Efficacy and safety of tanezumab in the treatment of chronic low back pain
Efficacy and safety of tanezumab in the treatment of chronic low back pain
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DOI：
10.1016/j.pain.2011.05.003
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发表时间：
2011-10-01
期刊：
影响因子：
7.4
通讯作者：
Brown, Mark T.
中科院分区：
文献类型：
--
作者：
Katz, Nathaniel;Borenstein, David G.;Brown, Mark T.
神经生长因子水平升高与慢性疼痛有关，包括慢性腰痛（LBP）。本研究检测了坦珠单抗（一种人源抗神经生长因子抗体）在成人慢性腰痛患者中的安全性和镇痛效果。患者接受静脉注射tanezumab 200 μ g/kg +口服安慰剂（n = 88），静脉注射安慰剂+口服萘普生500 mg，每日2次（n = 88），或静脉注射安慰剂+口服安慰剂（n = 41）。主要终点是第6周的平均LBP强度（aLBPI）。次要结局为：>= 30%或>= 50%的患者alpi下降比例、Roland-Morris残疾问卷和简短疼痛量表短表评分、患者LBP总体评估、患者研究用药总体评估和救援用药。从基线到第6周，tanezumab与萘普生（P = 0.004）和安慰剂组的平均alpi变化更大（P < 0.001）。更大比例的患者报告，与萘普生相比，坦珠单抗的aLBPI降低>= 30%,>= 50%
Increased nerve growth factor levels are associated with chronic pain conditions, including chronic low back pain (LBP). This study examined safety and analgesic efficacy of tanezumab, a humanized anti- nerve growth factor antibody, in adults with chronic LBP. Patients received intravenous tanezumab 200 mu g/kg plus oral placebo (n = 88), intravenous placebo plus oral naproxen 500 mg twice a day (n = 88), or intravenous placebo plus oral placebo (n = 41). Primary outcome was average LBP intensity (aLBPI) at Week 6. Secondary outcomes were proportion of patients with >= 30% or >= 50% reduction in aLBPI, Roland-Morris Disability Questionnaire and Brief Pain Inventory-short form scores, Patients' Global Assessment of LBP, Patients' Global Evaluation of study medication, and rescue medication use. Mean aLBPI change from baseline to Week 6 was greater with tanezumab vs naproxen (P = 0.004) and placebo (P < 0.001). Greater proportions of patients reported >= 30% and >= 50% reduction in aLBPI with tanezumab vs naproxen (P