Tafazal Suhayl I, Ng Leslie, Sell Philip
Department of Orthopaedics, University Hospitals of Leicester, Leicestershire, UK.
Eur Spine J. 2007 Feb;16(2):207-12. doi: 10.1007/s00586-006-0154-4. Epub 2006 Jul 25.
This is a double blind randomised controlled trial to assess the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis. The trial compared the outcome of salmon calcitonin nasal spray to placebo nasal spray in patients with MRI confirmed lumbar spinal stenosis. Lumbar spinal stenosis is one of the commonest conditions encountered by spine surgeons. It more frequently affects elderly patients and lumbar decompression has been used to treat the condition with variable success. Non operative measures have been investigated, but their success ranges from 15% to 43% in patients followed up for 1-5 years (Simotas in Clin Orthop 1(384):153-161, 2001). Salmon calcitonin injections have been investigated in previous trials and may have a treatment effect. Nasal salmon calcitonin has become available and if effective would have advantages over injections. Forty patients with symptoms of neurogenic claudication and MRI proven lumbar spinal stenosis were randomly assigned either nasal salmon calcitonin or placebo nasal spray to use for 4 weeks. This was followed by a 'washout' period of 6 weeks, and subsequent treatment with 6 weeks of nasal salmon calcitonin. Standard spine outcome measures including Oswestry disability index (ODI), low back outcome score, visual analogue score and shuttle walking test were administered at baseline, 4, 10 and 16 weeks. Twenty patients received nasal salmon calcitonin and twenty patients received placebo nasal spray. At 4 weeks post treatment there was no statistically significant difference in the outcome measures between the two groups. The change in ODI was a mean 1.3 points for the calcitonin group and 0.6 points for the placebo group (P = 0.51), the mean change in visual analogue score for leg pain was 10 mm in the calcitonin group and 0 mm in the placebo group (P = 0.51). There was no significant difference in walking distance between the two groups, with a mean improvement in walking distance of 21 m in the calcitonin group and 8 m in the placebo group (P = 0.78). At the end of the trial the ODI had improved by a mean of 3.7 points in the calcitonin group and 3.8 points in the placebo group (P = 0.44). This randomised placebo controlled trial has not shown any treatment effect in patients with lumbar spinal stenosis treated with nasal salmon calcitonin.
这是一项双盲随机对照试验，旨在评估鼻用鲑鱼降钙素治疗腰椎管狭窄症的有效性。该试验比较了MRI确诊的腰椎管狭窄症患者使用鲑鱼降钙素鼻喷雾剂与安慰剂鼻喷雾剂的疗效。腰椎管狭窄症是脊柱外科医生最常遇到的病症之一。它更常见于老年患者，腰椎减压术一直用于治疗该病症，但效果不一。已经对非手术措施进行了研究，但在随访1至5年的患者中，其成功率在15%至43%之间（Simotas，《临床骨科》1(384):153 - 161，2001年）。先前的试验已经对鲑鱼降钙素注射剂进行了研究，其可能具有治疗效果。鼻用鲑鱼降钙素已经上市，如果有效，将比注射剂具有优势。40名有神经源性间歇性跛行症状且MRI证实为腰椎管狭窄症的患者被随机分配使用鼻用鲑鱼降钙素或安慰剂鼻喷雾剂，为期4周。随后是6周的“洗脱期”，之后再进行6周的鼻用鲑鱼降钙素治疗。在基线、第4、10和16周时，采用标准的脊柱疗效指标，包括Oswestry功能障碍指数（ODI）、下背部疗效评分、视觉模拟评分和穿梭步行试验。20名患者接受鼻用鲑鱼降钙素治疗，20名患者接受安慰剂鼻喷雾剂治疗。治疗后4周，两组的疗效指标在统计学上没有显著差异。降钙素组ODI的平均变化为1.3分，安慰剂组为0.6分（P = 0.51），降钙素组腿部疼痛视觉模拟评分的平均变化为10 mm，安慰剂组为0 mm（P = 0.51）。两组之间的步行距离没有显著差异，降钙素组步行距离的平均改善为21 m，安慰剂组为8 m（P = 0.78）。试验结束时，降钙素组ODI平均改善3.7分，安慰剂组改善3.8分（P = 0.44）。这项随机安慰剂对照试验未显示鼻用鲑鱼降钙素治疗腰椎管狭窄症患者有任何治疗效果。
