1.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.
2.Analysis of effects of allicin prodrug on proliferation of esophageal cancer cell line Eca9706 and the expression of apoptosis gene
Chinese Journal of Biochemical Pharmaceutics 2014;37(7):43-45
Objective To explore and analyze the effects of allicin prodrug on proliferation of esophageal cancer cell line Eca9706 and the expression of apoptosis gene.Methods Different concentrations of allicin prodrugs were divided into a total of four groups:A1 group(10μg/mL),A2 group(20 μg/mL),A3 group (40 μg/mL),A4 group (normal saline,0 μg/mL),and respectively applicated in esophageal carcinoma cell line Eca9706.After culturing for 1 days,2 days,3 days,cell proliferation was detected by MTT and expression of p53 at the mRNA level was detected by RT-PCR.Results The optimum concentration of proliferation inhibition of allicin prodrug on esophageal cancer cell line Eca9706 was 20μg/mL and the best inhibition time was 2 days;the gene level of esophageal cancer cell line Eca9706 was inhibited with a dose-dependent.Conclusion Allicin prodrugs could effectively inhibit the proliferation of esophageal cancer cell line Eca9706,and control the proliferation of esophageal cancer cells by regulating the expression of apoptosis associated genes,so as to eliminate tumor cells.
3.Venous Catheter Bacterial Infection and Correlative Factors
Chinese Journal of Nosocomiology 1994;0(04):-
0.05).As for patients' age the old age group had the statistical significance vs the non-old age group(P
4.AN OBSERVATION OF A HUMAN DIPLOID FIBROBLAST CELL LINE UNDER LONG TERM PRESERVATION IN VITRO
Acta Anatomica Sinica 1953;0(01):-
A human diploid fibroblast cell line derived from normal abdominal skin of a 17-year-old female patient with ovary carcinoma was established and designated as HSF 79-2. The cultivation of skin fragments was employed in the primary explantation. The medium used was McCoy 5A supplemented with 15~25% calf serum. The grown fibroblasts were succesively subcultured at 1 to 2 split and stopped at the 45th to 54th passage.Having reached confluence the cells still had the ability to divide during 16 months observation if the medium was changed periodically. They displayed the property of dense growth and forming heavy, multilayer sheets, which became a visible membrane to the naked eyes. Under histological examination the membrane had the appearance of connective tissue. Part of the cells were subcultured again after 3,6, and 12 months maintenance in the same culture flask. Their growth character, ploidy, and the generation time were similar to that of the cells passaged normally.The characteristics of this cell line mentioned above appear to be shared by other diploid fibroblasts. It might be used for preserving cell lines and as a model for studying cell motility and differentiation.
5.Role of diet macronutrients in weight loss and adipocyte products
Chinese Journal of Endocrinology and Metabolism 1986;0(04):-
Obesity is a developing public health issue. As a core organ in energy storage and metabolic modulation, adipose tissue becomes an important target in body weight control. Total caloric intake limitation and /or macronutrient ratio regulation are commonly used in obesity therapy. The anti-obesity agents derived from adipocyte products may bring us new ways more suitable to physiological status in the future.
6.Precaution and management of biliary duct injury
International Journal of Surgery 2008;35(4):265-268
Biliary duct injury can arise severe complications,but the proper management can improve patients'prognosis and living quality.So we reviewed the current relevant references and hope it can do some help for clinicians.
7.Combined detection of cerebrospinal fluid in diagnosis of intracranial infection
International Journal of Laboratory Medicine 2015;(14):2027-2028
Objective To investigate the application of pathogenic examination and biomarkers detection of cerebrospinal fluid in diagnosis of intracranial infection .Methods Pathogenic and biomarkers examination were performed in cerebrospinal fluid of 49 cases with intracranial infection (infection group) and 49 cases of craniocerebral trauma but without intracranial infection (control group) .Results Adenosine deaminase activity obviously increased in tuberculous meningitis cases ,glucose levels decreased in bac‐terial meningitis and cryptococcal meningitis cases ,protein and IgA content increased in bacterial meningitis cases ,IgG levels in‐creased in bacterial meningitis and tuberculous meningitis cases ,IgM levels increased in tuberculous meningitis cases (P<0 .05) . There were no significant differences of biomarkers levels between viral meningitis cases and control group (P>0 .05) .Conclusion Combined pathogenic detection and biomarker detection of cerebrospinal fluid could be helpful for the diagnosis and treatment of intracranial infection .
8.Ubiquitin-like proteins and hepatocellular carcinoma
Chinese Journal of Clinical Oncology 2014;(14):933-937
Ubiquitin-like proteins are structurally similar to ubiquitin. These proteins are processed, activated, conjugated, and re-leased from conjugates by enzymatic steps that are similar to the corresponding mechanisms for ubiquitin. Ubiquitin-like proteins regu-late a wide array of cellular processes through modification processes, such as nuclear-cytosolic transport, transcriptional regulation, protein stability, response to stress, and progression through the cell cycle. A large number of recent studies have found dysfunctional ubiquitin-like proteins in hepatocellular carcinoma. These proteins are important in tumorigenesis, cell proliferation, apoptosis, and an-giogenesis. Anticancer drug studies revealed that regulating protein modification by using ubiquitin-like proteins may alter the anti-tu-mor effects of chemotherapy and thus influence the chemosensitivity of hepatocellular carcinoma. Results indicate that ubiquitin-like proteins may become a new target for cancer therapy. The mechanism of ubiquitin-like proteins in tumorigenesis and hepatocellular car-cinoma progression is of great significance in the diagnosis and treatment of hepatocellular carcinoma.
9.Clinical Characteristics of Nonvariceal Vascular Upper Gastrointestinal Bleeding: Analysis of 111 Cases
Chinese Journal of Gastroenterology 2017;22(7):411-414
Background:Nonvariceal vascular upper gastrointestinal bleeding is a special type of nonvariceal upper gastrointestinal bleeding (NVUGIB) with serious disease course and high mortality rate, which should be paid more attention by clinicians.Aims:To explore the etiological factors and therapeutic strategies of vascular NVUGIB for improving the diagnosis and treatment of the disease.Methods:Clinical data of 111 cases of vascular NVUGIB admitted from Jan.2012 to Dec.2016 at Daping Hospital, the Third Military Medical University were retrospectively analyzed.All cases were diagnosed by gastroscopy, abdominal CT or angiography.Results:One hundred and five patients underwent a gastroscopy within 24 hours of hospital admission.The major causes of bleeding were peptic ulcer involving blood vessels (62.2%) and vascular malformation (22.5%);other causes included Dieulafoy disease, gastrointestinal stromal tumor, malignant tumor, intra-abdominal infection, trauma and gastric angiotelectasis.Seventy-eight patients (70.3%) received endoscopic hemostasis, 19 received conservative medical therapy only, 13 were treated by interventional embolization and 5 underwent surgical operation.Hemostasis was achieved in 96.4% of the patients (107 cases);in four deceased, 3 were failures of endoscopic and interventional therapies.Conclusions:Peptic ulcer and vascular malformation are the major causes of vascular NVUGIB.Endoscopic therapy has generally been recommended as the first-line treatment, however, interventional embolization or surgical operation should be used directly if necessary.
10.Effects of thyroxine on serum lipid and bone metabolism in elderly patients with subclinical hypothyroidism
Chinese Journal of Geriatrics 2003;0(07):-
Objective To investigate the effects of L-thyroxine(LT4) on serum lipid and bone metabolism in aged patients with subclinical hypothyroidism (SH). Methods Seventy-eight patients with diagnosed SH were randomly assigned to receive LT4 (therapy group) or placebo(control group) for one year. Mean dose for LT4 replacement was (80.1?37.2) ?g/d. The changes of clinical symptoms, body mass index (BMI) and serum levels of total cholesterol(TC), triglycerides(TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol(LDL-C), apolipoprotein A 1(ApoA 1), apolipoprotein B 100 (ApoB 100 ), calcium ion(Ca 2+ ), phosphorus ion (P 3+ ) and alkaline phosphatase (AKP) and bone mineral density (BMD) were measured before and after therapy. Results After LT4 therapy, clinical symptoms were ameliorated. BMI and serum TC, TG, LDL-C and ApoB 100 levels were significantly reduced 〔(24.6?3.1 vs 23.3?2.2),(5.65?1.42 vs 4.43?0.81),(1.81?0.66 vs 1.43?0.40),(3.64?0.84 vs 2.68?0.63)mmol/L,(0.98?0.22 vs 0.83?0.21)g/L,P