度洛西汀与硫酸吗啡联合治疗癌痛的临床观察

目的：对比观察度洛西汀与硫酸吗啡缓释片与单用硫酸吗啡治疗癌痛的疗效与安全性，为肿瘤疼痛管理提供参考。方法：180例中重度癌痛患者被纳入这项随机、开放、为期12周的临床研究。研究对象均分入单药治疗组（硫酸吗啡缓释片，100～200mg／d）和合并治疗组（同等剂量的硫酸吗啡缓释片＋度洛西汀，前2周30mg／d，2周后60mg／d）。分别在基线及治疗后第4、8及12周进行随访与评估。用Short—FormMcGillPainQuestionnaire（SF—MPQ）和the10-pointvisualanalogscale（VAS）行疼痛评估。焦虑抑郁症状采用汉密尔顿焦虑与抑郁量表评估。采用治疗时出现的不良事件量表与脱落率评估耐受性。结果：单药治疗组与合并治疗组脱落率相似（第4周8．9）AUS10．0％，第8周15．6％VS17．8％及第12周23．3％YJS25．6%，均P〉0．05）。虽然便秘、出汗和心悸的不良反应频数合并治疗组较高，但差异未达统计学意义。在第4、12周VAS评分减分值合并治疗组显著高于单药治疗组[（3．3±0．9）US（2．1±0．6）；（6．4±0．8）US（4．5±0．5），均P〈0．01]。虽然SF—MPQ总分减分值两组间无统计学差异，但在疼痛情感维度方面，于治疗后第8、12周，合并治疗组减分值显著高于单药治疗组（4．2±1．3）US（2．3±1．0）；（6．8±2．9）VS（4．6±1．7），均P〈0．01]。结论：合用度洛西汀与硫酸吗啡缓释片治疗癌痛的疗效优于单用硫酸吗啡治疗，且耐受性好。

Clinical trial in the relief of cancer pain in a combined therapy by Du- loxetine plus Morphine sulfate

ABSTRACT AIM： In order to reference for clinical treatment, provide a good the efficacy and tolerability of Duloxetine plus Morphine sulfate with a single morphine treatment in cancer pain management were compared. METHODS： One hundred and eighty patients with moderate to se- vere cancer-related pain were enrolled in this randomized, open-label, 12-week clinical study. Subjects were assigned to either a single therapy group （Morphine sulfate sustained release tablet, 100-200 mg/day） or a combined therapy group （same dose of Morphine sulfate sustained release tablet plus Duloxetine 30 mg/day for the first 2 weeks and 60 rag/day thereafter）. The follow-up was performed at the baseline and the end of the 4th , the 8th- and the twelfth-week respectively. Short-Form McGill Pain Question naire （SF-MPQ） and the 10-point visual analog scale （VAS） were used to assess the severity of pain. Depressive and anxiety symptoms were as sessed using the Hamilton rating scale for de pression and Hamilton rating scale for anxiety. The treatment emergent symptom scale and dropout rate were recorded to evaluate the toler ability. RESULTS：A similar dropout rates were noted in the single treatment arms compared to combined treatment arms （8.9% at 4 weeks, 15.6% at 8 weeks and 23.3% at 12 weeks vs10.0% at 4 weeks, 17.8% at 8 weeks and 25.6% at 12 weeks, all P〈0.05）. Adverse e vents such as constipation, sudation and palpitation were higher in the combined treatment group than the single treatment group, but no significant group difference was found. A group difference markedly appeared between combined therapy group and single treatment group in the total score decreases in VAS in week 4 and week 12 [（3. 3±0. 9） vs （2.1±0.6）（6.4±0.8） vs （4.5±0.5）, P〈0.01, respectively]. Although no statistical difference appeared in SF-MPQ to tal score change, higher score-decrease values were found in respect to the painful emotion di mension in combined treatment group as com-