Milte Rachel, Song Jia, Docking Sean, Ratcliffe Julie, Cameron Ian D, Crotty Maria, Ada Louise, English Coralie, Lannin Natasha A
Caring Futures Institute, Flinders University, Adelaide, SA 5001, Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC 3004, Australia.
Toxins (Basel). 2025 Jul 4;17(7):341. doi: 10.3390/toxins17070341.
Spasticity is a persistent and debilitating consequence of stroke and effective rehabilitation is a healthcare priority. Botulinum neurotoxin A (BoNT-A) with supportive therapy has increasingly been embedded within clinical practice for treatment of post-stroke spasticity. But the evidence for this approach has hitherto been limited to the findings of a limited number of small trials. The InTENSE trial was undertaken specifically to provide high-quality clinical trial evidence focusing on the effect of BoNT-A and adjunctive therapy on upper limb spasticity. While the clinical trial did not detect a significant impact upon clinical outcomes, there remains a need to evaluate any impact on the broader use of healthcare resources and overall cost-effectiveness. A detailed cost-utility analysis of the InTENSE trial was undertaken. The costs over the 12-month follow-up period were compared with quality-adjusted life years (QALY) gained using utilities generated from the EQ-5D three level (EQ-5D-3L) instrument. There were no significant differences in QALY gained between the intervention and control groups identified, or in the majority of health and community care costs. The Incremental Cost-Effectiveness Ratio per QALY gained was estimated at AU $63,947.11 (Australian dollars), which is well above accepted thresholds for cost-effectiveness in Australia. The study was unable to identify evidence for the cost-effectiveness of treatment approaches combining BoNT-A with adjunctive therapy.
痉挛是中风的一种持续且使人衰弱的后果，有效的康复治疗是医疗保健的重点。肉毒杆菌神经毒素A（BoNT-A）联合支持性治疗越来越多地被纳入临床实践，用于治疗中风后痉挛。但迄今为止，这种治疗方法的证据仅限于少数小型试验的结果。“强化治疗（InTENSE）试验”专门开展，以提供高质量的临床试验证据，重点关注BoNT-A和辅助治疗对上肢痉挛的影响。虽然该临床试验未发现对临床结局有显著影响，但仍有必要评估其对更广泛的医疗资源使用和总体成本效益的影响。对“强化治疗（InTENSE）试验”进行了详细的成本效用分析。将12个月随访期内的成本与使用EQ-5D三级量表（EQ-5D-3L）得出的效用值所获得的质量调整生命年（QALY）进行了比较。在干预组和对照组之间，所获得的QALY或在大多数健康和社区护理成本方面均无显著差异。每获得一个QALY的增量成本效益比估计为63,947.11澳元，远高于澳大利亚公认的成本效益阈值。该研究未能找到证据证明BoNT-A与辅助治疗相结合的治疗方法具有成本效益。
