单球囊单、双侧扩张经皮椎体后凸成形术治疗骨质疏松性椎体压缩骨折的比较

The clinical comparison of unilateral and bilateral dilatation percutaneous kyphoplasty with single balloon for treatment of osteoporotic vertebral compression fractures

目的：比较单球囊单、双侧扩张经皮椎体后凸成形术治疗骨质疏松性椎体压缩骨折的临床疗效和安全性.方法：回顾性分析接受单球囊扩张经皮椎体后凸成形术治疗的44例骨质疏松性椎体压缩骨折患者的病例资料,男9例,女35例;年龄61 ～89岁,中位数72岁;均为单节段椎体压缩骨折;骨折部位,T102例、T116例、T1214例、L115例、L26例、L31例;单侧扩张22例,双侧扩张22例.对2组手术时间、X线曝光次数、骨水泥注入量、骨水泥渗漏率、疼痛视觉模拟评分、伤椎前缘高度丢失百分比、伤椎中部高度丢失百分比、Cobb角进行比较.结果：2组患者均顺利完成手术,单侧经皮椎体后凸成形术组较双侧经皮椎体后凸成形术组手术时间短、X线曝光次数少、骨水泥注入量少[（32.60±9.51）min,（49.70±10.87） min,t=3.742,P=0.002;（15.50±8.37）次,（25.70 ±9.87）次,t=2.982,P=0.008;（3.38±0.83） mL,（6.01±1.21）mL;t =5.664,P=0.000].术后X线及CT检查显示,双侧经皮椎体后凸成形术组骨水泥呈团块状分布于伤椎两侧或均匀弥散,单侧经皮椎体后凸成形术组骨水泥偏一侧呈团块状分布或越过中线弥散分布.2组患者均获随访,随访时间8 ～18个月,中位数11.5个月;骨折均愈合,愈合时间3～6个月,中位数4.5个月.术前2组患者疼痛视觉模拟评分、伤椎前缘高度丢失百分比、伤椎中部高度丢失百分比及Cobb角的组间差异均无统计学意义[（8.518±1.921）分,（8.786±1.580）分;t=0.505,P=0.616;（29.727 ±4.524）％,（30.261±4.192）％;t=0.406,P=0.687;（24.750±3.872）％,（25.022 ±4.682）％;t =0.210,P=0.835;24.543°±4.021°,25.121°±3.954°;t =0.481,P=0.633].术后1d,2组患者疼痛缓解,疼痛视觉模拟评分均较术前降低（t=25.561,P=0.000;t=35.927,P=0.000）;伤椎前缘高度丢失百分比、伤椎中部高度丢失百分比及Cobb角均较术前减小（t=42.400,P=0.000;t=38.572,P=0.000;t=47.929,P=0.000;t=27.563,P=0.000;t=38.627,P=0.000;t=31.531,P=0.000）;但2组间以上各项疗效评价指标比较,差异均无统计学意义[（2.886±1.205）分,（2.846±1.137）分;t=0.113,P =0.910; （11.546±2.903）％,（10.983±3.439）％;t=0.587,P =0.561;（10.159±2.648）％,（9.637±2.371）％;t =0.688,P=0.495;9.872°±2.361°,9.214°±1.859°;t=1.027,P=0.310].单侧经皮椎体后凸成形组术后并发骨水泥渗漏3例,双侧经皮椎体后凸成形组术后并发骨水泥渗漏2例,均无神经脊髓损伤、肺栓塞等并发症发生,未予特殊处理;2组患者骨水泥渗漏发生率比较,差异无统计学意义（x2=0.000,P=1.000）.结论：单球囊单、双侧扩张经皮椎体后凸成形术治疗骨质疏松性椎体压缩骨折均能有效缓解疼痛、恢复伤椎高度、纠正脊柱畸形,疗效相当,并发症少.但单侧扩张手术时间更短、X线曝光次数及骨水泥注入量更少,更适合于高龄体弱难以耐受长时间俯卧的患者.

Objective ： To compare the clinical curative effect and safety of unilateral versus bilateral dilatation percutaneous kyphoplas- ty （PKP）with single balloon for treatment of osteoporotic vertebral compression fractures （OVCF）. Methods：The medical records of 44 pa- tients with single - segment OVCF treated with single balloon PKP were analyzed retrospectively. The patients consisted of 9 males and 35 females ,and ranged in age from 61 to 89 years（ Mean = 72 yrs）. The fractures located in Ti0 （2） ,Tll （6） ,T12 （14） ,L1 （15） ,L2 （6）and L3 （ 1 ）. Unilateral dilatation PKP was performed in 22 patients and bilateral dilatation PKP was performed in 22 patients. Then the two groups were compared with eaeh other in such parameters as operative time, frequency of X-ray exposure, eonsumption of bone cement, incidence rate of bone cement leakage, visual analogue scores （VAS） ,loss of anterior border and middle height of injured vertebrae and kyphosis Cobb angle. Results：The surgery were performed successfully in all the patients and. the unilateral PKP had shorter operative time, fewer X-ray exposure and less consumption of bone cement than did bilateral PKP （ 32.60 ＋/- 9.51 vs 49.70 ＋/- 10.87 rain, t = 3. 742, P = 0. 002 ; 15.50 ＋/- 8.37 vs 25.70 ＋//- 9.87, t =- 2. 982, P = 0. 008 ; 3.38 ＋/- 0.83 vs 6.01 ＋/- 1.21 mL; t = 5. 664, P = O. 000）. Postoperative X-ray and CT examination showed that the bone eements were well-distributed or distributed in clumps in both sides of injured vertebra in bilateral PKP group,while the bone cements were distributed in clumps in one side of injured vertebra or dispersed across the midline in unilateral PKP group. The patients in the 2 groups were all followed up for 8 - 18 months with a median of 11.5 months. All fractures united between 3 and 6 weeks with a median of 4.5 weeks. There was no statistical difference in VAS, percentage of loss of injured vertebrae ante- rior border and middle height of injured vertebrae and kyphosis Cobb angle between the 2 groups before the treatment（8. 518 ＋/-1. 921 vs 8. 786 ＋/- 1. 580 points ; t = 0. 505,P = 0.616 ; 29. 727 ＋/- 4. 524% vs 30. 261 ＋/- 4. 192% ; t = 0. 406, P = 0. 687 ;24. 750 ＋/- 3. 872% vs 25. 022 ＋/- 4. 682% ;t = 0.210,P = 0. 835 ;24. 543 ＋/- 4. 021 vs 25. 121 ＋/- 3. 954 degrees ;t = 0. 481, P = 0. 633 ）. One day after the surgery, the pain was relieved and the postoperative VAS scores were lower than the preoperative VAS scores in the two groups （t = 25. 561, P = 0. 000 ; t = 35. 927, P = 0.000 ）. The percentage of loss of injured vertebrae anterior border height, percentage of loss of injured vertebrae middle height and kyphosis Cobb angle decreased （ t = 42. 400,P = 0. 000 ; t = 38. 572,P = 0. 000 ; t = 47. 929, P = 0. 000 ; t = 27. 563, P = 0. 000 ; t = 38. 627, P = 0. 000 ; t = 31.531, P = 0.000 ）. However, there were no statistical differences between the 2 groups in all the thera- peutic effect assessment indicators（2. 886 ＋/-1. 205 vs 2. 846 ＋/-1. 137 points;t =0. 113 ,P =0.910;11. 546 ＋/-2. 903% vs 10. 983 ＋/ -3.439% ;t =0. 587,P =0. 561;10. 159 ＋/-2. 648% vs 9. 637 ＋/- 2. 371% ;t =0. 688,P =0. 495;9. 872 ＋/- 2. 361 vs 9. 214 ＋/- 1. 859 degrees;t = 1. 027,P = 0.310）. The bone cement leakage were found after the surgery in three patients in unilateral PKP group and in two patients in bilateral PKP group and no treatment were performed. No complications such as nerve injury, spinal cord injury and pul- monary embolism were found in the two groups. There was no statistical difference in the incidence rate of bone cement leakage between the 2 groups（x2 = 0. 0013, P = 1. 000）. Conclusion：Unilateral dilatation PKP with single balloon is similar to bilateral dilatation PKP with sin- gle balloon in the effect on pain relief, injured vertebral height restoration and spinal deformity correction, with few complications. However, unilateral dilatation PKP has the advantage of shorter operative time,fewer X-ray exposure and less bone cement consumption, therefore it is more suitable to weak and aged patients who can not withstand prolonged face lying.