1.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.The clinical observation of Chinese medicine on TPOAb, TGAb of the patients with Hashimoto's thyroiditis
Ming DU ; Hong WANG ; Yingxin SHAO
International Journal of Traditional Chinese Medicine 2014;(5):419-421
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.
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.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.
8.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
9.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%.
10.Research advances in traditional Chinese medicine treatment for primary liver cancer
Huixian SONG ; Fei QIAO ; Ming SHAO
Journal of Clinical Hepatology 2016;32(1):174-177
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.