吗啡皮下自控镇痛泵治疗难治性癌痛的前瞻性多中心随机对照研究

摘要 目的：观察吗啡皮下自控镇痛泵治疗难治性癌痛的临床疗效。方法：采用前瞻性多中心随机对照研究，应用治疗方法分为试验组和对照组，其中试验组使用皮下自控阵痛泵给药，对照组口服吗啡片剂，5 d为一疗程，共计观察3疗程。观察两组患者治疗后疼痛积分改善情况；每疗程吗啡日均用量；疼痛起效时间、最佳缓解时间；镇痛维持时间及剂量稳定天数、爆发痛情况；生活质量改善及不良反应发生率；疗程费用情况。结果：两组患者数字疼痛评分法(numerical rating scale，NRS)评分在治疗后均较镇痛前显著降低（P＜0.05）；在吗啡用量比较方面，试验组吗啡用量显著低于对照组同期用量；试验组在疼痛缓解时间、疼痛最佳缓解时间方面均显著优于对照组；治疗期间试验组平均镇痛维持时间明显长于对照组（P＜0.05）；两组患者治疗后体力状况分析标准(performance status，PS)评分较治疗前显著改善；试验组便秘、嗜睡不良反应发生率显著低于对照组（P＜0.05）。试验组每疗程费用明显低于对照组，具有明显经济优势。结论：吗啡皮下自控镇痛泵给药方式控制难治性癌痛临床疗效确切，止痛效果明显。与对照组比较，疼痛起效时间短，疗程较吗啡用量少，不良反应发生率低，改善了患者生活质量，且减轻了患者经济压力。

A Prospective Multicenter Randomized Controlled Trial of Morphine Controlled Subcutaneous Analgesia Pump in the Treatment of Refractory Cancer Pain

ABSTRACT Objective: To observe the clinical efficacy of morphine controlled subcutaneous analgesia pump in the treatment of refractory cancer pain. Methods: A prospective multicenter randomized controlled study was conducted. The patients who met the criteria were randomly divided into experimental group and control group, the experimental group was treated with subcutaneous self-control pain pump, and the control group was given morphine tablets orally, 5 days as a course of treatment, a total of 3 courses. The improvement of pain score, the daily average dosage of morphine in each course of treatment, the onset time of pain, the best relief time, the duration of analgesic maintenance, the days of stable dose, the situation of burst pain, the improvement of quality of life and the incidence of adverse reactions, and the cost of each course of treatment were observed. Results: The NRS scores of the two groups after treatment were significantly lower than those before analgesia(P<0.05). In the comparison of morphine dosage, the dosage of morphine in the experimental group was significantly lower than that in the control group in the same period; the pain relief time and the best pain relief time in the experimental group were significantly better than those in the control group, during the treatment, the average duration of analgesia in the experimental group was significantly longer than that in the control group(P<0.05). The PS score of the two groups after treatment was significantly improved compared with that before the treatment(P<0.05). The incidence of constipation and drowsiness in the experimental group was lower than the control group, with statistical significance. Conclusion: The clinical effect of morphine controlled subcutaneous analgesia pump in the control of cancer pain has exact, and the analgesic effect. compared with the control group, the pain onset time was shorter, the course of treatment was less, the incidence of adverse reactions was lower, the quality of life of patients was improved, and the economic pressure of patients was reduced.