随着我国创新药品器械研发能力的不断提高,开展医疗器械临床试验的项目数量也在不断增多.医疗器械临床试验是验证器械安全性的重要环节,其结果的可靠性直接关系到器械上市后的安全,而临床试验的质量是临床试验的关键.通过对医疗器械临床试验各环节的质量风险因素进行规划、识别与评估,并探讨了降低风险的应对措施,建立完善医疗器械风险管理质量体系,实现临床试验全过程质量管理.

通过了解某医院药物临床试验保险购买情况,分析药物临床试验损害赔偿的归责原则及赔付的主体,建议通过强化伦理审查、临床试验管理和研究者GCP培训,完善临床试验保险制度,降低临床试验的风险,保障受试者的安全和合法权益等措施,希望对规范医疗产品临床试验研究发挥作用.

药物临床试验是新药研发过程中的重要环节,加强质量控制与完善质量保障体系是提高试验质量的最有效的方法.本文应用PDCA循环法,并结合机构日常质量管理工作对临床试验数据记录缺陷展开专项质量控制,监测数据变化,分析本院药物临床试验中数据记录存在的问题,并结合实际情况提出解决办法和相应对策,进行PDCA循环管理.通过采取有针对性的措施包括制定相关制度、强化培训、加强机构及监查员的监管职能、提高研究者对质量控制的意识等,进一步提升药物临床试验数据记录质量.PDCA循环在药物临床试验数据记录的质量控制中至关重要,其使药物临床试验质量显著提高.

[目的]探讨我院医护人员对临床试验的认知情况和对教育需求情况,为我院药物临床机构制定培训政策提供依据.[方法]随机抽取我院25个临床试验资质料室医护人员200名医护人员进行问卷调查,回收问卷180份,回收率为90％.问卷内容主要包括人口学信息、临床试验知识认知情况、参加临床试验培训情况.[结果]比较我院参加培训组与未培训组医护人员基本得分情况,培训组医护人员在临床试验基本知识、伦理学知识、质量控制得分高于未培训组,差异均有统计学意义(P＜0.05);对医护人员基本得分情况进行多因素分析发现,基本知识得分情况影响因素主要有职称、学历、是否接受过培训,其中参加过相关培训、学历较高、职称较高的医护人员临床试验基本得分较高.[结论]我院医护人员对临床试验的认知水平不高,加强对医护人员培训可以提高对临床试验的认知水平,加强师资队伍建设,探索临床试验资格管理和将临床试验纳入医护人员职称评审体系,是提高医护人员对临床试验认知程度的有效措施.

Guided by good clinical practice ( GCP) , M hospital cooperated with the Ethics Committee in quali-ty management of clinical trials and took the specific measures including perfecting the institution and standard op-erating procedures, implementing three level quality control institution, strengthening the training of GCP, and closely cooperating with drug and data management of clinical trials, quality control in the clinical trial, ethical re-view and supervision, quality control in the whole process (seamless connection). Seamless connection from the beginning of project acceptance and quality control in the whole process of clinical trials can effectively solve the ex-isting problems in clinical trials and improve the quality of clinical trials.

本文结合工作实际，从临床科研、临床伦理、循证医学、医务人员服务理念等方面阐述医疗机构开展临床试验在医疗和科研中的作用。

按照JCI标准,通过建立不良事件管理小组和健全不良事件的管理机制,从不良事件的记录、处理、上报分析、追踪随访管理等环节对不良事件进行规范的管理,促进持续的质量改进,最大限度的保障受试者的安全和权益.并结合作者工作经历,对本院在JCI评审中对临床试验中不良事件的管理具体做法进行探讨和总结.

药物临床试验是新药研究开发过程中的重要环节，其质量水平直接影响到医疗质量及用药者的生命安全。因此《药物临床试验质量管理规范》的严格执行尤为重要，本文对药物临床试验的内容进行分析探讨，阐述了我国药物临床试验的现状，并针对药物临床试验存在的问题提出若干对策，倡导提高药物临床试验质量。

近些年来，随着我国医学科研得到了突飞猛进的发展，也伴随着愈多的伦理问题不断出现。其科学与伦理之间也存在着各属性、变革速度、评价标准都不尽相同。医学伦理主要起到的作用是告诉人们，什么样的医学科研行为是应该做的，什么样的医学科研活动是恶的。同时，在医学科研中，也应该把握医学伦理观，充分体现出两者的辨证关系。

In the process of drug clinical trials,it is necessary to give full guarantee of personal rights of the subjects,and ensure the scientific nature and reliability of the test.Ethics committee and informed consent are the main measures to safeguard the rights and interests of the subjects.In order to protect the clinical trial subjects' rights and interests,it should set up an independent ethics committee,and put on records in the State Food and Drug Administration.In this paper,the authors also introduced the construction and records,standard business,existing problems and solving countermeasures in a hospital ethics committee.

目的比较新型EBM教学方案与传统EBM教学方案的教学效果,为探索新疆evidence-based medicine(EBM)普及的方法,构建新疆EBM普及教育管理制度提供依据.方法从新疆14个地区中随机抽取4个地区,分别随机划分实验组169位和对照组167位学员,进行EBM培训,实验组采用新型EBM教学方案;对照组采用传统EBM教学方案.培训结束后,对全部学员进行问卷调查,统计分析数据,比较两组差异.结果两组学员能力相比,在提高认知(x2=6.870,P=0.009)、文献检索(x2=22.670,P=0.000)、医患沟通(x2=6.288,P=0.012)和科研(x2=4.667,P=0.031)能力方面的差异具有统计学意义,在提高诊疗能力(x2=0.663,P=0.426)方面的差异无统计学意义;两组考试成绩相比,概论、病因、诊断、系统评价章节和总成绩差异有统计学意义,新型EBM教学方案优于传统EBM教学方案,在治疗和预后章节成绩差异不具有统计学意义.结论新型EBM教学方案能够很好地训练学员在认知、文献检索、医患沟通及科研方面的能力,提高学员对EBM理论掌握程度,对新疆EBM推广普及起到一定的推动作用.

Ethical significance of clinical research is drawing increasing attention both at home and abroad.Combined with practical work of hospital ethics,this paper discusses the construction of hospital ethics committee from the mode of ethics committee's work,standardization process(SOP),file management and team construction and other relevant aspects.Written documents and specification files are essential in the work of hospital ethics committee,in order to improve the normative operation of hospital ethics committee.A perfect regulation of ethics review system should be established,in order to guarantee the procedural operation of hospital ethics committee.

In the teaching process of nursing ethics,there are two issues arousing teachers' attention and worth discussing.The first issue is to lead the students to discuss the identity status of nurse,define a proper orientation of this specific occupation in order to help the nursing students themselves to have a comprehensive knowledge and cognition of the profession they are going to engage in.The second one is to emphasize understanding of the definition of respect.

This paper describes the role,method and experience,and working model of medical ethics in large-scale hospitals,and holds that the modern hospital management mode has transformed from scientific management to humanism-based management,whose essence is the transformation of managing concept,and the embody of management ethics and management culture.Important connotations and primary task including employing virtue in hospital management,obeying legal regulations in medical practice,and conducting humanistic medicine should be emphasized and concerned in hospital management.

In this paper,a unique case of organ transplantation was inspected by organ transplant ethics committee,through which we try to investigate the mode of current operation,problems and confusion of organ transplant ethics committee in China by the constitutive principles,inspection scope,process,content,especially the functional authority and other relevant contents of hospital ethics committee.

Informing is an initiative behavior of medical staff in their clinical practice.Besides,informing is a key principle of informed consent.The number of cases of infringing upon patient's informed consent is increasing because of the underestimate or ignorance of the obligation of informing.This paper discusses the concept,significance,content,and procedure of informing as well as the relationship between informed consent and informing.

Objective: To assess the dose-related blood pressure lowering efficacy of eplerenone for essential hypertension. Methods: According to the Cochrane reviewer's handbook, included studies were randomized controlled trials of eplerenone versus placebo. Electronic search was applied to the Cochrane Library CENTRAL published in the latest issue (2005,1), PubMed, Medlime,Embase,Ovid, Medscape, TRIP, CBM, NRR. Published and unpublished papers, including cardiovascular and hypertension journals and meeting abstracts were searched manually. Date were extracted by two independent reviewers extracted data. Trials were assessed for quality. Revman 4.2.7 software developed by the cochrane collaboration was used for meta-analysis. Results: Nine related articles were identified, but only three with patients were eligible and were included in the systematic review. All articles were high quality, from developed countries. Eplerenone 100 mg/d compared with placebo for clinic systolic BP, WMD=-9.17,95%CI(-10.62, -7.72 ), P0.01;for clinic diastolic BP, WMD=-3.94,95%CI(-4.67,-3.20), P0.01. Conclusions: Eplerenone 100 mg/d are well effective in reducing BP. Further large randomized, double blind, placebo-controlled trial are needed in long-term efficacy of eplerenone because measured outcomes are insteaded end-point outcome.

Objective To assess the efficacy of eplerenone by comparing with other classes of antihypertensive drugs for primary hypertension.Methods According to the Cochrane reviewer's handbook, included studies were randomized controlled trials of eplerenone versus other classes of antihypertensive drugs. Electronic search was applied to CENTRAL, published in the latest issue of the Cochrane Library, PubMed, MEDLINE,EMBASE,Ovid, Medscape, TRIP, CBM, NRR. Hand searchs published and unpublished papers, including cardiovascular and hypertension journals and meeting abstracts. Two independent reviewers extracted data. Trials were assessed for quality. A systematic review was made.Results Nine related articles were identified, but only three with patients were eligible and were included in the systematic review. All articles were high quality, from developed countries. Mean changes in DBP and SBP were significantly greater with eplerenone treatment than with losartan treatment in all patients (P0.001). No significant differences in the incidence adverse events of were observed between eplerenone and losartan. Reductions in clinic SBP were similar for both eplerenone and amlodipine.Reductions in clinic DBP were more significant in amlodipine compared with eplerenone (P=0.014). The overall incidence of adverse events was slightly lower than amlodipine. Eplerenone was as effective as enalapril in reducing both SBP and DBP. Withdrawal rates for adverse events and treatment failures were also equivalent.Conclusions Eplerenone was as effective and tolerated as other classes of antihypertensive drugs in the treatment of hypertensien. Further large-scale randomized, double blind, placebo-controlled trial are required in long-term safety and efficacy and different subgroup of eplerenone because measured outcomes are insteaded end-point outcomes and included RCTs are scare.

Objective To assess the efficacy and safety of Eplerenone for essential hypertension. Methods Included studies were randomized controlled trials of Eplerenone versus placebo. Electronic search was applied to CENTRAL,published in the latest issue of the Cochrane Library, PubMed, MEDLINE, EMBASE, CINAHL, OVID, Medscape, TRIP, CBM, NRR. Hand searches published and unpublished papers. Two independent reviewers extracted data. Trials were assessed for quality. RevMan4.2.7 software developed by the Cochrane Collaboration was used for meta-analysis. Results Nine related articles were identified, but only four with patients who were eligible and were included in the systematic review. All articles were of high quality, from developed countries. Eplerenone compared with placebo for clinic systolic BP, WMD=-9.23, 95%CI -10.20～-8.26, P 0.000 01; for clinic diastolic BP, WMD=-4.22, 95%CI -4.90～ -3.54, P 0.000 01; for totle adverse events, OR=0.91, 95%CI 0.53～1.56, P=0.74. Conclusions Based on the review, Eplerenone is well effective and tolerated in reducing BP. Further large randomized, double blind, placebo-controlled trials are needed in long-term safety and efficacy and different subgroups of Eplerenone.