EFFICACY OF TRICYCLICS IN TREATING CANCER PAIN

这项试验的目的是调查这样一种假设 阿米替林或地昔帕明(三环类抗抑郁药 大量去甲肾上腺素再摄取抑制)具有显著的 止痛特性在癌症患者辅助治疗中的应用 尽管经过优化，但患者感觉到的中等疼痛是不可接受的 用麻醉剂治疗。在三年的时间里，300名患有 这项为期10周的研究征集了中度到重度的疼痛。这个 研究药物的剂量将在6周内向上滴定 中等剂量的抗抑郁药150毫克/天。阿片剂的剂量将是 根据需要进行监控和调整。主要结果衡量标准将是 一分为二的止痛结果变量，它将从一个 每名患者每日视觉模拟评分的综合变化 疼痛强度(VAS-PI)及各阿片类药物剂量的变化。 次要结果衡量标准将包括情绪评分(身体/ 神经学检查)。此外，还将抽取血液样本进行评估 止痛是否与抗抑郁药物水平有关。要确定一个 可能的响应者的可能预测模型，数据将是 作为一项队列研究进行重新分析。这项研究的结果将 通过以下方式对癌症疼痛的护理产生重大影响 关于哪些患者群体将从中受益的具体指导 心理治疗。

The purpose of this trial is to investigate the hypothesis that amitriptyline or desipramine (tricyclic antidepressants which have substantial noradrenergic re-uptake inhibition) have significant analgesic properties as adjuvant therapy in treating cancer patients with moderate pain that the patients feel is unacceptable despite optimized treatment with narcotics. Over the three year period, 300 patients with moderate to severe pain are being solicited for this 10 week study. The dose of the study drugs will be titrated upward over 6 weeks in the mid-range anti-depressant dose of 150mg/day. The opiate dose will be monitored and adjusted if needed. The primary outcome measure will be a dichotomous analgesic outcome variable, which will be created from a combination of changes in each patients's daily Visual Analogue Score for pain intensity (VAS-PI) and changes in each patients opiate dose. Secondary outcome measures will include mood score (Physical/ Neurological Exam). In addition, blood samples will be drawn to evaluate if analgesia is related to anti-depressant blood levels. To determine a possible prediction model for the likely responders, the data will be reanalyzed as a cohort study. The results of this study will substantially impact on the care of cancer pain by either providing specific guidance for which groups of patients stand to benefit from this therapy.