Department of Orthopedic Surgery, Clinic Head-Orto, Aalborg University Hospital, Hobrovej 18-22, 9000 Aalborg, Denmark.
Department of Orthopedic Surgery, Clinic Head-Orto, Aalborg University Hospital, Hobrovej 18-22, 9000 Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Denmark.
Injury. 2019 Jul;50(7):1309-1317. doi: 10.1016/j.injury.2019.06.011. Epub 2019 Jun 5.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may delay bone healing. This knowledge is mainly derived from retrospective uncontrolled clinical studies and from animal experiments. The purpose of this prospective controlled study was to investigate whether ibuprofen influences pain, function, and bone healing after a Colles' fracture.
A single center, triple-blind, randomized clinical trial. 95 patients, 80 females and 15 males, with displaced Colles' fracture aged median 65 (range 40-85) years old were included and operated by external fixation from June 2012 through June 2015. 89 participants received interventional medicine and 83 completed the one-year follow-up. The 7-day ibuprofen group received 600 mg of ibuprofen three times a day, the 3-day ibuprofen group received ibuprofen for three days and a placebo for the following four days, and finally, the placebo group received a placebo for seven days. All patients received paracetamol 1000 mg four times a day and 50 mg tramadol if needed. The primary outcome were radiological changes in radius tilt, length, and inclination observed during and 6 weeks after the surgery. The analgesic outcome were 14 days experience of pain, and registered use of tramadol. The functional outcomes were the percentage differences in the motion between the injured and non-injured wrist, and the DASH score at 3 and 12 months. All analyses were performed according to the intention to treat.
No clinically relevant difference was observed in the radiological migration between the treatment groups, 0.064≤P ≤ 0.81. There was no difference in the pain score between the treatment groups, P = 0.13. The use of tramadol was lower in the ibuprofen groups than in the placebo group, P = 0.035. Ibuprofen treatment did not affect the range of motion, 0.148 ≤P ≤ 0.963. Patients in all groups demonstrated DASH score, and wrist motion improvement, close to 90% of normal amplitude. The complication rate was higher in the 7-day ibuprofen group compared to the placebo group, P = 0.043.
Ibuprofen treatment demonstrated a tramadol-sparing effect during the postoperative period. Neither wrist function nor radiological migration were influenced. The complication rate was higher in the ibuprofen-treated group compared the placebo-treated group.
非甾体抗炎药（NSAIDs）可能会延迟骨愈合。这一知识主要来源于回顾性非对照临床研究和动物实验。本前瞻性对照研究的目的是调查布洛芬是否会影响桡骨骨折后疼痛、功能和骨愈合。
单中心、三盲、随机临床试验。2012 年 6 月至 2015 年 6 月，共纳入 95 例女性 80 例、男性 15 例、年龄中位数 65 岁（范围 40-85 岁）、桡骨远端骨折、采用外固定治疗的患者。89 例患者接受介入治疗，83 例完成 1 年随访。7 天布洛芬组每天 3 次口服 600mg 布洛芬，3 天布洛芬组 3 天内服用布洛芬，之后 4 天服用安慰剂，最后安慰剂组 7 天内服用安慰剂。所有患者每天服用扑热息痛 1000mg4 次，如果需要，还服用 50mg 曲马多。主要观察指标为手术期间和术后 6 周桡骨倾斜、长度和倾斜的影像学变化。镇痛效果为 14 天的疼痛体验和曲马多的使用登记。功能结果为受伤和未受伤手腕之间运动的百分比差异，以及 3 个月和 12 个月时的 DASH 评分。所有分析均按意向治疗进行。
治疗组之间的影像学迁移没有观察到临床相关差异，0.064≤P≤0.81。治疗组之间的疼痛评分无差异，P=0.13。与安慰剂组相比，布洛芬组使用曲马多的比例较低，P=0.035。布洛芬治疗并未影响运动范围，0.148≤P≤0.963。所有组的患者 DASH 评分和腕关节运动均有所改善，接近正常幅度的 90%。与安慰剂组相比，7 天布洛芬组的并发症发生率更高，P=0.043。
布洛芬治疗在术后期间表现出曲马多节约效应。腕关节功能和影像学迁移均不受影响。与安慰剂治疗组相比，布洛芬治疗组的并发症发生率更高。
