Taguchi Toshihiko, Nakano Shogo, Nozawa Kazutaka
Japan Organization of Occupational Health and Safety, Yamaguchi Rosai Hospital, Sanyo-Onoda, Yamaguchi, Japan.
Pfizer Japan, Inc., Tokyo, Japan.
J Pain Res. 2021 Mar 16;14:757-771. doi: 10.2147/JPR.S293556. eCollection 2021.
Neuropathic pain (NeP) is common among patients with chronic pain associated with spine diseases. Practical effectiveness of pregabalin, one of the first-line treatments for NeP, has not been evaluated in an entire population of patients with spine diseases, including various pathophysiological conditions. This pooled analysis aimed to evaluate the therapeutic value of pregabalin for chronic pain with NeP component in patients with spine diseases in routine primary care settings.
We pooled data from two 8-week prospective observational cohort studies for patients with chronic low back pain with accompanying lower limb pain (NeP component), and patients with chronic cervical pain and accompanying upper limb radiating pain (NeP component) in routine primary care settings in Japan. For both studies, patients were treated for 8 weeks with pregabalin (alone/with other analgesics) or usual care with conventional analgesics (eg, non-steroidal anti-inflammatory drugs). Changes in pain numerical rating scale (NRS), Pain-Related Sleep Interference Scale (PRSIS), and EuroQol 5-dimension 5-level (EQ-5D-5L) scores from baseline to week 8 were summarized and compared between the pregabalin and usual care groups, and also for subgroups of primary diagnosis. Safety was evaluated by adverse events (AEs) in the pregabalin group.
The pooled dataset comprised 700 patients (pregabalin group: 302; usual care group: 398). All patient-reported outcomes (PRO) scores significantly improved from baseline to week 8 in the pregabalin than in the usual care group (NRS: P<0.0001; PRSIS: P<0.0001, and EQ-5D-5L: P=0.0006). Overall, all three PRO measures showed greater improvement in the pregabalin than in the usual care group, irrespective of the primary diagnosis. AEs were reported in 36.1% of the pregabalin group.
This analysis suggested multi-faceted effectiveness of treatment with pregabalin from the patient's perspectives under a "real-world" practice in all patients with chronic NeP from various spine diseases.
神经性疼痛（NeP）在患有与脊柱疾病相关的慢性疼痛的患者中很常见。普瑞巴林作为NeP的一线治疗药物之一，其实际疗效尚未在包括各种病理生理状况的脊柱疾病患者总体中得到评估。这项汇总分析旨在评估在常规初级保健环境中，普瑞巴林对患有脊柱疾病且伴有NeP成分的慢性疼痛患者的治疗价值。
我们汇总了两项为期8周的前瞻性观察队列研究的数据，研究对象为日本常规初级保健环境中患有慢性下腰痛并伴有下肢疼痛（NeP成分）的患者，以及患有慢性颈痛并伴有上肢放射性疼痛（NeP成分）的患者。在这两项研究中，患者接受了8周的普瑞巴林治疗（单独使用/与其他镇痛药联合使用）或常规镇痛药（如非甾体抗炎药）的常规治疗。总结并比较了普瑞巴林组和常规治疗组从基线到第8周疼痛数字评分量表（NRS）、疼痛相关睡眠干扰量表（PRSIS）和欧洲五维健康量表（EQ-5D-5L）评分的变化，以及主要诊断亚组的变化。通过普瑞巴林组的不良事件（AE）评估安全性。
汇总数据集包括700名患者（普瑞巴林组：302名；常规治疗组：398名）。与常规治疗组相比，普瑞巴林组从基线到第8周所有患者报告结局（PRO）评分均显著改善（NRS：P<0.0001；PRSIS：P<0.0001，EQ-5D-5L：P=0.0006）。总体而言，无论主要诊断如何，所有三项PRO指标在普瑞巴林组中的改善均大于常规治疗组。普瑞巴林组有36.1%的患者报告了不良事件。
该分析表明，在“真实世界”实践中，对于所有患有各种脊柱疾病慢性NeP的患者，从患者角度来看，普瑞巴林治疗具有多方面疗效。
