1 Department of Life, Health and Environmental Sciences, School of Medicine, University of L'Aquila, L'Aquila, Italy.
2 Department of Medicine, "San Salvatore" Hospital of L'Aquila, ASL 01 Avezzano-Sulmona-L'Aquila, L'Aquila, Italy.
Clin Rehabil. 2019 May;33(5):904-912. doi: 10.1177/0269215519829797. Epub 2019 Feb 13.
To evaluate the effectiveness and safety of oral administration of Linfadren in addition to conventional treatment in patients with post-trauma/surgery persistent hand edema.
Parallel-group randomized controlled trial.
Outpatient rehabilitation center.
A total of 60 outpatients (mean age 48.5 (standard deviation (SD) = 12.3) years) with post-trauma/surgery persistent hand edema.
Patients were randomized to either receive six-week conventional treatment plus Linfadren (Study Group) or conventional treatment (Control Group).
Primary outcome was hand edema as measured by figure-of-eight method. Secondary outcomes were hand function, patient's overall perceived treatment effectiveness and rescue medication request. Tolerability of Linfadren was also evaluated. Assessments were performed at baseline, at the end of treatment and three months after the end of treatment.
All patients completed the six-week program and 57 patients (95%) completed the three-month follow-up. At six weeks, the Study Group had significantly greater improvement in hand edema (423.3 (SD = 23.8) mm vs 439.4 (SD = 22.6) mm; P = 0.009) and upper limb function ( Quick Disabilities of Arm, Shoulder and Hand questionnaire: 23.6 (SD = 13.6) vs 37.7 (SD = 15.9); P = 0.005) compared to the Control Group. Moreover, the percentage of patients who perceived treatment as effective was significantly higher in the Study Group than in the Control Group both after treatment (70% vs 37%, P = 0.002) and at follow-up (77% vs 30%, P < 0.0001). The rescue medication request was not different between groups. No adverse events were recorded.
Linfadren in addition to conventional treatment was safe and more effective than conventional treatment alone in patients with post-trauma/surgery persistent hand edema.
评估林法仑口服给药联合常规治疗对外伤/手术后持续性手部肿胀患者的有效性和安全性。
平行分组随机对照试验。
门诊康复中心。
共 60 例（平均年龄 48.5（标准差（SD）=12.3）岁）外伤/手术后持续性手部肿胀患者。
患者随机分为接受 6 周常规治疗加林法仑（研究组）或常规治疗（对照组）。
主要结局指标为八字法测量的手部肿胀。次要结局指标为手部功能、患者整体治疗效果感知和急救药物需求。林法仑的耐受性也进行了评估。评估在基线时、治疗结束时和治疗结束后 3 个月进行。
所有患者均完成了 6 周的治疗方案，57 例（95%）完成了 3 个月的随访。在 6 周时，研究组手部肿胀（423.3（SD=23.8）mm 与 439.4（SD=22.6）mm；P=0.009）和上肢功能（快速残疾手臂、肩部和手部问卷：23.6（SD=13.6）与 37.7（SD=15.9）；P=0.005）改善明显优于对照组。此外，与对照组相比，研究组治疗后（70%比 37%，P=0.002）和随访时（77%比 30%，P<0.0001），患者认为治疗有效的比例明显更高。两组急救药物需求无差异。未记录到不良事件。
林法仑联合常规治疗在创伤/手术后持续性手部肿胀患者中比单独常规治疗更安全、更有效。
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