Fivenson David, Scherschun Lubomira
Henry Ford Health System, Detroit, MI 48202, USA.
Int J Dermatol. 2003 Dec;42(12):960-5. doi: 10.1111/j.1365-4632.2003.02039.x.
Controlled studies have shown that Apligraf(R) (Organogenesis Inc., Canton, USA) is more economical and more effective at healing venous leg ulcers (VLUs) than compression therapy alone. However, the clinical and economic impact of Apligraf on healing VLUs in clinical practice has not been fully examined.
A medical chart review was conducted of patients who were treated with Apligraf for one or more nonhealing VLUs over a 2-year period at the Henry Ford Hospital. Following Apligraf treatment, patients were followed for up to 9 months. Primary clinical outcome measures were mean change in baseline ulcer size (cm2) per week and percent reduction in baseline ulcer size at final study visit. Economic evaluation of Apligraf treatment was based on VLU-related medical care costs (US$) in relation to ulcer size (cm2) changes before and after Apligraf therapy.
Thirteen patients with 21 chronic VLUs were treated with Apligraf. All had at least one comorbidity, most commonly hypertension (38%). Twelve patients were known to have had a prior history of VLU. At baseline, mean ulcer duration was 23.9 months and median ulcer size was 13.5 cm2; for the 6 months preceding Apligraf treatment, in which patients received conventional compression therapy, mean ulcer size increased +0.72 cm2 per week. During the Apligraf post-treatment study period, mean ulcer size decreased by -2.37 cm2 per week. At final clinic visit, ulcers exhibited an average 60.5% reduction in baseline size; 21 ulcers (n = 13) showed 75% or greater reduction in size, compared with baseline. Economic data were available for five patients; among these individuals ulcer-related medical costs per unit change in ulcer size were lower following Apligraf treatment relative to such costs with conventional compression therapy applied during the Apligraf pretreatment period.
In a clinical practice setting, Apligraf is more effective and more economical at healing VLUs than conventional therapy alone.
对照研究表明，Apligraf（美国马萨诸塞州坎顿市的Organogenesis公司生产）在治疗下肢静脉溃疡（VLU）方面比单纯压迫疗法更经济且更有效。然而，Apligraf在临床实践中对治愈下肢静脉溃疡的临床和经济影响尚未得到充分研究。
对亨利福特医院在2年期间接受Apligraf治疗一个或多个未愈合下肢静脉溃疡的患者进行病历回顾。Apligraf治疗后，对患者进行长达9个月的随访。主要临床结局指标为每周基线溃疡面积（cm²）的平均变化以及最终研究访视时基线溃疡面积的缩小百分比。Apligraf治疗的经济评估基于与下肢静脉溃疡相关的医疗费用（美元）与Apligraf治疗前后溃疡面积（cm²）变化的关系。
13例患有21处慢性下肢静脉溃疡的患者接受了Apligraf治疗。所有患者至少有一种合并症，最常见的是高血压（38%）。已知12例患者既往有下肢静脉溃疡病史。基线时，平均溃疡持续时间为23.9个月，中位溃疡面积为13.5 cm²；在接受Apligraf治疗前的6个月里，患者接受传统压迫疗法，平均溃疡面积每周增加+0.72 cm²。在Apligraf治疗后的研究期间，平均溃疡面积每周减少-2.37 cm²。在最终临床访视时，溃疡面积平均比基线缩小了60.5%；21处溃疡（n = 13）面积比基线缩小了75%或更多。有5例患者可获得经济数据；在这些患者中，相对于Apligraf治疗前期应用传统压迫疗法时的费用，Apligraf治疗后每单位溃疡面积变化的溃疡相关医疗费用更低。
在临床实践环境中，Apligraf在治愈下肢静脉溃疡方面比单纯传统疗法更有效且更经济。
