METHODS: This study was designed as a randomized, controlled multicenter trial and conducted in 13 university-affiliated tertiary hospitals. A total of 330 patients undergoing TKA were randomized to either receive or not receive diosmin postoperatively. The diosmin group received 0.9 g of diosmin twice per day for 14 consecutive days starting on the day after surgery, whereas the control group received neither diosmin nor a placebo postoperatively. The primary outcome was lower-extremity swelling 1, 2, 3, and 14 days postoperatively. The secondary outcomes were postoperative pain assessed with use of a visual analogue scale, Hospital for Special Surgery score, range of knee motion, levels of the inflammatory biomarkers C-reactive protein and interleukin-6, and complications.
RESULTS: At all postoperative time points, diosmin was associated with significantly less swelling of the calf, thigh, and upper pole of the patella as well as with significantly lower pain scores during motion. However, no significant differences in postoperative pain scores at rest, Hospital for Special Surgery scores, range of motion, levels of inflammatory biomarkers, or complication rates were found between the diosmin and control groups.
CONCLUSIONS: The use of diosmin after TKA reduced lower-extremity swelling and pain during motion and was not associated with an increased incidence of short-term complications involving the outcomes studied. However, further studies are needed to continue exploring the efficacy and safety of diosmin use in TKA.
METHODS: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
方法:本研究设计为随机,对照多中心试验,并在13所大学附属三级医院进行。共有330例接受TKA的患者在术后随机接受或不接受地奥司明。地奥司明组从手术后当天开始,每天两次服用0.9克地奥司明,连续14天,而对照组术后既不接受地奥司明也不接受安慰剂。主要结果为术后1、2、3和14天下肢肿胀。次要结果是使用视觉模拟量表评估术后疼痛,医院特殊手术评分,膝盖运动范围,炎症生物标志物C反应蛋白和白细胞介素6的水平以及并发症。
结果:在所有术后时间点,Diosmin与小腿肿胀明显减少有关,大腿,和髌骨上极以及运动过程中疼痛评分明显降低。然而,静息时术后疼痛评分无显著差异,医院特殊手术评分,运动范围,炎症生物标志物的水平,或在地奥司明和对照组之间发现并发症发生率。
结论:TKA术后使用地奥司明减轻了下肢在运动过程中的肿胀和疼痛,并且与涉及研究结果的短期并发症的发生率增加无关。然而,需要进一步的研究来继续探索地奥司明用于TKA的疗效和安全性.
方法:治疗级别I.有关证据级别的完整描述,请参阅作者说明。