Chahal Gurdip S, Saithna Adnan, Brewster Mark, Gilbody Julian, Lever Suzanne, Khan Wasim S, Foguet Pedro
University Hospital Coventry and Warwickshire, Clifford Bridge Road, Walsgrave, Coventry, CV2 2DX, UK.
Ortop Traumatol Rehabil. 2013 Mar-Apr;15(2):125-9. doi: 10.5604/15093492.1045953.
There is no consensus on the optimal form of venous thromboembolic prophylaxis treatment in hip and knee arthroplasty patients, or on the safety and complication profile of the available chemical prophylaxis modalities. In this study we aimed to measure the return to theatre rate for any cause related to wound complications in patients undergoing total hip replacement and total knee replacement, and compare these rates between patients on oral Rivaroxaban 10mg OD and subcutaneous Enoxaparin 40mg OD in our department.
There were a total of 387 patients included in the study; 227 patients in group 1, who received Enoxaparin 40mg OD, and 160 patients in group 2, who received Rivaroxaban 10mg OD.
The primary outcome measure was re-operation rate due to wound complications. Secondary outcome measures were infection rate, incidence of deep vein thrombosis, pulmonary emboli, duration of hospital stay, change in haemoglobin and haematocrit and blood transfusion rate. In this retrospective cohort study we found that patients who received Rivaroxaban were more than twice as likely to return to theatre for wound complications compared to patients receiving Enoxaparin. Although not statistically significant, this increase is in line with previous studies. Infection rates increased from 0.9% to 1.9% after the introduction of Rivaroxaban and microbiologically confirmed superficial infections rose from 1.3% to 3.1% after Rivaroxaban was introduced in our unit. These rises were not statistically significant.
Our study highlights the need for large randomised controlled trials to assess post-operative complications following the introduction of Rivaroxaban for post-arthroplasty thromboprophylaxis.
对于髋膝关节置换术患者静脉血栓栓塞预防治疗的最佳形式,以及现有化学预防方法的安全性和并发症情况,目前尚无共识。在本研究中,我们旨在测量全髋关节置换术和全膝关节置换术患者因伤口并发症而返回手术室的发生率,并比较在我们科室接受每日一次口服10mg利伐沙班和每日一次皮下注射40mg依诺肝素的患者之间的这些发生率。
本研究共纳入387例患者;第1组227例患者接受每日一次40mg依诺肝素治疗,第2组160例患者接受每日一次10mg利伐沙班治疗。
主要观察指标是因伤口并发症导致的再次手术率。次要观察指标包括感染率、深静脉血栓形成、肺栓塞的发生率、住院时间、血红蛋白和血细胞比容的变化以及输血率。在这项回顾性队列研究中,我们发现与接受依诺肝素的患者相比,接受利伐沙班的患者因伤口并发症返回手术室的可能性高出两倍多。虽然无统计学意义,但这种增加与先前的研究一致。在引入利伐沙班后,感染率从0.9%升至1.9%,在我们科室引入利伐沙班后,微生物学确诊的浅表感染从1.3%升至3.1%。这些升高无统计学意义。
我们的研究强调需要进行大型随机对照试验,以评估引入利伐沙班进行关节置换术后血栓预防后的术后并发症。