Chinese Journal of Tissue Engineering Research ›› 2016, Vol. 20 ›› Issue (34): 5155-5162.doi: 10.3969/j.issn.2095-4344.2016.34.022
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Wang Bing-yang1, Niu Guang-ming2, Du Hua1, 2, Weng Li-xin1, 2
Received:
2016-05-22
Online:
2016-08-19
Published:
2016-08-19
About author:
Wang Bing-yang, Studying for master’s degree, School of Basic Medicine, Inner Mongolia Medical University, Hohhot 010059, Inner Mongolia Autonomous Region, China
CLC Number:
Wang Bing-yang, Niu Guang-ming, Du Hua, Weng Li-xin. Different wound dressings in the treatment of diabetic foot ulcers[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(34): 5155-5162.
2.1 糖尿病足溃疡发病机制 慢性糖尿病神经病变定义为临时或永久性的神经组织损伤,是糖尿病一种常见的并发症,特点是累积周围神经,导致周围神经受损,而且血流量降低。 糖尿病神经病变和周围性血管疾病通常是参与糖尿病足溃疡的主要因素[7],这两个因素可能单独或结合其他条件如微血管疾病、生物力学异常,使关节灵活性受限,增加对感染的易感性。一些研究报告指出,与糖尿病足溃疡治疗相关的困难大多是由于过度和持久的活性金属蛋白酶和/或由于低水平的金属蛋白酶抑制剂[8]。 此外,缺血和血管疾病通常会降低疗愈能力,其原因是由于氧气和伤口区域营养供应减少,这些问题主要是由于受损血管生成的生长因子的表达,即血管内皮生长因子和血小板源性生长因子[9]。也可能是一氧化氮异常,胶原蛋白积累,成纤维细胞和角质细胞的迁移和增殖异常,以及累积的细胞外基质组件及其重构基质金属蛋白酶等原因导致。当血小板接触到暴露的胶原时,愈合级联立即开始[8]。因为血小板聚集,凝血因子被释放,导致在损伤部位的纤维蛋白凝块沉积。纤维蛋白凝块作为一个临时矩阵,并设置为随后的愈合阶段。 糖尿病是一种已知与多种结缔组织异常有关的疾病,这些异常不利于糖尿病患者伤口愈合,尽管有足够和适当的管理,糖尿病足溃疡创面还是愈合缓慢或无法愈合。 2.2 不同敷料材料促进糖尿病足溃疡愈合 如急性伤口一样,增强糖尿病足溃疡愈合的过程已经建立,伤口敷料应该选择适当的生物材料,以防止感染,促进愈合(提供一个理想的湿润环境,帮助伤口关闭),在治疗过程中,药用辅料可提供持续和有效的生物活性物质释放,防止其在伤口愈合过程中迅速退化。糖尿病足溃疡在医学上可以多种方式分类,但所有的分类都以溃疡深度和是否存在骨髓炎或坏疽为标准。 2.2.1 伤口敷料的种类及主要特点 自然皮肤被认为是完美的伤口敷料,因此理想的伤口敷料应该试着复制它的属性。从历史上看,伤口敷料最初被认为在愈合过程中只是起一种被动保护作用。然而,近几十年来已发现湿润敷料可促进伤口更快地愈合。此外,潮湿的伤口环境也是一个诱导成纤维细胞和角质细胞增殖和迁移及增强胶原蛋白合成的重要因素,减少瘢痕形成。 除了保证最佳的水分对于伤口环境,目前伤口敷料也应该:①有能力提供湿润环境,进行气体交换,能够帮助排出伤口渗液和残骸清除,促进组织重建过程;②应该具有生物相容性,不引起任何过敏或免疫应答反应;③应该保护伤口继发感染,具有抗菌、抗炎作用;④应该很容易删除而不造成伤口创伤,以利于新生组织生成。但由于伤口的不同类型和伤口愈合阶段的不同,目前仍然没有一种敷料可有效应用于所有伤口。为了满足大多数伤口愈合的需求和愈合的不同阶段,已经开发了不同的伤口敷料适用于不同伤口类型[10]。 根据它们的主要类型和特点,最常用的糖尿病伤口愈合敷料材料可以分类如下: 凝胶:这类是潮湿机制的伤口敷料,通常包括一个支持材料(如半透薄膜、泡沫或聚酯纤维无纺布)和一层亲水/胶体粒子,可能含有生物相容性的凝胶的蛋白质(如胶原、明胶)或多糖(如纤维素及其衍生物)[11]。当接触伤口渗出物时,这些材料将吸收伤口液体,因此可以创建一个潮湿的环境。此外,它们也是水和氧气的半透膜。然而,水胶体敷料的应用在强烈的感染伤口一直被质疑,可能由于缺氧和过度潮湿的环境,可加强坏死组织的自我分解,因此会在伤口处增加感染的风险。凝胶通常应用于形成颗粒和上皮形成的伤口,因此他们也可用于坏疽伤口,利于促进伤口清创。这些材料可平均保持在糖尿病足溃疡伤口超过1周[12-13]。 水凝胶:这类敷料主要是用于维护高度潮湿的伤口环境,单一或混合水合聚合物(如凝胶的形式)在保留水方面提升20%。如果水含量高于95%,这些材料通常指定为高吸水性树脂。水凝胶可以共价或非共价交联,以控制不断膨胀的能力和维护其构象结构,而且他们可能可逆扩大(或缩小)在水环境中特定的 pH值和离子强度值。水凝胶能够促进清创的坏死组织自溶,更有效地干燥伤口,很少有渗出液[12-13]。这类伤口敷料的一大优点是,他们通常可以较好地应用和删除,没有极大干扰伤口床。然而水凝胶敷料的应用程序在伤口分泌物过多时,会导致伤口浸渍和无法愈合问题。 海绵泡沫敷料:此类敷料应用在温和或高消耗的伤口,他们一般依赖于使用特定的聚合物材料和泡沫厚度来吸收伤口液体。这些敷料是高度吸收剂,具有缓冲保护作用,符合身体皮肤表面。此外,他们很容易被操纵,可适应所需伤口的大小[14]。因其吸收性和防护特点,泡沫式敷料可留在伤口长达7 d。因此,泡沫已被提出作为糖尿病足溃疡治疗的潜在候选敷料[15]。 薄膜覆盖类型的伤口敷料:这类敷料通常是透明的,耐用,容易操作,价格便宜,可供大众使用;透氧和水蒸气,常常不透水和细菌,能够防止细菌污染;属于胶黏剂。薄膜敷料的主要缺点是,他们应该只用于很少有分泌物的伤口,通常可以持续应用四五天。由于薄膜敷料可以更好地修复伤口床,并具有改善流体屏障的属性,因此薄膜敷料也一直在开发和应用于糖尿病足溃疡治疗[1]。 不同的生物合成相容性材料和天然高分子化合物,以及它们的混合物或组合和不同的处理方法,已被提出并测定体外和体内伤口敷料的应用。这些敷料材料已商用,并已在临床上使用。为补充和加强一般伤口敷料功能,开发了几种不同的策略,如涉及的生物活性化合物(如生长因子、肽、合成药物和/或自然基础化合物/提取)的药用辅料。 2.2.2 不同聚合材料对糖尿病足溃疡的治疗 伤口愈合效率取决于几个因素,如伤口类型和阶段、损伤程度、患者情况、组织参与及选择的敷料,影响愈合的增强剂和治疗性物质(如果使用)药物和/或其他治疗增强剂可以被纳入伤口敷料聚合物矩阵主要用来改善和加速愈合。 不同组分聚合物材料表现出独特的化学、物理和生物特性,为了提供不同的功能性质,可设计不同尺寸和形状用于伤口敷料制备系统,一个最简单的方法来区分他们的来源:高分子材料的合成或自然基础聚合物和共聚物,改性高分子材料(通过自然的化学改性聚合物)或混合物/不同的聚合物和共聚物的组合也可以考虑。目前对糖尿病足溃疡的治疗已证明各种高分子材料可提高治疗,一些已商用[16]。 基于天然聚合物之上的糖尿病足溃疡敷料:天然聚合物可来源于微生物、动物或植物,通常具有蛋白质或多糖的性质。由于它们来源于动物或植物组织,大量的异质性和批次的变化主要限制了它们应用。其他问题包括,由于是外源或异种起源的原始材料,这些材料的成本相对较高(即蛋白质材料)和有传染病相关的风险。此外,稳定性差,力学性能也可能限制其广泛应用。然而,为了克服这些缺点,各种各样的化学合成和/或制作方式的修改执行,或将这些材料与其他高分子材料(包括合成聚合物)混合是另一个可行的选择[17-18]。 (1)甲壳素、壳聚糖及其衍生物:甲壳素是自然界中含多糖最多的生物之一[19-21] ,存在于一些软体动物和甲壳动物骨骼及真菌细胞壁中。常见的甲壳素来源虾蟹,可以较低的成本获得,这使甲壳素在各种商业生物材料应用中具有很强的吸引力[21-22]。甲壳素在水溶液中不溶解,它通常是转化为壳聚糖的脱乙酰度,在热碱性溶液中存在。因此,壳聚糖是一种线性共聚物D-氨基葡萄糖和N-乙酰-D-氨基葡萄糖。壳聚糖的化学、物理和生物学特性与其脱乙酰度和其分子量直接相关。壳聚糖具有可生物降解性、生物相容性、无抗原性、无毒、生物黏附性、抗微生物、生物活性及止血作用[23]。它也很容易通过化学水解,以及由某些酶即溶菌酶降解。 此外,壳聚糖氨基和羟基基团可很容易地反应而发生化学变性,使其具有高化学通用性。采用氨基的化学修饰会影响脱乙酰度,因此最终所得到的材料带有阳离子性质。壳聚糖容易溶解在相对较低的pH值溶液中[24]。壳聚糖也可溶于弱有机酸,与带负电荷的分子相互作用,这可能有助于其处理和进一步整合成颗粒、膜、纤维或海绵。此属性已使壳聚糖及其衍生物(单独或与其他聚合物材料相结合的/共轭聚合物材料)被广泛研究并作为交付矩阵的一些药物应用[24-25]。在酸性条件下,壳聚糖带正电荷,因此它更容易与存在于皮肤的带负电荷分子,如蛋白质、阴离子多糖和核酸相互作用。此外,以壳聚糖为基础的材料通常表现出正电荷(典型的伤口pH值)性质,成膜能力,温和的凝胶特性和强大的伤口组织的粘接性能,壳聚糖及其衍生物能够加强血液凝固和加速伤口愈合。特别是低脱乙酰度的壳聚糖膜已被证明修整表面伤口是有效的。其他资料也表明这些材料可增强中性白细胞、巨噬细胞和中性粒细胞的炎症作用,促进肉芽组织有一个适当的炎症反应[26-27]。 此外,壳聚糖可刺激成纤维细胞、血管生成,合成和定期沉积胶原纤维,促进组织增殖。 (2)透明质酸:透明质酸是一种天然多糖,即非硫酸化糖胺聚糖,是某些哺乳动物如软骨结缔组织细胞外基质的主要成分,如眼玻璃体、脐带和滑膜液[28-30]。在宿主体内,透明质酸具有非过敏性和生物相容性。此外,透明质酸还有结构和空间填充性能,润滑作用,以及对组织和细胞外基质的水吸附和保持能力。目前,在泡沫型和水凝胶型伤口敷料中已应用透明质 酸[31-32]。 (3)纤维素及其衍生物:纤维素是植物细胞壁的主要成分,是地球上最丰富的有机高分子材料。因此,它是一种可再生的生物材料,成本低,容易获 得[33-34]。此外,它也可很容易地转换成几个具有潜在优势的衍生物。 纤维素及其衍生物在空气、水和土壤中都有一些细菌和真菌降解,导致其机械强度下降,水溶性提 高[35-36]。此外,由于纤维素可减少对异物的炎症反应,因此以纤维素为基础的材料被认为是生物相容 性[37-38]。纤维素醚衍生物,如甲基纤维素、羟丙基纤维素、羟乙基纤维素、羟乙基甲基纤维素、羟丙基甲基纤维素和羧甲基纤维素具有冷热水溶性,其他特性,如有机溶剂中的溶解性、热塑性行为及生物活 性[39-41]。纤维素酯衍生物,如醋酸纤维素、醋酸纤维素、纤维素硫酸酯,也是纤维膜形成材料。此外,它们的分子量可是多种多样的,因此它们的水溶液黏度和凝胶特性可被调整。这些特点使其应用在几种药物制剂和各种生物医学中[40-42]。 (4)丝素:丝素蛋白可从家蚕中分离得到。由于其良好的生物相容性、血液相容性、降解缓慢,透气性和渗透性,在生物医学中备受关注。蚕丝纤维是由纤维蛋白(素)芯和胶蛋白(丝胶)围绕而成[43-46]。虽然蚕丝蛋白不促进免疫反应,但丝胶蛋白可能会产生相反的效果。此外,丝素蛋白能够支持表皮细胞和成纤维细胞附着、扩散和增殖,促进创面愈合[45-47]。 (5)葡聚糖:葡聚糖是亲水性的,水溶性高,在生物系统中为惰性,可通过羟基反应发生官能化[48]。葡聚糖及其衍生物具有生物降解性,生物相容性,抗蛋白吸附,并且不影响细胞活力。因此,它是一个良好的聚合物,用于医疗应用,如骨、真皮和皮下愈合和药物传递。它有利于炎症细胞浸润,促进血管生成细胞迁移到伤口。聚糖酐、葡聚糖聚合物已被应用于糖尿病患者局部溃疡或伤口感染中[49]。 基于合成聚合物之上的糖尿病足溃疡敷料: (1)聚乙烯醇:聚乙烯醇是具有亲水性、无毒、无致癌,经醇解、水解、氨解得到的醋酸乙烯酯生物相容性的聚合物[50-53]。 聚乙烯醇已被广泛用于组织工程和药物输送,除了它的高亲水性和吸水能力,它还可以被制作成颗粒、纤维、纺织品、海绵等形式。此外,它具有良好的化学和酶性能,以及良好的黏附性能和氧渗透。然而,聚乙烯醇表现出一些不利的机械性能(如强度和弹性)及相对较差的热稳定性。聚乙烯醇很容易溶解,因此不可能是一个长期或永久性敷料。聚乙烯醇及其衍生物已被用作常规伤口敷料,并对糖尿病创面治疗进行了测试[54]。除此之外,以聚乙烯醇为基础的敷料还被加载具有生物活性的化合物,如庆大霉素和环丙沙星抗菌药物的有效释放,可能有助于改善长期难愈合的并发症。 (2)聚乙二醇/聚环氧乙烷:聚乙二醇是一种聚醚也被称为聚环氧乙烷或聚氧化乙烯,这取决于它的分子质量。它具有亲水性、生物相容性、弹性、无毒性和非免疫原性的物质,抗蛋白吸附,并且可通过阴离子或阳离子聚合反应合成环氧乙烷[55]。聚乙二醇还可以与其他聚合物共混,如壳聚糖、聚乳酸-乙醇酸和聚富马酸,以提高其固有的溶解度、侵蚀、热性能、力学性能及结晶度和黏度。基于聚乙二醇嵌段共聚物的形成也是一个可行的选择。 基于聚乙二醇的水凝胶已被用于许多生物医学中,包括伤口敷料[56-57]。此外,因为这种类型的水凝胶可促进皮肤细胞增殖,增强胶原蛋白沉积和减少瘢痕形成,已被证明有利于糖尿病伤口愈合[58-61]。 (3)聚(α-酯):聚乳酸由于在药物释放和组织工程系统中有相对较高的强度和适当的降解率,是一个最流行的脂肪族聚酯之一。事实上,聚乳酸具有良好的机械特性、降解可控性和良好的生物相容性[51,62],然而其强大的疏水性限制了其潜在的应用。聚乙醇酸是另一个聚(α-酯),其亲水性和降解速度在水溶液中或在体内相对聚乳酸较快[63]。聚乳酸-羟基乙酸具有很强的生物相容性,可控的生物降解性,此外,它可加工成许多不同的形式,如粉末、颗粒、纤维等,纳米粒子聚乳酸-羟基乙酸微球rhEGF被证明提高成纤维细胞的生长率[58,61]。 聚己内酯是另一个具有生物相容性和可生物降解的聚酯,由于它可促进伤口更快愈合并减少炎症反应,已被用于组织再生和伤口愈合方面的研究。聚己内酯降解速率较聚乳酸、 聚乙醇酸和聚乳酸-羟基乙酸明显缓慢[58-59]。 2.3 其他药物对糖尿病足溃疡的治疗 现阶段,针对糖尿病足溃疡的治疗方法有抗菌药物、生长因子、传统药物、辅助疗法及创口敷料的应用等。糖尿病足长期溃疡和严重感染是导致坏疽、截肢的重要原因。因此,伤口护理、抗生素使用对伤口愈合和组织修复也极为重要,抗菌剂的选择很大程度上取决于微生物学的数据、临床评估和感染严重程度。 有科学家研究表明,来源于传统草药的天然合成产物属于初级保健系统。植物中存在的各种生命维持成分,可用于某些感染性疾病和慢性伤口的治疗。ampucare是中草药成分,其活性成分主要是印楝和姜黄,属于一种油基药物,用于局部治疗烧伤创面、创面等,具有抗炎和抗菌性能,同时也提高了创面血流量,有随着组织再生起到免疫调节作用的功能。贝卡普勒明是一种用于局部治疗糖尿病下肢溃疡(脚、脚踝和腿)药物,属于血小板源性生长因子类药物,可促进细胞的分裂和新的皮肤的形成。通过大鼠糖尿病模型试验表明,ampucare治疗组较贝卡普勒明治疗组在在糖尿病模型大鼠的伤口愈合中的功效更 好[20]。 多项研究已报道可使用辅助疗法改善糖尿病足溃疡伤口感染、愈合情况。这些辅助措施包括负压伤口治疗[7]、重组粒细胞集落刺激因子系统性高压氧疗法、幼虫(蛆)疗法和蜂蜜的使用[30,33]。"
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