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选择性环氧化酶-2抑制剂与吲哚美辛预防髋关节置换术后异位骨化的比较:一项纳入100例患者的双盲随机试验,随访1年

Selective COX-2 inhibitor versus indomethacin for the prevention of heterotopic ossification after hip replacement: a double-blind randomized trial of 100 patients with 1-year follow-up.

作者信息

Grohs Josef G, Schmidt Maximilian, Wanivenhaus Axel

机构信息

Department of Orthopedics, Medical University of Vienna, Austria.

出版信息

Acta Orthop. 2007 Feb;78(1):95-8. doi: 10.1080/17453670610013484.

DOI:10.1080/17453670610013484
PMID:17453399
Abstract

INTRODUCTION

Recent reports have suggested that selective COX-2 inhibition may be sufficient for the prevention of heterotopic ossification.

METHODS

We performed a randomized controlled study to evaluate the effect of the selective COX-2 inhibitor rofecoxib compared to that of indomethacin on the incidence and extent of heterotopic ossification in patients who had undergone hip replacement surgery. 50 patients received a daily dose of 25 mg rofecoxib and 50 patients received a daily dose of 100 mg indomethacin (25, 25, and 50 mg).

RESULTS

No ossifications were found in 48 patients. Grade-II ossifications were seen in 5/46 patients in the rofecoxib group and in 6/50 patients in the indomethacin group. Grade-III and grade-IV ossifications were seen in 3/46 patients in the rofecoxib group only. The differences were not statistically significant. The study medication had to be discontinued in 2 patients in the indomethacin group, due to dyspepsia.

INTERPRETATION

After short-term administration, the selective COX-2 inhibitor rofecoxib was effective in preventing heterotopic ossification after total hip arthroplasty.

摘要

引言

最近的报告表明,选择性COX-2抑制可能足以预防异位骨化。

方法

我们进行了一项随机对照研究,以评估选择性COX-2抑制剂罗非昔布与吲哚美辛相比,对接受髋关节置换手术患者异位骨化的发生率和程度的影响。50例患者每日服用25mg罗非昔布,50例患者每日服用100mg吲哚美辛(25mg、25mg和50mg)。

结果

48例患者未发现骨化。罗非昔布组46例患者中有5例出现II级骨化,吲哚美辛组50例患者中有6例出现II级骨化。仅罗非昔布组46例患者中有3例出现III级和IV级骨化。差异无统计学意义。吲哚美辛组有2例患者因消化不良而不得不停用研究药物。

解读

短期给药后,选择性COX-2抑制剂罗非昔布在预防全髋关节置换术后异位骨化方面有效。

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