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.

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

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

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.

Primary liver cancer is a common malignant tumor in the digestive system.Most patients are in the advanced stage when a con-firmed diagnosis has been made,and prognosis is often unfavorable.Traditional Chinese medicine (TCM)has unique advantages in the pre-vention and treatment of primary liver cancer.This article briefly introduces the etiology and pathogenesis of primary liver cancer,as well as syndrome differentiation and treatment of liver cancer with TCM,and summarizes the advances in multimodality therapies including TCM combined with transcatheter arterial chemoembolization,radical surgery for liver cancer,chemoradiotherapy,and molecular-targeted thera-py,in order to provide a reference for the clinical treatment and improvement in the prognosis of primary liver cancer.

Objective To explore the first-aid treatments and nursing measures of children with Adams-Stokes syndrome.Methods Totally 6 data of patients with Adams-Stokes syndrome who was successfully rescued were analyzed and discussed.Results The main cause of Adams-Stokes syndrome were Severe ventricular tachycardia.The third degree atrioventricular block,Severe myocarditis,Dilated cardiomyopathy,the common inducing factors of Adams-Stokes syndrome were Hypokalemia,psychological factors,overeating,constipation.Conclusion The premise of the successful rescue on Adams-Stokes syndrome children are regulated observation、knowing the patient' s condition well,the medicine and goods for first-aid treatment all ready,and timely finding,correct estimate,giving emergency treatments timely,appropriate nursing are the keys of its successful rescue.

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.

OBJECTIVETo explore the genotypes of human papilloma virus (HPV) in male patients with condyloma acuminate in Lishui area of Zhejiang Province, China.

METHODSUsing HybriMax, we identified the genotypes of HPV of the verruca samples from 110 male condyloma acuminate patients aged 16 - 65 years in Lishui area.

RESULTSHPV infection was detected in 107 (97.27%) of the condyloma acuminate patients, including 76 cases (71.02%) of simple infection and 31 cases (28.97%) of multiple infection. The peak age of infection was 21 - 40 years old. Totally, 14 genotypes of HPV were identified, including the high-risk genotypes as HPV16, 53, 52, 33, CP8304, 58, 51, 45, 66, 68, and 59, which accounted for 44.85% of the cases, and the low-risk ones as HPV6, 11, and 19 (43), with an infection rate of 93.45%.

CONCLUSIONThe low-risk genotype is a dominant type of HPV infection and the rates of high-risk genotype and multiple infection are high among the male condyloma acuminate patients in Lishui area.

Adolescent ; Adult ; Aged ; China ; Condylomata Acuminata ; virology ; Genotype ; Humans ; Male ; Middle Aged ; Papillomaviridae ; genetics ; Papillomavirus Infections ; virology ; Risk ; Young Adult

Objective To study syndrome and pathogenesis of patients of chronic hepatitis B treated by Lamivudine. Methods By Observing clinical information of Chinese medical symptoms, physical signs,tongue and pulse, TCM syndrome of 103 patients of Chronic Hepatitis B treated by Lamivudine were differentiated by two attending doctors and analyzed. Results Patten of 103 patients were: spleen deficiency and damp-heat (20.38%), spleen deficiency (20.38%), endoretention of damp-heat (19.41%), liver depression and spleen deficiency(13.59%), liver yin deficiency (8.73%); Syndrome of 103 patients were: spleen deficiency (47.57%), damp-heat (43.68%), liver depression (11.65%), liver yin deficiency (10.67%), blood stasis (8.73%), kidney yin deficiency (3.88%). Conclusion Pathogenesis of patients of chronic hepatitis B treated by Lamivudine was spleen-liver-kidney deficiency, and endoretention of damp-heat; Nature of disease was deficiency in origin and excess in superficiality, and simultaneous deficiency and excess; Common syndromes were spleen deficiency, damp-heat, liver depression, liver yin deficiency, blood stasis, and kidney yin deficiency.

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.