Wu Ai-Min, Zhou Yong, Li Qing-Long, Wu Xin-Lei, Jin Yong-Long, Luo Peng, Chi Yong-Long, Wang Xiang-Yang
The Department of Spinal Surgery, Second Affiliated Hospital of Wenzhou Medical University, Zhejiang Spinal Research Center, Wenzhou, Zhejiang, People's Republic of China.
The First Medical College, Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.
PLoS One. 2014 May 8;9(5):e97142. doi: 10.1371/journal.pone.0097142. eCollection 2014.
Dynamic interspinous spacers, such as X-stop, Coflex, DIAM, and Aperius, are widely used for the treatment of lumbar spinal stenosis. However, controversy remains as to whether dynamic interspinous spacer use is superior to traditional decompressive surgery.
Medline, Embase, Cochrane Library, and the Cochrane Controlled Trials Register were searched during August 2013. A track search was performed on February 27, 2014. Study was included in this review if it was: (1) a randomized controlled trial (RCT) or non-randomized prospective comparison study, (2) comparing the clinical outcomes for interspinous spacer use versus traditional decompressive surgery, (3) in a minimum of 30 patients, (4) with a follow-up duration of at least 12 months.
Two RCTs and three non-randomized prospective studies were included, with 204 patients in the interspinous spacer (IS) group and 217 patients in the traditional decompressive surgery (TDS) group. Pooled analysis showed no significant difference between the IS and TDS groups for low back pain (WMD: 1.2; 95% CI: -10.12, 12.53; P = 0.03; I2 = 66%), leg pain (WMD: 7.12; 95% CI: -3.88, 18.12; P = 0.02; I2 = 70%), ODI (WMD: 6.88; 95% CI: -14.92, 28.68; P = 0.03; I2 = 79%), RDQ (WMD: -1.30, 95% CI: -3.07, 0.47; P = 0.00; I2 = 0%), or complications (RR: 1.39; 95% CI: 0.61, 3.14; P = 0.23; I2 = 28%). The TDS group had a significantly lower incidence of reoperation (RR: 3.34; 95% CI: 1.77, 6.31; P = 0.60; I2 = 0%).
Although patients may obtain some benefits from interspinous spacers implanted through a minimally invasive technique, interspinous spacer use is associated with a higher incidence of reoperation and higher cost. The indications, risks, and benefits of using an interspinous process device should be carefully considered before surgery.
动态棘突间撑开器，如X-stop、Coflex、DIAM和Aperius，被广泛用于治疗腰椎管狭窄症。然而，对于动态棘突间撑开器的使用是否优于传统减压手术仍存在争议。
2013年8月对Medline、Embase、Cochrane图书馆和Cochrane对照试验注册库进行了检索。2014年2月27日进行了跟踪检索。纳入本综述的研究需满足以下条件：（1）随机对照试验（RCT）或非随机前瞻性比较研究；（2）比较棘突间撑开器使用与传统减压手术的临床结果；（3）至少30例患者；（4）随访时间至少12个月。
纳入两项RCT和三项非随机前瞻性研究，棘突间撑开器（IS）组204例患者，传统减压手术（TDS）组217例患者。汇总分析显示，IS组和TDS组在腰痛（加权均数差：1.2；95%置信区间：-10.12，12.53；P = 0.03；I² = 66%）、腿痛（加权均数差：7.12；95%置信区间：-3.88，18.12；P = 0.02；I² = 70%）、ODI（加权均数差：6.88；95%置信区间：-14.92，28.68；P = 0.03；I² = 79%）、RDQ（加权均数差：-1.30，95%置信区间：-3.07，0.47；P = 0.00；I² = 0%）或并发症（风险比：1.39；95%置信区间：0.61，3.14；P = 0.23；I² = 28%）方面无显著差异。TDS组再次手术发生率显著更低（风险比：3.34；95%置信区间：1.77，6.31；P = 0.60；I² = 0%）。
尽管患者可能通过微创技术植入棘突间撑开器获得一些益处，但使用棘突间撑开器与更高的再次手术发生率和更高的成本相关。手术前应仔细考虑使用棘突间装置的适应症、风险和益处。
