达芬奇机器人手术系统在我国胸心外科应用的科学性和伦理学系统评价  

Science and Ethics in Conducting Cardiothoracic Surgery with Da Vinci Surgical System in China:A Systematic Review

作　　者：李鸿浩[1] 刘雪梅 昝懿恒 文进[1] 黄钢[4] 钱永军[5] 李琰[6] 郑尚维[1] 

机构地区：[1]四川大学华西医院医院管理研究所,成都610041 [2]华西医院华西期刊 [3]华西临床医学院 [4]湛江师范学院,广东湛江524048 [5]华西医院心血管外科 [6]四川大学政治学院,成都610065

出　　处：《中国胸心血管外科临床杂志》2014年第3期380-388,共9页Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

基　　金：国家自然科学基金资助项目(71173054)~~

摘　　要：目的评价达芬奇机器人手术系统(da Vinci Surgical System,dVSS)在我国胸心外科应用的有效性、安全性和伦理性,为其临床应用提供证据。方法检索VIP、CNKI、万方数据库、CBM、国家卫计委官方网站等,PubMed、Cochrane图书馆、Google学术检索引擎、WHO临床试验注册检索平台、ClinicalTrials.gov、中国临床试验注册中心、澳大利亚-新西兰临床试验注册中心、英国ISRCTN,检索时限均为从建库至2014年1月,收集dVSS手术治疗在我国胸心外科疾病的临床研究,用GRADE评价纳入文献质量,对dVSS临床应用有效性、安全性和伦理性的相关指标进行评价。结果共纳入31篇文献,其中病例对照研究4篇,回顾性病例分析27篇,共1 037例胸心外科疾病患者,文献质量均为极低级别。dVSS在胸心外科的适应证包括冠状动脉旁路移植术、瓣膜成形术或置换术、胸部肿瘤切除术等。与开放手术及胸腔镜手术相比,dVSS安全性和有效性较佳,但疾病治疗经济负担较重。dVSS能使患者受益,有助于提高胸心外科医疗水平,该系统适用的科目和主体资格合法,但成熟度有待提升,相关措施有待完善。其在研究、引进及应用方面的伦理存在系列问题有待重视。结论 dVSS在胸心外科临床应用相对安全、有效,但研究质量有待提升;其在胸心外科临床应用的经济性、伦理学研究有待进一步开展。进一步完善dVSS在胸心外科临床应用的相关防范、追责及保护患者措施,并借助现有临床伦理审查平台体系,进行全程伦理监管。Objective To systematically evaluate the effectiveness, safety and ethics of Da Vinci Surigcal System （dVSS） in the field of cardiothoracic surgery, and provide evidence for its clinical application. Methods We searched VIP, CNKI, WanFang Database, CBM, official website of National Health and Family Planning Commission of People＇s Republic of China, PubMed, Cochrane Library, Google Scholar, WHO ICTRP search portal, ClinicalTrials.gov, Chinese Clinical Trial Registration Center, Australian-New Zealand Clinical Trials Registry and ISRCTN to collect clinical trials of dVSS for thoracic and cardiovascular diseases to evaluate its effectiveness, safety and ethics. The search time was from the establishment of each database to January 2014. The quality of included literatures was evaluated by Grades of Recommendations Assessment, Development and Evaluation （GRADE）. Results A total of 31 studies were identified including 4 case control studies and 27 retrospective studies involving 1 037 patients. The quality of included literatures was all very low. dVSS had been widely used in cardiothoracic surgery including coronary artery bypass grafting, valvuloplasty or valve replacement, thoracic tumor resection, etc. Compared with conventional surgery and thoracoscopy, the safety and effectiveness of dVSS was good, while its economic burden was heavier for the patients, dVSS could benefit patients and improve clinical level of cardiothoracic surgery. The disciplines and qualification of dVSS application was legal, but the maturity of its clinical use needed improvement, and relevant measures were required. The ethics in the research, introduction and application of dVSS had some problems which deserved more attention. Conclusions Clinical use of dVSS in cardiothoraeic surgery is relatively safe and effective, but research quality needs to be improved. More studies on the economics and ethics of dVSS are needed in the field of cardiothoracic surgery. Relevant measures of precaution, accountability and patient protectio

关 键 词：系统评价 达芬奇机器人手术系统 科学性 伦理学 心胸外科 

分 类 号：R655[医药卫生—外科学]