2.HIV/AIDS research in China: arising up from skyline.
Chinese Medical Journal 2006;119(23):1939-1940
3.Review of biosimilar regulatory guidelines and scientific principles:Experiences from Europe-an Medicines Agency (EMA) guidelines
Chinese Journal of Health Policy 2014;(10):21-26
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.
4. Analysis of microsatellite instability and loss of heterozygosity in thymoma
Tumor 2008;28(1):57-60
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.
5.Impact on evaluation of clinical efficacy of traditional Chinese medicine for level in soft targets of processing technology.
Ming-Yi SHAO ; Ming WEI ; Bo-Hua YAN
China Journal of Chinese Materia Medica 2014;39(7):1315-1317
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
6.Genotypes of human papilloma virus in male condyloma acuminata patients in Lishui area.
National Journal of Andrology 2015;21(11):1001-1004
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
7.Reliability and validity of the Chinese version of Interpersonal Stress-Coping Inventory for undergraduates
Ming LI ; Shuqin PANG ; Wei SHAO
Chinese Mental Health Journal 2010;24(1):55-58
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.
8.Quantitative determination of Ophiopogonin D in Zhe Ophiopogon japonicus(Thunb.)Ker-Gawl. and Chuan Ophiopogon japonicus(Thunb.) Ker-Gawl. by HPLC-ELSD
Jianpin YU ; Jianfeng SHAO ; Ming ZHU
Traditional Chinese Drug Research & Clinical Pharmacology 1993;0(04):-
HPLC-ELSD was used to determine the content of Ophiopogonin D in Zhe Opiopogon japonicus(Thunb.) Ker-Gawl. and Chuan Ophiopogon japonicus(Thunb.) Ker-Gawl. The chromatographic conditions were as follow: Alltima C18 column (250mm?4.6mm) and the column temperature at 30℃, drift tube temperature at 98 ℃with Gas flow rate being 2.8 L/min and acetonitrile : water (55∶45) as mobile phase with the flow rate being 1.0 mL/min. There was a good linearity (r=0.9992) within the range of 0.2565~6.4125 ?g. The average recovery rate was 102.0%and RSD=2.1%.
9.Preparation Techniques of Ginkgolides Drop Pills by Orthogonal Design
Shengrong SHAO ; Jun SUN ; Ming WU
Chinese Journal of Information on Traditional Chinese Medicine 2006;0(07):-
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.
10.Relationship between genetic polymorphism of N-acetyltransferase and early-onset Parkinson disease
Ping LIU ; Zhenhua LIU ; Ming SHAO
Chinese Journal of Neurology 2001;0(01):-
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