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Objective:To analyze the problems and risk factors of the investigator initiated out-of-range trial, propose countermeasures and suggestions, and provide reference for improving project standardization and quality, and preventing research risks.Methods:Through literature analysis and field research, combined with personal work experience, this study sorted and analyzed the problems in the regulation of out-of-range IIT conducted in hospital, and proposed countermeasures.Results:Through analysis, it was found that the current out-of-range IIT trial in China faces 5 problems: imperfect management regulations, incomplete IIT management organizational system in medical institutions, insufficient scientificity of research protocols, insufficient ethical review, and insufficient research funds.Conclusions:Out-of-range IIT is of great significance in promoting pharmaceutical innovation. Standardized management of such projects requires the efforts of regulatory authorities, medical institutions, and ethics committees, as well as the continuous improvement of researchers' awareness and research capabilities to promote the orderly, high-quality, and rapid development of IIT. Based on the above analysis, this article proposed countermeasures and suggestions: at the national level, summarize practical experience from various regions as soon as possible, improve IIT management regulations and technical guidelines; establishing clinical research and design guidance departments in medical institutions and strengthening scientific review; the ethics committee formulates ethical review standards and processes for out-of-range IIT projects to enhance review capabilities; establish a normalized clinical research training mechanism in hospitals; expand and standardize the channels for IIT funding.
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Objective:In order to strictly prevent academic misconduct, effectively improve the understanding and judgment ability of researchers on medical ethics issues involved in papers, and ensure scientific and standardized research results, strict ethical review is crucial.Methods:It mainly reviews whether the clinical research paper to be submitted has obtained an ethical approval certificate, whether the content of the paper exceeds the scope of ethical approval permission or violates research ethical standards, etc., and establishing a sound paper ethics review mechanism.Results:This paper summarizes the issues, points and considerations of ethical review before submission of clinical research papers, hoping to provide some practical methods and references for the ethical review of clinical research papers in China.Conclusions:Medical and health institutions mostly carry out biomedical research involving humans, and should pay more attention to ethical norms and requirements, educate and guide researchers to strengthen ethical awareness, and improve their attention and judgment ability to medical ethical issues in papers.
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@# Objective To explore the related factors of common postoperative complications after cranioplasty. Methods From November, 2009 to June, 2013, a total of 211 patients after cranioplasty were reviewed. The conventional two-dimensional titanium alloy was used. The incidence of scalp effusion, seizure and spontaneous intracerebral hemorrhage were recorded, and the related factors including gender, age, primary disease, skull defect site, attack time, concomitant hydrocephalus and intraoperative dural damage were analyzed. Results The incidence of these complications was 4.7% (10/211) in total. There were four cases with scalp effusion, five cases with seizures and one case with spontaneous intracerebral hemorrhage. The scalp effusion was related to hydrocephalus (χ2=4.804, P=0.028) and intraoperative dural damage (χ2=7.510, P=0.006). Seizure and spontaneous intracerebral hemorrhage were not related with any factors above (P>0.05). Conclusion The occurrence of postoperative scalp effusion can be reduced by repairing intraoperative dural damage, and dealing with extreme hydrocephalus timely.
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Objective To explore the factors associated with the complications of cranioplasty, infection and local epidural hematoma, such as age, sex, primary disease, skull defect and concomitant hydrocephalus. Methods 211 patients after cranioplasty were reviewed. Re-sults 8 cases (3.8%) complicated one of them, in which 6 cases with local epidural hematoma and 2 cases with infection. The infection was more likely related with the areas of skull defect (P=0.003). No factor was found related with the local epidural hematoma. Conclusion It is necessary to focus the size of the frontal sinus when repairing the the frontal bone, to avoid the screw into the frontal sinus caused infection.
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Objective To investigate the related factors of infection post ventricle-peritoneal shunt and explore some preventive mea-sures. Methods 85 cases after ventricle-peritoneal shunt for normal pressure cranial hydrocephalus were analysed retrospectively. The effect of intensive prevention was observed. Results The overall infection rate was 7%after ventricle-peritoneal shunt. There was significant dif-ference between the patients with or without infection post-operation in some factors, such as preoperative infection (pneumonia, urinary tract infection, intracranial infection, biliary infection);the operator;activities of daily living. It was 9.8%(6/61) under routine aseptic opera-tion, and was 0 (0/24) under intensive management. Conclusion Infection after ventricle-peritoneal shunt is associated with many factors, es-pecially the susceptibility and contact to infection. Intensive management can significantly prevent the infection.
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Objective To investigate the effect of integrin-linked kinase (ILK) on inducing mesenchymal stem cells (MSCs) to neuron stem-like cell in vitro. Methods MSCs isolated from umbilical cord were transfected with plasmid DNA encoding green fluorescent protein (GFP) and GFP-fusion ILK, wild and mutant, respectively;and cultured in serum-free media with basic fibroblast growth factor, epidermal growth factor and B27. It was assessed with the proliferative activity and the efficiency of differentiation into neural stem-like cell. Results MSCs transfected with GFP-fusion wild ILK expressed ILK and kinase-dead mutant ILK stably. The activity of proliferation increased and more of them differentiated into neural stem-like cell, which express CD133 and Nestin validated by PCR and Western blotting, and more of wild than of mutant. Conclusion Integrin-linked kinase may play a positive role in MSC differentiation into neural stem-like cell, which may associate with the activity of kinase.
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Objective To understand the study habits of medical postgraduates in basic cours-es so as to provide references for the reformation of teaching methods. Methods Totally 250 postgra-duates of grade 2010 in our university were investigated with self-made questionnaire. The contents of the questionnaire included basic condition of postgraduates, study methods and suggestions for teaching methods. Rate, percentage and Chi-square test were applied to do statistical analysis. Results Accor-ding to the results of the collected 246 copies of questionnaire, 91.5%(225/246) did not preview lessons before class, 93.5%(230/246) took notes in class, 78.9%(194/246) simply took notes in the book, 60.6%(149/246) preferred more detailed courseware and 27.2%(67/246) reviewed lessons after class. The percentage of simply taking notes in the book of local students (86.5%) was significantly higher than that of army ones (73.2%) (P=0.030), but the percentages of preferring more detailed courseware and reviewing lessons after class of local students were significantly lower than those of army ones (P=0.008, P=0.016). Conclusions The proportion of previewing before class is low among postgrauates. Postgraduates depend heavily on teachers and do not review after class in time. There are differences between local students and army students in taking notes and review habits. It is important to cultivate postgraduates’good study habits.
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@# Objective To investigate the diagnostic and predictive value of spasticity in shunting patients with normal pressure hydrocephalus (NPH).Methods Twenty-three secondary NPH patients who received ventriculo-peritoneal shunt were retrospected. Increased muscular tension were quantified pre and post-shunting by modified Ashworth scale. The dilatated ventricle was measured by Evans' index.Results Four weeks after shunting, spasticity was relieved to some extent on all the identical limbs side of the primary impairment cerebral and 78% cases was improved to zero scale. on the contralateral side limbs, the relieved rate was 86% and 46% cases improved to normal scale. Evans' index improved 35%.Conclusion Increased muscle tonus could be measurement quantified and is readily available and sensitive as a diagnostic criteria in secondary NPH.
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Objective The regulation of neuroendocrine hormones on the innate immune responses remains controversial.This report investigated whether the adrenal-derived hormones directly enhanced the innate immune responses and alternation of main pattern recognition receptors in adrenalectomized rats following blast injury.Methods Bilateral adrenalectomy was performed on Sprague-Dawley adult rats,who inflicted with mild blast wave injury in 7 d later.Peripheral blood leukocyte counting,macrophage phagocytosis,bacterial translocation(BT) in lungs,livers and mesenteric lymph nodes(MLN) were measured and analyzed,and TNF-? level in the lung tissue was detected.The mRNA expressions of scavenger receptor-A(SR-A),CD14 and Toll like receptor-4(TLR-4) were assessed with RT-PCR.Results After blast injury,the number of peripheral leukocytes was decreased(P