盐酸羟考酮缓释片联合阿米替林对重度癌症疼痛伴抑郁患者疗效分析

Randomized trial of oxycodone hydrochloride prolonged-release tablets with or without amitriptyline for severe cancer pain patients with depression

目的:研究盐酸羟考酮缓释片联合阿米替林对重度癌症疼痛(以下简称癌痛)伴抑郁患者的疗效。方法:34例重度癌痛伴抑郁患者随机分为2组,研究组应用盐酸羟考酮缓释片联合阿米替林治疗,盐酸羟考酮缓释片止痛治疗作为对照组,进行为期4周的临床观察。采用面部表情疼痛评分量表(FPS-R)和汉密尔顿抑郁量表(HAMD17)评估止痛效果和抑郁缓解,同时观察盐酸羟考酮缓释片用药量、药物不良反应等情况。结果:2组患者治疗后疼痛症状明显缓解(P<0.01);研究组治疗后症状改善明显,与治疗前比,HAMD17评分显著降低(P<0.01);与对照组治疗后比,HAMD17评分亦显著降低(P<0.01);研究组治疗第4周盐酸羟考酮缓释片日平均用药量明显低于对照组(P<0.01);2组药物不良反应情况无明显差异。结论:盐酸羟考酮缓释片联合阿米替林能有效控制重度癌痛,改善抑郁症状,改善晚期癌症患者的生活质量。

Objective： To investigate the clinical efficacy of oxycodone hydrochloride prolonged-release tablets with or without amitriptyline for severe cancer pain patients with depression. Methods： Thirty-four patients with severe cancer pain and depression were randomly divided into two groups. Oxycodone hydrochloride sustained-release tablets combined with amitriptyline were applied for 17 patients in treating group. Oxycodone hydrochloride sustained-release tablets without amitriptyline for cancer pain treatment as control group. All patients were observed for a period of four weeks. The facial pain rating scale（FPS-R） and Hamilton rating scale for depression（HAMD17） were used to assess the clinical efficacy. The dose and adverse drug reactions of Oxycodone were recorded. Results： Pain relieved in each groups of the patients after treatment（P〈0.01）. It was more effective that depression improved in treating group, HAMD17 scores were significantly lower than that of pretreatment and the control group（P〈0.01）. The average daily dosage of oxycodone hydrochloride prolongedrelease tablets for treating group was significantly lower than that for the control group during the fourth week（P〈0.01） and the adverse reactions between two groups have no significant difference. Conclusion： Oxycodone hydrochloride prolonged-release tablets combined amitriptyline can effectively control severe cancer pain, improve depressive symptoms and quality of life for advanced cancer patients.