Allen Richard P, Ritchie Sally Y
Johns Hopkins Bayview Medical Center, Neurology and Sleep Medicine, Baltimore, MD 21224, USA.
Sleep Med. 2008 Dec;9(8):899-902. doi: 10.1016/j.sleep.2007.08.017. Epub 2007 Nov 19.
To determine whether clinical response to the dopamine agonist, ropinirole, in the treatment of primary restless legs syndrome (RLS), depends upon the age-at-onset of RLS symptoms.
Pooled data from four 12-week, randomized, double-blind, placebo-controlled studies of ropinirole in patients with moderate-to-severe primary RLS were analyzed post hoc. The relationship between age-at-onset and response to treatment, based on change from the baseline International Restless Legs Syndrome Study Group (IRLSSG) rating scale (the International Restless Legs Scale [IRLS]) total score and the proportion of responders (rated 'much'/'very much' improved) on the Clinical Global Impression-Improvement (CGI-I) scale, was explored.
The range of age-at-onset of RLS symptoms was 2-75 years. No relationship was observed between the age-at-onset of RLS symptoms and baseline IRLS total score (correlation r=-0.06), and between dose administered at Week 12 last observation carried forward (LOCF) and age-at-onset (r=-0.04). The age-at-onset by treatment interaction was non-significant (P=0.952 for the IRLS and P=0.716 for the CGI-I scale), indicating there was no significant relationship between age-at-onset and the magnitude of ropinirole treatment effect.
These data suggest that ropinirole provides effective relief of symptoms, regardless of age at RLS symptom onset.
确定多巴胺激动剂罗匹尼罗治疗原发性不安腿综合征(RLS)的临床反应是否取决于RLS症状的发病年龄。
对四项为期12周、随机、双盲、安慰剂对照的罗匹尼罗治疗中重度原发性RLS患者的研究数据进行事后分析。基于基线国际不安腿综合征研究组(IRLSSG)评分量表(国际不安腿量表[IRLS])总分的变化以及临床总体印象改善(CGI-I)量表上反应者(评为“好多了”/“非常好多了”)的比例,探讨发病年龄与治疗反应之间的关系。
RLS症状的发病年龄范围为2至75岁。未观察到RLS症状的发病年龄与基线IRLS总分之间的关系(相关性r = -0.06),以及第12周末次观察向前结转(LOCF)时给予的剂量与发病年龄之间的关系(r = -0.04)。发病年龄与治疗的交互作用不显著(IRLS的P = 0.952,CGI-I量表的P = 0.716),表明发病年龄与罗匹尼罗治疗效果的大小之间无显著关系。
这些数据表明,无论RLS症状发作时的年龄如何,罗匹尼罗都能有效缓解症状。