Banovac K, Williams J M, Patrick L D, Haniff Y M
Department of Orthopaedics and Rehabilitation, University of Miami School of Medicine, Miami, Florida 33101, USA.
Spinal Cord. 2001 Jul;39(7):370-4. doi: 10.1038/sj.sc.3101166.
A randomized, prospective, double-blind, placebo-controlled clinical trial.
To determine the effect of indomethacin on the prevention of heterotopic ossification (HO) following spinal cord injury (SCI).
County Hospital, Miami, Florida, USA.
Sixteen patients were treated with slow-release indomethacin 75 mg daily and 17 patients received placebo for a period of 3 weeks. Prevention was started 21+/-14 days after SCI. In both groups of patients there was similar age of the patients as well as the level of SCI and ASIA impairment scale. Two methods were used to diagnose HO, bone scintigraphy and radiographic examination. Bone scintigraphy with technetium labeled methylene-diphosphonate was used for diagnosis of early stage, while radiography was used for diagnosis of late stage of HO development.
A significantly lower incidence of early HO was found in the indomethacin group (25%) than in the placebo group (65%; P<0.001). Similarly there was a significant reduction of late HO in the indomethacin group (12.5%) as compared to the placebo group (41%; P<0.001).
Our data suggest that indomethacin used during the first 2 months after SCI is effective in prevention of HO in a significant number of patients.
一项随机、前瞻性、双盲、安慰剂对照的临床试验。
确定吲哚美辛对预防脊髓损伤（SCI）后异位骨化（HO）的效果。
美国佛罗里达州迈阿密县医院。
16例患者每日接受75mg缓释吲哚美辛治疗，17例患者接受安慰剂治疗，为期3周。预防措施在脊髓损伤后21±14天开始。两组患者的年龄、脊髓损伤水平和美国脊髓损伤协会（ASIA）损伤量表相似。采用两种方法诊断异位骨化，即骨闪烁显像和X线检查。用锝标记的亚甲基二膦酸盐进行骨闪烁显像用于早期诊断，而X线检查用于异位骨化发展后期的诊断。
吲哚美辛组早期异位骨化的发生率（25%）显著低于安慰剂组（65%；P<0.001）。同样，与安慰剂组（41%）相比，吲哚美辛组晚期异位骨化也显著减少（12.5%；P<0.001）。
我们的数据表明，在脊髓损伤后的前2个月使用吲哚美辛对大量患者预防异位骨化有效。
