脊柱外科杂志  2021, Vol.19 Issue(5): 296-301   PDF    
经皮椎体成形术联合短节段椎弓根螺钉内固定术和经皮椎体成形术中采用填充网袋内注入骨水泥治疗无神经症状Ⅲ期Kümmell病
朱云荣1, 杨武1, 张云庆1, 许国华2     
1. 江阴市人民医院骨科,无锡 214400;
2. 海军军医大学长征医院骨科,上海 200003
摘要: 目的 探讨经皮椎体成形术(PVP)联合短节段椎弓根螺钉内固定术和PVP术中采用填充网袋内注入骨水泥治疗无神经症状Ⅲ期Kümmell病的疗效。方法 回顾性分析江阴市人民医院2015年1月—2019年12月收治的52例无神经症状Ⅲ期Kümmell病患者的临床资料。前期24例患者采用PVP联合短节段椎弓根螺钉内固定术治疗(A组),后期28例采用PVP术中向置入的填充网袋内注入骨水泥治疗(B组)。记录2组手术时间、术中出血量、住院时间、医疗费用及术前、术后3 d、术后3个月、末次随访时疼痛视觉模拟量表(VAS)评分、Oswestry功能障碍指数(ODI)、伤椎前缘高度压缩比、节段后凸Cobb角;观察术后并发症情况。结果 所有手术顺利完成。所有患者随访时间>12个月。B组手术时间、术中出血量、住院时间和医疗费用均少于A组,差异有统计学意义(P <0.05)。2组患者术后VAS评分和ODI均较术前显著改善,差异有统计学意义(P <0.05)。A组术后3个月及末次随访时VAS评分和ODI较术后3 d降低,差异均有统计学意义(P < 0.05);B组术后3个月及末次随访时VAS评分和ODI与术后3 d相比,差异无统计学意义(P > 0.05)。B组术后3 d VAS评分和ODI低于A组,差异均有统计学意义(P <0.05);末次随访时,2组VAS评分和ODI差异无统计学意义(P >0.05)。2组患者术后伤椎前缘高度压缩比和节段后凸Cobb角均较术前改善,差异有统计学意义(P <0.05)。B组术后3 d、术后3个月及末次随访时伤椎前缘高度压缩比及术后3 d、术后3个月节段后凸Cobb角大于A组,差异均有统计学意义(P <0.05)。A组发生骨水泥渗漏8例,B组3例,差异有统计学意义(P <0.05)。2组术后均未出现下肢神经症状和其他严重并发症。结论 对于无神经症状Ⅲ期Kümmell病患者,PVP联合短节段椎弓根螺钉内固定术和PVP术中采用填充网袋内注入骨水泥可获得相似的临床效果,前者更有助于改善伤椎高度、矫正后凸畸形,后者创伤小、恢复快且医疗费用低。
关键词: 胸椎    脊柱骨折    骨折,压缩性    骨质疏松    内固定器    骨代用品    椎体成形术    
Percutaneous vertebroplasty combined short-segmental pedicle screw fixation and percutaneous vertebroplasty with cement injected into filling mesh bag for treatment of stage Ⅲ Kümmell disease without neurological symptom
Zhu Yunrong1, Yang Wu1, Zhang Yunqing1, Xu Guohua2     
1. Department of Orthopaedics, Jiangyin People's Hospital, Wuxi 214400, Jiangsu, China;
2. Department of Orthopaedics, Changzheng Hospital, Navy Medical University, Shanghai 200003, China
Abstract: Objective To investigate the effect of percutaneous vertebroplasty(PVP) combined short-segmental pedicle screw fixation and PVP with cement injected into filling mesh bag for the treatment of stageⅢ Kümmell disease without neurological symptom. Methods From January 2015 to December 2019,the clinical data of 52 patients with stageⅢ Kümmell disease without neurological symptom in Jiangyin people’s Hospital were retrospectively analyzed. In the early stage,24 patients were treated with PVP combined short-segmental pedicle screw fixation(group A),and in the late stage,28 patients were treated with PVP with cement injected into filling mesh bag(group B). The operation time,intraoperative blood loss,hospital stay,medical expenses,and visual analogue scale(VAS) score,Oswestry disability index(ODI),compression ratio of anterior edge height of injured vertebra and segmental kyphosis Cobb’s angle at pre-operation,postoperative 3 d,postoperative 3 months and the final follow-up were recorded. The postoperative complications were observed. Results All the operations were successfully completed. All the patients were followed up for more than 12 months. The operation time,intraoperative blood loss,hospital stay and medical expenses in group B were less than those in group A,and the differences werestatistically significant(P <0.05). The VAS score and ODI of the 2 groups were significantly improved after operation compared with pre-operation,and the differences were statistically significant(P <0.05). In group A,the VAS score and ODI at postoperative 3 months and the final follow-up were significantly lower than those at postoperative 3 d,and the differences were statistically significant(P <0.05). In group B,there was no significant difference in VAS score and ODI between postoperative 3 months,the final follow-up and postoperative 3 d(P >0.05). At postoperative 3 d,the VAS score and ODI of group B were lower than those of group A,and the differences were statistically significant(P <0.05). At the final follow-up,there was no significant difference in VAS score and ODI between the 2 groups(P >0.05). The compression ratio of anterior edge height of injured vertebra and segmental kyphosis Cobb’s angle of the 2 groups were improved after operation compared with pre-operation,and the differences were statistically significant(P <0.05). At postoperative 3 d,postoperative 3 months and the final follow-up,the compression ratio of anterior edge height of injured vertebra and the segmental kyphosis Cobb’s angle in group B were higher than those in group A,and the differences were statistically significant(P <0.05). There were 8 cases of bone cement leakage in group A and 3 in group B,and the difference was statistically significant(P <0.05). There were no neurological symptoms of the lower extremity and other serious complications in both groups. Conclusions For patients with stageⅢ Kümmell disease without neurological symptom,PVP combined short-segmental pedicle screw fixation and PVP with cement injected into filling mesh bag can obtain similar clinical effect. The former is more helpful to improve the height of injured vertebra and correct kyphosis,while the latter with less invasive,faster recovery and low medical expenses.
Key words: Thoracic vertebrae    Spinal fractures    Fractures, compression    Osteoporosis    Internal fixators    Bone substitutes    Vertebroplasty    

Kümmell病是一种特殊类型的骨质疏松性椎体压缩性骨折,主要表现为椎体轻微骨折后椎体逐渐塌陷,出现后凸畸形[1-2]。Kümmell病常呈进行性发展,难以自愈,若不及时治疗,会导致患者长期腰背部疼痛,严重者还会出现下肢瘫痪[3]。经皮椎体成形术(PVP)和经皮椎体后凸成形术(PKP)治疗Ⅰ、Ⅱ期Kümmell病取得了良好的疗效,可达到消除疼痛、稳定椎体的目的[4-5]。目前对于无神经症状的Ⅲ期Kümmell病的治疗方式仍存在争议[6]。本研究对2015年1月—2019年12月江阴市人民医院收治的52例无神经症状的Ⅲ期Kümmell病患者临床资料进行回顾性研究,比较PVP联合短节段椎弓根螺钉内固定术和PVP术中采用填充网袋内注入骨水泥的临床疗效,以期为该类患者的临床手术决策提供参考。

1 资料与方法 1.1 一般资料

纳入标准:①按Li分期标准[7],确诊为Ⅲ期Kümmell病;②骨密度T值≤-2.5;③MRI和CT示椎管受累,但无神经症状表现。排除标准:①有手术禁忌证;②脊柱感染或肿瘤。

按照以上标准共纳入患者52例,前期24例患者采用PVP联合短节段椎弓根螺钉内固定术治疗(A组),后期28例采用PVP术中向置入的填充网袋内注入骨水泥治疗(B组)。A组男5例、女19例,年龄为(63.4±7.4)岁,骨密度T值为-(3.4±0.4);病变节段:T10 5例,T11 4例,T12 6例,L1 5例,L2 4例。B组男7例、女21例,年龄为(65.4±6.4)岁,骨密度T值为-(3.2±0.5);病变节段:T10 6例,T11 6例,T12 7例,L1 4例,L2 5例。2组患者术前一般资料差异无统计学意义(P > 0.05),具有可比性。

1.2 手术方法

所有手术均由同一手术经验丰富的医师团队完成。骨水泥为OSTEOPAL® V(Heraeus公司,德国),骨填充网袋为Mesh-HoldTM(山东冠龙医疗用品有限公司,中国),椎弓根螺钉系统为Legacy(Medtronic公司,美国)。

A组患者全身麻醉后取俯卧位。透视确定伤椎节段,体位复位后术区消毒,做背部正中切口,经椎旁肌间隙入路显露进针点。按照人字嵴置钉法于伤椎上下节段各置入椎弓根螺钉2枚,折弯连接棒,先拧紧尾侧钉尾,再拧紧头侧钉尾。术中C形臂X线机透视,若发现伤椎高度复位不满意,可行头侧螺钉撑开。移除两侧连接棒后观察伤椎高度有无丢失,若高度没有变化则在C形臂X线机透视下建立骨水泥通道,两侧分别注入聚甲酯丙烯酸甲酯(PMMA)骨水泥2 ~ 4 mL,具体注入量根据术中透视决定,原位锁定连接棒。若移除两侧连接棒后高度有丢失则再次撑开复位后依次单侧分别注入骨水泥。放置引流管后关闭切口。

B组患者采用局部麻醉,取俯卧位。根据透视确定伤椎节段,体位复位后术区消毒,在穿刺点做一长约3 mm的切口,穿刺针进入椎体后更换导针建立工作通道,置入扩张器,C形臂X线机透视下逐步扩张并旋转,置入网袋。通过推注器向网袋内注入PMMA骨水泥3 ~ 5 mL,C形臂X线机透视下观察推注骨水泥过程中椎体高度恢复及骨水泥弥散满意后关闭切口。

A组术后48 h拔除引流管后腰围保护下下床活动,B组术后24 h腰围保护下下床活动,所有病例定期随访并规范抗骨质疏松治疗。

1.3 疗效评价

记录2组手术时间、术中出血量、住院时间、医疗费用及术前、术后3 d、术后3个月、末次随访时疼痛视觉模拟量表(VAS)[8]评分、Oswestry功能障碍指数(ODI)[9]、伤椎前缘高度压缩比、节段后凸Cobb角;观察术后并发症情况。所有临床及影像学随访资料统计均由同一位医师完成。

1.4 统计学处理

采用SPSS 20.0软件对数据进行统计分析,采用Shapiro-Wilk检验判断2组数据是否呈正态分布,呈正态分布的计量资料以x±s表示,组间比较采用独立样本t检验,组内比较采用配对样本t检验;计数资料采用χ2检验;以P < 0.05为差异有统计学意义。

2 结果

所有手术顺利完成。所有患者随访时间 > 12个月,A组随访(15.6±2.4)个月,B组随访(16.4±1.9)个月。B组手术时间、术中出血量、住院时间和医疗费用均少于A组,差异有统计学意义(P < 0.05,表 1)。2组患者术后VAS评分和ODI均较术前显著改善,差异均有统计学意义(P <0.05,表 1)。A组术后3个月及末次随访时VAS评分和ODI较术后3 d降低,差异有统计学意义(P <0.05,表 1);B组术后3个月及末次随访时VAS评分和ODI与术后3 d相比,差异无统计学意义(P >0.05)。B组术后3 d VAS评分和ODI低于A组,差异均有统计学意义(P <0.05,表 1);末次随访时,2组VAS评分和ODI差异无统计学意义(P > 0.05)。2组患者术后伤椎前缘高度压缩比和节段后凸Cobb角均较术前改善,差异有统计学意义(P <0.05,表 1)。B组术后3 d、术后3个月及末次随访时伤椎前缘高度压缩比及术后3 d、术后3个月节段后凸Cobb角大于A组,差异均有统计学意义(P <0.05,表 1)。A组发生骨水泥渗漏8例,B组3例,差异有统计学意义(P <0.05,表 1)。2组术后均未出现下肢神经症状和其他严重并发症。2组典型病例影像学资料见图 12

表 1 2组疗效评价指标 Tab. 1 Efficacy evaluation index of 2 groups

女,66岁,T12 Kümmell病a:术前X线片示T12压缩b:术前CT示椎管狭窄c:术前MRI示T12裂隙d:术后3 d X线片示骨折复位、后凸畸形改善e:术后3个月X线片示伤椎高度较术后3 d有所丢失f:末次随访X线片示伤椎高度进一步丢失,后凸畸形进展 Female, 66 years old, T12 Kümmell disease a: Preoperative roentgenograph shows T12 compression b: Preoperative CT shows spinal stenosis c: Preoperative MRI shows T12 fissure d: Roentgenograph at postoperative 3 d shows satisfactory reduction and improvement of kyphosis deformity e: Roentgenograph at postoperative 3 months shows a loss of fractured vertebral body height compared with postoperative 3 d f: Roentgenograph at final follow-up shows a further loss of fractured vertebral body height and progressive kyphosis deformity 图 1 A组典型病例影像学资料 Fig. 1 Imaging data of a typical case in group A

女,63岁,T12 Kümmell病a:术前X线片示T12高度丢失,局部后凸畸形b:术前CT示T12真空裂隙,终板骨硬化c:术前MRI示T12椎体内液体d:术后3 d X线片示伤椎高度、后凸畸形改善e:术后3个月X线片示伤椎高度较术后3 d有所丢失f:末次随访X线片示伤椎高度进一步丢失,后凸畸形进展 Female, 63 years old, T12 Kümmell disease a: Preoperative roentgenograph shows a loss of T12 vertebral body height and kyphosis deformity b: Preoperative CT shows T12 vertebral vacuum fissure and endplate osteosclerosis c: Preoperative MRI shows vertebral effusion in T12 vertebral body d: Roentgenograph at postoperative 3 d shows satisfactory reduction and improvement of kyphosis deformity e: Roentgenograph at postoperative 3 months shows a loss of fractured vertebral body height compared with postoperative 3 d f: Roentgenograph at final follow-up shows a further loss of fractured vertebral body height and progressive kyphosis deformity 图 2 B组典型病例影像学资料 Fig. 2 Imaging data of a typical case in group B
3 讨论

Kümmell病又称创伤后椎体缺血性骨坏死,后期常常造成椎体塌陷、后凸畸形甚至脊髓受压[10-12]。Kümmell病分为3期:Ⅰ期,侧位X线片示椎体高度完整或轻度压缩,椎体高度丢失率≤20%,MRI T1WI呈低信号,T2WI呈高信号,存在轻微椎体裂隙征,临床无症状或表现为腰背痛;Ⅱ期,椎体高度丢失率 > 20%,椎体后缘完整,MRI T2WI呈不均匀高信号和椎体裂隙征,临床表现为胸壁、腰部疼痛和后凸畸形;Ⅲ期,椎体后缘不完整造成椎管受累,可能存在神经症状[13]。Maldague等[14]在1978年首次提出椎体内存在气体密度裂隙为Kümmell病的诊断标准。Kim等[15]认为,骨折椎体的假关节活动和骨折碎片损伤椎体节段动脉导致椎体发生缺血坏死为Kümmell病的诊断标准。虽然Kümmell病的诊断标准尚有争议,椎体内裂隙仍是最主要的诊断依据。近年,随着影像学技术的不断进步,椎体内裂隙征诊断率也得到了不断提高,侧位X线片、交叉侧位X线片和MRI的诊断率分别达到了14%,64%,96%[16-17]。杨惠林等[18]总结Kümmell病的诊断标准:①椎体不稳伴椎体进展性塌陷;②腰背部疼痛持续数周;③CT重建和MRI示椎体内存在裂隙。

对于Kümmell病,传统非手术治疗仅能缓解疼痛症状,伤椎不能自行愈合,常进展为椎体高度塌陷和进行性后凸畸形[19]。PVP和PKP治疗Ⅰ、Ⅱ期Kümmell病均可以获得良好临床疗效[20],PVP术中骨水泥在高压状态下渗透率高,但不能有效恢复压缩椎体的高度,PKP作为PVP的改良,利用球囊扩张器来恢复椎体高度,但Kümmell病患者伤椎有裂隙且常被瘢痕组织包绕,PVP/PKP术后骨与骨水泥界面应力增大,进而可能出现松动。Ⅲ期Kümmell病由于椎体后壁破损,PVP/PKP术中极易发生骨水泥渗漏,导致骨水泥压迫或灼伤神经根、脊髓。骨填充网袋是近年出现的一种手术器械,它可以早期稳定骨折从而快速缓解疼痛,又能减少骨水泥渗漏。骨填充网袋可对骨水泥进行包裹,在拔丝早期即可推注骨水泥,使骨水泥均匀弥散到网袋的各个方向,与骨小梁紧密连接,分层次注射可提高外围骨水泥硬度,维持骨水泥弥散状态的稳定性,大大降低骨水泥渗漏的发生[21]。术前仔细规划进针点及网袋的位置及术中C形臂X线机透视下严密观察骨水泥弥散情况是本研究组降低骨水泥渗漏的经验。尽管如此,单纯PVP术后仍然可能出现再次塌陷和节段Cobb角进行性增大等并发症[22]。Li等[23]的研究报道,使用网袋填充骨水泥术后3个月,伤椎高度继续丢失发生率为12.5%,其认为可能与患者骨质疏松严重程度、性别、随访时间及术后活动量有关。本研究结果显示,使用填充网袋的患者末次随访时伤椎前缘高度压缩比、Cobb角与术后3 d相比有所丢失,但差异无统计学意义。同时,术后3 d使用填充网袋的患者比直接注入骨水泥的患者表现出更好的疼痛缓解效果,术后恢复更快,住院时间更短,说明填充网袋的使用更有利于患者的短期功能恢复,主要得益于手术更为微创,手术时间短,出血量少。

对于中重度胸腰椎压缩性骨折(后凸角度 > 15°或前柱压缩率 > 40%)的患者,术后伤椎再塌陷和后凸角度增加是单纯使用椎体强化术的常见并发症[22]。单纯使用椎弓根螺钉系统纠正Kümmell病患者的后凸畸形,又因前中柱结构缺少坚强的支撑而导致内固定失败[24]。因此,椎弓根螺钉内固定联合伤椎骨水泥强化能有效降低内固定失败率和伤椎再塌陷率[25]。本研究结果显示,术后各时间点A组的伤椎椎体前缘高度压缩比及节段Cobb角的改善情况优于B组,但是术后3个月和末次随访时2组VAS评分与ODI无显著差异,这一定程度上说明脊柱后凸畸形的严重程度与疼痛或功能之间没有显著相关性,尽管有学者[26]认为,除了脊柱整体矢状面平衡以外,脊柱局部矢状面参数也是影响生活质量的重要因素。

综上,2种术式均可快速止痛、恢复伤椎高度、改善伤椎节段Cobb角,PVP术中向置入的填充网袋内注入骨水泥术后3 d的止痛效果更好,且具有手术时间短、术中出血量少、住院时间短和医疗费用低的优势。但本研究仍然存在一些不足之处,随访时间短,中长期是否会出现神经症状、伤椎塌陷、节段Cobb角增大及疼痛症状需要进一步长期随访观察,且本研究为单中心回顾性研究,样本量较小,临床循证等级较弱,研究结论尚需多中心前瞻性对照研究来进一步验证。

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