Romanelli Marco, Gilligan Adrienne M, Waycaster Curtis R, Dini Valentina
Department of Dermatology, University of Pisa, Pisa, Italy.
Department of Life Sciences, Truven Health Analytics, Fort Worth, TX, USA; Department of Pharmacotherapy, University of North Texas Health Sciences Center, Fort Worth, TX, USA.
Clinicoecon Outcomes Res. 2016 May 4;8:153-61. doi: 10.2147/CEOR.S104067. eCollection 2016.
Difficult-to-heal wounds pose clinical and economic challenges, and cost-effective treatment options are needed.
The aim of this study is to determine the cost-effectiveness of extracellular matrix (ECM) relative to standard of care (SC) on wound closure for the treatment of mixed arterial/venous (A/V) or venous leg ulcers (VLUs).
A two-stage Markov model was used to predict the expected costs and outcomes of wound closure for ECM and SC. Outcome data used in the analysis were taken from an 8-week randomized clinical trial that directly compared ECM and SC. Patients were followed up for an additional 6 months to assess wound closure. Forty-eight patients completed the study; 25 for ECM and 23 for SC. SC was defined as a standard moist wound dressing. Transition probabilities for the Markov states were estimated from the clinical trial.
The economic outcome of interest was direct cost per closed-wound week. Resource utilization was based on the treatment regimen used in the clinical trial. Costs were derived from standard cost references. The payer's perspective was taken.
ECM-treated wounds closed, on average, after 5.4 weeks of treatment, compared with 8.3 weeks for SC wounds (P=0.02). Furthermore, complete wound closure was significantly higher in patients treated with ECM (P<0.05), with 20 wounds closed in the ECM group (80%) and 15 wounds closed in the SC group (65%). After 8 months, patients treated with ECM had substantially higher closed-wound weeks compared with SC (26.0 weeks versus 22.0 weeks, respectively). Expected direct costs per patient were $2,527 for ECM and $2,540 for SC (a cost savings of $13).
ECM yielded better clinical outcomes at a slightly lower cost in patients with mixed A/V and VLUs. ECM is an effective treatment for wound healing and should be considered for use in the management of mixed A/V and VLUs.
难愈合伤口带来了临床和经济挑战，因此需要具有成本效益的治疗方案。
本研究旨在确定相对于标准治疗（SC），细胞外基质（ECM）用于治疗混合性动静脉（A/V）或静脉性腿部溃疡（VLU）伤口闭合的成本效益。
设计、设置和参与者：采用两阶段马尔可夫模型预测ECM和SC伤口闭合的预期成本和结果。分析中使用的结果数据来自一项为期8周的随机临床试验，该试验直接比较了ECM和SC。患者又接受了6个月的随访以评估伤口闭合情况。48名患者完成了研究；25名接受ECM治疗，23名接受SC治疗。SC定义为标准湿性伤口敷料。马尔可夫状态的转移概率根据临床试验进行估计。
感兴趣的经济结果是每闭合伤口周的直接成本。资源利用基于临床试验中使用的治疗方案。成本来自标准成本参考。采用支付方的视角。
ECM治疗的伤口平均在治疗5.4周后闭合，而SC治疗的伤口为8.3周（P = 0.02）。此外，接受ECM治疗的患者完全伤口闭合率显著更高（P < 0.05），ECM组有20个伤口闭合（80%），SC组有15个伤口闭合（65%）。8个月后，接受ECM治疗的患者的闭合伤口周数显著高于SC组（分别为26.0周和22.0周）。每位患者的预期直接成本，ECM为2527美元，SC为2540美元（节省成本13美元）。
对于混合性A/V和VLU患者，ECM以略低的成本产生了更好的临床结果。ECM是一种有效的伤口愈合治疗方法，在混合性A/V和VLU的管理中应考虑使用。
