Ont Health Technol Assess Ser. 2016 Jun 1;16(13):1-70. eCollection 2016.
Injuries to arms and legs following severe trauma can result in the loss of large regions of tissue, disrupting healing and function and sometimes leading to amputation of the damaged limb. People experiencing amputations of the hand or arm could potentially benefit from composite tissue transplant, which is being performed in some countries. Currently, there are no composite tissue transplant programs in Canada.
We conducted a systematic review of the literature, with no restriction on study design, examining the effectiveness and cost-effectiveness of hand and arm transplant. We assessed the overall quality of the clinical evidence with GRADE. We developed a Markov decision analytic model to determine the cost-effectiveness of transplant versus standard care for a healthy adult with a hand amputation. Incremental cost-effectiveness ratios (ICERs) were calculated using a 30-year time horizon. We also estimated the impact on provincial health care costs if these transplants were publicly funded in Ontario.
Compared to pre-transplant function, patients' post-transplant function was significantly better. For various reasons, 17% of transplanted limbs were amputated, 6.4% of patients died within the first year after the transplant, and 10.6% of patients experienced chronic rejections. GRADE quality of evidence for all outcomes was very low. In the cost-effectiveness analysis, single-hand transplant was dominated by standard care, with increased costs ($735,647 CAD vs. $61,429) and reduced quality-adjusted life-years (QALYs) (10.96 vs. 11.82). Double-hand transplant also had higher costs compared with standard care ($633,780), but it had an increased effectiveness of 0.17 QALYs, translating to an ICER of $3.8 million per QALY gained. In most sensitivity analyses, ICERs for bilateral hand transplant were greater than $1 million per QALY gained. A hand transplant program would lead to an estimated annual budget impact of $0.9 million to $1.2 million in the next 3 years, 2016 to 2018, to treat 3 adults per year.
Composite tissue transplant of the hand or arm may improve a patient's ability to function, but because the overall quality of evidence is of very low quality, there is considerable uncertainty as to whether benefits outweigh harms. Compared with standard care, both single- and double-hand transplants are not cost-effective.
严重创伤后手臂和腿部受伤可导致大片组织缺失，干扰愈合和功能，有时还会导致受损肢体截肢。手部或手臂截肢患者可能会从复合组织移植中获益，目前一些国家正在开展此类手术。而加拿大目前尚无复合组织移植项目。
我们对文献进行了系统综述，对研究设计无限制，考察手部和手臂移植的有效性和成本效益。我们用GRADE评估临床证据的整体质量。我们建立了一个马尔可夫决策分析模型，以确定手部截肢的健康成年人接受移植与标准护理相比的成本效益。使用30年时间范围计算增量成本效益比（ICER）。我们还估计了如果安大略省为这些移植提供公共资金，对省级医疗保健成本的影响。
与移植前功能相比，患者移植后的功能明显更好。由于各种原因，17%的移植肢体被截肢，6.4%的患者在移植后第一年内死亡，10.6%的患者经历慢性排斥反应。所有结果的GRADE证据质量都非常低。在成本效益分析中，单手移植被标准护理主导，成本增加（735,647加元对61,429加元），质量调整生命年（QALY）减少（10.96对11.82）。双手移植与标准护理相比成本也更高（633,780加元），但效果增加了0.17个QALY，转化为每获得一个QALY的ICER为380万加元。在大多数敏感性分析中，双侧手部移植的ICER每获得一个QALY大于100万加元。一个手部移植项目在2016年至2018年的未来3年中，估计每年预算影响为90万至120万加元，每年治疗3名成年人。
手部或手臂的复合组织移植可能会提高患者的功能能力，但由于证据的整体质量非常低，关于益处是否大于危害存在相当大的不确定性。与标准护理相比，单手和双手移植都不具有成本效益。
