Objective:To investigate the current situation of damage compensation for subjects in drugs clinical trials.Methods: Retrospective analyzes was conducted on 70 drug clinical trail from January 2008 to December 2014 in our hospital , including protocols、informed consent and insurance .Results: It was written in most proto-cols that sponsor undertook damage compensation due to experimental drugs , however , lack of detailed rules .Dam-age compensation for subjects was missed in some informed consents .17 drugs clinical trials provided insurance , the rate of jointing insurance 24 .3%.In international trail , the rate of jointing insurance ( 100%) was higher than that in domestic trail (9.1%).As to domestic trail, the rate of jointing insurance increased gradually .There was no difference between insurance of different periods .In 17 insurance , 13 were clinical trial liability insurance , oth-ers were product and general liability insurance;5 provided insurance instruction , only insurance certificate or poli-cy in others;2 insurance applied foreign language .Conclusion:Through project access system , strengthening the ethical approval , strengthening quality management to prevent the damage occurred , participants damage happened after fully protect the health and rights and interests of the subjects , and actively promote clinical trial insurance to perfect our subjects′damage compensation mechanism , the protection of the rights of the subjects , and reduce the risk of clinical trials .

Objective To investigate the expression of FOXO3a and MMP 9 in colorectal cancer tissues and their relationship . Methods Tissue microarray and immunohistochemical SP methods were used to detect the expression of FOXO 3a and MMP 9 in 78 cases of colorectal cancer tissues and 69 cases of corresponding normal intestinal mucosa tissues ,then analyze the relation be-tween their expression and the clinicopathologic parameters of the patients ,and the relation between the expression of FOXO3a and MMP 9 .Results (1)The positive expression rate of FOXO3a in 78 cases of colorectal cancer tissues and 69 cases of normal intesti-nal mucosa tissues are 57 .69% (45/78)and 95 .65% (66/69) ,the positive expression rate of MMP 9 in 78 cases of colorectal cancer tissues and 69 cases of normal intestinal mucosa tissues are 85 .90% (67/78) and 15 .94% (11/69) ,and the difference is significant (P=0 .000) .(2)The decreased expression of FOXO3a and the increased expression of MMP 9 in colorectal cancer are significantly correlated with the depth of tumor invasion ,tumor histological differentiation ,metastasis of lymph node and TNM stage (P<0 .05) ,but there is no significant relationship with patients′age ,gender and tumor size (P>0 .05) .(3)There was a negative corre-lation between the expression of FOXO3a and MMP 9 (r=0 .272 ,P<0 .05) .Conclusion The decreased expression of FOXO3a and the increased expression of MMP 9 may be closely related with carcinogenesis ,invasion and metastasis of colorectal cancer ,and their combination may be an important indicator to evaluate the malignant degree and prognosis of the colorectal cancer .

Objective:To investigate the improvement in antibiotics use in our hospital by comparing the prophylactic application of antibiotics in type I incision before and after antimicrobial drug special rectification. Methods:The medical records of 100 hospital-ized patients undergoing I incision respectively from May to December in 2011 (before the rectification), from May to December in 2012 ( during the rectification) and from May to December in 2013 ( after the rectification) were withdrawn randomly. The prophylactic application of antibiotics was statistically and comparatively analyzed. Results: After the antimicrobial drug special rectification, the prophylactic application rate of antibiotics was reduced from 100% to 28%, and in 7 kinds of operations stressed by the National Health and Family Planning Commission ( inguinal hernia repair, thyroid disease, breast disease, arthroscopy, carotid endarterectomy, skull tumor resection and endovascular interventional diagnosis) , the prophylactic use rate of antimicrobial drugs was reduced to 11%. The variety choice of antibiotics in type I incision was more reasonable. The irrationality rate of medication time and course was de-creased obviously, and the accuracy of dosage and usage was improved significantly. The combination of antibiotics was also notably decreased. Conclusion:The antimicrobial drug special rectification is effective, which can significantly improve the prophylactic appli-cation rationality of antibiotics for type I incision in our hospital.

With the increasingly strengthening of economic globalization and higher education internationalization,medical imageology as an important intersecting science in life sciences has more and more international communion and cooperation.In China many hospitals and medical colleges require large quantities of medical imageology professionals,and it is very necessary and important to develop the bilingual education in medical imageology,though a series of problems appear in the process.

The developing situation of "big image" makes the medical imaging become an increasingly huge and complicated system.It offers higher request to the medical imaging teaching.The internship of last term is always influenced by attending the graduate student's entrance examination and looking for job,the effect of teaching can't be assured,and it especially important to do well in field trip,thus it can reduce or avoid the phenomenon of "practice after graduate".

Objective: To investigate the association between the family relationship of college students in Shanghai and the psychological stress response under the COVID-19 epidemic. Methods: Totally 904 college students from universities in Shanghai were investigated with questionnaire of FACESII-CV and IES-R. Results: The score of family relationship intimacy was(61.32±6.29), the score of family relationship adaptability was(43.30±5.83), the score of psychological stress was(30.77±7.33), the score of internal dimension，avoidance, high alertness were(11.63±2.53)(11.69±2.64)(7.45±2.33). About 77.5%(701) and 17.3%(156) of college students showed mild and moderate stress reactions. Three dimensional scores of psychological stress response and two dimensional scores of family relationship differed significantly by age, grade, family income and parental education(P<0.01). Moreover, family relationship intimacy and adaptability scores showed negative associations with intrusive symptoms, avoidance symptoms, and high alert symptom dimension scores(P<0.05). Conclusion College students showed mild psychological stress under the COVID 19 epidemic with intrusion and avoidance symptoms as the most common. The intimacy and adaptability of family relationships are negatively associated with psychological stress response of college students under the epidemic. High-quality family relationships can reduce the psychological impact and adverse effects of the new crown epidemic on college students.

PURPOSE: This study is intended to investigate the effects of plants or plant-derived antioxidants on prevention of osteoporosis through the maintenance of reactive oxygen species (ROS) at a favorable level. MATERIALS AND METHODS: In this study, a novel antioxidant, namely 3,4,5-Trihydroxy-N-[4-(5-hydroxy-6-methoxy-pyrimidin-4-ylsulfamoyl)-phenyl]-benzamide (ZXHA-TC) was synthesized from gallic acid and sulfadimoxine. Its effect on osteoblast metabolism was investigated via the detection of cell proliferation, cell viability, production of ROS, and expression of osteogenic-specific genes including runt-related transcription factor 2 (RUNX2), bone sialoprotein (BSP), osteocalcin (OCN), alpha-1 type I collagen (COL1A1), and osteogenic-related proteins after treatment for 2, 4, and 6 days respectively. RESULTS: The results showed that ZXHA-TC has a stimulating effect on the proliferation and osteogenic differentiation of primary osteoblasts by promoting cell proliferation, cell viability, and the expression of genes BSP and OCN. Productions of bone matrix and mineralization were also increased by ZXHA-TC treatment as a result of up-regulation of COL1A1 and alkaline phosphatase (ALP) at the early stage and down-regulation of both genes subsequently. A range of 6.25x10(-3) microg/mL to 6.25x10(-1) microg/mL is the recommended dose for ZXHA-TC, within which 6.25x10(-2) microg/mL showed the best performance. CONCLUSION: This study may hold promise for the development of a novel agent for the treatment of osteoporosis.
Alkaline Phosphatase/metabolism ; Bone Morphogenetic Proteins/pharmacology ; Cell Differentiation/*drug effects ; Cell Proliferation/*drug effects ; Collagen Type I/genetics ; Core Binding Factor Alpha 1 Subunit ; Down-Regulation ; Gallic Acid ; Osteoblasts/*drug effects ; Osteocalcin/metabolism ; Osteogenesis/drug effects ; Osteoporosis/*prevention & control ; Reactive Oxygen Species ; Up-Regulation

Objective To conduct data mining of asthma-inducing medications in underage populations based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,so as to provide reference for the clinical application of related medications.Methods Adverse drug event(ADE)reports from the first quarter of 2013 to the fourth quarter of 2022 in the FAERS database were collected and screened for reports of asthma adverse events in the this population(under 18 years old),which were categorized into infants,toddlers,children,and adolescents according to different age groups,and were subjected to medication signal mining by using the reporting odds ratio method,the composite standardized method,and the information component method.Results A total of 1 915 reports were obtained after screening,involving 1 042(54.41％)males and 831(43.39％)females;the highest percentage of the reporting population was between 12 and under 18 years old,with a total of 762(39.79％);60.78％of the reports were reported by health professionals;and the results of the clinical referrals showed that serious adverse events occurred in 85.90％of the cases.306 suspected drugs were screened,52 drugs were determined to be valid signals,and 1 044 adverse events were reported,of which 16 drug inserts did not mention the risk of asthma,in order of elosulfatase alpha,canakinumab,tobramycin,vancomycin,ceftriaxone,cetirizine,phenylephrine,imiglucerase,cefuroxime,betamethasone,atropine,tadalafil,riscovastatin,cyclophosphamide,octreotide,and omeprazole.Conclusion The FAERS database was mined for adverse drug event signals and evaluated using the proportional disequilibrium method to identify 16 medicines that may trigger pharmacogenetic asthma and are not documented in the specification,which can be used to provide a good early warning for the clinic.At the same time,focusing on special populations,strengthening the assessment of lung function before medication and monitoring during and after medication,timely interventions were taken to reduce the harm of drug-derived adverse reactions and ensure the safe use of medication.

Objective Based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,data mining was conducted on hematological adverse events related to antibody drug conjugates(ADC),providing reference for the safe use of ADC drugs in clinical practice.Methods The report data from the third quarter of 2011 to the fourth quarter of 2022 were retrieved from the FAERS database.After data cleaning such as deduplication and name standardization,extract hematological adverse events related to ADC,and use report odds ratio method and the information component method for signal detection.Results A total of 101 610 adverse event reports were extracted,with 8 ADC drugs as the primary suspected drugs,and 5 768 ADC related hematological adverse event reports.Among them,3 423 cases of agranulocytosis were involved,and the signal intensity from strong to weak were sacituzumab govitecan(SG),gemtuzumab ozogamicin(GO),brentuximab vedotin(BV),polatuzumab vedotin(PV),enfortumab vedotin(EV),trastuzumab deruxtecan(TD),inotuzumab ozogamicin(IO)and ado-trastuzumab emtansine(TDM-1).There were 2 327 cases hematopoietic cell deficiency,with signals ranging from strong to weak were IO,SG,BV,EV,PV,TD,TDM-1,and GO.Report with clinical outcome of death of ADC drug related hematological adverse events included BV 179(16.84％),TDM-1 102(13.01％),TD 88(27.08％),GO 12(16.90％),IO 8(11.59％),EV 54(24.32％),PV 22(27.16％),and SG 84(21.05％).Adverse event time analysis showed that the number of events on the first day of TD,IO,and SG medication accounts for ≥ 40％of the total number of cases.The median time of hematological adverse events in TD,GO,IO,EV,PV,and SG was within one treatment course(21 days).Conclusion Attention should be paid to the risk of ADC drug-related hematological adverse event,during the clinical medication process,blood cell count changes should be closely monitored,and any abnormalities should be promptly diagnosed and treated.

OBJECTIVE To conduct data mining on drugs causing liver failure in underage populations based on the FDA Adverse Event Reporting System （FAERS） database， so as to provide reference for clinical use of related drugs. METHODS The data on reported adverse drug event （ADE） of liver failure in this population （under 18 years old） from the first quarter of 2013 to the third quarter of 2022 were retrieved from the FAERS database for mining and analysis； they were divided into infants（≤1 year old）， young children（＞1-＜6 years old）， children（6-＜12 years old） and adolescents（12-＜18 years old） according to the age. The reporting odds ratio （ROR）， proportional reporting ratio and Bayesian confidence propagation neural network of the proportional imbalance method were used to screen ADE signals. RESULTS A total of 1 051 ADE reports of liver failure were collected from the underage population involving 60 drugs. The highest incidence was found in adolescents （410 cases， 39.01%）， followed by young children （297 cases， 28.26%）. The instructions of 14 drugs did not mention hepatobiliary system injury and liver failure risk， including 31 cases of levetiracetam （2.95%），18 cases of metronidazole （1.71%）， 16 cases of each of topiramate and methylprednisolone （1.52% each）， 12 cases of dexamethasone （1.14%）， 11 cases of tisagenlecleucel （1.05%）， 10 cases of each of ferrous sulfate， metformin and busulfan （0.95% each）， 9 cases of propofol （0.86%）， 8 cases of onasemnogene abeparvovec （0.76%）， 5 cases of each of diphenhydramine and omeprazole （0.48% each）， 4 cases of sebeliesterase α （0.38%）， totaling 165 cases， accounting for 15.70% of the total reported cases. Metformin was contrary to the known liver safety， and E-mail：libingchemical@163.com metronidazole and levetiracetam were new risk signals， which caused more serious clinical outcomes. CONCLUSIONS Fourteen new pharmacovigilance signals which cause liver failure in the underage population are found in this study； the liver function of patients should be closely monitored when using these drugs. Among those drugs， metformin neither undergoes liver metabolism nor has been reported in the relevant literature， and the liver-related ADE caused by metformin deserves further attention. The clinical outcomes caused by metronidazole and levetiracetam are relatively serious and need to be given sufficient attention.