Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
China ; Clinical Trials as Topic ; standards ; Drug Evaluation ; Drug Therapy ; standards ; trends ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Quality Control ; Research

Objective:To analyze the clinical features of the patients with drug-induced liver injury ( DILI) combined with hepati-tis B to improve the awareness and attention to the disease by medical workers. Methods:Using retrospective analysis, the patients di-agnosed with DILI combined with hepatitis B from a tertiary-hospital were analyzed from January 2013 to January 2014. Results:Total-ly 30 cases of DILI combined with hepatitis B were collected, the number of male patients was higher than that of female patients, and most of them were elderly patients. The symptoms included weak, anorexia, yellow skin and sclera, tired of the oil, nausea, abdominal distension and so on. The patients with severe liver damage accounted for 80. 0%, 16. 7% was with moderate liver damage, and 3. 3%was with mild liver damage. Thirteen cases were mixed type, ten cases were hepatocellular type, and seven cases were cholestatic type. Conclusion:Middle-aged men may be prone to the disease, and the clinical manifestations are complex and diverse. Severe liver damage is majority, and often shows as mixed liver injury.

Objective:To establish a multidrug resistance cell line from human laryngeal cancer cells by VCR.Methods:Human laryngeal cancer cells(Hep-2) were exposed in stepwise escalating concentration of VCR until the resistant cell(Hep-2/v) line was developed. The IC50 and the resistance folds of multidrug resistance were detected with MTT assay. The differences of cell cycle distribution and Rhodamine accumulation between Hep-2 and Hep-2/v cells were studied through flow cytometry. The MDR1 gene were detected through real-time quantitative RT-PCR, and the corresponding protein was detected through western blot.Results:Hep-2/v cells was established, which had stable resistance to VCR and a resistance index of 45;Hep-2/v cells exhibited cross resistance to many other chemotherapeutic agents and its doubling time was prolonged;The number of cells in G_0/G_1 phase was increased while in S phase decreased(P＜0.05);Rhodamine accumulation in Hep-2 cells was much more than Hep-2/v cells(P＜0.01);The expression of MDR1 were increased than that of Hep-2 cells(P＜0.01).Conclusion:Hep-2/v cell line shows the typical multidrug resistance phenotype.It can be served as a model for the study of MDR.

The DNA fragment RM07 was isolated from halophilic archaea Halobacterium halobium, which can function as promoter not only in halophilic archaea, but also in Escherichia coli as eubacterial promoter. Sequencing analysis indicated that it possessed the typical consensus sequences (-35 and -10) of bacterial gene promoter, which was confirmed by further deletion analysis: With its -35 sequence deleted and -10 sequence left,DNA fragment RM07a nearly cannot initiate transcription;With its both -35 and -10 sequences,RM07b DNA fragment could be active as promoter at a level even higher than RM07. Our research also showed that the promoter function of RM07 fragment in Escherichia coli was under the control of environmental factors,especially its positive correlation with the increasing concentration of sodium chloride. Therefore, RM07 DNA fragment may be potential1 novel promoter source for constructing double-function vectors. It also has special significance in elucidating the issues of the fusing characteristics of archaea and lateral gene transfer between archaea and bacteria.

ObjectiveTo explore the neural basis of visual completion for the occluded faces.Methods2 types of visual stimuli were presented randomly: pictures of complete faces,pictures of incomplete faces(the occluded part was the left-top quadrant).Subjects were instructed to perform a gender discrimination task while event-related potentials(ERPs) were recorded.ResultsCompared with complete faces,incomplete faces enhanced the amplitude of N1 on the occipito-temporal scalp bilaterally,with the right hemisphere advantage.The peak latency of N2 elicited by incomplete faces was delayed compared with that of complete faces.ConclusionThe enhancement of N1 is related to visual completion processing that requires additional time.

ObjectiveTo investigate if there were potential components similar to auditory mismatch negativity (MMN) in the visual modality.MethodsEvent-related potentials (ERP) of 15 healthy adults were tested. Subjects were demanded to complete shape-matching task and double-matching task under 4 kinds visual stimuli including no-difference (Nd), contour-difference (Cd), shape-difference (Sd) and double-difference (Dd).ResultsWithin P1-N1 latent period (100～140 ms), three kinds of deviant stimuli (Cd, Sd, Dd) elicited a positivity, mismatch positivity (MMP). MMP amplitude elicited by Dd was a sum elicited by Cd and Sd (single-difference).ConclusionIn the visual modality, MMP elicited by warp stimulus may be an element similar to auditory MMN and reflect auto-processing of brain to visual stimulus.

Acupuncture Therapy ; Adult ; Female ; Humans ; Sjogren's Syndrome ; therapy

Actins ; metabolism ; Adenoma, Pleomorphic ; metabolism ; pathology ; surgery ; Diagnosis, Differential ; Glial Fibrillary Acidic Protein ; metabolism ; Humans ; Infant ; Keratins ; metabolism ; Male ; Nasal Cavity ; pathology ; Neoplasm Recurrence, Local ; Nose Neoplasms ; metabolism ; pathology ; surgery ; Reoperation ; Vimentin ; metabolism

Adult ; Diagnosis, Differential ; Female ; Humans ; Nevus, Sebaceous of Jadassohn ; diagnosis ; pathology ; Psoriasis ; diagnosis ; pathology

OBJECTIVE:To learn the application and tendency of hepatoprotective drugs in a third grade class A hospital dur-ing 2011-2014,and to provide reference for rational drug use. METHODS:DDDs analysis and consumption ordering method were adopted to analyze the change of DDDs,DDC and other index of hepatoprotective drugs in this hospital from 2011 to 2014. RE-SULTS:2011-2014,the amount and DDDs of Hepatoprotective injection in this hospital increased year by year,while oral dosage form decreased year by year. DDC order of each drug kept stable during 2011-2014;DDC and DDDs of drugs for promoting ener-gy metabolism were all in high level,and ornithine aspartate and ademetionine always took up the first 2 places in 4 years. Polyene phosphatidylcholine and Reduced glutathione injection were cheap,but had higher DDDs. Except Glutathione tablet,DUI of other hepatoprotective drugs had no great difference in 3 years,and fluctuated in 2014;hepatoprotective drugs with DUI>1 and DUI<1 occupied a large proportion. From 2010 to 2014,compared with previous year,the drugs with consumption sum/DDDs ratio num-ber close to 1 reduced significantly in the next year,decreasing year by year. CONCLUSIONS:In this hospital,injections are used too frequently,and overuse of drugs for promoting energy metabolism exist. Polyene phosphatidylcholine and Reduced glutathione injection can be used as a valuable drug in the clinic,and their cost are more acceptable,but not in excess.