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With the rapid development of clinical trials, the relevant medical research and molecular detection based on biological samples are closely related to the progress of clinical trials, making the role of biological samples in clinical trials increasingly obvious. The standardized supervision mode of biological samples is an important prerequisite for carrying out high-quality clinical trials. Although the laws and regulations related to clinical trials are becoming more and more perfect, there are still a large number of adverse events related to biological samples, which seriously affects the progress and results of clinical trials, and is one of the important challenges currently facing. Therefore, it is urgent to enhance the supervision of biological samples and improve the management methods of biological samples in clinical trials at this stage. Through in-depth discussion of the current status of biological sample management in clinical trials at home and abroad, this paper analyzed the issues existed during the supervision of biological samples, and supplemented the biological sample management methods by further combing the existing relevant laws and regulations and the Guidelines for the Ethical Management of Biological Samples in Clinical Trials, with a view to providing suggestions and ideas for optimizing the management mode of biological samples in clinical trials.
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Objective:Taking into account of the current situation that domestic laws and regulations of medical technology ethics review are not perfect, we put forward practical suggestions on ethical review supervision of the clinical application of new medical technologies from the perspective of standardization.Methods:Referring to the relevant laws, regulations and specific implementation guidelines of ethical review of clinical research, combined with the practical experience of the ethics committee of the host Hospital, this paper systematically summarizes the concept and characteristics and existing problems of new clinical applied medical technology, optimizes the working steps of technology access and ethical review, and establishes an ethical continuing review model.Results:A series of measurements are proposed, which including formulate the access process, improve the management system, optimize ethical review methods, etc. At the same time, pay more attention to the annual continuing review, adverse event report review, suspension/termination of approved research, closure report review, as well as site visit to improve the initiative and efficiency of ethical review. At last, it ensures the continuing of ethical review.Conclusions:It is very important to regulate new medical technology project entry and ethical review supervision in the practice. On one hand, it can effectively make up for the possible shortcomings of current laws and regulations and promote the introduction of new regulatory requirement. On the other hand, it can effectively reduce the medical technology risks and build good medical quality management, improve the system to better safeguard people′s health rights and interests.
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@#AIM: To observe the effects of combined anti-VEGF therapy on neovascular glaucoma.<p>METHODS: A total of 62 patients(68 eyes)with neovascular glaucoma admitted to our hospital from February 2012 to October 2018 were retrospectively analyzed. Group A were given intravitreal injection of anti-VEGF drug(conbercept ophthalmic injection)0.05mL, and complex trabeculectomy was performed 1wk after injection, and total retinal laser photocoagulation was performed 3wk after injection. Cyclocryosurgery was performed in group B. Intraocular pressure(IOP), best corrected visual acuity(BCVA), axial length and postoperative complications of patients in two groups were observed before treatment and 2wk, 1mo, 3mo and 6mo after treatment. <p>RESULTS: The regression degree of iris neocescularization in group A was significantly better than that in group B. IOP at 2wk, 1mo, 3mo and 6mo after surgery in the two groups showed statistical differences(<i>P</i><0.05). There was a statistically significant difference in axial length 6mo after treatment(<i>P</i><0.05). The total effective rate was 94% in anti-VEGF group(group A)and 78% in cyclocryosurgery group(group B), the difference was not statistically significant(<i>P</i>=0.073).<p>CONCLUSION: It is safe and effective for the combined treatment of anti-VEGF drug, combined trabeculectomy and total retinal laser photocoagulation in the treatment of neovascularization glaucoma.
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Objective:To observe the effect of external phrenic nerve electrical stimulation on respiratory function for convalescent stroke patients. Methods:From October, 2017 to July, 2018, 27 convalescent stroke patients were randomly divided into control group (n = 14) and observation group (n = 13). Both groups received routine rehabilitation, while the observation group accepted external phrenic nerve electrical stimulation additionaly. Their ventilation and respiratory muscle strength were measured before and four weeks after treatment. Results:The forced vital capacity (FVC), forced expiratory volume in 1st second (FEV1), peak expiratory flow (PEF), maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) improved in both groups after treatment (t > 5.075, Z = -3.366, P < 0.001), and improved more in FVC, FEV1, PEF and MIP in the observation group than in the control group (t > 0.921, Z = -2.746, P < 0.05). Conclusion:External phrenic nerve electrical stimulation can improve ventilation and inspiratory muscle strength for convalescent stroke patients.
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Objective:To observe the effect of external phrenic nerve electrical stimulation on respiratory function for convalescent stroke patients. Methods:From October, 2017 to July, 2018, 27 convalescent stroke patients were randomly divided into control group (n = 14) and observation group (n = 13). Both groups received routine rehabilitation, while the observation group accepted external phrenic nerve electrical stimulation additionaly. Their ventilation and respiratory muscle strength were measured before and four weeks after treatment. Results:The forced vital capacity (FVC), forced expiratory volume in 1st second (FEV1), peak expiratory flow (PEF), maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) improved in both groups after treatment (t > 5.075, Z = -3.366, P < 0.001), and improved more in FVC, FEV1, PEF and MIP in the observation group than in the control group (t > 0.921, Z = -2.746, P < 0.05). Conclusion:External phrenic nerve electrical stimulation can improve ventilation and inspiratory muscle strength for convalescent stroke patients.
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Normative development of human assisted reproduction technology not only depends on ethics con-sciousness of the employee, effective system guarantee and perfect supervision system but also depends on ethics consciousness of infertile couples. Popularizing the knowledge of reproductive ethics for infertile couples and foste-ring their ethics consciousness is a vital problem of normative development of human assisted reproduction technolo-gy and an effective way to solve the ethical issues of human assisted reproduction technology.
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<p><b>OBJECTIVE</b>To investigate the synergistic antitumor effects of combined use of p14ARF gene and 5-fluorouracil (5-Fu) in pancreatic cancer.</p><p><b>METHODS</b>A human pancreatic cancer cell line PC-3 was transfected with lipofectin-mediated recombinant p14ARF gene, and was then administered with 5-Fu. Cell growth, morphological changes, cell cycle, apoptosis, and molecular changes were measured using the MTT assay, flow cytometry, RT-PCR, Western blotting, and immunocytochemical assays.</p><p><b>RESULTS</b>After transfection of p14ARF, cell growth was obviously inhibited, resulting in an accumulation of cells in the G(1) phase. The proportion of cells in the G(1) phase was significantly increased from 58.51% to 75.92%, and in the S and G(2)/M phases decreased significantly from 20.05% to 12.60%, and from 21.44% to 11.48%, respectively, as compared with those of the control groups. PC-3/p14ARF cells that underwent 5-Fu treatment had significantly greater G(2)/M phase accumulation, from 11.48% to 53.47%. The apoptopic index was increased in PC-3/p14ARF cells from 3.64% to 19.62%. The MTT assay showed p14ARF-expressing cells were significantly more sensitive to 5-Fu (0.01 - 10 mg/L) than those devoid of p14ARF expression (P < 0.01). Western blotting showed p14ARF upregulates p53 expression.</p><p><b>CONCLUSION</b>Combined use of p14ARF gene and 5-Fu acts synergistically to inhibit pancreatic cancer cell proliferation, suggesting a new anticancer strategy.</p>