Atkinson Hampton J, Slater Mark A, Williams Rebecca A, Zisook Sidney, Patterson Thomas L, Grant Igor, Wahlgren Dennis R, Abramson Ian, Garfin Steven R
Department of Psychiatry, San Diego VA Healthcare System, San Diego, CA 92161, USA Department of Psychology, San Diego VA Healthcare System, San Diego, CA 92161, USA Department of Research, San Diego VA Healthcare System, San Diego, CA 92161, USA Surgery Services, San Diego VA Healthcare System, San Diego, CA 92161, USA Department of Psychiatry, University of California San Diego, La Jolla, CA 92093, USA Department of Orthopedic Surgery, School of Medicine, University of California San Diego, La Jolla, CA 92093, USA Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, CA 92182, USA Department of Mathematics, University of California San Diego, La Jolla, CA 92093, USA.
Pain. 1998 Jun;76(3):287-296. doi: 10.1016/S0304-3959(98)00064-5.
To assess the efficacy of nortriptyline, a tricyclic antidepressant, as an analgesic in chronic back pain without depression, we conducted a randomized, double-blind, placebo-controlled, 8-week trial in 78 men recruited from primary care and general orthopedic settings, who had chronic low back pain (pain at T-6 or below on a daily basis for 6 months or longer). Of these 57 completed the trial; of the 21 who did not complete, four were withdrawn because of adverse effects. The intervention consisted of inert placebo or nortriptyline titrated to within the therapeutic range for treating major depression (50-150 ng/ml). The main outcome endpoints were pain (Descriptor Differential Scale), disability (Sickness Impact Profile), health-related quality of life (Quality of Well-Being Scale), mood (Beck Depression Inventory, Spielberger State Anxiety Inventory, Hamilton Anxiety/Depression Rating Scales), and physician rated outcome (Clinical Global Impression). Reduction in pain intensity scores was significantly greater for participants randomized to nortriptyline (difference in mean change 1.68, 95%-0.001, CI -3.36, P = 0.050), with a reduction of pain by 22% compared to 9% on placebo. Reduction in disability marginally favored nortriptyline (P = 0.055), but health-related quality of life, mood, and physician ratings of overall outcome did not differ significantly between treatments. Subgroup analyses of study completers supported the intent-to-treat analysis. Also, completers with radicular pain on nortriptyline (n = 5) had significantly (P < 0.05) better analgesia and overall outcome than did those on placebo (n = 6). The results suggest noradrenergic mechanisms are relevant to analgesia in back pain. This modest reduction in pain intensity suggests that physicians should carefully weigh the risks and benefits of nortriptyline in chronic back pain without depression.
为评估三环类抗抑郁药去甲替林在无抑郁症状的慢性背痛患者中的镇痛效果，我们进行了一项随机、双盲、安慰剂对照的8周试验，研究对象为78名从初级保健机构和普通骨科诊所招募的男性，他们患有慢性下背痛（每天T-6及以下部位疼痛6个月或更长时间）。其中57人完成了试验；21名未完成试验的参与者中，4人因不良反应退出。干预措施包括惰性安慰剂或滴定至治疗重度抑郁症的治疗范围内（50-150 ng/ml）的去甲替林。主要结局指标包括疼痛（描述符差异量表）、残疾（疾病影响概况）、健康相关生活质量（幸福感量表）、情绪（贝克抑郁量表、斯皮尔伯格状态焦虑量表、汉密尔顿焦虑/抑郁评定量表）以及医生评定的结局（临床总体印象）。随机分配至去甲替林组的参与者疼痛强度评分的降低显著更大（平均变化差异为1.68，95%置信区间-3.36至-0.001，P = 0.050），与安慰剂组9%的疼痛减轻相比，去甲替林组疼痛减轻了22%。残疾程度的降低略微有利于去甲替林组（P = 0.055），但治疗组之间健康相关生活质量、情绪以及医生对总体结局的评定并无显著差异。对完成试验者的亚组分析支持意向性分析。此外，服用去甲替林的根性疼痛完成试验者（n = 5）的镇痛效果和总体结局显著（P < 0.05）优于服用安慰剂的完成试验者（n = 6）。结果表明去甲肾上腺素能机制与背痛的镇痛作用相关。疼痛强度的这种适度降低表明，医生应仔细权衡去甲替林在无抑郁症状的慢性背痛治疗中的风险和益处。
