Iberoamerican Cochrane Centre-Public Health and Clinical Epidemiology, IIBSant Pau, Barcelona, Spain.
Department of Social Medicine and Family Health, Universidad del Cauca, Popayán, Colombia.
BMC Musculoskelet Disord. 2022 Aug 31;23(1):827. doi: 10.1186/s12891-022-05775-y.
We assessed quality of life (QoL) of patients undergoing surgery for proximal femur fracture and performed a cost-effectiveness analysis of haemostatic drugs for reducing postoperative bleeding.
We analysed data from an open, multicentre, parallel, randomized controlled clinical trial (RCT) that assessed the efficacy and safety of tranexamic acid (TXA group) and fibrin glue (FG group) administered topically prior to surgical closure, compared with usual haemostasis methods (control group). For this study we conducted a cost-effectiveness analysis of these interventions from the Spanish Health System perspective, using a time horizon of 12 months. The cost was reported in $US purchasing power parity (USPPP). We calculated the incremental cost-effectiveness ratio (ICER) per QALY (quality-adjusted life-year).
We included 134 consecutive patients from February 2013 to March 2015: 42 patients in the TXA group, 46 in the FG group, and 46 in the control group. Before the fracture, EuroQol visual analogue scale (EQ-VAS) health questionnaire score was 68.6. During the 12 months post-surgery, the intragroup EQ-VAS improved, but without reaching pre-fracture values. There were no differences between groups for EQ-VAS and EuroQol 5 dimensions 5 levels (EQ-5D-5L) health questionnaire score, nor in hospital stay costs or medical complication costs. Nevertheless, the cost of one FG treatment was significantly higher (399.1 $USPPP) than the cost of TXA (12.9 $USPPP) or usual haemostasis (0 $USPPP). When comparing the cost-effectiveness of the interventions, FG was ruled out by simple dominance since it was more costly (13,314.7 $USPPP) than TXA (13,295.2 $USPPP) and less effective (utilities of 0.0532 vs. 0.0734, respectively). TXA compared to usual haemostasis had an ICER of 15,289.6 $USPPP per QALY).
There were no significant differences between the intervention groups in terms of postoperative changes in QoL. However, topical TXA was more cost-effective than FG or usual haemostasis.
ClinicalTrials.gov: NCT02150720. Date of registration 30/05/2014. Retrospectively registered.
我们评估了接受股骨近端骨折手术患者的生活质量（QoL），并对减少术后出血的止血药物进行了成本效益分析。
我们分析了一项开放、多中心、平行、随机对照临床试验（RCT）的数据，该试验评估了氨甲环酸（TXA 组）和纤维蛋白胶（FG 组）在手术闭合前局部给药与常规止血方法（对照组）相比的疗效和安全性。对于这项研究，我们从西班牙卫生系统的角度对这些干预措施进行了成本效益分析，时间范围为 12 个月。成本以美元购买力平价（USPPP）报告。我们计算了每 QALY（质量调整生命年）的增量成本效益比（ICER）。
我们纳入了 2013 年 2 月至 2015 年 3 月期间的 134 例连续患者：TXA 组 42 例，FG 组 46 例，对照组 46 例。骨折前，EuroQol 视觉模拟量表（EQ-VAS）健康问卷评分 68.6。手术后 12 个月内，组内 EQ-VAS 有所改善，但未达到骨折前的数值。EQ-VAS 和 EuroQol 5 维度 5 级（EQ-5D-5L）健康问卷评分在各组之间无差异，住院费用或医疗并发症费用也无差异。然而，FG 的单次治疗费用（399.1 美元）明显高于 TXA（12.9 美元）或常规止血（0 美元）。当比较干预措施的成本效益时，FG 因成本较高（13314.7 美元）而被简单排除，与 TXA（13295.2 美元）相比效果较差（效用分别为 0.0532 和 0.0734）。TXA 与常规止血相比，每 QALY 的 ICER 为 15289.6 美元。
在术后 QoL 变化方面，干预组之间没有显著差异。然而，局部 TXA 比 FG 或常规止血更具成本效益。
ClinicalTrials.gov：NCT02150720。注册日期 2014 年 5 月 30 日。回顾性注册。
