van der Heide Huub J L, Koorevaar Rinco C T, Lemmens J Albert M, van Kampen Albert, Schreurs B Willem
Department of Orthopedics 800, Radboud University Medical Center, P.O. Box 9100, 6500 HB, Nijmegen, The Netherlands.
Arch Orthop Trauma Surg. 2007 Sep;127(7):557-61. doi: 10.1007/s00402-006-0243-1. Epub 2006 Nov 16.
Nonsteroidal anti-inflammatory drugs (NSAIDs) prevent heterotopic ossification but gastrointestinal complaints are frequently. Selective cyclooxygenase-2 (COX-2) inhibiting NSAID produce less gastrointestinal side effects.
A prospective two-stage study design for phase 2 clinical trials with 42 patients was used to determine if rofecoxib (a COX-2 inhibitor) 50 mg oral for 7 days prevents heterotopic ossification. A cemented primary THA was inserted for osteoarthroses. After 6 months heterotopic bone formation was assessed on AP radiographs using the Brooker classification.
No heterotopic ossification was found in 81% of the patients, 19% of the patients had Brooker grade 1 ossification.
Using a two-stage study design for phase 2 clinical trials, a 7-day treatment of a COX-2 inhibitor (rofecoxib) prevents effectively the formation of heterotopic ossification after cemented primary total hip arthroplasty.
非甾体抗炎药（NSAIDs）可预防异位骨化，但胃肠道不适较为常见。选择性环氧化酶-2（COX-2）抑制性NSAIDs产生的胃肠道副作用较少。
采用前瞻性两阶段研究设计进行2期临床试验，纳入42例患者，以确定口服50mg罗非昔布（一种COX-2抑制剂）7天是否能预防异位骨化。为骨关节炎患者植入骨水泥固定的初次全髋关节置换术（THA）假体。6个月后，使用布鲁克分类法在前后位X线片上评估异位骨形成情况。
81%的患者未发现异位骨化，19%的患者有布鲁克1级骨化。
采用两阶段研究设计进行2期临床试验，使用COX-2抑制剂（罗非昔布）治疗7天可有效预防骨水泥固定的初次全髋关节置换术后异位骨化的形成。
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