Yamazaki Shintaro, Takayama Tadatoshi
Department of Digestive Surgery, Nihon University School of Medicine, 30-1, Ohyaguchi kami-machi, Itabashi-ku, Tokyo 173-8610, Japan.
World J Gastroenterol. 2008 Feb 7;14(5):685-92. doi: 10.3748/wjg.14.685.
Surgeons may be severely criticized from the perspective of evidence-based medicine because the majority of surgical publications appear not to be convincing. In the top nine surgical journals in 1996, half of the 175 publications refer to pilot studies lacking a control group, 18% to animal experiments, and only 5% to randomized controlled trials (RCT). There are five levels of clinical evidence: level 1 (randomized controlled trial), level 2 (prospective concurrent cohort study), level 3 (retrospective historical cohort study), level 4 (pre-post study), and level 5 (case report). Recently, a Japanese evidence-based guideline for the surgical treatment of hepatocellular carcinoma (HCC) was made by a committee (Chairman, Professor Makuuchi and five members). We searched the literature using the Medline Dialog System with four keywords: HCC, surgery, English papers, in the last 20 years. A total of 915 publications were identified systematically reviewed. At the first selection (in which surgery-dominant papers were selected), 478 papers survived. In the second selection (clearly concluded papers), 181 papers survived. In the final selection (clinically significant papers), 100 papers survived. The evidence level of the 100 surviving papers is shown here: level-1 papers (13%), level-2 papers (11%), level-3 papers (52%), and level-4 papers (24%); therefore, there were 24% prospective papers and 76% retrospective papers. Here, we present a part of the guideline on the five main surgical issues: indication to operation, operative procedure, peri-operative care, prognostic factor, and post-operative adjuvant therapy.
从循证医学的角度来看,外科医生可能会受到严厉批评,因为大多数外科出版物似乎都缺乏说服力。在1996年排名前九的外科期刊中,175篇出版物中有一半涉及缺乏对照组的初步研究,18%涉及动物实验,只有5%涉及随机对照试验(RCT)。临床证据有五个级别:1级(随机对照试验)、2级(前瞻性同期队列研究)、3级(回顾性历史队列研究)、4级(前后对照研究)和5级(病例报告)。最近,一个委员会(主席:幕内教授及五名成员)制定了日本肝细胞癌(HCC)外科治疗的循证指南。我们使用医学在线数据库检索了过去20年中包含四个关键词的文献:HCC、手术、英文论文。共系统检索并审查了915篇出版物。在第一次筛选(选择以手术为主的论文)中,478篇论文通过筛选。在第二次筛选(结论明确的论文)中,181篇论文通过筛选。在最终筛选(具有临床意义的论文)中,100篇论文通过筛选。这里展示了这100篇通过筛选的论文的证据级别:1级论文(13%)、2级论文(11%)、3级论文(52%)和4级论文(24%);因此,前瞻性论文占24%,回顾性论文占76%。在此,我们展示该指南关于五个主要外科问题的部分内容:手术指征、手术操作、围手术期护理、预后因素以及术后辅助治疗。