and 0.43%(4.1σ), respectively.Conclusion Clinical laboratories were advised to establish and monitor suitable QIs within laboratory and participate in QIs EQA schemes , thus they can improve their quality continuously .

Objective To establish and apply the procedure of survey on quality indicator in clinical laboratory and to analyze the status in quo of the 15 quality indicators in Zhejiang province .Methods A network platform for the survey on quality indicator in clinical laboratory was designed and developed by our center.The online questionnaires that should be reported back within one month were assigned to 473 laboratories.The developed software and SPSS 13.0 were used for statistical analysis .13 indicators expressed in rate were further evaluated with sigma scales .The 25th percentile, 50th percentile, and 75th percentile of the distribution of each quality indicator were regarded as the minimum , appropriate and optimum quality specifications, respectively.Results Totally 444 laboratories submitted the survey results.The overall sigma levels of 10/13 indicators were all >3, of which the inappropriate CV of internal quality control and unacceptable performances in EQA were still less than 3σin 15.8%and 9.2%of the laboratories.The rates of quality indicators in different scales of laboratories and diverse disciplines were significantly different .Pre-analytical TAT in routine examination for clinical chemistry and immunology was 50 min, on average.And the time for routine examination of blood , urine and stool was 30 min.Pre-analytical TAT in emergency examination for all four disciplines were all between 10 and 15 min. Intra-analytical TAT for clinical immunology was the longest , which was 154 min for routine examination and 40 min for emergency examination, respectively.The optimum quality specifications for 8 indicators were 6σ, while the minimum quality specifications were less than 1σfor 4 indicators.Conclusions According to the results of our survey, the pre-analytical quality indicator perform better than that of Intra-analytical and post-analytical phase.The laboratory should strengthen the laboratory information system technology construction to ensure the reliable data collection and long-time monitoring.

Objective To verify the antiviral effects of Siji Kangbingdu mixture (SJKBDM) against coxsackievirus A16 (CoxA16).Methods Vero cells and 5-day-old suckling mice, injected with 75/50 and 1×106 TCID50 CoxA16, were used as evaluation models.The preventive influences of SJKBDM against CoxA16 in Vero cells were assessed in the models.The effects of SJKBDM on the mortality, survival time, change rate of body weight, and clinical symptom scores of suckling mice were observed.Results ①The half maximal inhibitory concentration of SJKBDM on Vero cells was 9.59 mg·mL-1.②Toxic effects were not observed from 32.3 g·kg-1 single dose or continuous intraperitoneal injectin of SJKBDM in suckling BALB/c mice.③The SJKBDM had significant inhibitory effect against CoxA16 virus.Doses higher than 1.22 mg·mL-1 could significantly improve the Vero cell survival rate, and the SJKBDM inhibition of 75/50 TCID50 CoxA16 induced pathological changes in Vero cells.④The SJKBDM significantly improved clinical symptoms of mice with CoxA16 viral infection, especially with crude drug doses of higher than 1.62 g·kg-1.The survival rate and other indicators were comparable or slightly higher compared with ribavirin, and the clinical score was higher than that of ribavirin.Conclusion The SJKBDM has significant inhibitory effect on CoxA16 cell proliferation, significantly decreases death rate, and improves clinical symptoms of mice infected with CoxA16 virus.

OBJECTIVE:To observe the effect of Astragalus injection as an adjunctive therapy on the biology in patients with schizophrenia and its clinical efficacy. METHODS: A total of 100 patients with schizophrenia were randomly assigned to trial group(n=50) or control group(n=50). The trial group received routine antipsychotic drugs plus Astragalus injection (40 mL?d-1, iv gtt) for 7 days, and the control group received antipsychotic drugs alone without addition of traditional Chinese medicine for 7 days. All the patients received for a total of 4 courses of treatment. Besides, both groups received additional benzodiazepine but not other hipnotics. RESULTS: After treatment, there were significant differences between the trial group and the control group in ECG QTc duration, sugar level, therapeutic efficacy, PANSS scores (total score and the sub-item scores) and adverse reactions etc(P

OBJECTIVE: To assess and compare the two procedures, total thyroidectomy (TT) and partial thyroidectomy (PT), for papillary thyroid cancer in terms of associated injuries, postoperative complication, recurrence rate and survival, so as to provide a reference and basis for surgical procedure option of this disease. METHOD: Strictly specified into the exclusion criteria, the combination of computer retrieval and manual retrieval and retrieval systems such as CNKI, Wang Fan, PubMed, central, CBM database. Total thyroidectomy and partial thyroidectomy for the treatment of patients with thyroid papillary cancer related literature were compared, with the retrieval time until December 31, 2013. RESULT: According to the retrieval strategy 4630 literatures were found, and 20 witch matched the exclusion criteria were left, all were retrospective study. TT and PT group of recurrent laryngeal nerve injury rate are 5.9%, 2.0% respectively [OR = 0.39, 95% CI (0.17 - 0.90), P < 0.05], TT and PT group of parathyroid injury rate are respectively 4.9%, 0.8% respectively [OR = 0.23, 95% CI (0.08 - 0.68), P < 0.01]. The TT group of 10 years survival rate is 95.24% - 100%, and the PT group is 96.8% - 99.2% [OR = 0.03, 95% CI (0 - 0.34), P < 0.01]. Unstaged, unstaged TT group' postoperative recurrence rate is 4.7%, while PT group is 12.6% [OR = 3.21, 95% CI (1.57 - 6.57), P < 0. 01]. Postoperative recurrence of stage I TT group and PT group are 4.9%, 7.8% respectively [OR = 3.82, 95% CI (1. 07-13.66) P < 0.05]; The rate of stage II TT group is 0.5%, while the rate of PT group is 15.9% [OR = 17.23, 95% CI (4.03 - 73.73), P < 0.01]. CONCLUSION Different methods of primary thyroid papillary carcinoma surgical treatment can all obtaina good survival, but the rate of laryngeal recurrent nerve injury and parathyroid injury caused by partal throidectomy is relatively lower. As a result, partial thyroidectomy can be a good choice for early stage thyroid papillary carcinoma.
Carcinoma ; surgery ; Carcinoma, Papillary ; Humans ; Neoplasm Recurrence, Local ; Parathyroid Glands ; Postoperative Complications ; Recurrent Laryngeal Nerve Injuries ; Retrospective Studies ; Survival Rate ; Thyroid Cancer, Papillary ; Thyroid Neoplasms ; surgery ; Thyroidectomy ; methods

Objective To investigate the 15 quality indicators at medical institutions in China , and to explore the model of quality specifications .Methods Online questionnaires were sent to 8029 clinical laboratories ,with the results analyzed by SPSS 20 .The 25th percentile ,50th percentile ,and 75th percentile of the distribution ,according to the level of the hospital ,were regarded as the optimum , appropriate and minimum quality specifications for each quality indicator ,respectively .Results As shown in the median ,sigma values of most indicators were greater than 3 .The defect percentages of test uncovered by internal quality control (IQC)and test uncovered by inter-laboratory comparison were 47.46％ and 85.73％ ,respectively ,both too poor to calculate the sigma values. The turnaround time (TAT )differed greatly among the subjects.The longest time of pre-examination TAt and Intra-laboratory TAT were clinical immunity. The minimum quality specifications for the quality indicators were from 3σ to 6σ.Conclusions Laboratories should strengthen their IQc and inter-laboratory comparison with continuing education training to realize the continuous quality improvement .

Objective To investigate the effects and mechanism of interleukin 33 (IL-33) on renal tubular injury in mice with lupus nephritis.Methods Twelve-week-old female MRL/lpr mice were randomly divided into model group,IL-33 group and solvent control group with 10 rats in each group.Ten female MRL/MP mice of the same age were used as normal control group.The mice in IL-33 group were intraperitoneally injected with 100 μL of phosphate buffer saline (PBS),containing 2 μg of recombinant mouse IL-33,once a day for 14 days.The mice in control group and the model group were intraperitoneally injected with the same dose of PBS.All the mice were sacrificed at 14 weeks of age.Serum creatinine (Cr) and urea nitrogen (BUN) concentrations were determined by serum separation.The urine in 24 hours was collected testing urinary protein creatinine ratio and urinary protein quantification.The contents of E-cadherin,α-SMA,and JAK/STAT pathway signaling proteins,including JAK2,p-JAK2,STAT1,and p-STAT1,were detected by Western blot.Results The BUN,urinary protein creatinine ratio and urine protein level of the IL-33 group were significantly higher than those of the model group (all P＜0.05).The expression of renal tubular epithelial cells o-SMA in the IL-33 group was higher than that in the model group,and the difference was statistically significant (P＜0.05).Compared with the model group,the expression of E-cadherin in the tubular epithelial cells of IL-33 group decreased and the expression of p-JAK2 and p-STAT1 protein increased,and the differences were all statistically significant (all P＜0.05).Compared with the model group,the levels of JAK2 and STAT1 in IL-33 group change little,and the differences were not statistically significant (all P＞0.05).Conclusions IL-33 can cause tubulointerstitial lesions in lupus mice,and its mechanism may be related to the activation of JAK/STAT pathway.