口服松弛素可促进卒中患者康复

休斯顿——据一项随机对照研究结果，口服松弛素治疗可显著改善卒中患者认知和功能的恢复。

意大利翁布里亚Prosperius研究所Paolo Milia博士在内分泌学会年会上报告称：“我们推测在不久的将来，松弛素有可能成为一类新的治疗和预防手段，用于减少血管缺血性疾病的发生率和致残率，且不仅是脑部缺血性疾病，还包括其他组织器官。”

这项研究入组36例入住康复病房的卒中后患者，他们随即接受单纯康复治疗(对照组)或康复治疗+40 mg/d口服猪松弛素(松弛素组)。研究者分别采用连线测验(TMT)、 功能独立性评定(FIM)量表和改良Rankin量表，在入住时、入住后20天和40天时检测患者的认知功能、总体功能水平和日常活动能力。

结果显示，松弛素组20天认知功能明显优于对照组，平均评分分别为3.5和2.0；40天两组认知结果差异进一步扩大，平均评分分别为4.0 和2.0。松弛素组20天和40天总体功能评分均高于对照组，且差异显著。松弛素组基线、20天和40天日常活动能力评分分别为53、78和96，而对照组分别为59、69和75，前者40天功能恢复明显好于后者。此外，松弛素治疗不仅有效，而且安全，未观察到副作用。

据研究者介绍，松弛素于1926年被发现，与类胰岛素肽同属多肽类激素超家族。除了众所周知与妊娠相关的功能之外，松弛素还具有促进血管增生、抑制胶原合成、促进NO以及基质金属蛋白酶合成等广谱作用，可能还有我们尚不知道的更为广泛的功能。动物模型研究显示，松弛素具有心肌和脑缺血性损伤保护作用(J. Chem. Neuroanat. 2011;42:262-75)。

该研究所用松弛素为Sky BioHealth公司生产的猪松弛素(Vitalaxin Plus)。研究者报告无相关利益冲突。

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By: BRUCE JANCIN, Clinical Endocrinology News Digital Network

HOUSTON – Oral relaxin therapy resulted in significantly improved cognitive and functional recovery in poststroke patients participating in a randomized controlled trial.

"We speculate that in the near future, relaxin hormone could represent a new therapeutic and preventative tool to afford reduction of both incidence and disability of vascular ischemic diseases, not only of the brain but also of other organs and apparatuses," Dr. Paolo Milia declared in presenting the study findings at the annual meeting of the Endocrine Society.

The trial involved 36 poststroke patients admitted to a rehabilitation unit, where they were randomized to rehabilitation therapy plus 40 mg/day of oral porcine relaxin or to rehab alone. Investigators administered validated tests of cognitive function, global impairment, and daily activity at admission and again on days 20 and 40.

Cognitive function as assessed using the Trail Making Test was significantly better in the relaxin group on day 20, when their mean score was 3.5, compared with 2.0 in controls. The difference in cognitive outcome broadened by day 40, when the average score in the relaxin group was 4.0, compared with 2.0 in controls on rehabilitation therapy only, reported Dr. Milia of the Prosperius Institute in Umbertide, Italy.

Daily activity as measured using the Functional Independence Measure improved in the relaxin group from a baseline score of 53 to 78 at day 20 and 96 on day 40. In the control group, the average score was 59 at baseline, 69 at day 20, and 75 at day 40, indicating significantly greater functional recovery in the relaxin group at the 40-day mark.

Global function as assessed using the Modified Rankin Scale was higher in the relaxin group than in controls on days 20 and 40, with the difference between groups significant at both times.

The hormone treatment was safe as well as efficacious. No side effects occurred, he said.

Relaxin, discovered in 1926, belongs to the same peptide hormone superfamily as the insulin-like peptides. Relaxin’s known function revolves around pregnancy; however, the hormone also promotes angiogenesis, inhibits collagen synthesis, enhances nitric oxide synthesis, and boosts production of matrix metalloproteinases, a spectrum of effects leaving the door open to possible broader functions not well characterized as yet. In animal models, relaxin protects against ischemic injury to the myocardium and brain (J. Chem. Neuroanat. 2011;42:262-75), Dr. Milia noted.

The porcine relaxin utilized in this study, known as Vitalaxin Plus, is marketed by Sky BioHealth. The investigators reported having no financial disclosures.