Zhang Jiazhen, Jiang Yanbiao, Shang Zhizhong, Zhao Bing, Jiao Mingyue, Liu Wenbo, Cheng Maobo, Zhai Bao, Guo Yajuan, Liu Bin, Shi Xinli, Ma Bin
Center for Medical Device Evaluation, National Medical Products Administration, Beijing, 100081, PR China.
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, PR China.
Bioact Mater. 2021 Apr 20;6(11):4027-4052. doi: 10.1016/j.bioactmat.2021.03.035. eCollection 2021 Nov.
Biodegradable metals are promising candidates for bone defect repair. With an evidence-based approach, this study investigated and analyzed the performance and degradation properties of biodegradable metals in animal models for bone defect repair to explore their potential clinical translation. Animal studies on bone defect repair with biodegradable metals in comparison with other traditional biomaterials were reviewed. Data was carefully collected after identification of population, intervention, comparison, outcome, and study design (PICOS), and following the inclusion criteria of biodegradable metals in animal studies. 30 publications on pure Mg, Mg alloys, pure Zn and Zn alloys were finally included after extraction from a collected database of 2543 publications. A qualitative systematic review and a quantitative meta-analysis were performed. Given the heterogeneity in animal model, anatomical site and critical size defect (CSD), biodegradable metals exhibited mixed effects on bone defect repair and degradation in animal studies in comparison with traditional non-degradable metals, biodegradable polymers, bioceramics, and autogenous bone grafts. The results indicated that there were limitations in the experimental design of the included studies, and quality of the evidence presented by the studies was very low. To enhance clinical translation of biodegradable metals, evidence-based research with data validity is needed. Future studies should adopt standardized experimental protocols in investigating the effects of biodegradable metals on bone defect repair with animal models.
可生物降解金属是骨缺损修复的有前景的候选材料。本研究采用循证方法，调查并分析了可生物降解金属在骨缺损修复动物模型中的性能和降解特性，以探索其潜在的临床转化应用。回顾了与其他传统生物材料相比，使用可生物降解金属进行骨缺损修复的动物研究。在确定人群、干预措施、对照、结局和研究设计（PICOS）后，并遵循动物研究中可生物降解金属的纳入标准，仔细收集了数据。从收集的2543篇出版物数据库中提取后，最终纳入了30篇关于纯镁、镁合金、纯锌和锌合金的出版物。进行了定性系统评价和定量荟萃分析。鉴于动物模型、解剖部位和临界尺寸缺损（CSD）存在异质性，与传统不可降解金属、可生物降解聚合物、生物陶瓷和自体骨移植相比，可生物降解金属在动物研究中对骨缺损修复和降解表现出混合效应。结果表明，纳入研究的实验设计存在局限性，研究提供的证据质量非常低。为了加强可生物降解金属的临床转化，需要进行具有数据有效性的循证研究。未来的研究应采用标准化实验方案，以研究可生物降解金属对动物模型骨缺损修复的影响。
