Preclinical evaluation of strontium-containing bioactive bone cement.
Preclinical evaluation of strontium-containing bioactive bone cement.
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DOI：
10.1016/j.msec.2013.07.017
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发表时间：
2013-12
期刊：
影响因子：
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通讯作者：
Z. Li;N. Yuan;R. W. Lam;Z. Cui;Xian-Jin Yang;W. Lu
中科院分区：
文献类型：
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作者：
Z. Li;N. Yuan;R. W. Lam;Z. Cui;Xian-Jin Yang;W. Lu
锶（Sr）在骨科应用中越来越有吸引力，因为它们可以同时刺激骨形成和防止骨质流失。一种含锶生物活性骨水泥（Sr-BC）被设计用于治疗骨质疏松性骨折。Sr是一种微量元素，因此Sr- bc在人体植入时，含有Sr的安全性受到关注。按照ISO 10993标准进行Sr-BC的临床前生物相容性评价。MTT试验表明，该生物活性骨水泥对小鼠成纤维细胞无毒，满足骨科植入物的基本要求。三个独立的遗传毒性研究，包括Ames，染色体畸变和骨髓微核检测，表明Sr-BC中没有遗传毒性成分，这打消了这种新型骨水泥的安全性担忧。本研究的肌肉植入效果也令人鼓舞。术后1周观察骨水泥周围急性炎症反应；然而，在对照组和Sr-BC组之间没有观察到显著差异。这些反应可能是由于异物的存在，但组织在植入12周后愈合。综上所述，上述临床前结果为该种植体的安全性提供了额外的保证。Sr-BC可以作为传统骨水泥的潜在替代品。
Strontium (Sr) has become more attractive for orthopaedic applications as they can simultaneously stimulate bone formation and prevent bone loss. A Sr-containing bioactive bone cement (Sr-BC) has been designed to fix osteoporotic bone fracture. Sr is a trace element, so the safety of containing Sr is concerned when Sr-BC is implanted in human body. The preclinical assessment of biocompatibility of Sr-BC was conducted according to ISO 10993 standards. MTT assay showed that this bioactive bone cement was non-toxic to mouse fibroblasts, and it met the basic requirement for the orthopaedic implant. The three independent genetic toxicity studies including Ames, chromosome aberration and bone marrow micronucleus assays demonstrated absence of genotoxic components in Sr-BC, which reassured the safety concerns of this novel bone cement. The muscle implantation results in present study were also encouraging. The acute inflammation around the cement was observed at 1 week post-implantation; however, no significant difference was observed between control and Sr-BC groups. These responses may be attributed to the presence of the foreign body, but the tissue healed after 12 weeks implantation. In summary, the above preclinical results provide additional assurance for the safety of this implant. Sr-BC can be used as a potential alternative to the traditional bone cement.