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首页> 外文期刊>Current Science: A Fortnightly Journal of Research >Safety and efficacy of Chitra-CPCcalcium phosphate cement as bonesubstitute
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Safety and efficacy of Chitra-CPCcalcium phosphate cement as bonesubstitute

机译：Chitra-CPC磷酸钙骨水泥替代骨的安全性和有效性

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摘要

Calcium phosphate cements (CPCs) have gained im-portance in orthopaedics and dentistry as repair mate-rials for bony/dentinal defects. They are aqueous-based, mouldable and osteoconductive materials whichset into hydroxyapatite, the basic mineral of bone andteeth. A CPC product 'Chitra-CPC' has been deve-loped. This communication compiles the safety and ef-ficacy evaluation of Chitra-CPC. The evaluation planconsisted of acute systemic toxicity test (in mice for sys-temic response), intracutaneous reactivity test (in rab-bits for skin response), pyrogen test (in rabbits forpresence of pyrogens) and maximization sensitizationtest (in guinea pigs for allergic skin response). Soft tis-sue response was tested by implantation in rabbitparavertebral muscle, with histological evaluation at1, 4 and 12 weeks post-implantation. The efficacy ofthe product to heal bone defects was investigated byimplanting in rabbit femur with hydroxyapatite ce-ramic granules as the control. Local effects at macro-scopic and microscopic levels were assessed at timeperiods of 4,12, 26 and 52 weeks post implantation.The cement did not show any adverse effects in theacute systemic toxicity. Nor did it elicit any erythemicor edematous reactivity in the intracutaneous reactivitytest. The maximization sensitization study did not showany adverse skin response and the pyrogen test didnot evoke undue temperature rise. In the muscle im-plantation test, there was no haemorrhage, infectionor necrosis. Localized vascularization was present nearthe implanted region. Chronic inflammation was ob-served in 1 week, which became mild by 12 weeks withthe evidence of repair. Bone implantation studiesshowed that efficacy of Chitra-CPC and hydroxyapa-tite granules in bone healing is comparable. Both ma-terials were found to be osteoconductive, but with thedifference that Chitra-CPC resorbed progressively al-lowing simultaneous new bone formation. This provesthe osteotransductivity of Chitra-CPC, which is theideal property for a bone substitute.
机译：磷酸钙水泥（CPC）作为骨/牙本质缺损的修复材料已在骨科和牙科中占有重要地位。它们是水基的，可模制的，具有骨传导性的材料，可凝结成羟磷灰石（一种骨骼和牙齿的基本矿物）。已开发出CPC产品“ Chitra-CPC”。该通报汇编了Chitra-CPC的安全性和功效评估。评估计划包括急性全身毒性试验（对小鼠的系统反应），皮内反应性试验（对皮肤有反应的兔子），热原试验（对兔子有热原的存在）和最大化致敏试验（对豚鼠的过敏性皮肤）响应）。通过植入兔椎旁肌来测试软组织反应，并在植入后1、4和12周进行组织学评估。通过以羟基磷灰石陶瓷颗粒为对照，在兔股骨中植入，研究了该产品治疗骨缺损的功效。在植入后4、12、26和52周的时间评估宏观和微观水平的局部作用。水泥对急性全身毒性未显示任何不利影响。在皮内反应性测试中也未引起任何红斑性水肿反应性。最大化敏化研究未显示任何不良皮肤反应，热原测试未引起过高的温度升高。在肌肉植入试验中，没有出血，感染或坏死。在植入区域附近存在局部血管形成。慢性炎症在1周内观察到，到12周后逐渐恢复，并有修复迹象。骨植入研究表明，Chitra-CPC和羟基磷灰石颗粒在骨愈合方面的功效相当。两种材料都具有骨传导性，但不同之处在于Chitra-CPC逐渐吸收，从而减少了同时形成的新骨。这证明了Chitra-CPC的骨传导性，这是骨替代物的理想特性。

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