硬膜外注射糖皮质激素治疗腰椎间盘突出症疗效的回顾性分析

目的:评估抗抑郁药治疗带状疱疹后神经痛的疗效。方法:90例带状疱疹后神经痛患者随机分为对照组(n=47)和试验组(n=43)。对照组采用常规疗法包括:药物治疗、物理治疗和微创治疗等。试验组在对照组的基础上加用抗抑郁药帕罗西汀20 mg,每天一次。采用视觉模拟评分法(visual an-alogue scale,VAS)分别于治疗前和治疗第30天评估疼痛强度,并计算疼痛缓解率。结果:两组治疗后比治疗前疼痛强度均显著降低(P<0.05),治疗后组间比较,试验组疼痛缓解率显著高于对照组(P<0.05)。结论:抗抑郁药帕罗西汀可有效提高带状疱疹后神经痛的疗效。     

SUSTAINED EFFICACY OF INCOBOTULINUMTOXINA FOLLOWING REPEATED INJECTIONS FOR UPPER-LIMB POST-STROKE SPASTICITY: A POST HOC ANALYSIS

ObjectiveThis post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity.DesignData from the double-blind, placebo-controlled main period and three open-label extension cycles of two Phase 3, randomized, multicentre trials were pooled.MethodsSubjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, {"type":"clinical-trial","attrs":{"text":"NCT01392300","term_id":"NCT01392300"}}NCT01392300) or ≤ 400 Units at ≥12-week intervals based on clinical need (study 0410, {"type":"clinical-trial","attrs":{"text":"NCT00432666","term_id":"NCT00432666"}}NCT00432666). Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores were assessed.ResultsAmong 465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation) AS arm sumscore improved continuously: main period, –3.23 (2.55) (placebo, –1.49 (2.09)); extension cycles 1, 2, and 3, –4.38 (2.85), –4.87 (3.05), and –5.03 (3.02), respectively. DAS principal target domain responder rate increased from 47.4% in the main period (placebo 27.2%) to 66.6% in extension cycle 3. Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles.ConclusionIncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb poststroke spasticity.LAY ABSTRACTSpasticity (muscle overactivity) often occurs in patients after stroke and may lead to further disability. The results of 2 clinical trials were used to assess the effect of incobotulinumtoxinA injections (maximum dose used per injection session 400 Units) on arm and hand spasticity in patients after stroke. This study looked at the impact of treatment on disability and the burden on carers. The results from 4 treatment cycles were assessed. There was a continuous decrease in spasticity, together with improvements in disability in all treatment cycles. The burden on those who cared for patients also decreased. We showed that repeated incobotulinumtoxinA treatment across 4 cycles led to a decrease in spasticity, patient disability and burden on carers.Key words: botulinum neurotoxin, duration of effect, incobotulinumtoxinA, upper limb, spasticity, caregiver burden, rehabilitation

Stroke is an increasing cause of disability globally (1), and the development of spasticity in stroke survivors may contribute to further disability (2, 3). The prevalence of post-stroke spasticity ranges from 4.0% to 42.6% (2, 4, 5) and may be associated with reduced ability to perform the basic activities of daily living, and detrimental effects on quality of life (4, 6, 7). In addition to the loss of independence experienced by those affected, post-stroke spasticity can also result in a considerable burden on caregivers (6).The safety and efficacy of botulinum neurotoxin type A (BoNT-A) injections have been well established for the treatment of upper-limb post-stroke spasticity (8–13). Notably, the 24-week BEST study evaluated the efficacy and safety of onabotulinumtoxinA in adults with upper-limb or lower-limb post-stroke spasticity (n = 273), and the addition of onabotulinumtoxinA to the existing standard of care demonstrated improvements in passive goal-oriented activities compared with placebo, as well as additional benefits in active functional goals with no new safety signals (14).IncobotulinumtoxinA (Xeomin^®, Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) is a BoNTA approved for the treatment of upper-limb spasticity at doses up to 400 Units (U) at intervals no sooner than every 12 weeks in the USA (15); while in Europe doses of up to 500 U at intervals of at least 12 weeks are approved, enabling treatment of a greater number of muscles (16). Two Phase 3 studies have confirmed the efficacy and safety of incobotulinumtoxinA in subjects with upper-limb post-stroke spasticity (17, 18); both studies included a placebo-controlled main period (MP) comprising a single injection cycle, followed by an open-label extension (OLEX) period with 3 fixed, 12-week incobotulinumtoxinA injection cycles (study 3001) (17), or a maximum of 5 flexible-duration injection cycles (study 0410) (19), respectively. Compared with placebo, incobotulinumtoxinA resulted in significant improvements in muscle tone (Ashworth Scale; AS) and functional disability (Disability Assessment Scale, DAS, for the principal target domain) 4 weeks post-treatment in the MP of both studies (17, 18). These improvements were sustained during the OLEX period of both studies (19–21) and associated with significant improvement in caregiver burden from the study baseline to the end of the OLEX period in study 3001 (21).We report here the results of a post hoc analysis, using data pooled from the MP and the first 3 OLEX injection cycles of both studies, to assess the efficacy of incobotulinumtoxinA in a large subject population using the AS sumscore; a novel approach that allows for a holistic clinical assessment of arm spasticity. In addition, we assess the impact of repeated incobotulinumtoxinA injections on caregiver burden in this large population.