Mussano Federico, Ciccone Giovannino, Ceccarelli Manuela, Baldi Ileana, Bassi Francesco
Department of Biomedical Science and Human Oncology, University of Turin, Italy.
Spine (Phila Pa 1976). 2007 Apr 1;32(7):824-30. doi: 10.1097/01.brs.0000259227.51180.ca.
A systematic review of scientific literature.
The study aimed to determine whether bone morphogenetic proteins (BMPs) are more effective in treating bone defects than traditional techniques, such as grafting autologous bone.
BMPs were used in several human randomized controlled trials (RCTs). There are both logical arguments and an empirical basis for using RCTs to evaluate the effects of health care interventions and restrict systematic reviews to such a kind of study design.
An electronic search was made in the databases of MEDLINE, EMBASE (through MeSH and Emtree), and the Cochrane Central Register of Controlled Trials, extended to May 31, 2006, with no linguistic restrictions. RCTs that compare bone regeneration achieved through BMPs versus that obtained by traditional methods entered the study.
The 17 publications that met the criteria, divided into subgroups by type of bone, were tabulated by salient characteristics and evaluated through the items proposed by van Tulder et al. However, as the studies differed widely (in terms of site, sample size, dosage of active principle, carrier, clinical and radiologic data recording), it was possible to carry out a metaanalysis of clinical and radiologic outcome only for the subgroup that evaluated the vertebrae, where it was observed that BMPs offer a slightly but statistically significant greater efficacy than do traditional techniques.
The use of BMPs at the vertebrae can eliminate the need for surgery to harvest autologous bone. The only large study carried out on the other sites suggests that BMPs should be used at a concentration of 1.5 mg/mL to treat fractures of the tibia. However, further RCTs of good methodological quality are advisable so as to clarify the effectiveness of BMPs in clinical practice.
对科学文献的系统评价。
本研究旨在确定骨形态发生蛋白（BMPs）在治疗骨缺损方面是否比传统技术（如自体骨移植）更有效。
BMPs已用于多项人类随机对照试验（RCTs）。使用RCTs评估医疗保健干预措施的效果并将系统评价限制在这种研究设计上，既有逻辑依据，也有实证基础。
在MEDLINE、EMBASE（通过医学主题词表和Emtree）以及Cochrane对照试验中央注册库数据库中进行电子检索，检索截至2006年5月31日，无语言限制。比较通过BMPs实现的骨再生与传统方法获得的骨再生的RCTs纳入本研究。
符合标准的17篇出版物，按骨类型分为亚组，按显著特征列表，并通过van Tulder等人提出的项目进行评估。然而，由于研究差异很大（在部位、样本量、活性成分剂量、载体、临床和放射学数据记录方面），仅对评估椎骨的亚组进行了临床和放射学结果的荟萃分析，结果显示BMPs比传统技术具有略高但具有统计学意义的疗效。
在椎骨使用BMPs可消除自体骨采集手术的必要性。在其他部位进行的唯一一项大型研究表明，BMPs应以1.5 mg/mL的浓度用于治疗胫骨骨折。然而，建议进行更多方法学质量良好的RCTs，以阐明BMPs在临床实践中的有效性。
