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 study the significance of fascin protein expression in ductal intraepithelial neoplasia ( DIN) and invasive ductal carcinoma ( IDC) .Methods_Thirty cases of usual ductal hyperplasia ( UDH) , 30 ca-ses of flat epithelial atypia (FEA,DIN1a), 15 cases of atypical ductal hyperplasia (ADH,DIN1b), 2 cases of DCIS grade1(DIN1c),10 cases of DCIS grade2(DIN2)and 18 cases of DCIS grade3(DIN3)were immunohisto-chemically investigated using monoclonal antifascin antibody and compared with 120 cases of invasive ductal carci-noma (IDC).Results_Fascin protein expression was not found in normal breast tissue, UDH, FEA (DIN1a), ADH(DIN1b),DCIS grade1(DIN1c)and DCIS grade2(DIN2),but only seen in 2 of 18 cases of DCIS grade3 (DIN3)(11.1%), and 18 out of 120 cases of IDC (15%).Fascin protein expression was correlated with ER neg-ative( P<0.05) , PR negative( P<0.05) , tumor grade( P<0.05) and axillary lymph node status( P<0.05) , but not correlated with age,location,tumor sizeand HER2 expression.Conclusions_Fascin protein expression seems to be a late event, usually present in carcinoma.Targetting the fascin pathway may be a noval therapeutic strategy of mammary carcinoma.

Objective: To investigate the apoptosis of renal cells induced by tumor necrosis factor alpha (TNF-α) and nuclear factor-κB (NF-κB) in diabetic rats and intervention of rapamycin. Methods: A total of 20 rats (Goto-Kakizaki rats) with type 2 diabetes mellitus (T2DM) were randomly and equally divided into DM model group (DM group) and rapamycin treatment group (DMR group, received rapamycin treatment after DM model was established); another 10 Wistar male rats were regard as normal control group. Apoptosis of renal cells, expression levels of TNF-α and NF-κB and levels of blood lipids, blood glucose were measured in all groups after four weeks and eight weeks. Results: Four and eight weeks After model was established, compared with normal control group and DMR group, there were significant increase in renal cells apoptosis [RCA, four weeks: (0.217±0.031), (0.272±0.031) vs. (0.545±0.031), eight weeks: (0.358±0.031), (0.350±0.031) vs. (0.811±0.031)] and expressions of NF-κBp65 [OD: four weeks: (0.160±0.027), (0.131±0.027) vs. (0.411±0.027), eight weeks: (0.232±0.027), (0.275±0.027) vs. ( 0.634±0.027)] and TNF-α [OD: four weeks: (0.242±0.027), (0.275±0.027) vs. (0.617±0.027), eight weeks: (0.385±0.027), (0.342±0.027) vs. (0.912±0.027)] in DM group (P<0.01 all). Correlation analysis indicated that there were positive correlations between renal NF-κBp65 and TNF-α, among RCA and TNF-α, NF-κBp65 (r=0.956, 0.953, 0.886，P<0.01 all).

Objective To observe the effect of electroacupuncture at extensors plus acupoints based on syndrome differentiation on the wrist-ankle activity in post-stroke hemiplegia. Method A total of 168 patients with post-stroke hemiplegia were randomly divided into a control group and a treatment group, 84 cases each. Both groups were prescribed with Western medication, based on which, the control group received electroacupuncture at acupoints based on syndrome differentiation, and the treatment group received electroacupuncture at extensors plus acupoints based on syndrome differentiation. The changes of electromyography (EMG) in the two groups after the intervention were observed, and the clinical efficacies were compared between the two groups.Results The total effective rate was 95.1% in the treatment group versus 91.0% in the control group, and the between-group difference was statistically significant (P<0.05). After the intervention, the EMG of extensor carpi radialis in the treatment group was significantly different from that in the control group (P<0.05); the between-group difference was statistically insignificant in comparing the EMG of tibialis anterior muscle (P>0.05), but the intra-group differences were statistically significant in both groups(P<0.05). The value of M-amp/H-amp was changed significantly in both groups after the treatment (P<0.01), but the between-group difference was statistically insignificant after the treatment (P>0.05).Conclusion Electroacupuncture at extensors plus acupoints based on syndrome differentiation can increase the motor unit of carpi radialis and decrease the spasm of gastrocnemius in post-stroke hemiplegia, and consequently produce a remarkable clinical efficacy.

Animals ; Disease Models, Animal ; Female ; Interferon-gamma ; therapeutic use ; Lung ; drug effects ; pathology ; Random Allocation ; Rats ; Rats, Wistar ; Silicosis ; classification ; drug therapy ; Treatment Outcome

In this paper, the Fourier transform based minimum mean square error (FT-based MMSE) method is used to calculate the regional cerebral blood volume (rCBV) in magnetic resonance (MR) perfusion imaging, and the method is improved to handle the existing noise in the imaging process. In the experiments with signal-to-noise ratio (SNR) of 50 dB, the rCBV values were compared with the results using MMSE method. The effects of different SNRs on the estimation of rCBV were analyzed. The experimental results showed that MMSE was a simple way to filter the measurement noise, and could calculate rCBV accurately. Compared with other existing methods, the present method is not sensitive to environment, and furthermore, it is suitable to deal with the perfusion images acquired from the environment with larger SNR.
Blood Volume ; Brain ; blood supply ; Fourier Analysis ; Humans ; Magnetic Resonance Angiography

Objective To investigate effects of the amphiphilic peptides on membrane permeability of acinetobacter bauman-nii .Methods The LysAB3 and LysAB3-D (lack of amphiphilic peptides structure gene) was synthesized and inserted into the vec-tor pET28a(+ ) to construct the recombinant expression plasmid (pET28a-LysAB3 ,pET28a-LysAB3-D) .After expression in E . coli BL21(DE3) and purification with Ni2+-NTA Sepharose .Acinetobacter baumannii was observed by scanning electron microsco-py and fluorescence microscope ,pretreated with LysAB3 and LysAB3-D respectively .Results Under scanning electron microscopy , LysAB3-treated acinetobacter baumannii exhibited not only significant abnormalities ,including deep roughening of the cell surface , but also FITC readily accumulated in bacteria .It was different from LysAB3-D-treated .Conclusion These results indicate that the amphiphilic peptides structure increase membrane permeability of acinetobacter baumannii ,which helps LysAB3 degrade bacteria .

Nuclear proteins often form punctiform structures, but the precise mechanism for this process is unknown. As a preliminary study, we investigated the aggregation of an HSV-1 immediate-early protein,infected-cell protein 22 (ICP22), in the nucleus by observing the localization of ICP22-EGFP fusion protein.Results showed that, in high-level expression conditions, ICP22-EGFP gradually concentrates in the nucleus,persists throughout the cell cycle without disaggregation even in the cell division phase, and is finally distributed to daughter cells. We subsequently constructed a mammalian cell expression system, which had tetracyclinedependent transcriptional regulators. Consequently, the location of ICP22-EGFP in the nucleus changed with distinct induction conditions. This suggests that the cellular location of ICP22 is also influenced by promoter regulation, in addition to its own structure. Our findings provide new clues for the investigation of transcriptional regulation of viral genes. In addition, the non-protease reporter system we constructed could be utilized to evaluate the role of internal ribosome entry sites (IRES) on transcriptional regulation.

Objective To analyze the clinical characteristics, short-term and long-term outcome, overall survival and prognosis of nasal-type,natural killer T-cell lymphoma(NK/TCL) patients. Methods Clinical data of 45 patients with nasal NK/T cell lymphoma from Jan 2001 to Dec 2008 were analyzed retrospectively. Results The complete remission rate was 53.3% (24/45)and the partial remission rate was 17. 8% (8/45), the overall response rate was 71.1% (32/45). At a median follow-up of 15 months, the 1-year,3-year and 5-year survival rates were 68. 3% ,57. 1% ,and 43. 7% respectively. Multivariate analysis showed that B symptoms was independent prognostic factors of NK/TCL( P = 0. 001 ). Conclusions NK/TCL showed specific characteristics, and the long-term survival rate is still poor. Investigation of optional treatment is needed.

AlM: To observe the effects of the coelomic cavity injection of triamcinolone acetonide ( TA) combined with laser photocoagulation on patients with retinal vein occlusion.
METHODS:Fifty-six patients of retinal obstruction with macular edema were accepted from January 2010 to December 2012 in our hospital. All patients received iodized lecithin and Xueshuantong. And, patients with central retinal vein occlusion ( CRVO ) , hemi- central retinal vein occlusion ( hemi-CRVO ) and branch retinal vein occlusion ( BRVO ) treated by TA combined with laser photocoagulation, respectively. Follow-up period was of at least 6mo
RESULTS: After the treatment of 1, 3 and 6mo, the central foveal thickness was reduced significantly ( P<0. 05). After followed up 6-12mo, the total effective rate of CRVO, Hemi-CRVO and BRVO patients was 83% ~95% and all the patients had no significant adverse reactions.
CONCLUSlON:Basing on the traditional treatment, TA combined with laser photocoagulation is more effective in the treatment of retinal vein occlusion and is worthy of clinical usage.