Abel Santamaría Cuadrado Provincial Clinical-Surgical Hospital, Pinar del Río, Cuba.
Movement Disorders Clinic, International Neurological Restoration Center (CIREN), Havana, Cuba.
MEDICC Rev. 2021 Jan;23(1):49-54. doi: 10.37757/MR2021.V23.N1.10. Epub 2021 Jan 30.
No neuroprotective treatment has been able to successfully halt the progression of Parkinson disease or prevent development of associated complications. Recombinant erythropoetin (EPO), an erythropoiesis-stimulating agent originally indicated in anemia, produced and manufactured in Cuba (iorEPOCIM, CIMAB S.A, Havana, Cuba) has neuroprotective properties. NeuroEPO is a new nasal formulation of recombinant EPO with a low content of sialic acid and without hematopoietic effects. It has neuroprotective effects in animal models.
Evaluate short-term tolerance of intranasal NeuroEPO in patients with Parkinson disease.
As part of a monocentric randomized placebo-controlled double-blind study (registered at www.clinicaltrials.gov number NCT04110678), 26 patients with Parkinson disease (stages 1 and 2 on Hoehn & Yahr Scale), were randomly divided into two groups: NeuroEPO (n = 15) and placebo (n = 11), both treated intranasally either with the drug (1 mL, at a concentration of 1 mg/mL of NeuroEPO) or placebo once a week for 5 weeks. At each application, we recorded any adverse events and blood pressure. To assess potential hematopoietic effects of the drug, hematological and biochemical variables were evaluated one week before and one week after the intervention.
There were no significant differences (p = 0.22) between the two groups in terms of frequency of adverse events (20.0% in NeuroEPO and 9.1% in placebo groups). Three patients in NeuroEPO presented nausea, and one vomited (possibly due to the patient's positioning during drug application). One patient in placebo group reported polyuria and nasal irritation. In both groups, the adverse events were mild, brief, required no treatment and did not present sequelae.
Nasally administered NeuroEPO for five weeks in patients with Parkinson disease stages 1 and 2 on Hoehn & Yahr Scale is well tolerated.
目前尚无神经保护治疗能够成功阻止帕金森病的进展或预防相关并发症的发生。促红细胞生成素（EPO）是一种最初用于治疗贫血的促红细胞生成刺激剂，由古巴的 CIMAB S.A 公司生产（iorEPOCIM），具有神经保护作用。NeuroEPO 是一种新型的重组 EPO 鼻腔制剂，其唾液酸含量较低且无造血作用。它在动物模型中具有神经保护作用。
评估帕金森病患者短期使用鼻腔内给予 NeuroEPO 的耐受性。
作为一项单中心、随机、安慰剂对照、双盲研究（www.clinicaltrials.gov 注册号 NCT04110678）的一部分，将 26 名帕金森病患者（Hoehn & Yahr 量表 1 至 2 期）随机分为两组：NeuroEPO 组（n = 15）和安慰剂组（n = 11），两组患者均接受鼻腔内给药，每周一次，共 5 周。每次给药时，我们记录任何不良反应和血压。为评估药物的潜在造血作用，在干预前和干预后一周评估血液学和生化变量。
NeuroEPO 组和安慰剂组在不良反应的频率方面无显著差异（p = 0.22）（NeuroEPO 组为 20.0%，安慰剂组为 9.1%）。NeuroEPO 组有 3 名患者出现恶心，1 名患者呕吐（可能与患者给药时的体位有关）。安慰剂组有 1 名患者出现多尿和鼻腔刺激。两组患者的不良反应均为轻度、短暂，无需治疗，无后遗症。
在 Hoehn & Yahr 量表 1 至 2 期的帕金森病患者中，鼻腔给予 NeuroEPO 连续 5 周是可以耐受的。
