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.

ObjectiveTo explore the effects of different health management on adults with prediabetes.MethodsA total of 1182 pre-diabetics were enrolled in this prospective observation study and assigned to one-by-one interview group,in situ education group,communicative interview group and control group.Three intervention groups received life style intervention ( including health education and risk factor control) for 2 years.Analysis ofvariance,x2 test or q test were used for data analysis.ResultsAfteryear intervention,fasting plasma glucose (FPG)and 2 h plasma glucose of the intervention groups were significantly decreased ( P ＜ 0.05 ).FPG of the one-by-one interview group and the in situ education group was significantly lower than that of the communicative interview group at 6 months ( P ＜ 0.05 ). At 24months,FPG of the one-by-one interview group was lower than that of the in situ education group (P ＜0.05).The percentage of participants who showed appropriate blood glucose control was increased in the intervention groups. In addition,blood pressure,triglyceride,cholesterol,creatinine and body weight of those in the intervened groups were significantly improved compared with the control group ( all P ＜ 0.05 ),although electrocardiogram results and arteriosclerosisshowed nosignificant changes(P ＞ 0.05 ).Conclusion Health management may contribute to life style change and hypertension control of prediabetics.Furthermore,in situ education may be the most effective life style interventions.

Objective To establish the animal model(rabbit) of shoulder instability for providing the experimental basis of related studies.Methods shoulder joints of 6 skeletally matured New Zealand white rabbits were measured with the anatomical characteristics and joint motion range in order to determine the operative approach,the similarities of skeletal structure,surrounding muscles,joint capsule and ligaments between rabbit and human were compared.Eighteen rabbits,weighing between 2.5 and 3kg were randomized into 2 groups(experimental group 12 and control 6).In experimental group,instability model was established by means of the operation procedure as follows:the glenohumeral joint of right shoulder was exposed by cutting the subscapularis tendon,then the anteroinferior labrum and surrounding capsular ligament were excised.For control group,sham operation was performed by only curing the skin and superficial tissue,the subscapularis tendon and glenoid structures was kept intact.The specimens of 6 rabbits were harvested 6 weeks after operation.The remaining rabbits of both experimental and control groups were killed 12 weeks post the operation for specimens processing.The motion range and instability were measured in all specimens.Results The gross anatomy of shoulder ioint in rabbit is similar to human.In experimental group,the stability is showed less than control,grade 2 anterior instability was found.The motion range was restricted in all directions,such as external and internal rotation,extension and abduction compared to control group.Conclusion Rabbit is suitable to establish animal model for shoulder instability and related iniuries,the animal model which was designed by this study could provide valuable information for the research of anterior shoulder instability.

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

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