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

To increase the biotransfomation efficiency from the orotic acid to the uridine 5'-monophosphate(UMP),URA5 gene encoding orotate phosphoribosytransferase was amplified from Saccharomyces cerevisiae BY4742 by PCR,then it was inserted into the expression vector pYX212(contained orotidine monophosphate decarboxylase gene URA3)and the pYX212-URA5 was transformed into Saccharomyces cerevisiae BJX12 by electroporation.The recombinant strain was elementarily used to convert orotic acid to UMP.The results showed that pYX212-URA5/BJX12 could accumulate 7mmol/L UMP from 32mmol/L orotic acid in 26h,significantly higher than both control groups pYX212/BJX12(2.7mmol/L) and BJX12(2.4 mmol/L).

Objective To study the clinical effect of tension-free hernia repair in inguinal emergency hernia. Methods The tension-free hernia repair was administered in 83 patients with inguinal emergency hernia.All the cases were analyzed retrospectively.Results There were two postoperative deaths in 83 cases within three days after operation.Wound infection occurred in one case.The rest recovered soon.The average stay in hospital was 5.1 days. Conclusion The tension-free hernia repair can be applied to inguinal emergency hernia with satisfactory results.

Objective To assess the effects of surgical treatment for patients with blepharochalasis and its associated abnormali- ties. Design Retrospective case series, Participants 35 cases (52 eyes) with blepharochalasis in stable phase. Methods The correction of the abnormalities in upper eyelids: after designing the lid crease incision, the redundant eyelid skin and prolapsed fat were excised, and prolapsed lacrimal glands were sutured back into position in 18 cases (36 eyes) and ptosis was treated in 10 cases (16 eyes). The correction of abnormalities in lower eyelids: lower eyelid retraction was corrected in 4 cases (6 eyes). The correction of lateral canthus malformation: lateral canthus rounding was treated in 7 cases (14 eyes), accompanied with or followed by correction of baggy eyelid or ptosis. Main Outcome Measures The shape, location and movement of bilateral eyelids, the location of lacrimal glands and the cir- cumstance of tear secretion. Results During the follow-up of 6～60 months, the appearance and location of bilateral eyelids and can- thuses were satisfying, the function of eyelids were normal, and no dry eye symptoms were found. Two cases (3 eyes) appeared recurrent lacrimal gland prolapse 29 and 36 months postoperation and received surgeries for correction again. There was no recurrence after the second prolapse correction surgery in the follow-up of 18 and 24 months respectively. Conclusions Surgical treatment for patients with blepharochalasis and its associated abnormalities is safe and effective. Its recurrence rate is low.

Objective To discuss the clinical research status of traditional Chinese medicine treatment for mid-advanced non-small cell lung cancer based on literature analysis.Methods Clinical research articles about TCM treatment for mid-advanced non-small cell lung cancer were retrieved from PubMed, Cochrane Library, Web of Science, EBSCOhost, ScienceDirect, CBM, CNKI, VIP and Wanfang Data in March 6, 2014. RCTs and Q-RCTs were identified by retrieving. Metrology analysis was conducted from the aspects of publication time, article sources, publication organizations, cooperation and trial types, with a purpose to discuss the research status of this domain.ResultsTotally 432 articles were considered to be eligible for inclusion. The number of articles was on the rise. Academic journals were the most important sources of these articles. Publication organizations in Guangdong, Shanghai and Beijing produced the most articles. Cooperative researches increased, especially the cooperation between the same research units/universities. Research quality of RCT is increasing.Conclusion The quantity and quality of clinical researches on TCM treatment for mid-advanced non-small cell lung cancer have improved in different degrees. This domain shows great research prospect.