Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS).
Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS).
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DOI：
10.1136/jnnp-2017-317021
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发表时间：
2018-06
期刊：
影响因子：
--
通讯作者：
Saltuari L
中科院分区：
文献类型：
--
作者：
Creamer M;Cloud G;Kossmehl P;Yochelson M;Francisco GE;Ward AB;Wissel J;Zampolini M;Abouihia A;Berthuy N;Calabrese A;Loven M;Saltuari L
鞘内注射巴氯芬（ITB）是重度卒中后痉挛（PSS）患者的一种治疗选择，这些患者在其他干预措施下尚未达到其治疗目标。“卒中痉挛-随机化研究”（姐妹篇）是一项随机、对照、开放标签、多中心IV期研究，旨在评价ITB therapy与传统药物治疗（CMM）相比，口服解痉药治疗PSS的有效性和安全性。患有慢性中风且下肢（LE）至少两个受累肌肉群痉挛且Ashworth量表（AS）评分≥3的患者被随机（1：1）分配至ITB或CMM。两个治疗组在整个过程中均接受物理治疗。主要结果是从基线到第6个月，受累体侧LE的平均AS评分的变化。对所有随机化患者（主要分析）和所有接受治疗的随机化患者（安全性分析）进行分析。在随机分配至ITB组（n=31）或CMM组（n=29）的60例患者中，48例患者（每组24例）完成了研究。主要分析显示ITB therapy相对于CMM具有显著效应（平均AS评分降低，−0.99（ITB）vs −0.43（CMM）; Hodges-Lehmann估计值，−0.667（95.1%CI −1.0000至−0.1667）; P=0.0140）。与CMM（22/35，63%; 77起事件）相比，ITB（24/25例患者，96%; 149起事件）治疗期间报告不良事件的患者更多，尽管事件通常与ITB therapy的已知安全性特征一致。这些数据支持使用ITB therapy作为CMM的替代治疗成人全身性PSS。NCT 01032239;结果。
Intrathecal baclofen (ITB) is a treatment option for patients with severe poststroke spasticity (PSS) who have not reached their therapy goal with other interventions. ’Spasticity In Stroke–Randomised Study' (SISTERS) was a randomised, controlled, open-label, multicentre phase IV study to evaluate the efficacy and safety of ITB therapy versus conventional medical management (CMM) with oral antispastic medications for treatment of PSS. Patients with chronic stroke with spasticity in ≥2 extremities and an Ashworth Scale (AS) score ≥3 in at least two affected muscle groups in the lower extremities (LE) were randomised (1:1) to ITB or CMM. Both treatment arms received physiotherapy throughout. The primary outcome was the change in the average AS score in the LE of the affected body side from baseline to month 6. Analyses were performed for all patients as randomised (primary analysis) and all randomised patients as treated (safety analysis). Of 60 patients randomised to ITB (n=31) or CMM (n=29), 48 patients (24 per arm) completed the study. The primary analysis showed a significant effect of ITB therapy over CMM (mean AS score reduction, −0.99 (ITB) vs −0.43 (CMM); Hodges-Lehmann estimate, −0.667(95.1%CI −1.0000 to −0.1667); P=0.0140). More patients reported adverse events while receiving ITB (24/25 patients, 96%; 149 events) compared with CMM (22/35, 63%; 77 events), although events were generally consistent with the known safety profile of ITB therapy. These data support the use of ITB therapy as an alternative to CMM for treatment of generalised PSS in adults. NCT01032239; Results.
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影响因子：
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