碳酸化羟基磷灰石水泥充填对骨质疏松性椎体压缩骨折患者椎体高度及疼痛影响

背景:羟基磷灰石水泥是一种针对骨质缺损的新型材料,由粉剂和流体构成,可被混合成糊状,修复各种骨缺损。目的:采用新型骨缺损修复材料碳酸化羟基磷灰石水泥作为充填材料,观察椎体成型术后骨质疏松性椎体压缩骨折患者椎体高度及疼痛改善情况。设计:以患者为对象的观察对比实验。单位:解放军总医院骨科。对象:选择于2000-10/2003-08解放军总医院骨科收治的34例骨质疏松性胸腰椎压缩骨折患者。纳入标准:①经CT确诊。②患者知情同意。排除标准:病变椎体后壁骨折的骨质疏松性椎体压缩骨折患者。男,6例,女28例;平均年龄(72±13)岁;其中绝经后骨质疏松27例,皮质激素导致骨质疏松1例,男性老年性骨质疏松6例。方法:①采用随机抽签法将纳入患者分为实验组(n=23)和对照组(n=11)。所有患者均在局麻下经皮穿刺手术,在C型臂透视下单侧椎弓根穿刺进入病变椎体前柱。实验组患者充填碳酸化羟基磷灰石水泥。对照组患者同样方法充填聚甲基丙烯酸甲酯。②参照McGill-Melzack评分对所有患者术前及术后1d、第1,4,12周对患者进行视觉模拟评分在标尺0～100mm(0为无痛,100为剧痛)移动标出其数值,表示疼痛的强度及心理上的冲击程度,其中<30评为良好;30～40为基本满意;≥50为差]。③参照Lee等方法,通过测量术前和术后侧位X射线压缩性骨折椎体压缩部位高度A1和A2及相应部位上位椎体高度A3和下位A4,得到压缩性骨折椎体未压缩前原始高度A=(A3 A4)/2,计算术前椎体压缩率=(A-A1)/A,术后椎体压缩率=(A-A2)/A,椎体高度恢复率=(术前压缩率-术后压缩率)/术前压缩率。④观察患者术后伤口情况,术前、术后1d、1周检测患者血常规、血清钙磷。主要观察指标:①两组患者手术前后视觉模拟评分。②椎体高度压缩率和恢复率。③术后伤口情况,术前、术后1d、1周患者血常规、血清钙磷。结果:纳入患者34例均进入结果分析。①实验组患者术前视觉模拟评分为(91.5±21.7)分,术后为(44.5±27.2)分,并随术后时间延长视觉模拟评分逐渐减低,4周时与对照组无明显差异。②碳酸化羟基磷灰石水泥充填到椎体内生物相容性良好,椎体压缩率由术前(43.1±21.4)%恢复到(31.8±16.7)%。椎体高度恢复率为(27.3±18.5)%。③所有患者术后伤口均I期愈合,无伤口红肿、感染、炎性分泌物,未出现神经症状。两组患者血常规、血清钙磷均无明显变化。1例充填聚甲基丙烯酸甲酯患者和2例充填碳酸化羟基磷灰石水泥患者和出现椎旁渗漏,未出现神经症状。结论:碳酸化羟基磷灰石水泥作为椎体成型术充填材料安全、有效,可恢复患者椎体高度,缓解疼痛,但短期内疼痛缓解不如聚甲基丙烯酸甲酯。

Effect of carbonated hydroxyapatite cement for filling vertebral body on the vertebral heights and pain in patients with osteoporotic vertebral compression fractures

BACKGROUND: Carbonated hydroxyapatite cement (CHC) s a new kind of biomaterial for bone defect, which is made of powder and fluid, and can be mixed to be pasty to repair various bone defects.OBJECTIVE: To observe the improvement of vertebrae height and pain in patients with osteoporosis vertebral compression fracture (VCF) after vertebroplasty by using a new kind of bone graft biomaterial, taking CHC as the filling material to reinforce the vertebral body.DESIGN: A contrast observation trial taking patients as subjects.SETTING: Department of Orthopaedics, General Hospital of Chinese PLA.PARTICIPANTS: Totally 34 patients with thoracic or lumbar osteoporosis VCF who received the treatment in the Department of Orthopaedics, General Hospital of Chinese PLA between October 2000 and August 2003. Inclusive criteria: ①Definite diagnosis by CT; ② Informed consents were obtained from the patients. Exclusive criteria: The patients with osteoporosis vertebral compression fractures who suffered vertebral posterior wall fracture. There were 6 males and 28 females, and they were aged (72±13)years; Among the patients, 27 were diagnosed as postmenopausal osteoporosis, 1 as cortical hormone-induced osteoporosis and 6 male patients weresenile osteoporosis.METHODS: ①All the patients were randomly divided into two groups: Experimental group (n =23) and control group (n=11). All the patients were performed percutaneous operation with local anesthenia. All cases were performed percutaneous operation under local anesthesia. Under the C-arm monitored, one side pedicle puncture was performed to enter the anterior column of the involved VCF. Patients of the experimental group were filled with CHC. Patients of control group were filled with polymethyl Methacrylate (PMMA) with the same way. ② Referred to McGill-Melzack scoring. Among the scale 0-100 mm (0 was no pain, 100 was acute pain), the value indicated the painful intensity and mental assault degree. ＜ 30 scores indicated good, 30-40 basically satisfied and ≥ 50 poor .③ Referred to the method from Lee et al, the preoperative height (A1) and postoperative height (A2) of compression fracture position of VCF were measured according to the lateral X-ray film. At the same time, the upper vertebral height (A3) and the inferior vertebral height (A4) were measured at the same position. The original height (A) of the involved vertebra was calculated as (A)= (A3+A4)/2,and the preoperative vertebral compression rate =(A-A1 )/A, the postoperative vertebral compression rate =(A-A2)/A, the restoring rate = (the preoperative vertebral compression rate-the postoperative vertebral compression rate)/the preoperative vertebral compression rate. ④ The wounds of the patients were observed after operation. The levels of blood routine, serum calcium and serum phosphorus were detected before, one day and one week after operation. MAIN OUTCOME MEASURES: ① Preoperative and postoperative VAS scoring. ② The vertebral compression rate and restoring rate. ③ Wounds were observed after operation. The blood routine, the serum calcium and serum phosphorus were detected before, one day and one week after operation.RESULTS: Totally 34 patients were involved in the result analysis. ①The preoperative visual analogue scale (VAS) score of experimental group were (91.5±21.7) points, and the postoperative ones were (44.5±27.2) points. The difference of VAS score reduced gradually along with the postoperative time. There was no difference of VAS score between experimental group and the control group 4 weeks after operation. ② The biocompatibility of CHC in the vertebral body was fine. The vertebral compression rate of experimental group was recovered from (43.1±21.4)％ preoperatively to (27.3± 18.5)％ postoperatively. The rate of restored heights was (27.3±18.5)％. ③ All patients obtained Ⅰ stage wound healing, and none of them had infection, inflammatory secretion and nervous symptom. There were no differences in blood routine test, serum calcium, serum phosphorus between patients in two groups. One case filled by PMMA and two cases filled by CHC presented leakage, and none had nervous symptom.CONCLUSION: As the filling materials for vertebropalsty, CHC can restore the vertebral heights and relieve pain safely and effectively, however, its efficacy to relieve pain is not significant as PMMA in the short term.