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

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.

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.

Traditional Chinese medicine (TCM) is a very practical subject, which has its unique theoretical system and clinical characteristics. In the course of clinical practice, the exact clinical efficacy is the key of existence and development. But the existing evaluation system is difficult to objectively evaluate the clinical efficacy of TCM. Therefore, how to objectively evaluate the clinical efficacy and get definitive evidence is the focus of the evaluation of clinical efficacy of TCM. Relative to modern medicine, TCM is more concerned about the changes of feelings and clinical symptoms of the patient in the course of the evolution of the disease. Soft targets mainly used for the evaluation of the clinical efficacy of symptoms and functional activity of the disease. The level in soft targets of processing technology is often used methods in clinical evaluation. But it has often produced the phenomenon which the results of the evaluation is mutual contradiction, which will ultimately affect the effect of evaluation of clinical efficacy of TCM. In order to better evaluate the clinical efficacy of TCM, in the process of adoption of soft targets, it clearly identify it's role, highlighting the characteristics of interventions on disease, and as much as possibly avoid the level in soft targets of processing technology to real assess clinical efficacy of TCM.
Drug Therapy ; Drugs, Chinese Herbal ; therapeutic use ; Evaluation Studies as Topic ; Humans ; Medicine, Chinese Traditional ; Research Design ; Treatment Outcome

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 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 optimize the preparation condition of Ginkgolides drop pill. Methods The technique of preparation drop pill were optimized by orthogonal test. Results The optimized technique to prepare Ginkgolides drop pills:PEG4000∶PEG6000=1∶1,the temperature for the aqueous mixture was 85 ℃,the temperature for cool aqueous was 5 ℃,active ingredients∶excipient was 1∶3. Conclusion good quality of Ginkgolides drop pill can produced.

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 investigate the effectiveness, dose-effect and time-effect relationships for inhibiting neointimal proliferation by 103 Pd radioactive stent, and the safety of the radioactive stent. Methods By angiogaphic, morphometric and histopathologic analysis, we compared 1?000 ?Ci, 500 ?Ci and 100 ?Ci 103 Pd stents with non-radioactive stents on 5 weeks and 12 weeks after stenting in a micro-porcine coronary model of restenosis. Results The neointimal areas of 500 ?Ci and 100 ?Ci 103 Pd stents were significantly smaller than control stents. 1?000 ?Ci stents and control stents had similar neointimal areas. The neointimal areas of 500 ?Ci stents were significantly smaller than 100 ?Ci stents. Compared with control stents, 500 ?Ci stents reduced the neointimal areas by 49% and 50% respectively on 5 weeks and 12 weeks after stenting. Compared with 5 weeks after stenting, the effect of inhibiting neointimal proliferation by 100 ?Ci stents was reduced by 56% (32% vs 14%) on 12 weeks. The neointimal areas on both edge of 100 ?Ci stents were significantly larger than control stents. The neointimal areas on both edge of 1?000 ?Ci stents and 500 ?Ci stents were similar with control stents. No evident radiation damage had been found in the experimental animals who had 103 Pd stent. Conclusion There may be an effective dose window for 103 Pd radioactive stent in inhibiting neointimal proliferation. The effect of inhibiting neointimal proliferation was dose dependent. 103 Pd radioactive stent with appropriate activities may effectively, persistently inhibit neointimal proliferation with no adverse radiation sequelae. These results suggest that 103 Pd radioactive stent prevent restenosis. These data may be useful in predicting safe and effective activity for 103 Pd radioactive stent.