Milia Paolo, Caserio Marco, Bani Daniele, Rastelli Tito Filippo, Sonaglia Francesco, Bigazzi Bernardo, Bigazzi Mario
Ital J Anat Embryol. 2013;118(1 Suppl):92-7.
Relaxin is a peptide hormone that exerts specific effects on cardiovascular system and human brain, leading to the hypothesis that this hormone may play a protective role against CVD and integration and modulation of behavioral activation. We aimed to demonstrate the efficacy of Relaxin on functional recovery of post-stroke patients.
Patients admitted within a Rehabilitation Unit suffering from stroke have been evaluated. Patients have been randomized to RLX (40 mcg/d) plus rehabilitation vs a control group that underwent only rehabilitation. A preliminary analysis of 36 patients at 20 and 40 days was made using the mRS for global function, the Functional Independent Measure (FIM) for daily activity and Trail Making Test (TMT) for cognitive function.
Eighteen patients (age 72 (64-79), M 56%) randomized to RLX plus rehabilitation were compared to 18 patients (age 68 (64-78), M 50%) that underwent only rehabilitation. There was no difference between the two groups in terms of risk factors, stroke syndromes and etiology. At admission the two groups showed the same characteristics in terms of functional aspects (mRS, FIM; p ns) and cognitive function (TMT; p ns). After 20 days (T1) the treatment group (RLX+rehabilitation) showed no differences between the two groups (FIM 78 vs 69; p ns), while after 40 days (T2) patients treated with RLX+R showed an excellent recovery (FIM 96 vs 75; p0.001). In terms of cognitive function patients RLX+R revealed a better performance at T1 (TMT 3.5 vs 2; p 0.002) and still better at T2 (TMT 4 vs 2; p 0.001). These results have been confirmed in terms of global function both at T1 (mRS 2.5 vs 3; p0.001) and T2 (mRS 2 vs 3; p < 0.001).
Relaxin showed in this analysis a positive effects on stroke patient's recovery, thus offering the broad therapeutic potential role of RLX as new drug in post-stroke patients.
松弛素是一种肽类激素，对心血管系统和人脑具有特定作用，由此产生了该激素可能对心血管疾病起到保护作用以及对行为激活进行整合和调节的假说。我们旨在证明松弛素对中风后患者功能恢复的疗效。
对入住康复科的中风患者进行了评估。患者被随机分为接受松弛素（40微克/天）加康复治疗组和仅接受康复治疗的对照组。使用改良Rankin量表（mRS）评估整体功能、功能独立性测量（FIM）评估日常活动以及连线测验（TMT）评估认知功能，对36例患者在20天和40天时进行了初步分析。
将18例随机分配至接受松弛素加康复治疗组的患者（年龄72岁（64 - 79岁），男性占56%）与18例仅接受康复治疗的患者（年龄68岁（64 - 78岁），男性占50%）进行比较。两组在危险因素、中风综合征和病因方面无差异。入院时，两组在功能方面（mRS、FIM；p无统计学意义）和认知功能（TMT；p无统计学意义）表现出相同特征。20天（T1）后，治疗组（松弛素 + 康复治疗）与对照组之间无差异（FIM分别为78和69；p无统计学意义），而40天（T2）后，接受松弛素 + 康复治疗的患者显示出极佳的恢复情况（FIM分别为96和75；p<0.001）。在认知功能方面，接受松弛素 + 康复治疗的患者在T1时表现更好（TMT分别为3.5和2；p<0.002），在T2时表现更佳（TMT分别为4和2；p<0.001）。这些结果在整体功能方面于T1（mRS分别为2.5和3；p<0.001）和T2（mRS分别为2和3；p<|0.001）时均得到了证实。
在本分析中，松弛素对中风患者的恢复显示出积极作用，从而表明松弛素作为一种新药在中风后患者中具有广阔的治疗潜力。
