评估复合镇痛疗法(包括 B 族维生素组合)对合并骨关节炎和慢性非特异性腰背痛患者的疗效(开放标签试点临床试验结果

E. Filatova, A. Karateev, E. L. Shakhramanova, D. A. Ghukasyan, S. Y. Shkireeva, A. Lila
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引用次数: 0

摘要

目的:探讨非甾体抗炎药(NSAID)和维生素BC联合应用对骨关节炎(OA)和慢性非特异性腰背痛(NSLBP)患者痛觉系统功能障碍主要表现的影响。研究组由99名患有不同部位的骨关节炎和慢性非特异性腰背痛的患者组成(82%为女性,平均年龄(63.6±17.2)岁),这些患者的疼痛程度为中度至重度(数字评分量表≥4,NRS 0-10)。所有患者均接受依托考昔 60 毫克/天(最多 14 天)和 2.0 毫升№10 的 VBC(一种肠外给药药物,含有硫胺素 100 毫克、吡哆醇 100 毫克、氰钴胺 1.0 毫克和利多卡因 20 毫克)肌肉注射(IM)疗程。14 天后评估治疗效果。在治疗过程中,绝大多数患者的病情都有明显改善:活动时疼痛的中位严重程度(NRS)从 6.3 [5.0; 8.0] 降至 3.7 [3.0; 5.0],p=0.0001;功能障碍--从 3.8 [2.0; 6.0] 降至 2.2 [1.0; 3.0],p=0.001;疲劳--从 5.6 [4.0; 8.0] 降至 3.5 [0.0; 2.0],p=0.0001。71.6%的患者将治疗效果评为 "好 "或 "优"。六名患者出现了不良反应:2例--肌肉注射部位局部疼痛,1例--动脉高血压,3例--上腹部疼痛。无严重不良反应记录。联合使用非甾体抗炎药和 VBC 可显著改善 OA 和 NSLBP 患者的病情。
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Evaluation of the efficacy of complex analgesic therapy, including a combination of B vitamins, in patients with combination of osteoarthritis and chronic non-specific low back pain (results of an open-label pilot clinical trial)
The vitamin B1, B6 and B12 complex (VBC) is frequently used to treat acute and chronic low back pain.Objective: to investigate the effect of a combination of a non-steroidal anti-inflammatory drug (NSAID) and a VBC on the main manifestations of nociceptive system dysfunction in patients with combination of osteoarthritis (OA) and chronic non-specific low back pain (NSLBP).Material and methods. The study group consisted of 99 patients (82% women, mean age 63.6±17.2 years) with OA of various localization andNSLBP who had moderate to severe pain (≥4 on a numerical rating scale, NRS 0–10). All patients received etoricoxib 60 mg/day (up to 14 days) and a course of intramuscular (IM) injections of VBC (a drug for parenteral administration containing solutions of thiamine 100 mg, pyridoxine 100 mg, cyanocobalamin 1.0 mg and lidocaine 20 mg) 2.0 ml №10. Treatment outcome was assessed after 14 days.Results and discussion. During treatment, the vast majority of patients showed a significant improvement: the median severity of pain on movement (NRS) decreased from 6.3 [5.0; 8.0] to 3.7 [3.0; 5.0], p=0.0001; functional impairment  –  from 3.8 [2.0; 6.0] to 2.2 [1.0; 3.0], p=0.001; fatigue – from 5.6 [4.0; 8.0] to 3.5 [0.0; 2.0], p=0.0001. 71.6% of patients rated the treatment results as good or excellent. Six patients had adverse reactions: 2 – local pain at the site of the intramuscular injections, 1 – arterial hypertension, 3 – epigastric pain. No serious adverse events were recorded.Conclusion. The combined use of NSAIDs and VBC can provide significant improvement in patients with a combination of OA and NSLBP.
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