Efficacy and safety of tolperisone versus baclofen among Chinese patients with spasticity associated with spinal cord injury: a non-randomized retrospective study

There are many medications available to treat spasticity, but the tolerability of medications is the main issue for choosing the best treatment. The objectives of this study were to compare the efficacy and adverse effects of tolperisone compared to baclofen among patients with spasticity associated with spinal cord injury. Patients received baclofen plus physical therapy (BAF+PT, n=135) or tolperisone plus physical therapy (TOL+PT, n=116), or physical therapy alone (PT, n=180). The modified Ashworth scale score, the modified Medical Research Council score, the Barthel Index score, and the Disability Assessment scale score were improved (P<0.05 for all) in all the patients at the end of 6 weeks compared to before interventions. After 6 weeks, the overall coefficient of efficacy of the intervention(s) in the BAF+PT, TOL+PT, and PT groups were 1.15, 0.45, and 0.05, respectively. The patients of the BAF+PT group reported asthenia, drowsiness, and sleepiness and those of the TOL+PT group reported dyspepsia and epigastric pain as adverse effects. When comparing drug interventions to physical therapy alone, both baclofen plus physical therapy and tolperisone plus physical therapy played a significant role in the improvement of daily activities of patients. Nonetheless, baclofen plus physical therapy was tentatively effective. Tolperisone plus physical therapy was slightly effective. In addition, baclofen caused adverse effects related to the sedative manifestation (Level of Evidence: III; Technical Efficacy Stage: 4).

目前临床可用以治疗痉挛状态（spasticity）的药物种类繁多，但药物耐受性是遴选最优治疗方案的核心考量因素。本研究旨在对比甲苯哌丙酮（tolperisone）与巴氯芬（baclofen）分别用于脊髓损伤相关性痉挛患者时的疗效与不良反应。受试者被分为三组：巴氯芬联合物理治疗组（BAF+PT，n=135）、甲苯哌丙酮联合物理治疗组（TOL+PT，n=116）以及单纯物理治疗组（PT，n=180）。干预6周后，所有受试者的改良Ashworth量表（modified Ashworth scale）评分、改良医学研究委员会（modified Medical Research Council）评分、巴氏指数（Barthel Index）评分及残疾评估量表（Disability Assessment scale）评分均较干预前显著改善（所有指标P均<0.05）。干预6周后，BAF+PT组、TOL+PT组与PT组的综合疗效系数分别为1.15、0.45与0.05。BAF+PT组受试者报告的不良反应为乏力、嗜睡及困倦；TOL+PT组受试者则出现消化不良与上腹痛。相较于单纯物理治疗，巴氯芬联合物理治疗与甲苯哌丙酮联合物理治疗均能显著改善患者的日常活动能力。其中，巴氯芬联合物理治疗暂显优效，而甲苯哌丙酮联合物理治疗仅具轻度疗效。此外，巴氯芬可引发与镇静作用相关的不良反应（证据等级：III；技术效能分级：4）。