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 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.

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.

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 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.

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.

Objective:To investigate the use of proton pump inhibitors ( PPIs) in the patients with cirrhosis or hepatitis in one hospital and evaluate the use rationality .Methods:A retrospective study was carried out on 211 patients with the diagnosis of hepatitis or cirrhosis in the infectious disease ward between 2013 and 2014 , and the use rationality of PPIs was evaluated .Results: A total of 211 cases were inspected, and among them, 192 ones were treated with PPIs (91%) with 62 ones treated with PPIs irrationally, which accounted for 29.3%of the total cases.The main irrational use of PPIs was long treatment course (24.5%), inadequate prophylaxis indications (5.7%) and purposeless use (2.6%).Conclusion: Irrational use of PPI is common in hepatitis or cirrhosis patients . Clinical pharmacists should strengthen pharmaceutical care to improve the rational drug use .

Through the analysis of the selected case discussion, put forward the current often encountered in clinical practice for pure artificial insemination about some ethical problems in the implementation process of tech-nology, current situation and aims at the discussion the reproductive committee is carried out in the guidelines for the essence of artificial insemination technology functions:to provide correlation ethics consultation to demanders, 2 it is to assisted reproductive technology, and the correlation research to carry out the supervision and guidance.

Objective To analyze retrospectively the MR features of MELAS patients,in order to improve the early diagnosis of MELAS.Methods MR data of 1 6 MELAS patients confirmed by clinical diagnose and muscle biopsy were retrospectively analyzed. MR features of plain scan(n=1 6),ASL(n=3),MRA(n=1 5),DWI(n=14)and MRS(n=3)were analyzed.Results MRI data demonstrated brain lesions mainly distributed in posterior cerebral hemisphere extending to subcortical area,which was not consistent with the vascular supply territories.The lesions were observed as low signal on Spin-echo sequence of T1 WI,while high signal on T2 WI, FLAIR and DWI.The focal lesions showed increasing Lac peak on MRS.Fifteen of 16 patients underwent MRA and one showed increased arterial branches in lesion zones.Three patients had ASL scanning demonstrating high irrigation in lesion zones which would wander once relapsed.Meanwhile,old lesions showed encephalatrophy and cerebromalacia.All patients’muscle biopsy pathology showed ragged red muscle fibers.Under electron-microscopic,bioblasts were bigger and more than average level and muscle fibers atrophied.Mitochondrial DNA sequence of 3 patients showed mtDNA A3243G transgenation.Conclusion The DWI,MRS and ASL sequences show good ability in MELAS diagnosis and differential diagnosis.

Objective To elucidate the correlation between the dose of ultraviolet B (UVB) irradiation and apoptotic phase of keratinocytes (HaCaT cells). Methods Cultured immortalized human ker-atinocyte cell line, HaCaT cells, was irradiated with ultraviolet B (UVB) in doses of 20, 40, 60, 80, 100 and 120 mJ/cm2. Cellular viability, cell cycles and apoptosis were simultaneously detected at 2, 12, 24, 48 and 72 h after irradiation. The caspase-mediated apoptosis was detected by FITC-labelled VAD-FMK, which could irreversibly bind to activated caspases. FITC-Annexin V and PI double staining detected cell membrane-mediated apoptosis. Cell nucleus-mediated apoptosis was detected by DNA ladder electrophoresis. Results Cell cycle analysis revealed that UVB treated HaCaT cells were blocked predominantly in G2/M phase in a dose-dependent manner. Treatment with UVB decreased the viability of HaCaT cells in dose- and time-dependent manners. The rates of apoptosis were increased with increasing dose and prolongation of time after UVB irradiation. The apoptosis of UVB-treated HaCaT presented in an obvious time-dependent manner, in which caspase- and cell membrane-mediated apoptosis was predominantly in early phase and cell nucleus-mediated apoptosis predominantly in late phase. Conclusions The apoptosis of UVB treated HaCaT cells appears in dose- and time-dependent manners, which warrants further detection with multiple parameters and at different phases.