van der Heide Huub J L, Rijnberg Willard J, Van Sorge Adriaan, Van Kampen Albert, Schreurs B Willem
Department of Orthopaedic Surgery, the Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
Acta Orthop. 2007 Feb;78(1):90-4. doi: 10.1080/17453670610013475.
Although indomethacin is effective in preventing heterotopic ossification (HO) after primary total hip arthroplasty, side effects are frequently observed. In the last decade a new class of drugs--the COX-2 selective nonsteroidal anti-inflammatory drugs--has been developed. To investigate the effect of these COX-2 selective NSAIDs on heterotopic ossification (HO) after primary total hip arthroplasty (THA), we conducted a randomized controlled trial using either indomethacin or rofecoxib for 7 days.
186 patients received either indomethacin 3 times daily, or rofecoxib twice, and 1 placebo, daily for 7 days. HO was graded according to the 1-year postoperative radiographs according to the Brooker classification.
12 of the 186 patients included discontinued their medication before the end of the trial due to side effects. The remaining 174 patients were included in the analysis. In the indomethacin group (n = 89), 77 patients (87%) showed no HO, 9 showed HO of grade 1 and 3 showed HO of grade 2 according to the Brooker classification. In the rofecoxib group (n = 85) 73 patients (86%) showed no ossification, 9 showed grade 1, and 3 showed grade 2.
The prophylactic effect of rofecoxib for 7 days in preventing heterotopic ossification after primary total hip arthroplasty is comparable to the effect of indomethacin given for 7 days. These results indicate that the development of HO follows a COX-2 pathway.
尽管吲哚美辛在预防初次全髋关节置换术后异位骨化（HO）方面有效，但副作用却经常出现。在过去十年中，一类新型药物——COX-2选择性非甾体抗炎药——已被研发出来。为了研究这些COX-2选择性非甾体抗炎药对初次全髋关节置换术（THA）后异位骨化（HO）的影响，我们进行了一项随机对照试验，使用吲哚美辛或罗非昔布治疗7天。
186例患者分别每日服用3次吲哚美辛，或每日2次罗非昔布，以及1次安慰剂，共7天。根据术后1年的X线片，按照布鲁克分类法对异位骨化进行分级。
186例纳入研究的患者中有12例因副作用在试验结束前停药。其余174例患者纳入分析。在吲哚美辛组（n = 89），根据布鲁克分类法，77例患者（87%）未出现异位骨化，9例出现1级异位骨化，3例出现2级异位骨化。在罗非昔布组（n = 85），73例患者（86%）未出现骨化，9例出现1级，3例出现2级。
罗非昔布7天预防初次全髋关节置换术后异位骨化的效果与吲哚美辛7天的效果相当。这些结果表明异位骨化的发生遵循COX-2途径。
