Bala Malgorzata M, Riemsma Robert P, Nixon John, Kleijnen Jos
II Department of Internal Medicine, Jagiellonian University Medical College, Krakow, Poland.
Clin J Pain. 2008 Nov-Dec;24(9):741-56. doi: 10.1097/AJP.0b013e318179032a.
We conducted a systematic review to assess the (cost)effectiveness of spinal cord stimulation (SCS) in relieving certain kinds of pain for people with chronic pain owing to failed back surgery syndrome (FBSS).
We considered randomized trials, controlled observational studies of adult patients with chronic pain owing to FBSS, and case series with at least 50 patients permanently implanted, at least 60% FBSS patients and at least 1-year follow-up. SCS was additional to usual care and compared with usual care. The primary outcome was reduction of pain. Medline, Embase, Lilacs, Cinahl, and Cochrane Library databases were searched from inception until September 2006. An update search was carried out in January 2008.
For the effectiveness analysis, 1 fully published randomized controlled trial, one randomized controlled trial with 6 month results (both of moderate quality), 1 retrospective cohort study, and 13 case series (all of low quality) were included. The mean period of follow-up was between 6 months and 8.8 years. These studies show that SCS is effective in the treatment of FBSS in terms of pain reduction. The effect was consistent in all analyzed studies. Improvements were also reported for other outcomes, such as quality of life and functional status. All the studies reported some complications, most of which were technical problems. In terms of cost-effectiveness, 3 studies met the inclusion criteria and offered the same conclusion that SCS is both more effective and less costly in the long-term, but there is an initial high cost associated with device implantation and maintenance.
我们进行了一项系统评价,以评估脊髓刺激(SCS)缓解因腰椎手术失败综合征(FBSS)导致慢性疼痛患者特定类型疼痛的(成本)效益。
我们纳入了针对因FBSS导致慢性疼痛的成年患者的随机试验、对照观察性研究,以及至少有50例永久植入患者、至少60%为FBSS患者且至少随访1年的病例系列。SCS是常规治疗之外的干预措施,并与常规治疗进行比较。主要结局是疼痛减轻。检索了Medline、Embase、Lilacs、Cinahl和Cochrane图书馆数据库,检索时间从建库至2006年9月。2008年1月进行了更新检索。
在有效性分析中,纳入了1项完全发表的随机对照试验、1项有6个月结果的随机对照试验(两者质量均为中等)、1项回顾性队列研究和13个病例系列(均为低质量)。平均随访时间在6个月至8.8年之间。这些研究表明,SCS在减轻疼痛方面对FBSS的治疗有效。在所有分析的研究中,效果是一致的。其他结局如生活质量和功能状态也有改善报告。所有研究均报告了一些并发症,其中大多数是技术问题。在成本效益方面,3项研究符合纳入标准,并得出相同结论,即从长期来看,SCS既更有效且成本更低,但与设备植入和维护相关的初始成本较高。