华西口腔医学杂志 ›› 2012, Vol. 30 ›› Issue (5): 505-508.doi: 10.3969/j.issn.1000-1182.2012.05.013

• 临床研究 • 上一篇    下一篇

我国口腔颌面外科临床随机对照试验的报告质量评价

董稳航1,2 李春洁1 项陈洋3 史宗道1 田卫东1,2   

  1. Dong Wenhang1,2, Li Chunjie1, Xiang Chenyang3, Shi Zongdao1, Tian Weidong1,2.
  • 收稿日期:2011-05-18 修回日期:2011-11-05 出版日期:2012-10-01 发布日期:2012-10-01
  • 通讯作者: 田卫东,Tel:13608053216
  • 作者简介:董稳航(1988—),女,河南人,硕士
  • 基金资助:

    2010年四川大学大学生创新性实验计划基金资助项目(101061162)

Quality assessment on reports of randomized controlled trials of oral and maxillofacial surgery in China

1.四川大学华西口腔医院创伤与整形外科; 2.口腔疾病研究国家重点实验室, 四川大学;3.四川大学华西口腔医院牙体牙髓病科, 成都610041   

  1. 1. Dept. of Trauma and Plastic Surgery, West China School of Stomatology, Sichuan University, Chengdu 610041, China; 2. State Key Laboratory of Oral Diseases, Sichuan University, Chengdu 610041, China; 3. Dept. of Conservative Dentistry and Endodontics, West China School of Stomatology, Sichuan University, Chengdu 610041, China
  • Received:2011-05-18 Revised:2011-11-05 Online:2012-10-01 Published:2012-10-01

摘要:

目的对2000—2009年发表的属于我国口腔颌面外科范畴的随机对照试验(RCT)的报告质量进行评价,了解我国口腔颌面外科临床试验报告质量的现状。方法采用计算机检索中国生物医学文献数据库、维普中文科技期刊数据库和中国期刊全文数据库,同时配合手工检索2000—2009年我国19种口腔医学期刊发表的文献,纳入属于口腔颌面外科范畴且声明采用随机方法分组的RCT,并采用国际公认的临床试验报告统一标准(CONSORT)进行报告质量评价。结果共纳入53篇RCT,根据CONSORT条目对其进行评价,RCT的报告质量普遍不高,平均得分仅为(8.2±2.5)分。结论2000—2009年发表的属于我国口腔颌面外科范畴的RCT报告质量与CONSORT标准比较尚有较大差距,今后的报告应进一步规范。

关键词: 口腔医学, 临床试验报告统一标准, 随机对照试验, 报告质量

Abstract:

Objective To evaluate the report quality of randomized controlled trials(RCT) of oral and maxillofacial surgery in China during 2000—2009. Methods A comprehensive electronic search was carried out through Chinese Biomedical Literature Database(CBM), VIP Database for Chinese Technical Periodicals(VIP) and China National Knowledge Infrastructure(CNKI), and 19 kinds of journals of stomatology in China were also hand-searched. We identified RCT published between 2000 and 2009, and classified into oral and maxillofacial surgery and labeled “random”and assessed the quality of these reports using the consolidated standards of reporting trials(CONSORT) statement. Results 53 RCT articles were included. Reporting quality of the 53 articles was not high and the CONSORT score was 8.2±2.5. Conclusion The reporting quality of RCT of oral and maxillofacial surgery in China is poor. The  CONSORT statement should be used to standardize the reporting of RCT.

Key words: stomatology, consolidated standards of reporting trials, randomized controlled trials, reporting quality