Yao Dongying, Li Shu, Pang Long, Li Pengcheng
Sports Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Department of Orthopedics and Orthopedic Research Institute, West China Hospital, Sichuan University, Chengdu, China.
Front Neurol. 2025 Sep 1;16:1623280. doi: 10.3389/fneur.2025.1623280. eCollection 2025.
Chronic low back pain (CLBP) poses a significant global health burden often managed with non-steroidal anti-inflammatory drugs (NSAIDs). Tanezumab, a nerve growth factor (NGF) inhibitor, presents a potential alternative, but its comparative efficacy and safety relative to NSAIDs remain uncertain. This study aimed to compare tanezumab and NSAIDs for CLBP.
This is a systematic review with meta-analysis, following the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines and Cochrane Handbook. PubMed, Excerpta Medica Database (EMBASE), the Cochrane Library, and Web of Science were searched for literature published before March 10, 2025. Outcome measures included low back pain intensity (LBPI), Roland-Morris Disability Questionnaire (RMDQ) scores, adverse events (AEs), and response rates. Manager V.5.3.3 was used for statistical assessments.
Three randomized controlled trials (RCTs) were included, comprising 835 participants. Tanezumab at 10 mg dose demonstrated significantly greater reduction in LBPI scores at 1-week, 4-week, 8-week, and 12-week follow-ups compared to NSAIDs. Improvement in RMDQ scores was also superior with 10 mg tanezumab at 2-week and 16-week follow-ups. The 5 mg dose, however, did not exhibit a significant difference in functional improvement compared to NSAIDs. Both the 5 mg and 10 mg tanezumab doses showed similar rates of AEs compared to NSAIDs, except for a higher incidence of abnormal peripheral sensation with 10 mg tanezumab. Response rates ≥ 50% were significantly higher with 10 mg tanezumab compared to NSAIDs.
Tanezumab at 10 mg demonstrates better pain relief and functional improvement for CLBP compared to NSAIDs, though it increases the risk of mild peripheral sensation abnormalities. The 5 mg dose, shows a comparable safety profile but no significant therapeutic advantages. While joint safety events significantly impacted development of tanezumab for OA, their rare occurrence in peripheral joints with pre-existing OA and absence in the lumbar spine within CLBP trials suggests its risk-benefit profile appears more acceptable in CLBP than in OA.
慢性下腰痛（CLBP）给全球带来了沉重的健康负担，通常使用非甾体抗炎药（NSAIDs）进行治疗。泰尼珠单抗是一种神经生长因子（NGF）抑制剂，是一种潜在的替代药物，但其相对于NSAIDs的疗效和安全性仍不确定。本研究旨在比较泰尼珠单抗和NSAIDs治疗CLBP的效果。
本研究是一项系统评价和荟萃分析，遵循系统评价和荟萃分析的首选报告项目（PRISMA）指南及Cochrane手册。检索了PubMed、医学文摘数据库（EMBASE）、Cochrane图书馆和科学网，查找2025年3月10日前发表的文献。观察指标包括下腰痛强度（LBPI）、罗兰-莫里斯残疾问卷（RMDQ）评分、不良事件（AE）和缓解率。使用Manager V.5.3.3进行统计评估。
纳入了三项随机对照试验（RCT），共835名参与者。与NSAIDs相比，10mg剂量的泰尼珠单抗在1周、4周、8周和12周随访时，LBPI评分显著降低。在2周和16周随访时，10mg泰尼珠单抗的RMDQ评分改善也更优。然而，5mg剂量与NSAIDs相比，在功能改善方面没有显著差异。与NSAIDs相比，5mg和10mg剂量的泰尼珠单抗AE发生率相似，但10mg泰尼珠单抗外周感觉异常发生率更高。与NSAIDs相比，10mg泰尼珠单抗的缓解率≥50%显著更高。
与NSAIDs相比，10mg的泰尼珠单抗在缓解CLBP疼痛和改善功能方面效果更好，但会增加轻度外周感觉异常的风险。5mg剂量的安全性相当，但没有显著的治疗优势。虽然关节安全事件显著影响了泰尼珠单抗用于骨关节炎（OA）的研发，但在已有OA的外周关节中罕见，在CLBP试验的腰椎中未出现，这表明其在CLBP中的风险效益比似乎比OA中更可接受。
