In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.

Humans ; Parathyroid Neoplasms ; diagnosis ; epidemiology ; therapy ; Prognosis

Acquired Immunodeficiency Syndrome ; drug therapy ; immunology ; Antiretroviral Therapy, Highly Active ; Child ; China ; HIV Infections ; drug therapy ; immunology ; Humans ; Male ; Research

Objective: To investigate the frequency of microsatellite instability (MSI) and loss of heterozygosity (LOH) in thymoma and its relationship with clinicopathological parameters. Methods: We selected 5 microsatellite polymorphism markers and extracted DNA from 28 specimens of paired thymomas/normal tissues. MSI and LOH in the specimens of thymomas and relevant pericancerous tissues were detected by polymerase chain reaction (PCR) followed by 6% polyacrylamide gel electrophoresis (PAGE) with silver staining. SP immunohistochemical method was used to assess the expressions of epithelial growth factor receptor (EGFR), p53, Bcl-2, and Ki-67 proteins in thymoma. Results: MSI or LOH was detected in 11 out of 28 thymoma tissues. The frequency of MSI was 21.4% (6/28), 10.7% (3/28), 14.3% (4/28), 10.7% (3/ 28), and 0% (0/28) at loci of D6S1708, TP53, DM, D11S988, and D8S136. LOH at D6S1708 (5/6) was a common genetic alteration. DM had only MSI alteration and D11S988 had only LOH alteration. There was no significant association between MSI and LOH with age, sex, with or without myasthenia gravis (MG), histological classification, clinical staging, and immunohistochemical staining (EGFR, p53, Bcl-2, and Ki-67 proteins) (P > 0.05). Conclusion: D6S1708, TP53, DM, and D11S988 are sensitive loci for studying microsatellite DNA imbalance in thymoma. Microsatellite DNA imbalance may play a certain role in occurrence and develoyment of thymoma, and the relationship between MSI or LOH and clinicopathological features of thymoma needs further investigation.

Objective To observe the effect of the Chinese medicine on the patients’ thyroid autoantibodies TPOAb and TGAb of Hashimoto's thyroiditis. Methods 100 cases of Hashimoto's thyroiditis were randomly divided into group A and group B, with 50 cases in each group. Group A was given levothyroxine sodium(L-T4) to maintain thyroid function(FT3,FT4,TSH)in the normal range, at the same time Chinese medicines of soothing liver and strengthening spleen, nourishing the liver and kidney, activating blood and removing blood stasis were additionally added;while group B was taken L-T4 to maintain the thyroid function in the normal range. The levels of TPOAb, TGAb were determined before and after treatment in both groups. Results After the treatment, the level of TGAb and TPOAb[respectively(106.3±29.5)IU/ml,(871.5± 209.3)IU/ml] in group A were decreased compared with their previous level [respectively(385.5±76.6)IU/ml, (1621.5±399.2)IU/ml], the difference was statistically significant(t were 48.2、10.6,P<0.01). The level of TGAb and TPOAb [respectively(437.6±135.4)IU/ml,(1798.6±434.6)IU/ml] in group B were slightly increase than their previous level[respectively(383.9±105.8)IU/ml,(1633.2±396.5)IU/ml], with no significant difference. The levels of TPOAb and TGAb in group A had significant difference than those in group B after the treatment(t were 22.3、19.6,P<0.01). Conclusion TCM combined with L-T4 can reduce the level of thyroid autoantibodies of TPOAb and TGAb-in patients.

Objective To compare sensitivity and specificity of the acute physiology,age,and chronic health evaluation system Ⅱ (APACHE Ⅱ),the acute physiology,age,and chronic health evaluation system Ⅲ (APACHE Ⅲ) system in predicting prognosis after cardiac operation.Methods A prospective study of 1 180 consecutive patients entering in a single cardiac postoperative intensive care unit of Anzhen hospital was assigned between November 2013 to January 2014.APACHE Ⅱ and APACHE Ⅲscore was calculated daily at least three days or until death,then compared the calibration and discrimination of the two different system using Hosmer-Lemeshow goodness-of-fit and receiver operating characteristic(ROC) curve.Results In discrimination analysis,ROC value of the first day after operation was(APACHE Ⅱ 0.699 、APACHE Ⅲ 0.734),ROC of the maximum(APACHE Ⅱ 0.836,APACHE Ⅲ 0.862),ROC of the maximum during the first 3 days(APACHE Ⅱ 0.814、APACHE Ⅲ 0.855),ROC of the change between the third day and the first day(APACHE Ⅱ 0.524 、APACHE Ⅲ 0.549).In calibration analysis,we compared the x2 value and overall corrected percentage of the first day value,the maximum value,the maximum value during the first 3 days,the change value between the third day and the first day of the three different system.x2 value of APACHE Ⅱ was(15.688,10.132,8.061,42.253),x2 value ofAPACHE Ⅲ was(13.608,11.196,19.310,47.576).Conclusion APACHE Ⅲ was better than APACHE Ⅱ in prediction of death risk after cardiac surgery.

The effect of Ultraviolet (UV) rays on the activity of parasporal crystal of Bacillus thuringiensis, var. Kurstaki HD-1 strain was studied by SEM, SDS-PAGE, bioassay and other methods. It was found that the morphology and surface structure of PC were damaged ,and its solubility in alkaline solution or silkworm gut juice was decreased after being irradiated by UV, the solubility was lost completely after a long time irradiation over 5 hours, so the processed PC could not be degraded into protoxin with insecticidal activity and was denatured.

Objective:To evaluate the reliability and validity of the Chinese version of Interpersonal Stress-Coping Inventory for Undergraduates(ISI).Methods:Totally 421 college students of 1～3 grades in two colleges of Anhui province were selected.They were asked to complete the ISI and Simplified Coping Style Questionnaire(SCSQ)at the same time to test the reliability and validity of ISI.Two weeks later,52 of them were retested to test the re-test reliability.Results:Cronbach α of the Chinese version of ISI was 0.79,re-test reliability was 0.87.ISI Scores were correlated with SCSQ scores(r=0.69).Exploratory factor analysis was applied to the data,and three subscales were derived:positive coping,negative coping,and dilution coping.The factor loadinps were 0.41～0.68.The explained variances were 14.82,14.10,and 7.06 respectively.Conclusion:The Chinese version of Interpersonal Stress-Coping Inventory has good psychometric quality and can be used in Chinese undergraduates of interpersonal stress coping research.

Objective To investigate the relationship between the slow acetylator genotype induced by the genetic polymorphism of N acetyltransferase 2 (NAT2) gene and the early onset Parkinson disease. Methods Polymerase chain reaction restriction fragment length polymorphism (PCR RFLP) method was used and three mutant alleles M1, M2 and M3 of NAT2 were studied in 126 patients with idiopathic early onset Parkinson disease and 122 age matched randomly selected controls. Results The frequencies of alleles M1, M2 and M3 of NAT2 in patients were 8 7%,26 6% and 13 1%,respectively,however,there were 2 9%,19 7% and 14 8% in controls, respectively The difference in frequency of allele M1 was statistically significant( P =0 005) The frequency of slow acetylator genotype was higher in patients (23 0%) than in controls (10 7%), showing an OR of 2 507( P =0 009). Conclusion Our study suggests that the slow acetylator genotype of N acetyltransferase 2 might be associated with the occurrence of the idiopathic early onset Parkinson′s disease