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.Syndrome analysis on patients of chronic hepatitis B treated by Lamivudine
Lingfeng WAN ; Hongbing ZHAO ; Ming SHAO
International Journal of Traditional Chinese Medicine 2011;33(2):146-148
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.
6.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.
7.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
8.Evaluation the effect of APACHE Ⅱ and APACHE Ⅲ after cardiac surgery
Juanjuan SHAO ; Fei CHEN ; Ming JIA
Chinese Journal of Thoracic and Cardiovascular Surgery 2014;30(11):665-667
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.
9.The first-aid treatment and nursing of six Adams-Stokes syndrome children
Xiumin SHAO ; Yanwen JI ; Ming LIU
Chinese Journal of Postgraduates of Medicine 2015;38(z1):100-102
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.
10.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.