Abstract：
Persistent posttraumatic/postsurgery ankle edema (PPAE) is edema that persists from 2 weeks to 3 months after injury or surgery. PPAE has negative effects on the healing process and quality of life. This study aimed to evaluate the efficacy of a phytochemical product containing diosmin, coumarin, and arbutin (Linfadren) in addition to the conventional treatment, in patients with PPAE.
Between October 2018 and February 2020, 60 outpatients with PPAE (42 with ankle fractures and 18 with ankle sprains) were enrolled and randomized (1:1 ratio) to receive either 6-week conventional treatment plus Linfadren (study group) or conventional treatment alone (control group). Primary outcome was ankle edema as measured by the \"figure-of-8-20\" method. Secondary outcomes were ankle function measured by the Lower Extremity Functional Scale (LEFS), and patient\'s overall perceived treatment efficacy. Tolerability of Linfadren was also evaluated. Assessments were performed at baseline, at end of treatment (6 weeks after baseline), and 3 months after the end of treatment (follow-up). A subgroup analysis was also conducted for the injury type (fracture/sprain) to identify if this factor affected the results of the primary outcome measure.
At the end of treatment, the study group had a significantly greater improvement in ankle edema, improved ankle function, and more patients who considered this treatment effective compared with the control group. The measured difference in circumference by the figure-of-8-20 method averaged 4% at 6 weeks and 5% at 3 months. No difference between groups was seen in rescue medication. No adverse events were recorded. Subgroup analysis revealed no significant influence of the injury type on the primary outcome measure.
Linfadren in addition to conventional treatment was more effective than conventional treatment alone in patients with PPAE.
Level I, randomized controlled trial.
Between October 2018 and February 2020, 60 outpatients with PPAE (42 with ankle fractures and 18 with ankle sprains) were enrolled and randomized (1:1 ratio) to receive either 6-week conventional treatment plus Linfadren (study group) or conventional treatment alone (control group). Primary outcome was ankle edema as measured by the \"figure-of-8-20\" method. Secondary outcomes were ankle function measured by the Lower Extremity Functional Scale (LEFS), and patient\'s overall perceived treatment efficacy. Tolerability of Linfadren was also evaluated. Assessments were performed at baseline, at end of treatment (6 weeks after baseline), and 3 months after the end of treatment (follow-up). A subgroup analysis was also conducted for the injury type (fracture/sprain) to identify if this factor affected the results of the primary outcome measure.
At the end of treatment, the study group had a significantly greater improvement in ankle edema, improved ankle function, and more patients who considered this treatment effective compared with the control group. The measured difference in circumference by the figure-of-8-20 method averaged 4% at 6 weeks and 5% at 3 months. No difference between groups was seen in rescue medication. No adverse events were recorded. Subgroup analysis revealed no significant influence of the injury type on the primary outcome measure.
Linfadren in addition to conventional treatment was more effective than conventional treatment alone in patients with PPAE.
Level I, randomized controlled trial.
摘要：
■持续创伤后/手术后踝关节水肿（PPAE）是指在损伤或手术后2周至3个月内持续的水肿。PPAE对愈合过程和生活质量有负面影响。这项研究旨在评估含有地奥司明的植物化学产品的功效，香豆素,和熊果苷（林法德伦）除了常规治疗外，PPAE患者。
■在2018年10月至2020年2月之间，纳入了60例PPAE门诊患者（42例踝关节骨折和18例踝关节扭伤），并随机（1：1比例）接受为期6周的常规治疗加林法达伦（研究组）或单独进行常规治疗（对照组）。主要结果是通过“8-20图”方法测量的踝关节水肿。次要结果是通过下肢功能量表（LEFS）测量的踝关节功能，和患者的整体感知治疗效果。还评估了Linfadren的耐受性。在基线时进行评估，在治疗结束时（基线后6周），治疗结束后3个月（随访）。还对损伤类型（骨折/扭伤）进行了亚组分析，以确定该因素是否影响主要结局指标的结果。
■治疗结束时，研究组的踝关节水肿改善明显,改善踝关节功能,与对照组相比，更多的患者认为这种治疗有效。通过8-20图方法测量的周长差异在6周时平均为4％，在3个月时平均为5％。两组之间在抢救药物方面没有差异。没有记录到不良事件。亚组分析显示，损伤类型对主要结局指标没有显着影响。
■在PPAE患者中，除了常规治疗外，林法达伦比单独的常规治疗更有效。
■一级,随机对照试验。
■在2018年10月至2020年2月之间，纳入了60例PPAE门诊患者（42例踝关节骨折和18例踝关节扭伤），并随机（1：1比例）接受为期6周的常规治疗加林法达伦（研究组）或单独进行常规治疗（对照组）。主要结果是通过“8-20图”方法测量的踝关节水肿。次要结果是通过下肢功能量表（LEFS）测量的踝关节功能，和患者的整体感知治疗效果。还评估了Linfadren的耐受性。在基线时进行评估，在治疗结束时（基线后6周），治疗结束后3个月（随访）。还对损伤类型（骨折/扭伤）进行了亚组分析，以确定该因素是否影响主要结局指标的结果。
■治疗结束时，研究组的踝关节水肿改善明显,改善踝关节功能,与对照组相比，更多的患者认为这种治疗有效。通过8-20图方法测量的周长差异在6周时平均为4％，在3个月时平均为5％。两组之间在抢救药物方面没有差异。没有记录到不良事件。亚组分析显示，损伤类型对主要结局指标没有显着影响。
■在PPAE患者中，除了常规治疗外，林法达伦比单独的常规治疗更有效。
■一级,随机对照试验。
