Strilciuc Stefan, Grad Diana Alecsandra, Vlădescu Cristian, Buzoianu Anca Dana, Albu Carmen, Mureșanu Dafin Fior
Department of Genomics, MEDFUTURE Institute for Biomedical Research, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
RoNeuro Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania.
J Med Life. 2025 Apr;18(4):387-392. doi: 10.25122/jml-2025-0087.
Traumatic brain injuries (TBIs) are a leading cause of death and long-term disability worldwide, with incidence and injury mechanisms varying by age group and region. Impairment of functional status, diagnoses of anxiety and depression are encountered post-TBI. Studies have shown that Cerebrolysin can have positive effects among TBI survivors. We conducted a cost-effectiveness analysis (CEA) among patients with moderate TBI, using data from the CAPTAIN II trial. This exercise was carried out on a three-month timeline from the provider's perspective. Two models were incorporated in the CEA: control (placebo group) and treatment (Cerebrolysin group). Our analysis showed that Cerebrolysin had a high probability of being cost-effective, based on Glasgow Outcome Scale Extended (GOSE) (in over 80% of patients with moderate TBI), Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety scores (for the former two, in over 95% of patients with moderate TBI), when assuming a lasting effect (12 months) of the CAPTAIN trial intervention protocol. A model-based approach is needed to account for potential sources of bias beyond the 90-day observation period of this clinical trial. Furthermore, economic evaluations incorporating patients diagnosed with all TBI severities are needed.
创伤性脑损伤（TBI）是全球范围内死亡和长期残疾的主要原因，其发病率和损伤机制因年龄组和地区而异。TBI后会出现功能状态受损、焦虑和抑郁的诊断。研究表明，脑蛋白水解物对TBI幸存者可能有积极影响。我们利用CAPTAIN II试验的数据，对中度TBI患者进行了成本效益分析（CEA）。这项分析从医疗服务提供者的角度，在三个月的时间范围内进行。CEA纳入了两个模型：对照组（安慰剂组）和治疗组（脑蛋白水解物组）。我们的分析表明，基于格拉斯哥扩展预后量表（GOSE）（超过80%的中度TBI患者）、医院焦虑抑郁量表（HADS）抑郁和焦虑评分（对于前两者，超过95%的中度TBI患者），假设CAPTAIN试验干预方案有持续效果（12个月），脑蛋白水解物具有高成本效益的可能性。需要一种基于模型的方法来解释该临床试验90天观察期之外潜在的偏倚来源。此外，还需要纳入所有TBI严重程度诊断患者的经济评估。
