普瑞巴林与甲钴胺联合治疗神经性疼痛的维持释放：来自印度的真实体验。
Sustained-release pregabalin with methylcobalamin in neuropathic pain: an Indian real-life experience.
机构信息
Unichem Laboratories Ltd, Unichem Bhavan, Mumbai, India.
出版信息
Int J Gen Med. 2013 May 29;6:413-7. doi: 10.2147/IJGM.S45271. Print 2013.
INTRODUCTION
Neuropathic pain is intense in nature and difficult to manage. Thus, the primary goal is maximum relief from pain. The aim of this study was to assess the efficacy and safety of a fixed-dose combination of sustained-release pregabalin and methylcobalamin in reducing neuropathic pain in Indian patients, in the real-life situation.
METHODS
This was a multicenter, prospective, open-labeled, single-arm, observational, 14-day study. Patients received fixed dose combination of 75 or 150 mg sustained-release pregabalin combined with 1500 mcg immediate release methylcobalamin, depending on the clinical requirement. Data was collected for pain reduction and other positive and negative symptoms associated with neuropathy, including hyperesthesia, paresthesia, numbness/tingling, burning sensation, muscle weakness, sleep disturbances, and impairment of movement. Pain intensity was measured on a ten-point visual analog scale (VAS) (0 represented "no pain," and 10 represented "worst pain ever"). The safety of the drug was also evaluated throughout the study duration. Data was analyzed using appropriate statistical methods.
RESULTS
The overall reduction in mean VAS score over 14 days was 72.3%. The reduction in mean VAS score was significant as early as the first week. Both positive and negative symptoms of peripheral neuropathy were significantly improved in >50% patients within the 2 weeks. Giddiness (4.7%), followed by sedation (3.6%), dizziness (2.9%), drowsiness (2.3%), and nausea (2.3%) were the most commonly observed adverse effects. The overall efficacy and tolerability was rated as good to excellent by >95% of the investigators and patients.
CONCLUSION
Fixed dose combination of sustained-release pregabalin and methylcobalamin significantly reduced neuropathic pain, with significant improvement in both the positive and negative symptoms associated with neuropathy, in Indian patients and was well tolerated.
简介
神经病理性疼痛性质剧烈，难以控制。因此，首要目标是最大限度地缓解疼痛。本研究旨在评估固定剂量组合的缓释普瑞巴林和甲钴胺在减轻印度患者神经病理性疼痛方面的疗效和安全性，这是在真实情况下进行的。
方法
这是一项多中心、前瞻性、开放标签、单臂、观察性的 14 天研究。根据临床需要，患者接受 75 或 150mg 缓释普瑞巴林与 1500mcg 即刻释放甲钴胺的固定剂量组合治疗。收集数据以评估疼痛减轻和其他与周围神经病变相关的积极和消极症状，包括感觉过敏、感觉异常、麻木/刺痛、烧灼感、肌肉无力、睡眠障碍和运动障碍。疼痛强度使用 10 分视觉模拟量表（VAS）进行测量（0 表示“无疼痛”，10 表示“最剧烈疼痛”）。整个研究过程中还评估了药物的安全性。数据使用适当的统计方法进行分析。
结果
在 14 天内，平均 VAS 评分总体下降了 72.3%。早在第一周，平均 VAS 评分的下降就具有统计学意义。在 2 周内，超过 50%的患者周围神经病变的阳性和阴性症状均显著改善。头晕（4.7%）、镇静（3.6%）、头晕（2.9%）、嗜睡（2.3%）和恶心（2.3%）是最常见的不良反应。>95%的研究者和患者认为整体疗效和耐受性良好至极好。
结论
固定剂量组合的缓释普瑞巴林和甲钴胺可显著减轻神经病理性疼痛，显著改善与周围神经病变相关的阳性和阴性症状，在印度患者中具有良好的耐受性。
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