Vosáhlo Jiří, Salus Adam, Smolko Michael, Němcová Barbora, Nordmeyer Veit, Mikles Milos, Rau Stefanie M, Erik Johansen Odd
Orthopaedic and Traumatology Department, Jihlava Hospital, Jihlava, Czech Republic.
Rehabilitation Department, Jihlava Hospital, Jihlava, Czech Republic.
Ther Adv Musculoskelet Dis. 2023 Jul 29;15:1759720X231186875. doi: 10.1177/1759720X231186875. eCollection 2023.
Early mobilization after total hip replacement (THR) is key for fast recovery but is often limited by pain. Oral enzyme combinations (OECs) have demonstrated anti-inflammatory and pain-relieving effects.
This prospective, randomized, double-blind, placebo-controlled exploratory trial evaluated the effects of pre- and post-operative use of OEC (90 mg bromelain, 48 mg trypsin, 100 mg rutoside) following elective THR, on post-operative recovery.
Candidates for primary elective cementless THR owing to osteoarthritis were eligible for participation [age ⩾50 years, body mass index 25-35 kg/m, C-reactive protein (CRP) ⩽6 mg/L]. Following randomization to OEC or placebo, intervention started pre-operatively and continued onwards until day 42. Main outcomes included post-operative CRP levels (days 1-7), self-reported hip pain at rest (by 0-10 cm visual analogue scale on post-operative days 1-42), post-operative analgesic use [by cumulative analgesic consumption score (CACS) days 7-42], tolerability and adverse events.
Patients ( = 34) were recruited from a tertiary orthopaedic hospital in the Czech Republic, of whom 33 completed the study (OEC/placebo: = 15/18). Baseline characteristics across the groups were comparable. Compared with placebo, the OEC group had numerically lower CRP levels on post-operative days 1-7, including peak level [mean (standard deviation) OEC placebo: 81.4 (28.3) 106.7 (63.3) mg/L], which translated into a significant 32% lower CRP area under the curve ( = 0.034). The OEC group reported significantly less pain during post-operative days 1-7 placebo (analysis of variance treatment × visit [(4) = 3.989]; = 0.005). Analgesic use was numerically reduced as assessed through an accumulated CACS. No deleterious effects on haemorheological parameters were observed in either group.
Pre- and post-operative use of OEC significantly reduced CRP levels and patient self-reported pain. OEC may be an efficacious and safe treatment option to facilitate post-operative recovery following THR.
EudraCT number 2016-003078-41.
全髋关节置换术（THR）后的早期活动是快速康复的关键，但常受疼痛限制。口服酶组合（OECs）已显示出抗炎和止痛作用。
这项前瞻性、随机、双盲、安慰剂对照的探索性试验评估了选择性THR术后使用OEC（90毫克菠萝蛋白酶、48毫克胰蛋白酶、100毫克芦丁）对术后恢复的影响。
因骨关节炎行初次选择性非骨水泥THR的患者符合参与条件[年龄≥50岁，体重指数25 - 35 kg/m²，C反应蛋白（CRP）≤6 mg/L]。随机分为OEC组或安慰剂组后，干预在术前开始并持续至第42天。主要结局包括术后CRP水平（第1 - 7天）、静息时自我报告的髋关节疼痛（术后第1 - 42天采用0 - 10厘米视觉模拟评分）、术后镇痛药物使用情况[通过累积镇痛药物消耗评分（CACS）评估第7 - 42天]、耐受性和不良事件。
从捷克共和国一家三级骨科医院招募了患者（n = 34），其中33例完成了研究（OEC/安慰剂组：n = 15/18）。各组的基线特征具有可比性。与安慰剂组相比，OEC组术后第1 - 7天的CRP水平在数值上较低，包括峰值水平[均值（标准差）OEC组 安慰剂组：81.4（28.3） 106.7（63.3）mg/L]，这使得曲线下CRP面积显著降低32%（P = 0.034）。OEC组报告术后第1 - 7天的疼痛明显少于安慰剂组（方差分析治疗×访视[(4) = 3.989]；P = 0.005）。通过累积CACS评估，镇痛药物使用在数值上有所减少。两组均未观察到对血液流变学参数的有害影响。
术前和术后使用OEC可显著降低CRP水平和患者自我报告的疼痛。OEC可能是促进THR术后恢复的一种有效且安全的治疗选择。
EudraCT编号2016 - 003078 - 41。
