新型分段式双球囊撑开器治疗多节段骨质疏松性胸腰椎压缩性骨折的病例对照研究

Treatment of multsegments osteoporotic vertebral compression fracture by new design stagewise double-saccule：a case-control study

目的：探讨新型分段式双球囊撑开器（NDSDS）在经皮椎体后凸成形术（PKP）治疗多节段骨质疏松性胸腰椎椎体压缩性骨折中的应用价值。方法采用前瞻性区组随机对照的研究方法,将2011年1月—2013年6月解放军第一八四医院收治的40例多节段骨质疏松性胸腰椎椎体压缩性骨折患者（108椎）数字表法随机分为2组：观察组20例（53椎）,采用 NDSDS 于术中撑开；对照组20例（55椎）,采用传统球囊撑开器于术中撑开。观察2组患者手术前后 Cobb 角、疼痛视觉模拟评法（VAS）评分及 Oswestry 功能障碍指数（ODI）的变化以评价临床效果,并记录平均单个椎体手术时间。结果40例患者均随访6~24个月,平均（14±3.4）个月。观察组术前 Cobb 角56.05°±9.58°、术后1周差值29.25°±4.84°、24周差值26.80°±4.65°,术前疼痛 VAS 评分（7.80±0.62）分、术后1周差值（5.10±1.21）分、24周差值（5.35±1.13）分,术前 ODI 76.9±3.34、术后1周差值54.5±10.58、24周差值52.7±5.82；对照组术前 Cobb 角57.05°±10.49°、术后1周差值31.00°±6.91°、24周差值28.75°±6.77°,术前疼痛 VAS 评分（7.97±0.76）分、术后1周差值（5.20±1.24）分、24周差值（5.50±1.14）分,术前 ODI 79.7±4.17、术后1周差值62.6±5.03、24周差值58.6±5.58,2组间比较差异均无统计学意义（P 值均〉0.05）,2组内手术前后比较差异均有统计学意义（P值均〈0.05）。观察组单个椎体穿刺时间为（15.04±5.03）min,对照组为（20.39±10.09）min,两组差异有统计学意义（P 〈0.05）。结论在 PKP 手术治疗多节段骨质疏松性胸腰椎压缩性骨折中,应用 NDSDS 可减少手术创伤,缩短手术时间；因此,该方法是一种简单、安全、有效的方法。

Objective To explore the clinical results of new design stagewise double-saccule （NDSDS） for treatment of osteoporotic vertebral compression fracture（OVCF） of thoracolumbar. Methods This was a prospective, single-center, randomized clinical trial. Forty patients （108 vertebral） with OVCF of thoracolumbar were managed from January 2011 to June 2013 in the 184th Hospital of PLA, and were randomly divided into two groups. Observation group： 20 patients （53 vertebral） were treated by NDSDS. Control group： 20 patients （55 vertebral） were treated by traditional saccule. Cobb angle, visual analogue scale （VAS） and Oswestry disability index （ODI） were observed, and the operative time of single-vertebral was recorded. Results All patients were followed up 6 - 24 months, average （14 ± 3. 4 ） months. Observation group： The preoperative Cobb angle was 56. 05° ± 9. 58° , the difference was 29. 25° ± 4. 84° 1 week after operation and 26. 80° ± 4. 65° 24 weeks after operation. Preoperative VAS was 7. 80 ± 0. 62, the difference was 5. 10 ± 1. 21 1 week after operation and 5. 35 ± 1. 13 24 weeks after operation. Preoperative ODI was 76. 9 ± 3. 34, the difference was 54. 5 ± 10. 58 1 week after operation and 52. 7 ± 5. 82 24 weeks after operation. Control group： Preoperative Cobb angle was 57. 05° ± 10. 49°, the difference was 31. 00° ±＆amp;nbsp;6. 91° 1 week after operation and 28. 75° ± 6. 77° 24 weeks after operation, preoperative VAS was 7. 97 ± 0. 76 , the difference was 5. 20 ± 1. 24 1 week after operation and 5. 50 ± 1. 14 24 weeks after operation, preoperative ODI was 79. 7 ± 4. 17, the difference was 62. 6 ± 5. 03 1 week after operation and 58. 6 ± 5. 58 24 weeks after operation. All index above had no significant difference interclass （all P values 〉 0. 05）, and had significantly difference in group before and after operation （all P values 〈 0. 05）. The observation group operative time of single-vertebral was （15. 04 ± 5. 03） min and the control group was （20. 39 ± 10. 09） min （P 〈 0. 05）. Conclusions It is a simple, safe and efficient way to treat patients with OVCF by using NDSDS, which has little trauma and low pain.