Buijs G J, Stegenga B, Bos R R M
Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
J Dent Res. 2006 Nov;85(11):980-9. doi: 10.1177/154405910608501102.
The use of osteofixation devices should be evidence-based if uncomplicated bone healing is to be achieved. Numerous studies describe and claim the advantages of biodegradable over titanium devices as a bone fixation method. Here, we systematically review the available literature to determine the clinical efficacy and safety of biodegradable devices compared with titanium devices in oral and maxillofacial surgery. In addition, related general aspects of bone surgery are discussed. We conducted a highly sensitive search in the databases of MEDLINE (1966-2005), EMBASE (1989-2005), and CENTRAL (1800-2005) to identify eligible studies. Eligible studies were independently evaluated by two assessors using a quality assessment scale. The study selection procedure revealed four methodologically 'acceptable' articles. Owing to the different outcome measures used in the studies, it was impossible to perform a meta-analysis. Therefore, the major effects regarding the stability and morbidity of fracture fixation using titanium and biodegradable fixation systems were qualitatively described. Any firm conclusions regarding the fixation of traumatically fractured bone segments cannot be drawn, due to the lack of controlled clinical trials. Regarding the fixation of bone segments in orthognathic surgery, only a few controlled clinical studies are available. There does not appear to be a significant short-term difference between titanium and biodegradable fixation systems regarding stability and morbidity. However, definite conclusions, especially with respect to the long-term performance of biodegradable fixation devices used in maxillofacial surgery, cannot be drawn.
若要实现简单的骨愈合，骨固定装置的使用应基于循证医学。众多研究描述并宣称，作为一种骨固定方法，可生物降解装置相较于钛制装置具有优势。在此，我们系统回顾现有文献，以确定在口腔颌面外科中，可生物降解装置与钛制装置相比的临床疗效和安全性。此外，还讨论了骨外科的相关一般问题。我们在MEDLINE（1966 - 2005年）、EMBASE（1989 - 2005年）和CENTRAL（1800 - 2005年）数据库中进行了高灵敏度检索，以识别符合条件的研究。两名评估者使用质量评估量表对符合条件的研究进行独立评估。研究选择过程筛选出四篇方法学上“可接受”的文章。由于研究中使用的结局指标不同，无法进行荟萃分析。因此，定性描述了使用钛制和可生物降解固定系统进行骨折固定的主要稳定性和发病率影响。由于缺乏对照临床试验，无法就创伤性骨折骨段的固定得出任何确凿结论。关于正颌外科中骨段的固定，仅有少数对照临床研究。在稳定性和发病率方面，钛制和可生物降解固定系统之间似乎没有显著的短期差异。然而，无法得出明确结论，尤其是关于口腔颌面外科中使用的可生物降解固定装置的长期性能。
