盐酸美沙酮片维持治疗重度或难治性癌性疼痛310例的临床观察

目的 观察盐酸美沙酮片治疗重度或难治性癌性疼痛的镇痛效果和与吗啡片的等效剂量（剂量转换比），以及不良反应。方法 对伴有重度或难治性癌痛的晚期癌症患者予吗啡即释片滴定，疼痛强度NRS≤3分后转换为盐酸美沙酮片口服止痛。结果305例重度或难治性癌痛患者接受盐酸美沙酮片2周治疗后有效率为88.85％（其中骨转移痛、肿瘤侵犯或压迫神经的疼痛、难治性疼痛有效率分别为89.89％、86.08％、84.62％）。 305例患者第2周末的日平均使用盐酸美沙酮片剂量为（24.56±23.69）mg，其中94.43％患者仅需分2次给药即可。172例成功剂量转换患者稳态的日使用吗啡即释片剂量为（52.08±40.77）mg，转换为盐酸美沙酮片第2周末的日使用剂量平均为（18.36±10.60）mg，转换比约为3∶1。与药物相关的不良反应发生率在1％以下的有尿潴留、疲乏、幻觉、尿频、瘙痒等，发生率1％～3％的有嗜睡、恶心、呕吐、冷汗，头晕发生率为8.06％，便秘发生率为18.06％，未发生与美沙酮相关的严重不良事件，未发现与美沙酮相关的肝、肾功能异常和心电图变化。结论 盐酸美沙酮片对于重度或难治性癌性疼痛有效且日使用剂量明显低于吗啡，与吗啡的转换比略高于NCCN指南推荐，不良反应及其发生率与吗啡相似。

Clinic observation of methadone hydrochloride tablets as therapy for 310 patients with severe or refractory cancer pain

Objective To evaluate the toxicity and efficacy of methadone hydrochloride tablets as therapy for patients with severe or refractory cancer pain,and the equivalent dose of morphine tablets（ dose conversion ratio）,and its safety. Methods Three hundred and ten advanced cancer patients with severe or refractory cancer pain were consecutively enrolled in this study. The patients used morphine sustained-release tablets for the titration,when their pain intensity NRS≤3 then replace methadone hydrochloride tablets for pain treatment. Results Three hundred and five patients with severe or refractory cancer pain who accept methadone hydrochloride tablets treatment for 2 weeks,pain treatment efficient（ response rate,RR） was 88. 85%. The RR of bone metastases pain,neuropathy pain and refractory cancer pain were 89. 89%,86. 08%,84. 62% respectively. An average day-dose of methadone hydrochloride tablets was 24. 56 ± 23. 69 mg,94. 43% of patients within 2 times to take medicine in the 305 patients by the second weekend. One hundred and seventy-two patients with successful dose conversion steady state using morphine sustained-release tablets dose was 52. 08 ± 40. 77 mg per day,into the second weekend methadone hydrochloride tablets using dose averaged 18. 36 ± 10. 60 mg per day,conversion rate was about 3： 1. The incidence of adverse events associated with drugs under 1% of uroschesis,fatigue,illusion,frequent urination,itching,etc.,under 3% of the incidence of drowsiness,nausea,vomiting and cold sweat,dizziness rate was8. 06%,constipation rate was 18. 06%. There was no case of serious adverse events correlative with Methadone Hydrochloride Tablets,laboratory examination found no effect on liver and kidney function and no electrocardiogram（ ECG） change. Conclusion Methadone hydrochloride tablets has definite analgesic effect for chronic cancerous pain,dosage is significantly lower than that of morphine. The transformation rate is slightly higher than the NCCN guidelines recommend. The clinical manifestations