上肢国际痉挛研究-II（ULISII）的结果：一项大型国际前瞻性队列研究，旨在调查在真实临床管理中使用肉毒毒素 A 治疗后的实践和目标达成情况。
Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management.
机构信息
Department of Palliative Care, Policy and Rehabilitation, School of Medicine, King’s College London, London, UK.
Neurorehabilitation, Gailtal-Klinik, Hermagor, Austria.
出版信息
BMJ Open. 2013 Jun 20;3(6):e002771. doi: 10.1136/bmjopen-2013-002771.
OBJECTIVE
To describe real-life practice and person-centred outcomes in the treatment of poststroke upper limb spasticity with botulinum toxin A (BoNT-A).
DESIGN
Observational, prospective study.
SETTING
84 secondary care centres in 22 countries.
PARTICIPANTS
456 adults (≥18 years) with poststroke upper limb spasticity treated with one cycle of BoNT-A.
METHODS/OUTCOMES: Muscle selection, BoNT-A preparation, injection technique and timing of follow-up were conducted according to routine practice for each centre.
PRIMARY OUTCOME
achievement of the patient's primary goal for treatment using goal-attainment scaling (GAS). Measurements of spasticity, standardised outcome measures and global benefits were also recorded.
RESULTS
The median number of injected muscles was 5 (range 1-15) and the most frequently injected muscles were the long finger flexors, followed by biceps and brachioradialis. The median (range) follow-up time was 14 (2.6 to 32.3) weeks. The common primary treatment goals were passive function (132 (28.9%)), active function (104 (22.8%)), pain (61 (13.4%)), impairment (105 (23%)), involuntary movement (41 (9%)) and mobility (10 (2.2%)). Overall, 363 (79.6%) (95% CI 75.6% to 83.2%) patients achieved (or overachieved) their primary goal and 355 (75.4%) (95% CI 71.2% to 79.2%) achieved their secondary goal. Mean (SD) change from baseline in GAS T-scores was 17.6 (11.0) (95% CI 16.4 to 18.8; p<0.001). GAS T-scores were strongly correlated with global benefit and other standard measures (correlations of 0.38 and 0.63, respectively; p<0.001).
CONCLUSIONS
BoNT-A demonstrated a clinically significant effect on goal attainment for the real-life management of upper-limb spasticity following stroke. The study confirms the feasibility of a common international data set to collect systematic prospective data, and of using GAS to capture person-centred outcomes relating to passive and active functions and to pain.
REGISTRATION
ClinicalTrials.gov identifier: NCT01020500.
目的
描述 A 型肉毒毒素（BoNT-A）治疗脑卒中后上肢痉挛的真实实践和以患者为中心的结局。
设计
观察性、前瞻性研究。
地点
22 个国家的 84 个二级保健中心。
参与者
456 名接受 BoNT-A 一个周期治疗的成年脑卒中后上肢痉挛患者（≥18 岁）。
方法/结果：根据每个中心的常规实践，选择肌肉、BoNT-A 制剂、注射技术和随访时间。
主要结局
使用目标实现量表（GAS）评估患者的主要治疗目标是否实现。还记录了痉挛程度、标准化结局测量和整体获益。
结果
中位数注射肌肉数为 5 个（范围 1-15），最常注射的肌肉是长指屈肌，其次是肱二头肌和肱桡肌。中位数（范围）随访时间为 14 周（2.6 至 32.3）。常见的主要治疗目标是被动功能（132 例[28.9%]）、主动功能（104 例[22.8%]）、疼痛（61 例[13.4%]）、损伤（105 例[23%]）、不自主运动（41 例[9%]）和移动能力（10 例[2.2%]）。总体而言，363 例（79.6%）（95%CI75.6%至 83.2%）患者达到（或超过）了主要目标，355 例（75.4%）（95%CI71.2%至 79.2%）达到了次要目标。GAS T 评分自基线的平均（标准差）变化为 17.6（11.0）（95%CI16.4 至 18.8；p<0.001）。GAS T 评分与整体获益和其他标准测量值高度相关（相关性分别为 0.38 和 0.63；p<0.001）。
结论
BoNT-A 在治疗脑卒中后上肢痉挛的真实实践中对实现目标具有显著的临床效果。该研究证实了收集系统前瞻性数据的常见国际数据集的可行性，以及使用 GAS 来捕捉与被动和主动功能以及疼痛相关的以患者为中心的结局的可行性。
注册
ClinicalTrials.gov 标识符：NCT01020500。
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