椎体成形术与保守治疗方法的中长期疗效对比

Vertebroplasty compared with conservative method of integrated Chinese and Western Medicine in patients with osteoporotic vertebral compression fractures

目的对照分析经皮椎体成形术（PVP）与中西医结合的保守方法治疗骨质疏松性椎体压缩骨折（OVCF）的中长期疗效。方法自2009年12月至2013年8月问以相同的研究标准连续选取江苏省中医院诊治的OVCF患者，经过充分的沟通后根据患者意愿分为PVP组及中西医结合的保守治疗组进行前瞻性对照研究，保守治疗2～6周内的患者可转入PVP组。以视觉模拟评分（VAS）及Oswestry功能障碍指数（ODI）问卷分别对患者治疗前、治疗后1周、1、3、6个月及1、2、3、4、5年的状况进行评分，并记录两组患者的病死率及并发症等信息。根据组问数据的不同特点分别采用t检验、X2检验、秩和检验、方差分析及确切概率法等进行统计学分析。结果2009年12月至2013年8月间接受治疗的294例OVCF患者中，有181例（PVP组103例，包括6例保守治疗组转入病例）符合课题的研究标准。两组患者治疗前的组问基线资料具有同质可比性（P〉0．05）。PVP组治疗后1周、1、3、6个月时的VAS（3．67～1．13）、ODI（23．55～5．83）评分明显优于保守治疗组VAS（7．38～2．39）、ODI（36．10～13．88）评分（均P〈0．01），随访1年时的组问评分差异无统计学意义，而随访2～5年的PVP组VAS（1．67～1．32）、ODI（4．58～3．77）评分要优于保守治疗组VAS（2．14～2．56）、ODI（6．98～7．33）评分（均P〈0．05）。随访至2014年12月，有17例患者死亡（PVP组8例），31例患者出现新发骨折（PVP组19例），保守治疗组患者感染、褥疮、深静脉血栓等的伴发病发生率要高于PVP组，而PVP组的58例骨水泥渗漏患者均无临床症状。结论和保守治疗方法相比，PVP可快速改善OVCF患者的疼痛及生活质量且疗效持久，但对于疼痛较轻的患者，中西医结合的保守方法可能是更好的选择。

Objective To compare the effects of percutaneous vertebroplasty （PVP） versus conservative method of integrated Chinese and Western Medicine for pain relief and functional outcome in patients with painful osteoporotic vertebral fractures. New fraetm＇es and secondary adverse effects were also analyzed during a mid-long tern] follow-up period. Methods Patients were recruited to this prospective nonrandomized trial from a single hospital. Patients were aged 55 years or older, had vertebral compression fractures on spine radiograph （level of fracture at T6 or lower; bone oedema on MRI） , with back pain for 6 weeks or less, and a visual analogue scale （VAS） score of 6 or more. Patients were nonrandomly assigned to PVP group or conservative treatment group according to their own desire. After 2 weeks, patients from the conservative group could change therapy to PVP. VAS for pain and Oswestry disability index （ODI） questionnaire scores were assessed before and 1 week, I month, 3,6, 12, 24, 36, 48, and 60 months after the treatment. Other data included patients＇ baseline characteristics before the treatment, new fractures and secondary adverse effects were also recorded. Results A total of 181 consecutive patients were nonrandomly allocated to receive PVP （n = 103） or conservative treatment （ n = 78） between December 2009 and August 2013. Six patients transferred to PVP group after 2 weeks conservative therapy. Pain relief and functional outcomes were significantly better in PVP group than in conservative group, as determined by VAS scores （3.67-1.13 vs7.38-2.39） and ODI scores （23.55 -5.83 vs 36.10-13.88） at 1 week, 1 month, 3 and 6 months （ all P 〈 0. 01 ）. Both VAS and ODI scores decreased in PVP group showed no statistical significance at 1 year when compared with conservative group （P 〉 0. 05）. However, pain relief and functional outcomes were significantly better at most of the subsequent follow-up points. The patients with complete pain relief （VAS 〈 1 ） were significantly better in PVP group than in conservative group （P 〈 0. 01 ） at all of the follow-up points. There were 17 patients died （ PVP group ： n = 8 ） and 31 cases occurred secondary vertebral fractures （PVP group： n = 19） during the follow-up periods. No serious complications or adverse events were related to PVP technique. Conclusion PVP has immediate pain relief and functional improvement compared with conservative treatment. PVP should be considered as the treatment of first choice for symptomatic osteoporotic vertebral fractures. However, tor patients with VAS 〈 5, conservative method of integrated Chinese and Western Medicine may perform well.