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

Purpose:To evaluate the Application of Ultrasound Guided Mammotome Minimallay Invasive Biopsy System in diagnosis and treatment of breast masses. Methods:68 breast lesions in 42 patients were performed by Ultrasound Guided Mammotome Minimallay Invasive Biopsy System in order to evaluateits diagnostic and therapeutic ifficacy. Results:40 lesions were diagnosed as fibroadenoma , 19 lesions as fibroadenomatoid hyperplasia, 7 lesions as breast adenosis,2 lesions diagnosed as galactocele in operation but fibre and fat tissue after operation by pathology. 67 lesions were excised by mammotome system. 1 lesion was stopped duete hmorrage,1 case had serious hematoma. 1 case had machine failure but was resolved. The excision times were on the average 28 in every lesion,the lengh of incision is only 3mm,and the duration of operation was 30 minutes. No evidence of recurrence was found by physical examination and the ultrasound evaluation during the follow up 1~6 monthes. Conclusions:Ultrasound guided mammotome minimallay invasive biopsy system excision for benign breast mass was complete and the postoperative breast appearance was satisfactory.

Purpose To investigate the genetic changes of ALK gene in sporadic neuroblastoma in China, and to explore its role in neuroblastoma. Methods Total 56 cases of NB with overexpressed ALK protein were studied by fluorescence in situ hybridization ( FISH) , using interphase Vysis LSI ALK dual-color and break apart rearrangement probes. Literature under the subject was searched through PubMed. Results Of the 56 cases, ALK gain was found in 9 (16%) cases, ALK amplification was found in 1 (1. 8%) case only. No alterations of ALK were detected in the remaining 46 cases. Conclusion As a major predisposition gene as well as a poten-tial therapeutic target for neuroblastoma, the frequency of aberrant copy numbers of ALK gene in Chinese NB patients is closely similar with previously published results.

OBJECTIVE:To observe the therapeutic effect of compound glycyrrhizin combining ursodeoxycholic acid in the treatment of chronic hepatitis B.METHODS:87patients with chronic hepatitis B were enrolled to,on whom,the anti-viral therapy proved to be ineffective and who suffered a long-term abnormal liver functions,of the total,47were randomly as?signed to receive compound glycyrrhizin plus ursodeoxycholic acid(treatment group),and40to receive compound glycyrrhizin plus vitamin C(control group).Course of treatment for both groups was8weeks.RESULTS:As compared with the control group,the liver function and immune function for the treatment group had a better amelioration(P

AIM:To optimize total flavone of herba epimediumon microporosity osmotic pump tablets by boxbehnken design-response surface methodology. METHODS:Osmotic agent (lactose),dosage of plastificator (dibutyl phthalate),and coating weight gain were selected as key factors of influencing total flavone delivery. Total flavones cumulatiive yield in 12 h and fitting approximation was regarded as the response. Design Expert method useful for the modeling and analysis was to optimize the response. RESULTS:Response surface surface obtained repre-sented maximum one which conformed to the zero-order delivery rate equation. CONCLUSION:Optimal excipient formulation of total epimedium flavone microporosity osmotic pump tablet consists of 0. 18 g of lactose,0. 26 ratio of dibutyl phthalate to acetyl celulose and 7. 7% of coating weight gain.

Objective To observe the clinical efficacy of surround electroacupuncture in relieving pain after operation for mixed hemorrhoids. Method Seventy-two patients with mixed hemorrhoids were randomized into a treatment group and a control group, 36 cases in each group. The two groups both received the corresponding interventions once in 15 min after the operation: the treatment group received electroacupuncture treatment, and the control group was only placed in a simulated environment of electroacupuncture but without receivimg any needling treatment. The pain intensity was evaluated by using Verbal Rating Scale (VRS), Wong-Baker Faces Pain Rating Scale, and Visual Analogue Scale (VAS) at 11 different time points after the treatment: once every 1 h in 8 h after the treatment, once at the first defecation, once respectively 24 h and 48 h after the treatment. The data were statistically analyzed afterwards. Result At 3 h and 4 h after the treatment and at the first defecation after the treatment, the VRS scores of the treatment group were significantly lower than that of the control group (P<0.05); respectively at 4 h, 5 h, 6 h, 7 h, and 8 h after the treatment and at the first defecation, the Wong-Baker scores of the treatment group were significantly lower than that of the control group (P<0.05); respectively at 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, and 8 h after the treatment, at the first defecation, as well as at 24 h after the treatment, the VAS scores of the treatment group were significantly lower than that of the control group (P<0.05); it indicates that the pain intensity of the treatment group should be lower than that of the control group at the above time points, and the analgesic effect in the treatment group lasts a longer time, running a lower risk of losing effectiveness compared to the control group (P<0.05). Conclusion Real-time acupuncture treatment after the operation is significantly effective in relieving pain after operation for hemorrhoids.

Objective To analyze retrospectively the MR features of MELAS patients,in order to improve the early diagnosis of MELAS.Methods MR data of 1 6 MELAS patients confirmed by clinical diagnose and muscle biopsy were retrospectively analyzed. MR features of plain scan(n=1 6),ASL(n=3),MRA(n=1 5),DWI(n=14)and MRS(n=3)were analyzed.Results MRI data demonstrated brain lesions mainly distributed in posterior cerebral hemisphere extending to subcortical area,which was not consistent with the vascular supply territories.The lesions were observed as low signal on Spin-echo sequence of T1 WI,while high signal on T2 WI, FLAIR and DWI.The focal lesions showed increasing Lac peak on MRS.Fifteen of 16 patients underwent MRA and one showed increased arterial branches in lesion zones.Three patients had ASL scanning demonstrating high irrigation in lesion zones which would wander once relapsed.Meanwhile,old lesions showed encephalatrophy and cerebromalacia.All patients’muscle biopsy pathology showed ragged red muscle fibers.Under electron-microscopic,bioblasts were bigger and more than average level and muscle fibers atrophied.Mitochondrial DNA sequence of 3 patients showed mtDNA A3243G transgenation.Conclusion The DWI,MRS and ASL sequences show good ability in MELAS diagnosis and differential diagnosis.

Objective To detect the changes of the brain white matter microstructure at the acute stage of posttraumatic stress disorder(PTSD)resulting from a single,extreme and long-lasting trauma.Methods DTI scans were performed on 1 7 survivors of coal mine disaster(PTSD group)and 1 7 cases of normal control(control group).The differences of the mean diffusivity(MD)values measured from the whole brain DTI between the two groups were analyzed based on tract based spatial statistics (TBSS).MD data were statistically compared between the two groups based on nonparametric random permutation test(RPT),and the brain areas of significant differences between the two groups were obtained.Results Compared with the control group,MD values were increased in the bilateral rostral corpus callosum body and left precorona radiata,and decreased in the bilateral superior and posterior corona ra-diate,posterior limb of the left internal capsule,left cerebral peduncle and left thalamic.The differences were statistically significant (P <0.01 TFCE-corrected).Conclusion TBSS is a comprehensive and accurate method for evaluate the changes of brain white mat-ter in PTSD cases.TBSS can provide an objective basis of the pathological brain neural structures imaging for early diagnosis and in-tervention of PTSD.

Objective:To study the effect of endoscope on the treatment of Hepatocellular Carcinoma (HCC) combined with biliary tract obstrucition (BTO).Methods:We have analyzed retrospectively the results of twelve patients suffering from HCC combined with BTO from 5,1990 to 5,2000.Among these cases,various reasons were found.5 of them were intrabilitary cancer embolus,7 were billary calculus.7 of them were treated with endoscope and following surgical resection,1 was treated with endoscope、TAE and resection,the 3 rest of them were solely treated with endoscope.Results:Of all the 12 cases,1 died of resection,2 failed to follow the survey,these 3 cases above took 25%;among the rest of 9 cases,2 of them survived for 3 to 6 months,3 for half to 1 year,3 for 1 to 2 year,1 for at least 2 years.Those cases suviving for more than 1 year were received surgical resection.Conclusions:We should have no fixed way but to deal with each patient of HCC combined with BTO on his/her merits.As our recognition towards them began accumulating,we found that,in the early stage of obstruction,active endoscopic treatment would prove to be preferable.If combined with other therapy such as surgical resection and TAE,Endoscopy would improve the curative effect of HCC combined with BTO substantially.

Objective To evaluate the effect of continuity of health education model for patients undergoing bone cancer during the first chemotherapy.Methods This model was designed based on KAP(Knowledge,Attitude or Belief,Practice) theory,literature review and questionnaire and performed in 103 bone cancer patients during the first chemotherapy.Results All the patients were assessed,with the founding that the pass rate of knowledge test,treatment compliance and degree of satisfaction were increased significantly(all P<0.05).Conclusions The health education model could help patients learn knowledge about bone cancer,build health behavior and deal with complications.Additionally,it improves the pass rate of knowledge test,satisfaction, and compliance.