OBJECTIVE: To strengthen the risk management in clinical drug trial so as to minimize the risk.METHODS: Based on modern risk management theory as well as the practical condition of the current clinical drug trial,an aggregate analysis was done and some opinions and suggestions were put forward.RESULTS: Under current model,it is objective and inevitable for the risks involved in clinical trial,but which could be reduced or avoided by taking some effective measures such as risk predication,standardization of clinical trial,ADR monitoring etc.CONCLUSION: There is risk in the drug clinical trial and it is necessary to conduct risk management.

Objective To investigate the effect of minocycline on isoflurane-induced hippocampal neuroapoptosis and cognitive dysfunction in aged rats. Methods Forty-five male SD rats were randomly assigned into 3 groups ( n=15): blank control group ( group C) , 1.5% isoflurane group ( group I) and 50 mg??kg-1 minocycline+1.5% isoflurane group ( group M+I) . Minocycline was injected intraperitoneally 12 h before the start of anesthesia for group M+I.Group I and group M+I were exposed to 1.5% isoflurane for 4 h, while group C were exposed to 30% O2-70% N2.At the end of anesthesia, five rats in each group were randomized to analyse arterial blood gas. The other rats in each group were sent back to their home cage until they were fully awake.Fourteen days after anesthesia, Morris water maze was used to assess the cognitive function, and then hippocampi of rats were dissected for detection of the expression of cleaved caspase3, Bax and Bcl-2. Results No difference was found in arterial gas analysis among the 3 groups (P>0.05).Compared with group C, the rats in the group I spent more time locating the platform on the third and fourth training days and the time percentage that the rats in group I spent in the target quadrant was much less (P<0.05).However, these changes were reversed in group M+I (P<0.05).The isoflurane-induced increased level of Bax and cleaved caspase3 and decline of anti-apoptotic factor Bcl-2 were restored by minocycline pretreatment ( P<0.05) . Conclusion Minocycline could attenuate cognitive dysfunction induced by isofluranein aged rats.The mechanism is associated with inhibition of hippocampal neuroapoptosis which is increased by isoflurane.

Aiming at the characteristics of telemedicine service,we summarized our telemedical consultation work during 2006-2008.We believed that telemedical consultation from big hospitals are very important in maintaining physical and moral health conditions and treating severe sickness of grassroots officers and soldiers,it can also play active roles in the construction of basic army unit hospitals.

Objective:To investigate the clinical significance of epidermal growth factor receptor(EGFR),proliferating cell nuclear antigen(PCNA),laminin(LN)and type IV collagen expression in salivary adenoid cystic carcinoma(SACC).Methods:EGFR gene in 78 cases of SACC with complete clinical data was detected by fluorescence in situ hybridization(FISH)technique,the expression of EGFR,PCNA,LN and type IV collagen protein was detected by immunohistochemistry technique(IHC),their correlation with the clin-icopathological parameters was analysed by SPSS 13.00 software.Results:EGFR gene amplification levels(69.2%)was positively related to the ratio of EGFR protein positive expression(7 1 .8%),the expression of EGFR,PCNA,LN and type IV collagen was posi-tively related to the clinical pathological parameters(P<0.05).There was a positive correlation between EGFR and PCNA expression (P<0.05),a negative correlation between LN protein and type IV collagen protein expression(P<0.05).Conclusion:EGFR gene is amplified in SACC.EGFR,PCNA,LN and type IV collagen take part in the occurrence and development of SACC.

OBJECTIVETo evaluate further the nature of HLA-DQB1 alleles association with dermatomyositis/polymyositis (DM/PM).

METHODSHLA-DQB1 typing of 52 patients with DM/PM were investigated by polymerase chain reaction-sequence specific primer method, and the frequencies of HLA-DQB1 alleles were compared.

RESULTSIt was found that the patients with DM/PM had significantly increased frequency of HLA-DQB1*0401(RR=3.56, P=1.79 10(-3), Pc<0.05).

CONCLUSIONThe results suggest that HLA-DQB1*0401 gene contribute to genetic susceptibility to DM/PM.

Adolescent ; Adult ; Aged ; Alleles ; Child ; Dermatomyositis ; genetics ; Female ; Gene Frequency ; HLA-DQ Antigens ; genetics ; HLA-DQ beta-Chains ; Humans ; Male ; Middle Aged

Objective:To improve the quality standard for compound Huanghuai tablets. Methods: The main components of the preparation including Flos Sophorae Immaturus, Radix Scutellariae Baicalensis, Radix Paeoniae Rubra, Radix et Rhizoma Rhei Palma-ti, Rhizoma Imperatae, Caulis Spatholobi, Semen Coicis and Spica Prunellae Vulgaris were identified by TLC qualitatively. The content of rutin in Flos Sophorae Immaturus was determined by HPLC. A DIKMA? Spursil C18 (250 mm × 4. 6 mm, 5 μm) column was used with methanol-0. 2% phosphoric acid solution (45:55) as the mobile phase. The flow rate was 1. 0 ml·min-1 , the detection wave-length was set at 350 nm, the column temperature was maintained at 25℃, and the injection volume was 20μl. Results:The spots in TLC were clear without any interference. The calibration curve was linear within the range of 0. 0116-0. 1859 mg · ml-1 ( r =0. 9999) for rutin. The average recovery was 98. 93% (RSD=1. 14%,n=6). Conclusion: The improved quality standard is sim-ple, specific and reproducible, which can be used for the quality control of compound Huanghuai tablets.

Objective:To explore the enhancement effect of different concentrations of contrast media on blood vessels and hollow organs in CT enterography.Methods:Sixty patients with CT enterography were enrolled from January to August 2019 at Shanghai Ninth People's Hospital, and were prospectively randomly divided into three groups (group A: 90 ml 400 mg/ml contrast media, group B: 90 ml 350 mg/ml contrast media, and group C: 79 ml 400 mg/ml contrast media). Evaluation parameters included CT value, signal noise ratio (SNR) and contrast noise ratio (CNR) of main abdominal vessels (abdominal aorta, superior and inferior mesenteric atery, jejunal artery, ileum artery, superior and inferior mesenteric vein), jejunum, ileum and inflammatory bowel disease. The overall image quality and direct jejunum ileum artery quality scores were evaluated. One-way ANOVA was used to compare the parameters among the three groups.Results:There was no statistical difference in CT value, SNR and CNR of each measurement index among the three groups in plain scan ( P>0.05). The CT value, SNR and CNR of abdominal aorta, superior mesenteric artery, inferior mesenteric artery, jejunal artery and ileal artery in group A and C were higher than those in group B in arterial phase ( P<0.05), but there was no significant difference between group A and group C ( P>0.05). The CT value, SNR and CNR of superior mesenteric vein, inferior mesenteric vein, normal jejunum, ileum and inflammatory lesions in group A were higher than those in group B and C in venous phase ( P<0.05), but there was no significant difference between group B and group C ( P>0.05). The overall image quality scores of group A, B and C were (3.8±0.7), (3.4±0.6), (3.4±0.6), respectively, with no significant difference ( F=3.075, P=0.054). The direct jejunum ileum artery scores of the three groups were (3.5±0.5), (3.1±0.5), (3.4±0.5), respectively, the difference was statistically significant ( F=3.684, P=0.031). Conclusion:At the same injection rate and scanning parameters, contrast media at 400 mg/ml can provide better vessel and hollow organ enhancement.

Objective:To investigate the construction and application of telemedicine system in Tibet Autonomous Region.Methods:From June to July 2020, medical institutions at all levels in Tibet Autonomous Region were visited. Relevant information was collected through discussion, questionnaires and field visits, and the data of effective questionnaires were statistically analyzed.Results:A total of 125 medical institutions were visited, covering 7 regions of Tibet Autonomous Region, of which 74 medical institutions were able to realize audio-video two-way communication with the telemedicine platform of the PLA General Hospital. Seventy-three valid questionnaires were collected, and 64(88%)hospitals had software or hardware audio and video terminals. Twenty-five hospitals had never carried out remote consultation, accounting for 34%. The annual remote consultation amount of 35 hospitals was less than 10 cases, and that of 11 hospitals was 11-100 cases. Only 2 hospitals had carried out remote ECG and remote ultrasound diagnosis, with an annual consultation volume of more than 100 cases.Conclusions:The hospitals at or above the county level in Tibet Autonomous Region have established telemedicine system, but there are few remote services, the system idle rate is high, and the distance education resources are not matched.

Objective:To construct a value evaluation framework for high-value medical consumables,providing a guidance for medical insurance access and hospital access management scenarios in China.Methods:It conducted literature review,qualitative in-terviews and quantitative surveys.A total of 12 experts were invited for qualitative interviews,while 100 experts from four fields of health technology assessment,medical insurance,hospital management,and clinical practice participated in the quantitative survey.Through those process,it generated the composition of the value framework and the scoring of each item.Differences in ratings be-tween different scenarios and experts were analyzed through chi-square tests.The recommendation level for each item was graded.Re-sults:A comprehensive value evaluation framework for high-value medical consumables was established,which included 6 core dimen-sions,comprised 16 items for secondary dimensions and 50 items for tertiary dimensions.It showed significant differences between the medical insurance access and hospital access scenarios,as well as among different fields of experts in the same scenario.furthermore,grading the items in two scenarios.The medical insurance access scenario had 8 highly recommended items,and the hospital access scenario had 24 highly recommended items.Conclusion:Value evaluation should encourage multi-dimensional assessments and inter-disciplinary participation,continually improving the management of high-value medical consumables in medical insurance and hospital access.

Adipose Tissue ; Cadaver ; Humans ; Vertebral Artery