美沙酮按需转换法治疗癌性疼痛的临床研究*

Clinical research with methadone Ad libitum(AL) method in the treatment of cancer pain *

摘要:

目的：探讨美沙酮按需转换法治疗癌性疼痛的有效性和安全性。方法：选取南京大学医学院附属金陵医院疼痛科2022年11月至2023年9月全身大剂量使用阿片类药物疼痛控制不佳的癌性疼痛患者31例,采用20mg/次(间隔≥2h)按需口服美沙酮转换,记录并观察美沙酮转换前、转换后第1-7天和第14天患者疼痛评分 (numerical rating scale,NRS) ；记录转换前、转换第1天、第3天及第7天不良反应；记录转换后第1天至第5天补救次数；评估转换前和转换后第7、14天患者生活质量(Quality of Life,QOL )；评价并计算患者满意度和转换成功率(NRS降低≥50%,且无不能耐受的不良反应)。结果：与转换前相比,转换后第1-7天及第14天患者NRS评分均降低(P<0.05),生活质量明显改善(P<0.001)。补救次数随滴定时间的延长而降低。患者未出现不能耐受的药物不良反应,总体满意度为4.0(1.0),美沙酮转换成功率93.5%。结论：全身大剂量阿片类药物使用患者,采用20mg/次口服美沙酮按需转换效果确切、不良反应少,患者生活质量获得改善且满意度高,适合中国人群,可供临床参考。

Abstract:

Abstract Objective:To investigate the effectiveness and safety of methadone with Ad libitum(AL) method for the treatment of cancer pain.Methods: A total of 31 patients with inadequately controlled cancer pain, despite the use of high-dose opioid analgesics, were selected from the Pain Department of Jinling Hospital affiliated to Medical School of Nanjing University , from November 2022 to September 2023. As-needed oral methadone conversion was administered at 20 mg per dose (with an interval of ≥ 2 hours). Average pain Numeric Rating Scale (NRS) scores were observed and recorded before and on days 1 to 7 and day 14 after methadone conversion. Adverse reactions were recorded before and on days 1, 3, and 7 after conversion. Rescue frequencies were recorded from days 1 to 5 after conversion. Patient quality of life (QOL) was assessed before and on days 7 and 14 after conversion. Patient satisfaction and conversion success rate (pain NRS reduction ≥ 50%, with no intolerable adverse reactions) were evaluated and calculated.Results:Compared to before conversion, average pain NRS scores were significantly reduced on days 1 to 7 and day 14 after conversion (P < 0.05), and QOL was significantly improved (P < 0.001). Rescue frequencies decreased with the extension of titration time. No intolerable adverse drug reactions occurred, and the overall satisfaction rate was 4.0 (1.0), with a methadone conversion success rate of 93.5%.Conclusion:In patients using high-dose systemic opioid analgesics, oral methadone conversion at 20 mg per dose as needed showed clear effectiveness, minimal adverse reactions, improved patient quality of life, and high satisfaction rates. This approach is suitable for the Chinese population and can be considered for clinical use.