Chinese Journal of Tissue Engineering Research ›› 2021, Vol. 25 ›› Issue (16): 2612-2617.doi: 10.3969/j.issn.2095-4344.3148
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Li Yanle1, Yue Xiaohua1, Nie Zhen2, Zhang Junwei1, Li Zhaohui1, Nie Weizhi1, Jiang Hongjiang1#br#
Received:
2020-05-13
Revised:
2020-05-16
Accepted:
2020-06-17
Online:
2021-06-08
Published:
2021-01-07
Contact:
Nie Weizhi, Chief physician, Wendeng Orthopedic Hospital of Shandong Province, Weihai 264400, Shandong Province, China
Jiang Hongjiang, Chief physician, Wendeng Orthopedic Hospital of Shandong Province, Weihai 264400, Shandong Province, China
About author:
Li Yanle, Master, Physician, Wendeng Orthopedic Hospital of Shandong Province, Weihai 264400, Shandong Province, China
Supported by:
CLC Number:
Li Yanle, Yue Xiaohua, Nie Zhen, Zhang Junwei, Li Zhaohui, Nie Weizhi, Jiang Hongjiang. Characteristics and application of bioabsorbable materials in orthopedics[J]. Chinese Journal of Tissue Engineering Research, 2021, 25(16): 2612-2617.
2.1 生物可吸收金属材料 传统金属植入物材料是316L不锈钢、钴铬合金、钛合金等惰性金属,这些最早被采用的生物材料具有强度高、韧性好、效果可靠和使用方便等优点[3],但这些耐腐蚀植入物长期置入体内会引发金属过敏反应、应力遮挡及需要二次取出等问题,严重影响了临床使用[4]。可吸收金属材料能有效解决这些问题,具有较大的发展潜力。目前可降解金属主要包括镁、铁、锌及其合金,其中对镁基金属的研究最多,镁合金可吸收螺钉通过临床试验[5],Magnezix?制成的镁基骨螺钉是世界上第一种镁基可吸收植入物,并于2016年通过欧盟及其他国家批准上市[6-7]。第一批由镁稀土合金组成的固定和加压螺钉已经用于临床,尤其是在矫形外科领域。铁基金属在屈服强度、抗拉强度、断裂延伸率等方面优于镁基金属,但其在体内腐蚀率低,且腐蚀后的产物在生理环境中性质稳定,容易长期滞留于体内引起代谢相关的并发症[8]。锌基金属是介于铁和镁之间的中等腐蚀率的新型可吸收金属,具有更好的生物相容性和生物降解性,在可吸收缝合线及可吸收螺钉、钢板、髓内针等植入物制造中具有广泛的应用前景[9-10]。 ATKINSON 等[11]、ACAR等[12]研究镁合金可吸收加压螺钉内固定与标准钛螺钉内固定治疗拇外翻畸形的临床疗效及可比性,两者临床功能评分、疼痛评分及影像学检查均有显著改善,且两组无显著差异,证实了镁合金可吸收螺钉治疗拇外翻的有效性。GIGANTE 等[13]在关节镜下应用镁合金可吸收螺钉治疗胫骨撕脱骨折,患者术后功能恢复良好,螺钉6个月后完全吸收,12个月后被新生骨取代,未发生相关并发症。KOSE等[14]对11例应用生物可吸收镁加压螺钉治疗的踝关节骨折病例资料进行回顾性分析,随访12-24个月,结果显示所有患者骨折愈合良好,且无不良反应发生。GRüN等[15]研究镁可吸收植入物在小型和大型生长动物模型中的降解行为,研究结果显示镁可吸收植入物在植入后6,12,24?周对骨形成和生长无不良影响,无纤维化、硬化性包膜等不良反应,两种生长动物模型的降解速率无明显差异,均表现出缓慢而均匀的降解性能。 2.2 生物可吸收高分子材料 可吸收高分子材料是指在一定时间和条件下能够能被微生物或其分泌物在酶或化学分解为CO2和H2O的高分子材料,其优点是终产物不在体内蓄积,几乎没有毒性作用。可吸收高分子材料分为天然高分子材料(具体包括壳聚糖、胶原蛋白等)和人工高分子材料(具体包括聚乙交酯、聚丙交酯、聚羟基丁酸酯等)。 2.2.1 天然高分子材料 壳聚糖是甲壳素的脱乙酰化产物,甲壳素大量存在于蟹、虾及昆虫等的甲壳和真菌类的细胞壁中,是天然高分子聚合物。壳聚糖具有良好的生物相容性、生物活性、生物降解性、低免疫反应、抗菌性及促进伤口愈合等特性,且因其与骨基质的主要成分糖胺聚糖的结构相似,因而具有良好的细胞黏附力[16-17];此外,壳聚糖具有显著的骨诱导性,它能促进细胞黏附、成骨细胞和间充质细胞的增殖,并能刺激新生血管,促进骨功能性重建[18-20]。刘超等[21]将18只健康雌性新西兰大白兔随机分为空白组、模型组与壳聚糖组,其中空白组不建立骨质疏松性骨缺损模型,模型组和壳聚糖组建立骨质疏松性骨缺损模型,模型组不放入任何材料处理,壳聚糖组给予壳聚糖支架处理,测量术前及术后腰椎骨密度、腰椎组织学评分、腰椎最大负荷、抗弯曲强度与载荷/位移等生物力学;采用生物素双抗体夹心酶联免疫吸附法检测骨形成特异性标志物骨特异性碱性磷酸酶和骨吸收特异性标志物Ⅰ型胶原羧基端末肽含量,得出结论:壳聚糖支架在兔骨质疏松性腰椎骨缺损修复中应用具有良好的生物相容性与安全性,可促进骨缺损后的骨形成和骨吸收,从而提高修复效果,改善腰椎生物力学功能。 胶原蛋白存在于人体不同组织中,目前为止胶原蛋白分为20多类,其中Ⅰ-Ⅳ型胶原蛋白最为常见,其在人体内分布见表2[22]。Ⅰ型胶原蛋白在人体组织中分布最为广泛,研究最多[23-25],是骨基质主要成分,能诱导骨髓间充质干细胞向成骨细胞分化[26],已被广泛应用于骨组织工程修复,例如引导性骨组织再生、引导性牙周组织再生,硬骨、软骨修复材料及组织工程支架结构[27]。SCHNEIDER等[28]的一项多中心研究对116例接受Ⅰ型胶原蛋白凝胶治疗剥脱性骨软骨炎病例进行1-5年的随访,用IKDC评分、目测类比评分和SF-36评分作为评价指标,优良率为80%-88%。李政等[29]将自体软骨细胞结合Ⅰ型胶原蛋白三维支架技术应用在7例剥脱性软骨炎软骨缺损的临床治疗中,进行一两年的随访,用Lysholm评分、主观IKDC评分、疼痛评分、患者满意度调查及MRI结果作为评价指标,结果表明自体软骨细胞结合Ⅰ型胶原蛋白三维支架治疗膝关节大面积剥脱性骨软骨炎是可显著改善患肢功能和缓解疼痛,是安全有效的治疗方法。 2.2.2 人工高分子材料 目前已开发用作骨修复的人工合成高分子材料主要有聚酯类,如聚乳酸(又称为聚丙交酯)、聚乙醇酸(也称为聚乙交酯)、聚己内酯等[30]。聚乙醇酸在生物流体中的降解速率高于聚乳酸;聚己内酯由于其结晶度和亲水性较高,降解速率较低,远低于聚乳酸[31]。其中聚乳酸应用最为广泛,根据旋光性的不同可分为外消旋聚乳酸、左旋聚乳酸、右旋聚乳酸3种异构体。左旋聚乳酸和右旋聚乳酸是半结晶聚合物,拉伸强度高,降解速度慢,是外科整形材料、手术缝合线及内植材料等的理想材料;外消旋聚乳酸是非晶态共聚物,强度低,降解速率快,常应用于药物运输载体和低强度组织再生支架[32]。聚乙醇酸是结构最简单的线性脂肪族聚酯,具有良好的生物相容性、可降解性和良好的加工性,同时具有记忆功能,是形状记忆材料研究的重点之一,目前主要用于手术缝线、复合骨组织支架、可吸收螺钉、涂层抗电解和纤维抗氧化等方面[33]。聚己内酯是一种半结晶线性聚酯,具有较低的熔点和玻璃化转变温度,拉伸强度很低(23 MPa),断裂伸长率很高(700%),易溶于很多有机溶剂,可与多种高分子共聚,具备良好的热塑性和成型加工性;另外,聚乙醇酸具有细胞相容性、组织相容性、可降解性和弹性功能,目前主要用于手术缝合线和骨科夹板,以及用作药物载体治疗骨髓炎或骨结核[34]。 SMIT等 [35]将左旋聚乳酸与钛合金的椎间融合器植入山羊腰椎椎间隙内并进行对比观察,随访6-36个月,通过CT扫描所得到的重建结果评估骨密度、骨小梁厚度、间距和数量、连接密度及结构模型指数,结果显示左旋聚乳酸椎间融合器骨小梁随着时间推移有数目、质量、方向、厚度等方面的改变,而钛合金椎间融合器骨小梁的上述改变要晚于左旋聚乳酸椎间融合器。PARTIO等[36]对伴有终末期跖趾关节强直的拇外翻患者进行了9年的随访研究,回顾性研究了聚-L-D-乳酸间置人工关节置换的效果,结果显示所有患者术后跖趾间评分和目测类比评分均有不同程度的改善,术后疼痛(目测类比评分)下降显著(P?<?0.00 1),表明聚L-D-乳酸植入物是治疗第一跖趾关节终末期退行性变的较好选择。 2.3 生物无机材料 生物无机材料中主要是磷酸钙类生物陶瓷材料在骨科中应用较多,主要包括磷酸三钙、磷酸四钙、羟基磷灰石及它们的混合物等,这些生物陶瓷材料经过一定处理后具有良好的生物性能,包括生物相容性、骨传导性及骨结合性。例如可注射骨水泥通过快速成型可用于椎体成形及椎体后凸成形手术中,具有良好的可操作性及优良的生物活性和生物相容性,能够在材料界面与人体骨形成化学键合,从而诱导更迅速的骨修复和再生[37]。天然骨是胶原蛋白和羟基碳酸磷灰石的复合物,其中无机成分30%是无定形磷酸钙,70%是羟基磷灰石,磷酸钙作为正常骨组织骨盐的主要成分之一,尤其是β-磷酸三钙,具有优异的生物相容性、骨传导性和骨诱导活性,并且其相关衍生物也不引起细胞毒性作用[38-39],其力学特性随孔隙率变化,孔隙率升高其抗拉抗压能力降低,脆性增加,断裂韧性降低,但是可降解性会相应提高[40-41],在骨修复和骨替代应用中具有巨大的潜力。 RUSSMUELLER 等[42]从静脉血中提取人外周血单个核细胞,向破骨细胞分化,然后在牛骨片和玻璃片上加入5种颗粒羟基磷灰石/β-磷酸三钙生物材料进行培养,培养21 d后,用扫描电镜观察生物材料对骨片破骨细胞吸收的诱导作用,抗酒石酸酸性磷酸酶染色鉴定破骨细胞样细胞,扫描电镜图像显示5种生物材料的骨吸收面积均大于对照组,结果表明破骨细胞在生物材料羟基磷灰石颗粒中活性较强,能更快促进骨吸收,加快骨组织生成。CIVININI 等[43]研究新型生物陶瓷增强成骨性能和新骨形成的吸收动力学,前瞻性评价了15个髋关节股骨头坏死的髓芯减压和注射硫酸钙/磷酸钙复合材料的治疗效果,在术后1周内、12个月、2年进行髋关节定量CT扫描,最后进行至少4年的随访,一系列定量和定性CT扫描数据表明,硫酸钙/磷酸钙复合材料在很短的时间内吸收,其留下的开放孔结构使得新血管浸润和沉积,为新骨生长提供了理想的环境。 2.4 生物复合材料 生物复合材料是指由2种或2种以上不同材料复合而成的生物医学材料,不仅兼具组分材料的性质,还能获得单一组分材料所不具有的新性能,具有广泛的应用的前景。 可吸收金属材料具有较好的机械性能,例如屈服强度、抗拉强度、断裂延伸率、硬度等,较聚合物材料稳定性更好[44],然而镁(Mg)螺钉腐蚀形成的氢气会聚集在种植体周围,造成骨囊肿、长期溶骨性损害和骨愈合延迟。而聚合物材料腐蚀机制明确,可以预测其在体内外腐蚀行为和腐蚀速率,然而其固有透光性,在X射线片、MRI等检查中不能被发现,且其承重性能不如可吸收金属材料。有研究表明,可以通过聚己内酯聚合物涂层来改善可生物降解镁的初始耐蚀性[45],该复合材料较聚合物优化了力学性能,较可吸收金属材料改善了降解速度,具有更高的应用价值。壳聚糖只能溶于酸或酸性水溶液,在生物体内其韧性和强度显著减低,限制了其应用,故研究中常常将壳聚糖与羟基磷灰石或其他材料按一定比例混合来提高其生物性能[46]。聚乳酸易加工成型,可与其他材料复合形成不同性能的聚乳酸复合物,纳米羟基磷灰石/胶原是具有模仿天然骨组成成分和分级结构特征的复合体,具有良好的生物相容性和骨传导性,但脆性大、不易成型,将羟基磷灰石与聚合物基体复合得到的复合材料,既具有羟基磷灰石的生物相容性及生物活性,同时又具有高分子材料的加工性能、机械性能及优良的降解性能。BHUIYAN等[47]将5%聚乳酸与纳米羟基磷灰石/胶原复合制备了复合材料,发现人成骨细胞易于在其表面附着与生长,可用于组织工程骨架材料研发。SINGH等[48]将生物聚合物与生物陶瓷复合材料所研制的支架植入兔动物模型的骨不连节段性骨缺损中,评价其生物相容性和骨组织再生能力,组织学分析表明该复合支架在骨组织再生、血管化和缺损重建方面具有很强的潜力。 如今的新型复合材料融入纳米技术,制备工艺不断更新,使得其在分子结构、空间构象、硬度、压强、韧性及生物相容性等方面较传统材料均得到了明显提高[49]。SURYAVANSHI等[50]研发一种用于骨-软组织固定的新型复合生物材料,在聚己内酯聚合物中分别加入0%,10%,20%和30%的MgO纳米粒子及0%,5%,10%,20%和30%的脱胶真丝纤维,制备了MgO-真丝-聚己内酯、真丝-聚己内酯和MgO-聚己内酯复合材料。结果显示当MgO质量分数为10%、真丝复合材料质量分数为20%时,复合材料的力学性能最好,拉伸强度提高1.7倍,拉伸模量提高7.5倍,具有良好的细胞存活率、黏附性和血液相容性,促进细胞的增殖和分化;MgO填料对提高拉伸强度的贡献较大,而真丝纤维对模量的贡献较大,对力学性能有协同作用;将MgO-真丝-聚己内酯复合螺钉植入SD大鼠皮下进行体内生物安全性研究,在重要脏器组织病理学和血液指标方面均未见毒性反应,得出结论复合螺钉在人工骨中表现出2倍的聚己内酯拔出强度,可应用于前交叉韧带重建中骨-软组织固定。左旋聚乳酸在体内降解过程中会产生副产物,使周围组织酸化,从而引发炎症反应。为了克服这些问题,在左旋聚乳酸基质中添加了纳米氢氧化镁作为生物活性填料,通过中和左旋聚乳酸降解引起的酸化环境来抑制炎症反应。KANG等[51]通过2种方法制备低聚乳酸表面改性的纳米氢氧化镁,结果显示表面改性纳米氢氧化镁的加入不仅提高了力学性能(如杨氏模量),而且由于界面相互作用的增加改善了氢氧化镁颗粒在左旋聚乳酸基体中的均匀性。此外,表面修饰纳米氢氧化镁的左旋聚乳酸复合材料具有较低的细胞毒性和免疫原性,减少了水解降解过程中的体积侵蚀。 "
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