Mibielli Marco Antonio Naslausky, Nunes Carlos Pereira, Goldberg Henrique, Buchman Luiz, Oliveira Lisa, Mezitis Spyros G E, Wajnzstajn Fernanda, Kaufman Renato, Nigri Rafael, Cytrynbaum Natasha, Cunha Karin Soares, Santos Alessandra, Goldberg Stephanie Wrobel, Platenik Natália Carvalho, Rzetelna Helio, Futuro Daniel Bertoluci, Da Fonseca Adenilson de Souza, Geller Mauro
UNIFESO Medical School, Teresópolis, Brazil.
UERJ Medical School, Rio De Janeiro, Brazil.
J Pain Res. 2020 Oct 13;13:2531-2541. doi: 10.2147/JPR.S277024. eCollection 2020.
We report the results of low back pain treatment using a combination of nucleotides, uridine (UTP), cytidine (CMP) and vitamin B, vs a combination of vitamins B, B, and B.
Randomized, double-blind, controlled trial, of a 60-day oral treatment: Group A (n=317) receiving nucleotides+B and Group B (n=317) receiving B vitamins. The primary endpoint was the percentage of subjects in each group presenting adverse events (AEs). Secondary endpoints were visual analog scale (VAS) pain scores at Visit 2 (day 30) and Visit 3 (day 60) in relation to pretreatment values, Roland-Morris Questionnaire (RMQ) scores and finger-to-floor distance (FFD) (percentage of subjects per group presenting improvement ≥5 points and ≥3cm, respectively).
Seventy-five (24%) and 105 (33%) subjects (=0.21) presented 133 and 241 AEs, with 3159% of subjects presenting ≥2 AEs (=0.0019) in Group A and Group B, respectively. Twenty-four subjects in Group B were discontinued due to AEs, while no AE-related discontinuations occurred in Group A (<0.0001). VAS score reduction after 30 and 60 days of treatment was statistically significant (<0.0001) in both groups, with Group A showing greater reduction at Visit 2 (<0.0001). RMQ score improvement ≥5 points occurred in 99% of subjects from each group, and FFD improvement ≥3 cm occurred in all subjects.
Treatment with nucleotides+B was associated with a lower number of total AEs, fewer AEs per subject, and no AE-related treatment discontinuation. Pain intensity (VAS) reduction was superior at 30 days of treatment in the nucleotides+B group and equivalent between groups at 60 days of treatment. Improvements in efficacy measures RMQ and FFD were observed in both groups at treatment days 30 and 60.
我们报告了使用核苷酸、尿苷（UTP）、胞苷（CMP）和维生素B组合与维生素B1、B6和B12组合治疗腰痛的结果。
一项为期60天口服治疗的随机、双盲、对照试验：A组（n = 317）接受核苷酸+B治疗，B组（n = 317）接受B族维生素治疗。主要终点是每组出现不良事件（AE）的受试者百分比。次要终点是第2次就诊（第30天）和第3次就诊（第60天）时与治疗前值相关的视觉模拟量表（VAS）疼痛评分、罗兰-莫里斯问卷（RMQ）评分以及手指到地面距离（FFD）（每组分别有≥5分和≥3cm改善的受试者百分比）。
A组75名（24%）和B组105名（33%）受试者（P = 0.21）分别出现133例和241例不良事件，A组和B组分别有31.59%的受试者出现≥2例不良事件（P = 0.0019）。B组有24名受试者因不良事件停药，而A组未发生与不良事件相关的停药情况（P < 0.0001）。两组治疗30天和60天后VAS评分降低均有统计学意义（P < 0.0001），A组在第2次就诊时降低幅度更大（P < 0.0001）。每组99%的受试者RMQ评分改善≥5分，所有受试者FFD改善≥3cm。
核苷酸+B治疗的总不良事件数量较少，每个受试者的不良事件较少，且未发生与不良事件相关的治疗停药情况。在治疗30天时，核苷酸+B组疼痛强度（VAS）降低更显著，治疗60天时两组相当。在治疗第30天和第60天时，两组在疗效指标RMQ和FFD方面均有改善。
