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分析了人体器官移植技术临床应用与伦理委员会对43例活体器官移植的医学伦理审查资料,通过研究这些案例的临床情况、供受构成、伦理审查内容和伦理审查结果,分析活体器官移植的伦理审查规范和伦理审查现状,并对目前活体器官移植中存在的伦理问题进行探讨,为规范器官移植伦理审查流程、完善器官移植相关法规制度提出了实质性建议,认为要加强并完善活体器官移植的医学伦理审查,不仅要着眼于相关法律法规和规章制度的修订,更要着眼于医学伦理委员会审查能力的建设和审查方式的探索。 相似文献
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分析讨论了机构伦理委员会方便跟踪审查的优势及审批速度迟滞,审批工作不够规范、专业化,难以避免的利益冲突等不足之处;指出了区域伦理委员会审批速度加快,伦理审查水平提高,有利于统一标准的优势及其对研究实施环境不够熟悉,跟踪审查不够方便和及时的不足之处,认为两者可以互为补充。指出要保证区域伦理委员会能够顺利运转,政府主管部门还应配套和完善相应的法规。明确区域伦理委员会的职能和审查范围,完善管理机制。 相似文献
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伦理审查作为规范研究行为、控制研究风险的重要手段,在医院科研课题临床研究增多和精细化管理面前,遭遇一定的问题与挑战。本文针对首都医科大学附属北京胸科医院科研课题伦理审查中遇到的伦理知识知晓、审查方式选择、样本库伦理及跟踪审查等问题的影响因素和原因进行深入分析,并提出加强委员准入、考核和培训,丰富伦理审查形式,强化与学术审查协同,规范样本库泛知情签署流程,推进伦理追踪审查等相应的解决对策。本文认为准确把握科研课题实施和遵循伦理间的平衡点,确保临床科研健康规范地发展,对提高医院科研课题临床研究的伦理审查质量,完善伦理审查体系,有较强的实用价值。在未来,要结合国际国内及医院的相关标准和实际情况,制定对于临床科研课题的伦理审查规范将是我们下一步的工作重点,并为其他医院开展科研课题伦理审查提供借鉴。 相似文献
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对我国伦理审查现状的思考 总被引:1,自引:0,他引:1
我国伦理审查能力相对薄弱的现状已难以完全满足医疗技术迅速发展及公众知情权的需求,伦理审查存在着伦理委员会的独立性无法得到有效保障、缺乏标准操作规程、持续监管缺失、缺乏信息反馈及伦理审查内容不规范等问题。反思我国伦理审查的现状,应从以下几个方面着手改进伦理审查监管体系:建立独立的伦理委员会、完善伦理审查法律法规体系、加强伦理审查委员会的跟踪审查、增强受试者的监督意识、加强伦理委员会成员的培训及规范伦理审查内容。 相似文献
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目的:了解儿童临床试验伦理审查管理的现状。方法:选取上海市34所三甲医院,就开展涉及儿童的临床试验的资质、伦理委员会基本情况、伦理审查规范的建立情况、临床试验及临床研究伦理审查开展情况进行问卷调查。结果:儿童临床试验伦理审查的规范化管理滞后,医院伦理委员会在儿童临床试验伦理审查的过程中存在不少的问题,如开展儿童临床试验伦理审查的伦理委员会管理要求不一致,不同医院对儿童临床试验伦理审查的要求和遵循标准有差异。结论:应给予儿童临床试验更多关注,对儿童临床试验伦理审查委员会的组建与管理应有特殊要求,建立全面覆盖弱势人群临床试验伦理规范的伦理培训要求,完善儿童临床试验伦理审查的特殊规范准则。 相似文献
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本文对有利于我国伦理审查体系建构的资源进行梳理与分析,认为我国相关政策规章是我国伦理审查体系建构的重要依托但却有滞后性,国际相关伦理准则对于我国伦理审查体系的建构有积极作用却也有其局限性,对国外如美国伦理审查委员会运作监管体系的产生、发展历程的考察,适时适当地"移植"西方研究伦理管制模式与制度具有一定的现实可行性,能够... 相似文献
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Objective: To evaluatel the value of D-dimers in patients with acute aortic dissection (AAD). Methods: This study consisted of 16 patients with AAD and 27 non-AAD patients. Serum D-dimets were measured by Sta-Liatest D-DI immunoturbidimetric assay. Results: D-dimer level was higher (P < 0.001) in patients with AAD(7.91 ± 5.52 μg/ml) than that in non- AAD group(1.57±1.24 μg/ml). D-dimer was positive (>0.4 μg/ml) in all patients with AAD and in 10 control group patients (37%). Among patients with acute AAD, D-dimers tended to be higher in Stanford A than in Stanford B (8.67 ± 4.31 μg/ml vs. 3.24±1.27 μg/ml, P <0.01). D-dimer values tended to be higher in more extended disease(3.84 ± 1.65 μg/ml, 8.57 ± 3.58 μg/ml and 11.87 ± 5.69 μg/ml in thoracic aorta, thoracic and abdominal aorta, thoracic and abdominal aorta and iliacal arteries, respectively, P < 0.05 for both 8.57 ± 3.58 and 11.87 ± 5.69 vs. 3.84 ± 1.65 ). Including the control group into the analysis, we found a sensitivity of 100%, a negative predictive value of 100%, and a specificity of 66% and a positive predictive value of 64% for D-dimer in diagnosis of AAD in our patients with suspected AAD. Conclusion: D-dimer was elevated in patients with AAD. A negative D-dimer test result could be useful in excluding AAD. 相似文献
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Jiageng Zhu Jun Li Ruipeng Ji Jianghao Su Mingshun Shen Zhigang Cao 《南京医科大学学报(自然科学版)》2007,21(2):125-128
Objective: To set up a simple and reliable rat model of combined liver-kidney transplantation. Methods: SD rats served as both donors and recipients. 4℃ sodium lactate Ringer's was infused from portal veins to donated livers,and from abdominal aorta to donated kidneys, respectively. Anastomosis of the portal vein and the inferior vena cava (IVC) inferior to the right kidney between the graft and the recipient was performed by a double cuff method, then the superior hepatic vena cava with suture. A patch of donated renal artery was anastomosed to the recipient abdominal aorta. The urethra and bile duct were reconstructed with a simple inside bracket. Results: Among 65 cases of combined liver-kidney transplantation, the success rate in the late 40 cases was 77.5%. The function of the grafted liver and kidney remained normal. Conclusion: This rat model of combined liver-kidney transplantation can be established in common laboratory conditions with high success rate and meet the needs of renal transplantation experiment. 相似文献
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Tao Ye * Zhi-quan Liu Jian-jun Mu Xi-han Fu Jun Yang Bao-lin Gao and Xiao-hong Zhang Department of Cardiology First Hospital of Xi'an Jiaotong University Xi'an Hanzhong Cardiovascular Institute Hanzhong 《中国医学科学杂志(英文版)》2004,19(4):248-251
Objective To observe blood pressure change with age in salt-sensitive teenagers whose salt sensitivity were determined by repeated testing.Methods Salt sensitivity was determined through intravenous infusion of normal saline combined with volume-depletion by oral diuretic furosemide in 55 teenagers. After five years, salt sensitivity was re-examined and subject blood pressure was followed up. Blood pressure changes in salt-sensitive teenagers were compared to that of non-salt sensitive teenagers over five years.Results After 5 years, the repetition rate of salt sensitivity determined by intravenous saline loading is 92.7%. In teenagers with salt sensitivity on the baseline, both the systolic blood pressure increments and increment rates were much higher than non-salt sensitive teenagers (12.7±12.1 mmHg vs. 2.8±5.2 mmHg, P< 0.01; 12.2%± 12.0% vs. 2.5% ±4.4%, P< 0.001,respectively). There was a similar trend for diastolic blood pressure (8.4 ± 6.4 mmHg vs. 3.7 ± 6.4 mmHg, P = 0.052; 13.2% ±10.6 % vs. 6.8%± 10.1%, P = 0.053, respectively).Conclusions Salt sensitivity determined by intravenous saline loading showed good reproducibility. Blood pressure increments with age were much higher in salt-sensitive teenagers than non-salt sensitive teenagers, especially in terms of systolic blood pressure. 相似文献
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目的:评价使用安心颗粒对急诊经皮冠状动脉介入术(PPCI)术后生活质量的影响.方法:将160例接受PPCI的急性ST段抬高型心肌梗死患者随机分为安心颗粒组(术前顿服安心颗粒8.8g,术后安心颗粒4.4 g/次,每日2次)和对照组(仅接受基础药物治疗).所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀.分别在入院时、出院前1d、出院后180 d时,应用心肌梗死多维度量表(MIDAS)、中文版SF-36评价量表对患者生活质量评分.并观察术后30 d以内的出血并发症、血小板减少症发生情况.结果:入院时和出院前1d,两组患者的心肌梗死MIDAS、SF-36量表评分比较无差异(P>0.05);出院后180 d时,与对照组比较,安心颗粒组MIDAS、SF-36评分明显减低(P<0.05);组内与入院时比较,两组出院前1d、出院后180 d时,MIDAS、SF-36评分均降低(P<0.05).两组患者在随访期间均无大量出血、少量出血、重度和极重度血小板减少症发生,安心颗粒组有4例、对照组有7例发生不明显出血(P>0.05).两组发生轻度血小板减少症的患者数比较无差异(P>0.05).结论:PPCI使用安心颗粒,能改善急性ST段抬高型心肌梗死患者的生活质量,且不增加出血风险. 相似文献
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Jingming Zhu Ningning Hui Xiuhong Jiang Huaxing Zhang Chengzhang Fu 《南京医科大学学报(自然科学版)》2007,21(6):386-389
Objective:To investigate the influences of urapidil and nicardipine on rabbit sinus function,atrio-ventricular node function and hemodynamics.Methods:Thirty-two Angora's rabbits were selected and randomly divided into four groups.U1 group:urapidil 0.25 mg/kg;U2 group:urapidil 0.5 mg/kg;N1 group:nicardipine 10 μg/kg;N2 group:nicardipine 20 μg/kg.All these medicine were administrated within 30 seconds.Measurements were taken before and after the administration of urapidil or nicardipine for the following data:mean blood pressure(MAP),heart rate(HR),sino-atrial conduction time(SACT),maximal sinoatrial recovery time(SNRTmax)corrected sinus node recovery time(CSNRT),index of sinus node recovery time(SNRTI),Wenckebach A-V conduction frequency (WB),and P-R interval.Results:Significant MAP and HR changes were identified in all of the four groups before and after administration of both urapidil and nicardipine.No significant changes could be found in the rest of the parameters.Intergroup analysis showed that SACT and CSNRT of N1 and N2 groups were shorter than those of the U2 group(P<0.01);the MAP decreased(P<0.01)and the HR increased drastically(P<0.01).Conclusions:Neither urapidil(0.25 mg/kg,0.5 mg/kg)nor nicardipine(10μg/kg,20μg/kg)has any significant influence on rabbit sinus function or rabbit atrio-ventricular node function.Nicardipine could be a better choice than urapidil for parafunctional sinus node patients. 相似文献
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Objective:To investigate the gene expression of osteoprotegerin(OPG) and osteoclast differentiation factor(ODF) in the bone tissue of patients with hip fracture due to osteoporosis. Methods:OPGmRNA and ODFmRNA in the bone tissue in 50 cases of osteoporosis sufferers(over 50 years old) with hip fracture(Observer Group) and 30 cases of hip facture sufferers with no osteoporosis(Control group) were analyzed with the Semi-Quantitative RT-PCR method. Results:The mRNA expressed of ODF, OPG were both high in the patients with hip fracture. In the control group, the expression of OPG mRNA was observed, while the expression of ODF mRNA was very slight. Conclusion:Aged patients contained all signals including OPG, ODF that are essential for inducing osteoclastogenesis and promoting bone resorption. 相似文献
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The clinicopathological and immuohistochemical analysis of solid-pseudopapillary tumor of the pancreas: report of 9 cases 总被引:1,自引:0,他引:1
Shaoqin Chen Shengquan Zou Qibao Dai Peisheng Huang Weihua Cai Hong Li 《南京医科大学学报(自然科学版)》2007,21(6):398-401
Objective:To investigate the clinical features, pathological characteristics and immunophenotype of solid-pseudopapillary tumor of the pancreas(SPTP). Methods:Nine surgically treated cases of SPTP were retrospectively reviewed. Hematoxylin and Eosin(HE) staining and immunohistochemical staining were used to analyze all cases, and the general clinical data was collected. Results:Six patients were asymptomatic except for a palpable mass. Two patients complained of vague-epigastric pain. One patient appeared jaundice. The tumor was encapsulated and solid tissues alternately with cystic tissues. Histologically, the histological structure of solid portion was pseudopapillary with a fibrovascular core. Tumor cells were uniform and medium-sized which were arranged in sheets ets or nests or pseudopapillary patterns. Immunohistochemical studies demonstrated that SPTP proved positive in vimentin(9/9 cases), AAT(9/9 cases), NSE(9/9 cases), ACT(7/9 cases), CK20(2/9 cases), CgA(1/9 cases), S-100(3/gcases), PR(4/gcases), Syn(3/9 cases) and CD56(5/9cases), negative in CEA and ER. Conclusion:SPTP is a tumor predominantly occurring in young women frequently without special symptoms. This tumor has various characteristical histological patterns with different immunophenotype. 相似文献
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Scientific principles and rigorous processes should be followed in developing clinical guidelines for therapeutic interventions of integrative medicine
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A clinical guideline for the therapeutic interventions of integrative medicine may be defined as a written document which states a series of recommendations on therapeutic interventions of integrative medicine for a special disease or condition. The guideline may provide assistance to medical professionals in making clinical decisions aimed at improving the clinical outcome of patients and reducing the costs of medical care(~'4~. Recommendations issued by a guideline should be based on the best available evidence in both Western and Chinese medicine. For fulfilling this purpose, the development of clinical guidelines for therapeutic interventions in the field of integrative medicine should follow scientific principles and undergo a rigorous processes. 相似文献
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Objective:To probe into the influence of changes of ovarian hormones on the pathogenesis of the specific sub-type premenstrual syndrome(PMS)and reveal partial microcosmic mechanisms of adverse flow of liver-qi.Methods:Estradiol(E2)and progesterone(P)levels in serum were determined at different phases of menstrual cycle by radioimmunoassay.Results:In the group of PMS with adverse flow of liver-qi.the secretive peak value Of E2 and P at the follicular phase significantly decreased,and the secretive peak value at the luteal phase did not come into being.Conclusions:Low E2 and P secretive peak at the follicular phase and absence of secretive peak at the luteal phase is one of the microcosmic mechanisms of PMS with adverse flow of liver-qi.One of the pathophysiologic mechanisms of specific sub-type PMS is probably the continuous low level of E2and P. 相似文献
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Real-time three-dimensional echocardiography (RT3DE)is a new ultrasound technique that enables dynamic threedimensional visualization and quantification of the heart in real time. Investigation of feasibility and methodology of RT3DE in determining left ventricular (LV) and right ventricular (RV) volumes, RT3DE was performed in 35 normal adults using Philips SONOS 7500 system with a 2-4 MHz matrix array transducer. The 60°×60° "pyramid" volume database was obtained and analyzed on a TomTec echo workstation. Both LV and RV volumes were calculated with four 3DE methods (i.e. apical 2, 4, 8, and 16-plane) through manually tracing ventricular endocardial borders in end diastole and end systole. Stroke volumes were then calculated. LV volume was also measured by 2DE Simpson's rule using GE VIVID 7 ultrasound machine. 相似文献