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.

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.

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 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

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 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.