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.

Objective:To prepare injectable interferon ?-2b(IFN-?-2b) loaded microsphere and develop a long-acting dosage form.Methods: IFN-?-2b loaded microspheres were prepared with poly(lactic-co-glycolic acid)(PLGA) as carrier material by double emulsion(w/o/w) method and solid in oil in oil(s/o/o) method separately.Physical and chemical characteristics of microspheres(mean diameter,morphology and drug entrapment efficiency) were evaluated;the in vitro release behavior and influencing factors of the microspheres were determined by micro-BCA(bicinchoninic acid) method;and IFN-?-2b stability during encapsulation and in vitro release was evaluated by sodium dodecyl sulfate polyacrylamide gel electropheresis.Results: The 2 types of microspheres produced had good shape and dispersive quality and a drug entrapment efficiency of more than 80%.IFN-?-2b bulk ultrafitration can significantly influence the mean diameter and in vitro release behavior of microspheres prepared by w/o/w method.The accumulated release(within 1 month) of the microspheres prepared by both methods was significantly improved when using PLGA with lower inherent viscosity.SDS-PAGE test showed aggregation of IFN-?-2b with s/o/o method,while there was no difference between the electrophoretic behavior of bulk IFN-?-2b and IFN-?-2b in microspheres prepared by w/o/w method.Conclusion: IFN-?-2b can be encapsulated into injectable microspheres to yield a one-month continuous release by both w/o/w method and s/o/o method.

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.

Background The potential protective effect of ischemia postconditiomng for hypoxia has been determined in many tissues and organs.But its mechanism in retina is still lack.Objective The aim of this study was to investigate the protective effect of ischemia postconditioning on retinal ischemia reperfusion injury.Methods Thirty-six health male Wistar rats were randomized into the normal control group,sham group,ischemia reperfusion group and ischemic postconditioning group.Retinal ischemia reperfusion models were induced by elevating the intraocular pressure to 110 mmHg for 60 minutes,and then the ischemic postconditioning was performed right away,1 minute and 10 minutes after ischemia in the rats of the ischemic postconditioning Ⅰ,Ⅱ,Ⅲ group,respectively.Electroretinogram (ERG) was recorded in the rats 7 days after operation,and the rats were sacrificed by excessive anesthesia.Retinal specimens were prepared for the histopathological examination.The retinal thickness and the recovery rates of ERG a,b waves and oscillation potentials (OPs) were compared among the groups using ANOVA of SPSS software.Results One day after experiment,the structure of rat retinas was nearly normal.However,retinal edema and vacuolar degeneration were seen in the rats of the ischemia reperfusion group and ischemic postconditioning Ⅰ,Ⅱ,Ⅲ groups primarily in the inner plexiform layer (IPL),inner nuclear layer (INL).The retinal thickness values of the entire layer,IPL and INL were significantly higher in the ischemia reperfusion group and ischemic postconditioning Ⅰ,Ⅱ,Ⅲ groups compared with the normal control group (all at P＜0.05).Seven days after experiment,the retinas were thinner in the rats of the ischemia reperfusion group than those of the rats in the sham group,but the retinal thickness values in the ischemic postconditioning Ⅰ,Ⅱ,Ⅲ groups were significantly increased in comparison with the ischemia reperfusion group (all at P＜0.05).In addition,the recovery rates of ERG a,b,OPs amplitudes were significantly lower in the ischemia reperfusion group and ischemic postconditioning Ⅰ,Ⅱ,Ⅲ groups compared with the normal control group (all at P＜0.05).However,the recovery rates of ERG a,b,OPs amplitudes evidently elevated in the ischemic postconditioning Ⅰ,Ⅱ,Ⅲ groups in comparison with the ischemia reperfusion group (all at P＜0.05).Conclusions Ischemia postconditioning can protect the structure and function of retina from ischemia reperfusion injury.Ischemia postconditioning plays the maximal effect immediately to 1 minute after ischemia reperfusion injury in Wistar rat.

Abstract? AlM: To explore the effect of Danshen injection iontophoresis combined with lumbrukinase on early patients with retinal vein occlusion ( RVO ) , and observe the prognosis to provide objective basis for clinical?METHODS: Eighty-two patients ( 117 eyes ) with early RVO were randomly selected in our hospital from January, 2011 to April, 2014, 41 cases (59 eyes) of control group treated with Lumbrokinase. Forty-one cases ( 58 eyes) of the observation group, treated with Danshen injection iontophoresis combined with lumbrokinase. The main indexes were the treatment effect, visual acuity and retinal circulation time.?RESULTS: The total effective rate of the observation group was 85. 4% ( 35/41 ), more than that of control group 68. 3% ( 28/41 ), the difference was statistically significant (P<0. 05). The invalid rate of the observation group was 14. 6% (6/41), lower than that of the control group 31. 7% ( 13/41 ), the difference was statistically significant (P<0. 05). The vision of the observation group 4. 8 ~5. 0 was 53. 7% (22/41), more than that of control group 41. 5% ( 17/41 ), the difference was statistically significant ( P < 0. 05 ). The restore vision of the observation group 4. 3 ~ 4. 7 was 31. 7% (13/41), lower than that of the control group 41. 5% ( 17/41 ), the difference was statistically significant ( P<0. 05 ). After treatment, retinal circulation time of two groups were lower than before treatment, the difference was statistically significant (P<0. 05). After treatment of retinal vein circulation time of the observation group was 8. 15 ± 1. 30s, 9. 70 ± 1. 28s lower than that of the control group, the difference was statistically significant (P<0. 05).?CONCLUSlON: There is better effective on Danshen injection iontophoresis combined with Lumbrokinase for early retinal vein occlusion, and can improve the patient's visual acuity, promote the rehabilitation of patients.

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.