【作者】 邹德波；

【导师】 周东生；

【作者基本信息】 山东大学 ， 外科学， 2012， 博士

【摘要】 目的：探讨PKP治疗良、恶性VCFs的方法、疗效、并发症及注意事项,评价其临床意义及椎体穿刺活检的价值。方法：(1)回顾性分析2007年6月至2010年6月间因胸腰段良性VCFs行PKP治疗的病例,共117例169个椎体。按术中PKP穿刺情况分为单侧穿刺组和双侧穿刺组,按疼痛发生至手术时间分为急性期组、亚急性期组和慢性期组,统计全组及各亚组患者的手术时间、出血量、PMMA灌注量、VAS、ODI、骨折椎体高度恢复、后凸矫正程度、PMMA渗漏及术后邻近节段骨折情况,对各亚组数据进行统计学分析。(2)回顾性分析2007年6月至2010年6月间因MRI怀疑恶性VCFs入院治疗的病例,共46例67个椎体。所有患者进行椎体穿刺活检和PKP治疗。统计术前MRI诊断恶性VCFs的特征性表现和术后病理学结果并进行分析；统计全组及良性组、恶性组的手术时间、出血量、PMMA灌注量、VAS及ODI,对亚组评分进行统计学分析。结果：(1)PKP治疗良性VCFs的一般结果平均每椎体手术时间为(45.8±11.3)min,出血量为(32.4±7.0)ml,PMMA灌注量为(4.16±1.10)ml。术前患者VAS为(8.26±1.12)分、ODI为(81.20±6.70)分、局部后凸角为(22.97±4.04)。、椎体前缘相对高度为(62.32±7.66)%、椎体中部相对高度为(67.22±6.43)%,术后3天时VAS为(2.70±0.90)分、ODI为(30.09±6.34)分、局部后凸角为(13.96±3.04)°、椎体前缘相对高度为(84.74±7.85)%、椎体中部相对高度为(86.98±8.15)%,均较术前有统计学意义(P<0.05)；末次随访时VAS为(2.09±0.88)分、ODI为(24.32±8.20)分、局部后凸角为(13.96±2.65)°、椎体前缘相对高度为(83.85±8.07)%、椎体中部相对高度为(86.66±8.30)%,均较术前有统计学意义(P<0.05)。术中共发生16例(9.5%)21个椎体不同程度PMMA渗漏,所有渗漏均未引起临床症状。(2)良性VCFs单侧组和双侧组PKP治疗前后情况比较术中单侧组患者的每椎体手术时间、出血量、PMMA灌注量分别为(34.8±2.9)min、(27.1±4.8)ml、(3.3±0.5)ml,双侧组的每椎体手术时间、出血量、PMMA灌注量分别为(55.7±5.3)min、(38.2±3.4)m1、(5.0±0.7)m1,两组间比较,差异具有统计学意义(P<0.05)。单侧组术前、术后3天及末次随访时VAS分别为(8.20±1.10)分、(2.69±0.89)分、(2.13±0.88)分,双侧组术前、术后3天及末次随访时VAS分别为(8.32±1.15)分、(2.71±0.93)分、(2.04±0.87)分,同组术后VAS均较术前有显著性差异(P<0.05),但两组间同期比较无显著性差异(P>0.05)。单侧组术前、术后3天及末次随访时ODI评分分别为(80.89±6.40)分、(29.80±6.19)分、(25.15±7.40)分,双侧组术前、术后3天及末次随访时ODI评分分别为(81.54±7.05)分、(30.39±6.53)分、(23.43±8.98)分,同组术后ODI均较术前有显著性差异(P<0.05),但两组间同期间比较无显著性差异(P>0.05)。单侧组术前、术后3天及末次随访时局部后凸角分别为(23.15±3.73)°、(13.47±3.17)°、(14.74±2.78)。,双侧组术前、术后3天及末次随访时局部后凸角分别为(22.79±4.37)°、(12.41±2.81)°、(13.11±2.23)°。术后两组患者的局部后凸角较术前减小,差异具有统计学意义(P<0.05),但两组间同期间比较无显著性差异(P>0.05)。单侧组术前、术后3天及末次随访时椎体前缘相对高度分别为(61.74±7.92)%、(83.69±8.10)%、(82.87±8.59)%,双侧组术前、术后3天及末次随访时椎体前缘相对高度分别为(63.00±7.40)%、(85.88±7.48)%、(85.82±8.30)%；单侧组术前、术后3天及末次随访时椎体中部相对高度分别为(66.49±6.87)%、(86.20±8.16)%、(84.91±7.40)%,双侧组术前、术后3天及末次随访时椎体中部相对高度分别为(68.02±5.86)%、(87.84±8.12)%、(87.57±8.33)%。术后两组患者的伤椎前缘及中部高度均有增加,差异有统计学意义(P<0.05),但两组间同期间比较无显著性差异(P>0.05)。术后单侧组出现10例PMMA渗漏,发生率为11.2%。双侧组有11例PMMA渗漏,发生率为13.8%。经Pearson χ2检验,两组间PMMA渗漏率无显著性差异(P>0.05)。(3)良性VCFs急性期组、亚急性期组、慢性期组PKP治疗前后比较急性期组术前、术后3天及末次随访时VAS评分分别为(8.26±1.17)分、(2.83±0.83)分、(2.14±0.72)分,亚急性期组术前、术后3天及末次随访时VAS评分分别为(8.26±1.12)分、(2.59±0.91)分、(2.05±1.05)分,慢性期组术前、术后3天及末次随访时VAS评分分别为(8.25±1.11)分、(2.67±0.97)分、(2.06±0.86)分。三组患者术后腰背部疼痛均显著减轻,术后3天及末次随访时VAS评分均较术前有显著性差异(P<0.05),但三组间同期间比较无显著性差异(P>0.05)。急性期组术前、术后3天及末次随访时ODI评分分别为(80.90±6.875)分、(31.24±5.708)分、(24.33±6.712)分,亚急性期组术前、术后3天及末次随访时ODI评分分别为(81.38±6.459)分、(29.54±6.316)分、(24.00±10.643)分,慢性期组术前、术后3天及末次随访时ODI评分分别为(81.33±6.928)分、(29.33±7.010)分、(24.67±6.829)分。三组患者术后腰背部活动功能改善,术后3天及末次随访时VAS评分均较术前有显著性差异(P<0.05),但三组间同期间比较无显著性差异(P>0.05)。急性期组术前、术后3天及末次随访时的局部后凸角分别为(24.33±6.712)°、(14.52±3.278)°、(12.02±2.363)°,亚急性期组术前、术后3天及末次随访时局部后凸角分别为(23.66±3.819)°、(13.33±2.698)°、(14.26±2.500)°,慢性期组术前、术后3天及末次随访时局部后凸角分别为(20.39±3.901)。、(13.64±3.796)。、(14.42±2.802)。,术后三组患者的脊柱局部后凸角均较术前减小,差异具有统计学意义(P<0.05),但三组间同期间比较无显著性差异(P>0.05)。急性期组术前、术后3天及末次随访时椎体前缘相对高度分别为(63.24±6.308)%、(86.57±6.929)%、(85.95±7.057)%,亚急性期组术前、术后3天及末次随访时椎体前缘相对高度分别为(62.36±7.117)%、(85.72±6.164)%、(84.74±6.038)%,慢性期组术前、术后3天及末次随访时椎体前缘相对高度分别为(61.22±9.529)%、(81.53±9.548)%、(80.42±9.981)%,术后三组患者的伤椎前缘高度均有增加,差异具有统计学意义(P<0.05),但三组间同期间比较无显著性差异(P>0.05)。急性期组术前、术后3天及末次随访时椎体中部相对高度分别为(67.62±±±4.988)%、(87.24±6.942)%、(86.81±7.082)%,亚急性期组术前、术后3天及末次随访时椎体中部相对高度分别为(68.05±5.291)%、(89.13±6.879)%、(88.85±6.998)%,慢性期组术前、术后3天及末次随访时椎体中部相对高度分别为(65.86±8.636)%、(84.36±9.992)%、(84.11±10.209)%,术后三组患者的伤椎中部高度均有增加,差异具有统计学意义(P<0.05),但三组间同期间比较无显著性差异(P>0.05)。急性期组发生13(20.6%)个椎体PMMA渗漏,亚急性期组发生4(7.1%)个椎体PMMA渗漏,慢性期组发生13(8.0%)个椎体PMMA渗漏。经Pearson χ2检验,急性期组与亚急性期组、慢性期组存在显著性差异(P<0.05),亚急性期组与慢性期组无显著性差异(P>0.05)。(4)PKP治疗可疑恶性VCFs的一般结果平均每椎体手术时间为(40.39±7.72)min,出血量为(38.52±5.32)ml,骨水泥灌注量为(4.41±0.93)ml。术前患者VAS为(8.24±1.04)分、ODI为(83.30±6.86)分,术后3天时VAS为(3.09±0.81)分、ODI为(30.65±4.99)分,均较术前有显著性差异(P<0.05)。共发生11(16.4%)个骨折椎体不同程度PMMA渗漏,所有渗漏均未引起临床症状。(5)可疑恶性VCFs椎体穿刺活检结果及MRI诊断阳性率获取64个椎体的病理标本并最终明确病理诊断,成功率为95.52%。64个椎体活检标本中,病理报告是良性组织15个,恶性组织49个,活检阳性率为76.56%。良性结果均为骨质疏松性椎体骨折。恶性结果的病因中,肺癌占16个椎体,消化道癌11个,乳腺癌7个,肾癌4个,骨髓瘤3个,肝癌2个,子宫癌2个,未查明原发病灶低分化腺癌2个,鳞状细胞癌2个。MRI诊断恶性VCFs特征的灵敏度、特异度和准确度,椎体后缘球形隆起为73.47%、53.33%、68.7%；硬膜外包块为79.59%、80%、79.69%；椎弓根受累及为91.84%、66.67%、84.62%；T1WI均匀低信号为89.80%、40%、78.13%。灵敏度、特异度和准确度最高的分别为椎弓根受侵及、硬膜外肿块和椎弓根受侵及；灵敏度、特异度和准确度最低的分别为椎体后缘球形隆起、T1WI均匀低信号、椎体后缘球形隆起。(6)良性组和恶性组PKP治疗效果比较良性组和恶性组的手术时间分别为(40.80±8.06)min、(39.09±6.67)min;出血量分别为(39.20±5.42)ml、(3.636±4.52)ml；注入的PMMA量分别为(4.40±0.91)ml、(4.44±1.04)ml,两组间比较均无显著差别(P>0.05)。良性组患者术前VAS为(7.73±1.10)分,术后3天时为(2.82±0.75)分；恶性组患者术前VAS为(8.40±0.98)分,术后3天时为(3.17±0.82)分,术后均较术前有统计学意义(P<0.05)。良性组患者术前ODI为(81.27±6.89)分,术后3天时为(30.73±4.67)分；恶性组患者术前ODI为(83.94±6.82)分,术后3天时为(30.63±5.15)分,术后均较术前有统计学意义(P<0.05)术后良性组出现2例PMMA渗漏,发生率为13.3%。恶性组有9例PMMA渗漏,发生率为18.37%。经continuity corrected检验,两组间PMMA渗漏率无显著性差异(P>0.05)。所有渗漏均未引起临床症状。结论：(1)PKP能够迅速止痛、稳定骨折椎体、恢复椎体高度、矫正后凸畸形、防止椎体再塌陷,提高患者生活质量,是治疗良、恶性VCFs的可靠方法。(2)单、双侧PKP均可有效治疗良性VCFs,单侧组具有手术时间短、创伤小、出血少、痛苦小等优点。(3)亚急性期时行PKP术,可获得良好的畸形矫正效果、较小的PMMA渗漏率。(4)MRI可以初步鉴别良、恶性VCFs,经皮椎体穿刺活检能够准确诊断VCFs性质,在怀疑恶性VCFs时应采用。更多还原

【Abstract】 Objective:To investigate the methods, efficacy, complications and precautions of percutaneous kyphoplasty for the treatment of benign and malignant VCFs, evaluate its clinical significance and the importance of percutaneous vertebral biopsy.Methods:(1)117patients including169thoracolumbar benign VCFs treated by PKP from June2007to June2010were retrospectively analyzed. According to the number of pedicle punctured during PKP, the patients were divided into unilateral pedicle-punctured group and bilateral pedicle-punctured group; according to the duration time from pain generated to the PKP, the patients were divided into the acute phase group, sub-acute phase and chronic phase group. The data of operation time, amount of bleeding, amount of injected PMMA, VAS, ODI, vertebral height restoration and degree of kyphotic correction of the whole group and subgroup were statistically collected; each subgroup data were statistically analyzed. (2)46patients including67vertebrae suspected malignant VCFs by MR I from June2007to June2010were retrospectively analyzed. All patients were treated with percutaneous vertebral biopsy and PKP treatment. The characteristics diagnosed of the malignant VCFs in preoperative MRI and postoperative pathology results were statistically analyzed; the data of operation time, amount of bleeding, amount of injected PMMA, VAS and ODI of the whole group and benign and malignant group were collected; the subgroup data were statistical analyzed.Results:(1) The general results of PKP treatment of the benign VCFsThe average operation time of each VCFs was (45.8±11.3) min, amount of bleeding (32.4±7.0) ml and amount of injected PMMA (4.16±1.10) ml. Preoperative, VAS was (8.26±1.12) point, ODI (81.20±6.70) point, local kyphotic angle (22.97±4.04) degree, anterior vertebral relative height (62.32±7.66)%, central vertebral relative height (67.22±6.43)%;3-day after postoperation, VAS was (2.70±0.90), ODI (30.09±6.34), local kyphotic angle (13.96±3.04) degrees, anterior vertebral relative height (84.74±7.85)%, central vertebral relative height (86.98±8.15)%, statistically different compared with preoperative data (P<0.05); the VAS of last follow-up (2.09±0.88), ODI (24.32±8.20), local kyphotic angle (13.96±2.65) degrees, anterior vertebral relative height (83.85±8.07)%, central vertebral relative height (86.66±8.30)%, statistically different compared with preoperative data (P<0.05). PMMA extravasations were found in16patients (9.5%) including21vertebral, and did not present any clinical symptoms.(2) Comparison of the unilateral and bilateral group of the benign VCFs treated by PKP before and after surgeryThe average operation time of each VCFs, amount of bleeding and amount of injected PMMA in the unilateral group was (34.8±2.9) min,(27.1±4.8) ml and (3.3±0.5) ml respectively, while in the bilateral group; the data was (55.7±5.3) min,(38.2±3.4) ml and (5.0±0.7) ml respectively. The difference between the two groups was statistically different (P<0.05)In the unilateral group, the VAS of the preoperation,3-day postoperation and the last follow-up were (8.20±1.10),(2.69±0.89) and (2.13±0.88) point respectively, while in the bilateral group, the data were (8.32±1.15),(2.71±0.93) and (2.04±0.87) point respectively. The postoperative scores compared with preoperative were statistically different (P<0.05), however, the scores between the two groups over the same period showed no significant difference (P>0.05). The ODI of the preoperation,3-day postoperation and the last follow-up were (80.89±6.40),(29.80±6.19) and (25.15±7.40) point respectively, while in the bilateral group, the data were (81.54±7.05),(30.39±6.53) and (23.43±8.98) point respectively. The postoperative scores compared with preoperative were statistically different (P<0.05), however, the scores between two groups over the same period showed no significant difference (P>0.05)In the unilateral group, the local kyphotic angle of the preoperation,3-day postoperation and the last follow-up were (23.15±3.73),(13.47±3.17), and (14.74±2.78) degree respectively. While in the bilateral group, the data were (22.79±4.37),(12.41±2.81) and (13.11±2.23) degree respectively. The postoperative kyphotic angle of the two groups decreased when compared with that of preoperation, and the difference was statistically significant (P<0.05); however, the scores between the two groups over the same period showed no significant difference (P>0.05)In the unilateral group, the anterior vertebral relative height of the preoperation,3-day postoperation and the last follow-up were (61.74±7.92)%,(83.69±8.10)%and (82.87±8.59)%respectively. While in the bilateral group, the data were (63.00±7.40)%,(85.88±7.48)% and (85.82±8.30)%respectively. The central vertebral relative height of the preoperation,3-day postoperation and the last follow-up were (66.49±6.87)%,(86.20±8.16)%and (84.91±7.40)%respectively, while in the bilateral group, the data were (68.02±5.86)%,(87.84±8.12)%and (87.57±8.33)%respectively. Both the anterior and central height of the fractured vertebral body of the two groups increased after operation, the difference was statistically different when compared with that of preoperation (P<0.05); however, the scores between the two groups over the same period showed no significant difference (P>0.05)In the unilateral group,10cases of bone cement extravasations were found during operation, and the rate was11.2%. In the bilateral group,11cases of bone cement extravasations were found during operation, and the rate was13.8%. The bone cement leakage rate between the two groups showed no significant difference with Pearson χ2test (P>0.05)(3) Comparison of the acute, sub-acute and chronic phase of the benign VCFs treated by PKP before and after surgeryIn the acute phase, the VAS of t the preoperation,3-day postoperation and the last follow-up were (8.26±1.17),(2.83±0.83) and (2.14±0.72) score respectively; in the sub-acute phase, the data were (8.26±1.12),(2.59±0.91) and (2.05±1.05) point respectively; in the chronic phase, the data were (8.25±1.11),(2.67±0.97) and (2.06±0.86) point respectively. The low back pain of the three groups significantly improved postoperatively. The VAS score of3-day postoperation and the last follow-up were statistically different when compared with that of preoperation (P<0.05); however, the scores among three phases over the same period showed no significant difference (P>0.05)In the acute phase, the ODI of the preoperation,3-day postoperation and the last follow-up were (80.90±6.875),(31.24±5.708) and (24.33±6.712) point respectively; in the sub-acute phase, the data were (81.38±6.459),(29.54±6.316) and (24.00±10.643) point respectively; in the chronic phase, the data were (81.33±6.928),(29.33±7.010) and (24.67±6.829) point respectively. The ODI score of3-day postoperation and the last follow-up were statistically different when compared with that of preoperation (P<0.05); however, the scores among the three phases over the same period showed no significant difference (P>0.05)In the acute phase, the local kyphotic angle of the preoperation,3-day postoperation and the last follow-up were (24.33±6.712),(14.52±3.278) and (12.02±2.363) degree respectively; in the sub-acute phase, the data were (23.66±3.819),(13.33±2.698) and (14.26±2.500) degree respectively; in the chronic phase, the data were (20.39±3.901),(13.64±3.796) and (14.42±2.802) degree respectively. The postoperative kyphotic angle of the three phases decreased compared with that of preoperation, and the difference was statistically significant (P<0.05); however, the scores among the three phases over the same period showed no significant difference (P>0.05)In the acute phase, the anterior vertebral relative height of the preoperation,3-day postoperation and the last follow-up were (63.24±6.308)%,(86.57±6.929)%and (85.95±7.057)%respectively; in the sub-acute phase, the data were (62.36±7.117)%,(85.72±6.164)%and (84.74±6.038)%respectively; in the chronic phase, the data were (61.22±9.529)%,(81.53±9.548)%and (80.42±9.981)%respectively. All the anterior height of the fractured vertebral bodies of the three phases increased after operation, and the difference was statistically different compared with that of preoperation (P<0.05); however, the scores among the three phases over the same period showed no significant difference P>0.05)In the acute phase, the central vertebral relative height of the preoperation,3-day postoperation and the last follow-up were (67.62±4.988)%,(87.24±6.942)%and (86.81±7.082)%respectively; in the sub-acute phase, the data were (68.05±5.291)%,(89.13±6.879)%and 3.85±6.998)%respectively; in the chronic phase, the data were (65.86±8.636)%,(84.36±9.992)%and (84.11±10.209)%respectively. All the central height of the fractured vertebral bodies of the three phases increased after operation, the difference was statistically different compared with that of preoperation (P<0.05); however, the scores among the three phases over the same period showed no significant difference (P>0.05)PMMA extravasations were found13vertebrae in the acute phase group (20.6%),4in the sub-acute phase group(7.1%) and13in the chronic phase group (8.0%). with Pearson χ2test, the difference between the acute group and sub-acute group or chronic group were statistically significant, however, the difference between the sub-acute group and chronic group was not significant.(4) The general results of PKP treatment of suspected malignant VCFsThe average operation time of each VCFs was (40.39±7.72) min, the amount of bleeding (38.52±5.32) ml and injected PMMA (4.41±0.93) ml. The VAS score was (8.24±1.04) and ODI (83.30±6.86) point preoperatively. The VAS score was (3.09±0.81) and ODI (30.65±4.99) score three days after operation, which was statistically different compared with that of preoperation (P<0.05). Bone cement extravasations took place in11vertebral fractures (16.4%) during PKP, which showed no clinical symptoms.(5) The results of biopsy of suspected malignant VCFs and the positive rate of MRI diagnosis64vertebras’specimens were obtained and pathologically diagnosed eventually. The success rate of biopsy was95.52%. The pathology reported15benign and49malignant in all of the64vertebral biopsy specimens, and the positive biopsy rate was76.56%. Benign results were all osteoporotic vertebral fractures. Malignant results included16lung cancer,11gastrointestinal cancer,7breast cancer,4renal cell carcinoma,3myeloma,2liver cancer,2uterine cancer, and the others did not identify the primary lesion including poorly differentiated2adenocarcinoma and2squamous cell carcinoma.The sensitivity, specificity and accuracy of the malignant VCFs characteristics in MRI were73.47%,53.33%,68.7%of the spherical bulge of posterior edge;79.59%,80%,79.69%of the epidural mass;91.84%,66.67%,84.62%of the pedicle involvement;89.80%,40%,78.13%of uniform low signal on T1WI. The highest sensitivity, specificity and accuracy were pedicle involvement, the epidural mass and pedicle involvement respectively; and the lowest sensitivity, specificity and accuracy were the spherical bulge of posterior edge, low signal on T1WI and the spherical bulge of posterior edge respectively.(6) Comparison of the benign and malignant VCFs treated by PKPThe operation time of the benign and malignant group was (40.80+8.06) min and (39.09±6.67) min, blood loss was (39.20±5.42) ml and (3.636±4.52) ml, the amount of injected PMMA (4.40±0.91) ml and (4.44±1.04) ml respectively. No significant difference was seen when the two groups were compared (P>0.05). The benign group’s VAS was (7.73±1.10) point before PKP, which was (2.82±0.75) point3days after operation; the malignant group’s VAS was (8.40±0.98) point before PKP, which was (3.17±0.82) point3days after operation. Postoperative score was significantly different compared with that of preoperation (P<0.05). The benign group’s ODI was (81.27±6.89) point before PKP, which was (30.73±4.67) point3days after operation; the malignant group’s ODI was (83.94±6.82) point before PKP, which was (30.63±5.15) point3days after operation. Postoperative score was significantly different compared with that of preoperation (P<0.05)PMMA extravasations were found in2VCFs in the benign group (13.3%) and9VCFs in the malignant group (18.37%). With Pearson χ2test, the difference of the bone cement extravasations rate between benign and malignant group was not statistically different (P>0.05). All extravasations did not present any clinical symptoms.Conclusion:(1) PKP is a reliable method for the treatment of benign and malignant VCFs, which can quickly relieve pain, stabilize vertebral fracture, restore vertebral height, decrease kyphotic angle, prevent vertebral collapse and improve patients’ quality of life.(2) Both unilateral and bilateral PKP could treat benign VCFs effectively. However, the unilateral PKP has the advantages of shorter operation time, less trauma, less bleeding and less pain, etc.(3) PKP could achieve better kyphotic deformity correction and smaller PMMA extravasation rate when perfomed in sub-acute phase.(4) MRI can identify benign and malignant VCFs preliminarily. Percutaneous vertebral biopsy could identify the nature of the VCFs accurately and should be performed in suspected cases.更多还原