【罂粟摘要】预防股骨颈骨折手术患者心肌损伤的限制性与自由性输血策略：一项可行性随机试验
预防股骨颈骨折手术患者心肌损伤的限制性与自由性输血策略：一项可行性随机试验
翻译：牛振瑛 编辑：佟睿 审校：曹莹
贵州医科大学 高鸿教授课题组
股骨颈骨折患者的最佳输血策略尚不确定，特别是在合并心血管疾病的情况下。
我们对两种输血策略进行了前瞻性、单中心、随机的可行性试验。将接受股骨颈骨折手术的患者随机分为限制性输血（限制性策略被定义为血红蛋白输注低限为70g/L或更少，目标血红蛋白范围为70-90g/L）组和自由输血（自由输血被定义为血红蛋白输注阈值为90g/L或更少，目标血红蛋白范围为90-110g/L）组。可行性结果包括：招募的合格患者的比例、方案依从性、血红蛋白差异和是否进行输血。主要的临床观察指标是心肌损伤，使用肌钙蛋白评估。次要观察指标包括主要不良心脏事件、术后并发症、住院时间、死亡率和生活质量。
我们招募了907名符合条件的患者中的200名(22%)，其中62名(31%)显示血红蛋白降低(降至90g/L或更低)，因此接受了干预。总体方案依从性在自由组为81%，在限制性组为64%。限制组术前、术后第1天的血红蛋白浓度相近，第2天较低(平均差异[MD]，7.0g/L；95%可信区间[CI]，1.6-12.4)。限制组出院前30d内最低血红蛋白(MD，5.3g/L；95%CI，1.7-9.0)低于自由组。总体而言，限制组58%的患者没有接受输血，而自由组只有4%(比例差异，54.5%；95%CI，36.8-72.2)。与主要临床结局的比例分别为14/26(54%，自由组)和24/34(71%，限制组)，差异为-16.7%(95%CI，-41.3~7.8；P=0.18)，在统计学上没有显著差异。
在股骨颈骨折患者中对两种输血策略进行临床试验与临床相关的心脏结局测量是可行的。
A restrictive versus liberal transfusion strategy to prevent myocardial injury in patients undergoing surgery for fractured neck of femur: a feasibility randomised trial (RESULT-NOF)
Background: The optimum transfusion strategy in patients with fractured neck of femur is uncertain, particularly if there is coexisting cardiovascular disease.
Methods: We conducted a prospective, single-centre, randomised feasibility trial of two transfusion strategies. We randomly assigned patients undergoing surgery for fractured neck of femur to a restrictive (haemoglobin, 70-90 g/L) or liberal (haemoglobin, 90-110 g/L) transfusion strategy throughout their hospitalisation. Feasibility outcomes included:enrolment rate, protocol compliance, difference in haemoglobin, and blood exposure. The primary clinical outcome was myocardial injury using troponin estimations. Secondary outcomes included major adverse cardiac events, post-operative complications, duration of hospitalisation, mortality, and quality of life.
Results: We enrolled 200 (22%) of 907 eligible patients, and 62 (31%) showed decreased haemoglobin (to 90 g/Lor less) and were thus exposed to the intervention. The overall protocol compliance was 81% in the liberal group and 64% in the restrictive group. Haemoglobin concentrations were similar preoperatively and at postoperative day 1 but lower in the restrictive group on day 2 (mean difference [MD], 7.0g/L; 95% confidence interval [CI], 1.6-12.4). Lowest haemoglobin within 30 days/before discharge was lower in the restrictive group (MD, 5.3g/L; 95% CI, 1.7-9.0). Overall, 58% of patients in the restrictive group received no transfusion compared with 4% in the liberal group (difference in proportion, 54.5%;95% CI, 36.8-72.2). The proportion with the primary clinical outcome was 14/26 (54%, liberal) vs 24/34 (71%, restrictive), and the difference in proportion was e16.7% (95% CI, -41.3 to 7.8; P=0.18).
Conclusion: A clinical trial of two transfusion strategies in hip fracture with a clinically relevant cardiac outcome is feasible.
翻译：牛振瑛
编辑：佟睿
审校：曹莹