达芬奇手术系统安全性和有效性的快速评估

Safety and Effectiveness of Da Vinci Surgical System: A Rapid Review

目的快速评估达芬奇手术系统与传统手术方法的有效性和安全性,为卫生政策制定者和临床工作者提供当前可得的最佳决策证据。方法计算机检索EMbase、PubMed、h e Cochrane Library、Web of Science、CNKI、VIP、CBM、WanFang Data以及专业卫生技术评估(HTA)相关网站,检索时限均为从建库截至2012年10月9日。由2位研究者按照纳入与排除标准独立筛选文献、提取资料和评价质量后,基于二次研究的数据采用定性描述方法报告研究结果,并根据再评价结果做出最终推荐意见和推荐强度。结果共纳入21个研究,包括HTA 7篇和系统评价/Meta分析14篇,涉及手术主要有前列腺根治术、子宫切除术、肾切除术、冠状动脉旁路移植术和胃底折反术。HTA和系统评价/Meta关注的疾病不同,但结果均显示达芬奇手术系统针对不同疾病的临床有效性和安全性结果有所差异。与传统手术方法相比,达芬奇手术系统虽延长了手术时间,但可缩短住院时间、降低手术过程中的转换率、失血量和输血率;与传统腹腔镜手术相比,达芬奇手术系统可缩短手术时间和住院时间,降低手术过程中的转换率、失血量和输血率。结论现有证据表明,达芬奇手术系统针对不同疾病的临床有效性和安全性结果不一致。基于纳入的HTA和系统评价/Meta分析都缺乏前瞻性随机对照试验,大多数研究基于观察性研究,证据质量不高,决策者应综合证据情况审慎决策。

Objectives The primary objectives of this rapid health technology assessment （RHTA） were to assess the safety and effectiveness of Da Vinci surgical system compared with traditional e surgeries, so as to provide the currently-available best evidence for health decision makers and clinical workers. Methods A comprehensive search of electronic databases （EMbase, PubMed, The Cochrane Library, Web of Science, CNKI, VIP, CBM and WanFang Data） and relevant professional HTA websites were conducted from inceptionto October 9, 2012. Two reviews independently screen literature according to the inclusion and exclusion criteria, extracted data, and assess the quality of included studies. The data based on secondary studies were reported, and a final recommendation and its level was made based on assessment outcome. Results A total of 21 studies were included, encompassing 7 HTAs and 14 systematic reviews/metaanalyses. The included studies involved radical prostatectomy, hysterectomy, nephrectomy, coronary artery bypass graft, and gastric fundoplication. Though the included HTAs and systematic reviews/meta-analyses focus on different diseases, the outcomes showed significant differences existed between Da Vinci surgical system and other routine surgery in clinical effectiveness and safety of different diseases. Compared with routine surgery, Da Vinci surgical system shortened hospital stay; decreased operation conversion rates, blood loss and blood transfusion rates during surgery; but it increased operative time. Besides, compared with traditional laparoscopic surgery, Da Vinci surgical system shortened operation time and hospital stay, and decreased operation conversion rates, blood loss and blood transfusion rates during surgery. Conclusion Current evidence shows that the clinical effectiveness and safety outcomes of Da Vinci surgical system differ in diseases. Currently, most included HTAs and systematic reviews/meta-analyses are based on observational studies,relevant prospective randomized controlled trials lack, and the evidence is graded as low quality, health decision makers are suggested to apply this evidence with caution on the basis of comprehensive consideration.