Chinese Journal of Tissue Engineering Research ›› 2015, Vol. 19 ›› Issue (3): 465-471.doi: 10.3969/j.issn.2095-4344.2015.03.025
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Jin Qiao, Shen Wen
Online:
2015-01-15
Published:
2015-01-15
About author:
Jin Qiao, Physician, Department of Orthopedics, Xuanwu TCM Hospital, Beijing 100050, China
CLC Number:
Jin Qiao, Shen Wen . Percutaneous vertebroplasty and percutaneous kyphoplasty with bone cement injection: re-evaluation of their clinical applications[J]. Chinese Journal of Tissue Engineering Research, 2015, 19(3): 465-471.
2.1 骨水泥经皮PVP、PKP的发展过程 1984年法国神经放射科医师Galibert及Deramond[1]首次将PVP应用于临床,并于1987年首先报道了运用PVP治疗椎体侵袭性血管瘤,取得了良好的疗效;1989年Kaemmerlen等[2]将这一技术成功应用于脊椎转移瘤;1990年Galibert等又进一步提出该技术可扩大应用于椎体恶性肿瘤及 OVCFs等。此后这一技术被广泛用于治疗骨质疏松症及肿瘤等所致的椎体压缩骨折和骨质破坏,其以止痛迅速、创伤小、安全性高、操作简便等优点逐渐在世界范围内得到应用。1994年,美国的Reiley等首先提出PKP的构想,即在注入骨水泥之前,在塌陷的椎体内置入一种可膨胀性球囊,通过扩张球囊抬升终板,达到恢复椎体高度、矫正后凸畸形,进而能够以较低压力注入骨水泥,降低骨水泥渗漏风险[3]。Liebermann等[4]在Belkoff和Mathis体外试验的基础上开始在人体行PKP手术,此项技术于1998年被美国FDA 批准应用于临床,在之后的十几年里被迅速推广,已逐步成为OVCFs的首选治疗方法。 PVP、PKP在治疗骨质疏松性椎体骨折、疼痛性椎体血管瘤、骨髓瘤及各种脊柱转移瘤等方面取得了满意的效果,近年来的研究发现,对于无神经压迫症状的爆裂骨折,这种微创方法也可取得满意疗效,可减少患者卧床时间[5]。PVP与PKP具有创伤小、手术安全性高等优点,Mendel等[6]采用脊柱、癌症、肿瘤、PVP、PKP、椎体强化、栓塞、预后、安全性、疼痛、生活质量11个关键词搜索到1 665篇文献,其中28篇文献对877例 1 599个节段进行了PVP手术,其神经并发症发生率在0-8.1%;12篇文献对333例481个节段采用PKP手术,均未出现神经并发症;即使是合并症较多、手术耐受性较差的高龄患者,也可以接受PKP治疗,改善临床症状,提高生活质量[7]。但是对PVP治疗OVCFs的质疑也从未停止过,2009-08-06出版的《新英格兰医学杂志》发表了两项关于PVP治疗OVCFs的多中心、随机双肓、安慰剂对照研究结果显示,OVCFs患者PVP术后疼痛和功能的改善程度与假手术(安慰对照)组相似[8-9],虽然仔细分析后发现这两项研究在病例纳入标准、样本数量、亚组分类等若干方面或多或少存在一定缺陷,还是引起了广泛的关注和讨论,PVP手术尽管受到了一定质疑,但目前已在临床广泛开展应用多年,而且对于一种治疗方法效果的评价,最好是通过循证医学研究的方法来证实其有效性,这是近年来医学研究必须遵循的原则,相信每一位亲自进行过椎体成形术的医生都可以深切地体会到这种技术的有效性,所以在没有充分的循证医学研究证实PVP治疗OVCFs无效之前,大部分医生还是会继续向符合指征的患者推荐这种手术。 2.2 PVP、PKP骨水泥渗漏 PVP、PKP的并发症主要包括骨水泥渗漏、相邻椎体骨折、肋骨骨折、过敏反应、骨水泥毒性反应与肺栓塞等,骨水泥渗漏是PVP、PKP手术最常见的并发症,据统计,在全部临床并发症中,有超过50%都与骨水泥的渗漏有关,骨水泥渗漏按照部位可分为硬膜外渗漏、椎间孔渗漏、椎间盘渗漏、脊柱旁软组织渗漏、椎旁静脉渗漏和穿刺针道渗漏等[34]。绝大多数的骨水泥渗漏不会引起临床症状,Eck等[35]对行椎体PKP手术的Meta分析中,共纳入3 034例行PKP手术患者,骨水泥渗漏总发生率为7%,而有症状的渗漏发生率为0.3%。 椎管内硬膜外渗漏或椎间孔渗漏会造成脊髓或神经根受压,引起根性症状或截瘫表现;另一个骨水泥渗漏所致的严重并发症即是肺栓塞,椎体内有丰富的静脉 丛走行,如骨水泥渗漏至静脉后随血流到肺部,可导致肺栓塞发生。少量PMMA 进入椎管和肺动脉者不会引起临床症状,但达到一定量后就会引起严重后果,甚至死亡,患者会出现呼吸困难、心动过速、血氧下降、咳嗽、咳痰等症状[36],致死性肺栓塞是PVP、PKP罕见的并发症,Hulme等[37]发表的系统综述中总结PVP 、PKP 术后肺栓塞的风险分别是0.6%和0.01%。有研究表明部分肺栓塞病例无明显症状或仅有一过性的胸痛,因此容易被忽视、漏诊。肺栓塞一旦引起临床症状,病情凶猛,因而重在预防,有文献报道发生肺栓塞的概率与一次手术的椎体数量及PMMA 注入体积呈正相关,因此强调1次手术不宜超过3个节段,以降低手术风险。 Hadjipavlou等[38]统计分析2 729个行PVP术的椎体和1 279个行PKP术的椎体骨水泥渗漏率:总体渗漏率PVP为29%,PKP仅为8.4%,并且PVP的硬膜外渗漏率明显较PKP高,而硬膜外渗漏可导致神经根或脊髓损伤。Hulme等[37]分析了69个临床研究的结果,发现总体渗漏率PVP高达41%,而PKP仅为9%;硬膜外骨水泥渗漏占PVP渗漏的比例高达32%,而PKP仅11%。由此可见,PVP的骨水泥渗漏以椎管内硬膜外渗漏较多见,可引起灾难性的后果。Layton等[39]临床观察同样发现PKP手术骨水泥渗漏率较PVP低;一项Mete分析结果表明PKP的平均渗漏率仅为8%左右[40],因此总的来说,PKP在骨水泥渗漏的风险方面较PVP安全性高,这可能与PVP灌注剂比PKP稀薄,并且注射压力较大有关。 无论是PVP还是PKP,术前需完善影像学检查,评价椎体终板是否完整,术中穿刺针远离终板,待骨水泥较黏稠时再注射,推注过程宜缓慢,以降低注射压力,也可先注射0.5-1.0 mL,稍等片刻(15-20 s)后再继续注射,减少骨水泥渗漏的概率。另外术中需要有良好的监测设备,在密切监测下缓慢注射骨水泥,一旦发现有渗漏迹象立即停止,这也是防止渗漏的关键措施。由于疼痛缓解程度与注射量不成正比,所以不宜追求骨水泥充填量或完全填满椎体而增加骨水泥渗漏风险。 2.3 PVP、PKP术后椎体再发骨折 随着PVP、PKP临床应用时间的延长,有关PVP、PKP术后再骨折的报道逐渐增多,而文献报道最多和争议最大的是手术椎体再骨折和手术相邻椎体再骨折[10]。 2.3.1 手术椎体再骨折 随访发现,PVP、PKP术后均会出现手术椎体再发骨折,手术椎体再发骨折主要通过临床表现及影像学诊断,患者术后可有反复腰背痛或疼痛缓解后复发等表现,也有患者无明显疼痛症状,仅在影像学检查时发现手术椎体再发骨折或椎体高度丢失,对于再发骨折的诊断及定义,目前尚无统一标准。有学者认为,PVP、PKP由于治疗本身及机体对骨水泥的异物反应,加速了局部的骨质吸收,从而增加了手术椎体再发骨折的风险[11-12]。Kim等[11]随访发现,PKP术后手术椎体再骨折发生率为12.5%(10/80),发生时间平均为术后3.4个月,认为行PKP手术时球囊扩张对周围正常骨组织并没有起到挤压的作用,而仅仅是像千斤顶一样将正常骨组织抬高而已,骨水泥注入椎体后只在球囊扩张的部位聚集成团块,并没有向周围骨组织弥散,骨水泥团块与上下终板间存在部分无骨水泥填充的区域,而此处的松质骨由于本身骨质疏松的原因已是很脆弱,在长期应力作用下此区域很容易出现再骨折,使得椎体高度丢失,这也是PKP术后手术椎体高度丢失大于PVP的原因。Wilke[13]也持同样观点,他发现PKP术后手术椎体上终板中央塌陷比PVP严重,认为手术椎体上终板塌陷与骨水泥在椎体内弥散不充分有关,而PVP组由于骨水泥注射压力较大,在椎体内弥散相对充分,故上终板塌陷发生率较低。Lin等[14]研究发现增大的椎体前缘高度是PKP术后手术椎体新发骨折最大的危险因素,其强调PKP手术不应过分恢复椎体高度、减少畸形程度。国内学者杨丰建等[15]对PVP、PKP术后患者随访1年,发现PKP组手术椎体高度丢失量大于PVP组。 虽然PVP、PKP术后均会发生手术椎体再骨折,但经过PVP术后大样本资料的长期随访,Chen等[12]发现PVP术后手术椎体再发骨折的发生率较低,为0.56%(10/1 800),且发生时间较晚,平均在38.7周,进一步比较后发现,手术椎体再骨折组椎体前缘高度恢复率大于无再骨折组。Heo等[16]同样发现PVP术中不是所有椎体高度恢复都是有益的,过度恢复手术椎体高度也是再发骨折的一个危险因素,在其研究中PVP术后手术椎体再骨折的发生率为2.4%(6/250),并发现手术椎体再发压缩骨折与骨水泥弥散进入血管并栓塞,导致相应区域发生缺血性骨坏死有关,除此之外,其认为PVP、PKP术后手术椎体再发骨折与骨质疏松症密切相关,术后需使用药物规律治疗骨质疏松症,降低手术椎体再骨折的风险。 由此可以得出,适当的矫正后凸畸形和恢复椎体高度可以恢复脊柱的正常生理曲度,但纠正的角度及高度并非越大越好,至于后凸角度及椎体高度恢复至何种程度才是最有益的?仍有待进一步的生物力学及临床研究证实。 2.3.2 相邻椎体再骨折 国内外已有相关文献报道PVP、PKP术后出现非手术椎体再骨折现象,尤其是手术椎体相邻椎体再骨折,或许是因为对于邻近椎体再发骨折的诊断标准不一致,文献报道其发生率差异很大(8%-52%)[17],然而相邻椎体再骨折是手术椎体注入PMMA后增加了治疗节段的硬度,改变了脊柱的生物力学及负荷传递机制所致?还是骨质疏松的自然病程?目前仍存在争议。Uppin等[18]报道177例患者行PVP治疗,其中22例患者36个椎体发生继发性骨折,有24个继发骨折出现在相邻节段椎体。田斐等[19]总结了9篇有关PVP、PKP治疗OVCFs的文献发现,PVP、PKP术后患者继发骨折的比例平均为17%,邻近椎体骨折所占总体继发骨折的比例加权统计后大约为62%。 有学者认为椎体成形治疗增加了相邻椎体再发骨折的风险[20],至于相邻椎体骨折的相关因素,研究发现PVP或PKP向椎体注入骨水泥后,椎体钢度上升,加速了椎间盘退变,尤其当骨水泥渗漏至椎间盘时增加了相邻椎体骨折的风险[21-22];然而由Klazen等[23]所牵头的一项前瞻性多中心随机对照研究发现椎间盘渗漏与邻近椎体再骨折发生率无关;Lee等[17]也得出同样结论,认为椎间盘渗漏并非邻近椎体再骨折的危险因素。有临床研究发现相邻椎体再骨折与骨密度指数、后凸角的大小有关,且后凸角度恢复程度与相邻椎体再骨折发生率呈正相关,强调手术不宜过度恢复椎体高度及后凸角度,由于椎体高度的恢复与骨水泥注射体积呈正相关,目前尚不能明确这种新发椎体骨折的风险是椎体高度恢复引起、还是骨水泥注射体积增加的继发效应[10,20,24]。Berlemann等[25]通过力学实验研究发现,经过PMMA强化后的椎体硬度增加很多,增加的硬度改变了脊柱的力学传递机制,并且首次治疗椎体的数量越多对整个脊柱负荷传递的影响就越大,其他椎体新发骨折的概率就越大。相关实验发现,手术椎体骨水泥填充率越高邻近椎体塌陷所需负荷越小,邻近椎体再骨折发生率越高[26]。徐晖等[27]有限元分析同样表明,随着骨水泥填充量的增加,相邻椎体骨折的发生率随之增高。也有学者则持相反意见[28-29],认为邻近椎体再骨折与手术椎体骨水泥的注射量无关,与PVP、PKP手术也无关[23,30]。Felder-Puig等[30]总结了8篇临床综述及11篇对照研究后得出结论为邻近椎体再骨折与PVP、PKP手术无关。Wardlaw等[31]所做的随机对照研究发现PKP术后非手术椎体再骨折发生率与保守治疗相似,PKP手术并不增加非手术椎体再骨折的发生率,非手术椎体再骨折只是骨质疏松自然病程的一部分。Movrin[20]则认为邻近椎体再骨折与骨质疏松(骨密度、患者年龄)症相关,患者年龄越大骨质疏松越严重,发生邻近椎体再骨折的风险就越大,骨质疏松症是一种全身性疾病,为防止其他椎体骨折,PVP、PKP后不能忽视抗骨质疏松症的全身治疗。研究发现在椎体成形治疗前、治疗后使用抗骨质疏松药物能降低椎体再骨折发生率[32]。 Rohlmann等[33]通过力学实验证实PMMA注入椎体后,仅轻微增加了相邻椎间盘的压力与相邻椎体终板的最大Von Mises压力,而骨折引起的背部肌力增大对椎间盘与终板的影响则远大于骨水泥强化所造成的影响,相邻椎体及其它椎体继发骨折是增大的脊柱负荷所导致,与手术无关。总之,PVP、PKP术后相邻椎体再发骨折是多种因素所致,其发生机制尚不明了,需要临床医生对再发骨折的病因及机制不断深入研究及探索,降低其发生率,从而减轻患者的痛苦和负担,提高生活质量。 目前,为学者所接受的PVP、PKP术后再发椎体骨折原因大体可以归为两类:椎体再发骨折是骨质疏松症自然病程的一部分,PVP、PKP手术并不增加椎体再骨折的风险; PVP、PKP恢复了椎体高度,矫正了后凸畸形,增加了椎体硬度,这些对脊柱的生物力学均会产生影响,改变了椎体负荷传递机制,进而增加了椎体继发骨折的风险。椎体再发骨折(包括手术椎体和非手术椎体)的危险因素是复杂多样的,这可能也是临床上常常得出矛盾结论的原因,以上两种观点均需大量基础及临床流行病学研究结果予以证实。 2.4 PVP、PKP手术方式的选择 对于骨质疏松及良恶性肿瘤引起的椎体骨质破坏,如何选择手术方式,是PKP?还是PVP?哪一种手术方式更好?想必做过这两种手术的医生都有过相同的疑问。综合文献来看,PVP、PKP在改善脊柱伤病的局部症状、提高整体健康、止痛等方面均比传统方法均具有更好的疗效,且两者并发症发生率都较低[35,41]。Eck等[35]对PVP、PKP治疗 OVCFs及椎体肿瘤等各种原因引起的椎体骨折进行了一项荟萃分析,结果发现PVP能使患者的目测类比评分从术前的8.36分降至术后2.68分,PKP能使患者的目测类比评分从术前的8.06分降至术后3.46分,这两种手术均能有效缓解患者疼痛。仅从止痛效果这一点来讲,PKP并不具有显著优越性,PKP的优势在于能够更好恢复椎体高度、改善后凸畸形[42];Grohs等[43]认为PKP较PVP能够更大程度的纠正脊柱后凸畸形,改善脊柱不正常应力。但也有相关研究发现PVP对恢复椎体高度和矫正后凸畸形同样起到一定程度的作用[44-46];Hiwatashi等[44]测量了37例共85节椎体PVP前后高度情况,结果椎体高度平均增加2.2 mm,最大恢复高度为15 mm。Murphy等[47]综合文献将PKP与PVP作了进一步比较后发现,PVP、PKP对椎体高度的恢复以及后凸畸形矫正的差异并不像想象的那么大;Mathis[48]认为对于急性或亚急性椎体骨折的患者,体位复位和牵引是恢复椎体高度和矫正后凸畸形的主要原因,而PKP的球囊撑开仅起着小部分的作用,PVP利用骨水泥注射时的压力联合手术时体位复位,对椎体高度也有一定程度的恢复作用。这可能是前纵韧带对伤椎上下椎间盘的牵拉作用使发生压缩的椎体皮质骨被拉开而获得初步复位,此时有利于骨水泥能以较低压力灌注弥散于骨小梁间隙内,扩大骨水泥与椎体的接触面积,减少骨折微动,使椎体承受压力更大[49-50],故对于此类骨折椎体,若手术医师能够熟练掌握体位复位技巧,可行PVP治疗,降低患者医疗费用。Alvarez等[51]通过随访及临床观察了解到,PVP可显著提高 OVCFs患者的生活质量;有生物力学研究表明[52],PVP、PKP均能明显增加骨折椎体强度,恢复刚度。但Tomita等[53]认为对椎体刚度的恢复,PKP组不及PVP组。 虽然PKP能够更好恢复椎体高度、改善后凸畸形、降低骨水泥渗漏风险,但PVP具有价格低廉、手术操作简单、医师和患者受X射线辐射损伤较小、远期并发症少等优点,况且目前对椎体高度和后凸畸形矫正的益处还存在争议,所以PVP目前仍有广泛的临床应用价值,将适合PVP治疗的病例综述如下: 2.4.1 骨折椎体延迟愈合或长期不愈合 OVCFs致椎体内小动脉发生损伤,可发生非感染性骨缺血坏死[54],此类椎体侧位X射线片示椎体内出现低密度透亮裂隙,即气体聚积于骨内,脊柱后伸时裂隙内出现气体而前屈时消失,动力侧位X线片表现为“开合征”,故此类椎体手术时,体位复位效果较好,有学者研究发现椎体骨折不愈合患者可以通过体位复位使骨折椎体获得良好的复位,实施PVP治疗可获得满意疗效[55]。 2.4.2 椎体血管瘤 Deramond等[56]认为大多数椎体血管瘤无形态改变,不需复位;椎体骨壁完整,骨水泥渗漏风险较小,故疼痛性椎体血管瘤可行PVP治疗,缩短手术时间,降低医疗费用。Jang等[57]临床研究发现PVP可有效改善椎体血管瘤所引起的疼痛,同时提高椎体稳定性。需要强调的是椎体血管瘤血运较丰富,要掌握好骨水泥灌注时间和灌注量,严格按照比例配制骨水泥,而且必须在“黏稠期”时进行注射,结合良好的术中影像监视,不要追求骨水泥弥散而增加注入量,避免骨水泥渗漏至静脉后导致肺栓塞。 2.4.3 陈旧性椎体压缩骨折 陈旧性椎体压缩骨折由于椎体骨小梁压缩后接触紧密,往往压缩程度比较严重,故陈旧骨折或愈合期的骨折复位非常困难,此时PKP球囊复位能力有限,难以纠正椎体发生的形变。Garfin等[58]临床观察发现,PKP对骨折超过3个月的椎体高度恢复不明显,此类椎体行PVP注入骨水泥时压力较大,骨水泥渗漏风险较高,注入量少且易导致分布不均匀,在纠正后凸畸形方面也很难获得满意临床效果。有学者认为陈旧性 OVCFs行PVP治疗时对骨水泥推注时机及推注过程要求较高,需要经验丰富的手术医师谨慎操作,预防骨水泥渗[59]。 2.4.4 重度椎体压缩骨折 重度椎体压缩骨折椎体塌陷严重,椎体与椎弓根轴线往往不在同一水平,穿刺时很难达到理想位置,当针道贴近终板时,PKP用精细钻扩髓、球囊扩张有增加终板骨折和渗漏的危险。回顾性研究发现重度椎体压缩骨折PKP渗漏率高达31.3%,其中椎间盘渗漏占53.3%,这很可能与终板破裂有关[60]。PVP术中穿刺定位相对容易,具有一定优势,因此,对重度椎体压缩骨折,球囊置人困难,扩张会破坏终板,可行PVP直接注射,简化操作步骤。Hentschel等[61]研究发现对于椎体塌陷严重(不到原高度1/3)时PKP操作时置入球囊比较困难,球囊张开时容易引起上下终板破裂,增加骨水泥渗漏风险,而PVP治疗重度椎体压缩骨折可取得良好疗效。Chin等[62]观察发现先采用体位复位使椎体高度得到部分恢复,再行PVP的方法,可取得更好的效果。 2.4.5 恶性椎体肿瘤 有学者建议椎体恶性转移性肿瘤行PVP治疗,因为这类病椎塌陷大多不严重,而且PKP球囊扩张有导致肿瘤扩散的危险[63]。恶性转移性肿瘤转移至椎体时,椎体后缘可有破坏,椎体后壁骨折或破坏时球囊扩张有使骨块向后方移位压迫脊髓或神经根的风险,而Shimony等[64]发现对伴有椎体后缘破坏的恶性转移瘤椎体行PVP治疗,可获得满意疗效,神经损伤等并发症较低。 对于椎体骨髓瘤患者,PVP同样可以获得优良疗 效[65];Foumey等[66]报道PVP治疗多发性骨髓瘤椎体病变能够达到理想的止痛效果,能够加强病变椎体的强度和稳定性。"
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