The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Product Surveillance, Postmarketing ; methods ; Quality Control ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections ; drug therapy

Diagnosis, Differential ; Endophthalmitis ; diagnosis ; diagnostic imaging ; etiology ; pathology ; Humans ; Infant, Newborn ; Male ; Meningoencephalitis ; complications ; diagnosis ; diagnostic imaging ; pathology ; Suppuration ; Tomography, X-Ray Computed

Carcinoma, Non-Small-Cell Lung ; diagnostic imaging ; Humans ; Lung ; diagnostic imaging ; Lung Neoplasms ; diagnostic imaging ; Perfusion Imaging ; Radiotherapy, Intensity-Modulated ; methods ; Tomography, Emission-Computed, Single-Photon ; methods

Humans ; Immunoglobulin E ; Mouth Diseases ; Syndrome

Objective To investigate the relationship among carotid atherosclerosis,plasma homocysteine and D-dimer level in patients with acute cerebral infarction.Methods Two hundred and eightyseven cases of patients with acute cerebral infarction treated in Pudong Hospital,Shanghai from January 2011 to March 2012 were enrolled into the observation group and 287 cases of healthy people not suffering from cerebral infarction or other patients had nothing to do with cerebrovascular disease were selected into the control group.The serum levels of plasma homocysteine were determined by fluorescence polarization immunoassay (FPIA) and D-dimer level by double antibody clip method.At the same time,neck vascular artery ultrasound were performed by MycoCardR Reader Ⅱ.The relationship of carotid atherosclerosis with plasma homocysteine and D-dimer were compared between these two groups.Results There were significant differences on total cholesterol ((4.25 ± 0.92) mmol/L vs (4.98 ± 0.88) mmol/L,t =3.244,P ＜ 0.05),triacylglycerol ((1.48 ±0.82) mmol/L vs (1.78 ± 1.09) mmol/L,t =3.564,P ＜ 0.05),low density lipoprotein ((2.52-0.76) mmol/L vs (2.92 ± 0.73) mmol/L,t =2.987,P ＜ 0.05),high-density lipoprotein ((1.38 ± 0.26) mmol/L vs (1.06± 0.29) mmol/L,t =3.964,P ＜ 0.05),systolic pressure ((130.28 ± 14.78) mm Hg vs (152.98 ± 20.45) mm Hg,t =3.264,P ＜ 0.05),diastolic pressure ((78.45 ± 16.02) mm Hg vs (93.81 ± 16.88) mm Hg,t =2.785,P ＜0.05) and common carotid artery IMT(left:(0.86 ±0.41)mm vs (1.18 ±0.25)mm,t =2.164,P ＜0.05;right:(0.87 ± 0.39)mm vs (1.12 ± 0.29)mm,t =2.254,P ＜ 0.05) between observation group and control group.Homocysteine concentration and the D-dimer level of patients with carotid atherosclerosis were significant higher than that without carotid atherosclerosis (homocysteine concentration:(12.89 ± 6.56) μnol/L vs (3.17 ± 0.12) μnol/L,t =2.324,P ＜ 0.05 ; D-dimer level:(1.53 ± 0.59) mg/L vs (0.33 ± 0.23) mg/L,t =2.753,P ＜ 0.05).Conclusion The plasma homocysteine concentration and the D-dimer levels are correlated with carotid atherosclerosis in patients with acute cerebral infarction.

10.3969/j.issn.1000-3606.2013.06.014

How to expand and deepen the educational function of library of college and university of traditional Chinese medicine by giving play to its strong points was analyzed in the new model of students'independent study , and measures to improve the information literacy and comprehensive literacy of students were elaborated, such as developing teaching reference books database, performing guidance for different readers, carrying out different activities that make entertainment a medium of education , in order to help students to acquire special knowledge outside of classroom .

Objective To analyze blood lipid components in simple obesity children and to explore the effects of obesity in the lipid metabolism and its clinical significance.Methods A total of 90 children,including 50 simple obesity children(obesity group)and 40 normal children(control group),were enrolled in this study.The age ranged from 2.5 to 16.0 years.Their blood lipid profiles of all the children were analyzed.The blood lipid profiles were examined by biochemical analysis,including triglyeride(TG),total cholesterol(TC),low density lipoprotein(LDL) and high density lipoprotein(HDL),and the livers of all the children were analyzed.The blood lipid profiles were examined by ultrasonograph.Results 1.There were no significant differences in age and height in obesity group and control group,but there were significant differences in body mass index(BMI) and blood pressure(P0.05),which had no statistical meaning.3.Liver ultra sonogram showed that 18 cases had fatty liver(36%) in simple obesity children.Conclusions Metabolic disorder of blood lipid is present in simple obesity children,who have a tendency to get fatty liver.LDL is markedly elevated in obesity group.Arteriosclerotic cardiovascular disease should be prevented at earlier period of childhood.

Objective:To study the isolation, culture and identification of the TMJ cells and to observe the biological characteristics of cultured fibrochondrocytes. Methods:The TMJ discs were dissected from two 1 month goats under sterile conditions and were digested with collagenase. The cells were collected. Morphological changes and attachment efficiency were constantly observed under phase-contrast microscope. Immunohistochemical staining for type I collagen as well as toluidine blue staining were performed. Ultrastructures of the TMJ cells were observed under transmission electron microscope. Results: Most of the primary fibrochondrocytes presented a short spindle-shape while the rest showed polygon-shape. On the 7th day, the perliferating fibrochondrocytes started to contact each other to form a monolayer covering the bottom of the incubation disc. Immunohistochemical staining of type I and toluidine blue staining exhibited positive results. The fibrochondrocytes cytoplasms were rich in mictochondria and endoplasm reticulum. Conclusion: The fibrochondrcytes isolated from one-month-old goat TMJ disc have good proliferation ability in vitro and cells from passage 1 to 3 might be used as seed cells for TMJ disc tissue engineering.