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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 changes in small intestinal motility during the process of gallbladder cholesterol stone formation.Methods Forty guinea pigs were divided into two groups of 20 each,the experiment group fed on high cholesterol diet ( cholesterol 2％ ),while the control group on normal diet.Animals were sacrificed at 8 weeks.Slow wave and tension of the isolated small intestinal muscle specimen were measured using a multi-channel physiological recorder,and its relation to gallstone formation was assessed.Results Compared with the control group,the frequency and amplitude of the slow wave significantly reduced in the experimental group (5.70 ± 1.05/min vs.17.45 ± 1.50/min and 0.23 ± 0.31 my vs.0.78 ±0.17 mv respectively,P ＜0.05).The t-value between the two groups were -27.083 and - 13.236 respectively; Frequency of contraction and muscle tension also reduced significantly (5.94 ± 1.25/min vs.15.85 ± 1.76/min and 0.78 ±0.002 g vs.1.20 ±0.11 g respectively,P ＜0.05).Thet-value between the two groups were - 19.448 and - 17.307 respectively.Conclusions Reduced small intestinal motility is present in guinea pigs fed on a lithogenous diet,and may have a role in the pathogenesis of cholesterol gallstone formation.

Objective To study the repair of great vessels injured by firearm in extremities. Methods From May 2002 to Sep. 2005, 15 cryopreserved homologous arteries were transplanted to repair the defects of great vessels of extremities in 14 patients, including 5 cases of defect of brachial arteries, 1 case of defect of axillary artery, 1 case of popliteal artery damage and 7 cases of defect of femoral arteries. The average length of homologous arterial transplants was 9.5 cm. After operation, all the 14 patients were monitored and treated according to principles of microsurgery. Result No early reject reaction was found in all the 14 cases, and all the wounds healed after Ⅱ stage treatment. With Doppler ultrasonic examination 2-3 weeks after healing, it was proved that 100% of the vessels were patent. In 4 to 8 month follow up, the function of the extremities recovered well, and no delayed reject reaction was observed. Conclusion The vessels after cryopreservation is a suitable biomaterial in homologous transplantation for repairing the defect of great vessels of the extremities as a result of firearm injury.

Objective To investigate the clinical characteristics and operative treatment of humeral super-middle fracture combined with brachial artery injury. Methods 9 cases of humeral super-middle fracture combined with brachial artery injury have been treated in our department since 2000 with reduction, axial external fixation, and autotransplantation of great saphenous vein to repair brachial artery. Results All patients were followed up for 1 to 2 years. No stenosis occurred at the anastomosed veins and the limbs survived well. All fractures achieved clinical healing except 1 case who had nonunion following refracture and had to undergo secondary operation. Conclusion The operation is simple and easy, but effective in treatment of the humeral super-middle fracture combined with brachial artery injury.

BACKGROUND: Scholars disagree with each other about the small saphenous vein effects on skin flap and how to dispose vascular proximal pedicles.OBJECTIVE: To analyze effects of different methods of the small saphenous vein disposal on flap survival using sural neurocutaneous island flap retrograde metastasis for repairing defects of soft tissue of instep, heelstick and ankle.DESIGN, TIME AND SETTING: The case control observation experiment was performed at the General Hospital of Guangzhou Military Area Command of Chinese PLA from March 1998 to April 2007.PARTICIPANTS: A total of 56 patients with defects of soft tissue of instep, heelstick and ankle were divided into 2 groups,small sapbenous vein deligation in proximal pedicle flap group (group A) (n=38), and proximal small saphenous vein and great saphenous vein or tributaries at recipient site anastomosis flap group (group B) (n=18).METHODS: During sural neurocutaneous island flap retrograde metastasis for repair,(3.5×4.0)cm-(4.0×4.5) cm flap was obtained in 35 cases, and (4.0×4.5) cm -(10.0×12.0) cm in 21 cases.MAIN OUTCOME MEASURES: Outcome of flap survival at different incision area and implanted methods.RESULTS: No vein articulo occurred in 21 cases, which flap areas were (4.0×4.5) cm -(10.0×12.0) cm. Five of 35 cases which flap areas were (3.5×4.0) cm -(4.0×4.5) cm developed vein articulo.The necrotic rate of flaps in group B was significantly lower compared to the group A (P=0.017 67).CONCLUSION: When the area of skin flap is smaller than (4.0×4.5) cm, the proximal end of the small saphenous vein should be anastomosed with the great saphenous vein or tributaries connecting with the great saphenous vein at recipient site.The small saphenous vein is not a superficial vein, which only cross the skin flap, but it has trophic action on the skin flap.

AIM: To compare and analyze the stereopsis of intermittent exotropia children under the different backgrounds of dynamic stimuli and static stimuli.
METHODS: We collected 56 children ( male 26, female 30 with intermittent exotropia at the age from 5y to 12y and examined their stereopsis under the different backgrounds of dynamic stimuli and static stimuli using a multidimensional sense perception training software. The differences between the dynamic stereopsis and static stereopsis were compared.
RESULTS: Totally 17 cases ( 30%) had both dynamicstereopsis and static stereopsis, 39 cases ( 70%) had either dynamic or static stereopsis deficit, only 10 cases ( 26%) had dynamic stereopsis, 25 cases ( 64%) static stereopsis left and 4 cases ( 10%) were without any form of stereopsis. The positive rate of dynamic stereopsis was better than the positive rate of static stereopsis, with statistical significance (P<0. 05).
CONCLUSION: Dynamicstereopsis is better than the static stereopsis to intermittent exotropia children.

Objective:To evaluate the stability and bio-safety of warming moxibustion gel-unguentums( WMG) . Methods: With the commercially available package and at 40℃ ± 2℃, RH (75% ± 5%) for six months,the stability of WMG was inspected. Guinea pig skin sensitization test, rabbit skin irritation test and cell toxicity test were used to investigate the safety. Results:Compared to the results of 0 month, there was no difference in the sample character, containing paste percentage, adhesion, shape, weight difference and all theindices in TLC identification. Cell toxicity test showed that WMG had slight cytotoxicity. Guinea pig skin sensitization test and rabbit skin irritation test indicated that the grade of skin reaction was zero and the primary stimulus index of skin tissues was also zero. Conclusion:The quality of WMG is stable and the production preparation technology is feasible. Moreover, it is safe in transder-mal administration.

OBJECTIVE: To study the effects of Anxin Granules on dyslipidemia in rabbits caused by high fat plus high cholesterol diet. METHODS: Thirty-two healthy New Zealand male white rabbits were randomly divided into 4 groups: normal control group, untreated group, Zhibituo Tablet-treated group and Anxin Granule-treated group. Rabbits in the normal control group were fed with regular chow, while rabbits in the other three groups were fed with high fat plus high cholesterol diet. Zhibituo Tablets and Anxin Granules were administered to the rabbits in Zhibituo Tablet-treated group and Anxin Granule-treated group at a daily oral dose respectively. At the end of the 10th week, the levels of serum total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein A(1) (ApoA1) and apolipoprotein B (ApoB) were tested in each group, and the ultrastructures of the aorta were also observed by an electron microscope. RESULTS: Anxin Granules could reduce the levels of TC, TG, LDL-C and ApoB. The results observed by electron microscope showed that, as compared with the untreated group and the Zhibituo Tablet-treated group, the atherosclerosis of aorta in the Anxin Granule-treated group was lighter. And it was found that there were few lipid droplet vacuoles in cytoplasm of the endothelial cells, and various cell organs and elastic membrane were existed, but no lipid droplet vacuoles in cytoplasm of the medial smooth muscle cells. CONCLUSION: Anxin Granules can regulate the metabolism of blood lipid and inhibit the formation of atherosclerosis caused by hyperlipidemia in rabbits.

Aspergillosis, Allergic Bronchopulmonary ; diagnosis ; drug therapy ; Child ; Humans ; Male