Xiao Xiaoguang, Sun Jianhai, Zhang Dongsheng, Li Linjun, Zhou Haibo, Li Yongjun, Li Quan, He Zhongshi, Fu Yang, Duan Qiwen, Zheng Guping, Tang Ze, Chu Qian, Chen Yuan
Department of Oncology, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, People's Republic of China.
Department of Oncology, Hubei Zhongshan Hospital, Wuhan, Hubei, People's Republic of China.
J Pain Res. 2024 Apr 12;17:1441-1451. doi: 10.2147/JPR.S451698. eCollection 2024.
Studies have shown that oral oxycontin tablets can be used for opioid titration. The European Society for Medical Oncology (ESMO) guidelines for adult cancer pain recommend opioid titration through the parenteral route, usually the intravenous or subcutaneous route. Patient-controlled subcutaneous analgesia (PCSA) with hydromorphone needs further evaluation for opioid titration. This prospective multicenter study was designed to compare the efficacy and safety of hydromorphone PCSA with oral oxycontin tablets for opioid titration of cancer pain.
Eligible patients with cancer pain were randomly assigned in a 1:1 ratio to the PCSA group or the oxycontin group for dose titration. Different titration methods were given in both groups depending on whether the patient had an opioid tolerance. The primary endpoint of this study was time to successful titration (TST).
A total of 256 patients completed this study. The PCSA group had a significantly lower TST compared with the oxycontin group (median [95% confidence interval (CI)], 5.5[95% CI:2.5-11.5] hours vs.16.0 [95% CI:11.5-22.5] hours; <0.001). The frequency (median; interquartile) of breakthrough pain (Btp) over 24 hours was significantly lower in the PCSA group (2.5;2.0-3.5) than in the oxycontin group.(3.0; 2.5-4.5) (=0.04). The pain was evaluated by numeric rating scale (NRS) score at 12 hours after the start of titration. The pain score (median; interquartile) was significantly lower in the PCSA versus the oxycontin group (2.5;1.5-3.0) vs 4.5;3.0-6.0) (=0.02). The equivalent dose of oral morphine (EDOM) for a successful titration was similar in both groups (=0.29), but there was a significant improvement in quality of life (QoL) in both groups (=0.03). No between-group difference in the incidence of opioid-related adverse effects was observed (=0.32).
Compared with oral oxycontin tablet, the use of PCSA with hydromorphone achieved a shorter titration duration for patients with cancer pain (<0.001), without significantly increasing adverse events (=0.32).
研究表明，口服羟考酮片可用于阿片类药物滴定。欧洲医学肿瘤学会（ESMO）成人癌痛指南推荐通过肠外途径进行阿片类药物滴定，通常是静脉或皮下途径。氢吗啡酮患者自控皮下镇痛（PCSA）用于阿片类药物滴定需要进一步评估。这项前瞻性多中心研究旨在比较氢吗啡酮PCSA与口服羟考酮片在癌症疼痛阿片类药物滴定中的疗效和安全性。
符合条件的癌痛患者按1:1比例随机分配至PCSA组或羟考酮组进行剂量滴定。根据患者是否有阿片类药物耐受性，两组采用不同的滴定方法。本研究的主要终点是成功滴定时间（TST）。
共有256例患者完成本研究。PCSA组的TST显著低于羟考酮组（中位数[95%置信区间（CI）]，5.5[95%CI:2.5 - 11.5]小时对16.0[95%CI:11.5 - 22.5]小时；<0.001）。PCSA组24小时内爆发性疼痛（Btp）的频率（中位数；四分位间距）显著低于羟考酮组（2.5；2.0 - 3.5）（3.0；2.5 - 4.5）（P = 0.04）。滴定开始后12小时通过数字评分量表（NRS）评分评估疼痛。PCSA组的疼痛评分（中位数；四分位间距）显著低于羟考酮组（2.5；1.5 - 3.0）对4.5；3.0 - 6.0）（P = 0.02）。两组成功滴定的口服吗啡等效剂量（EDOM）相似（P = 0.29），但两组的生活质量（QoL）均有显著改善（P = 0.03）。未观察到阿片类药物相关不良反应发生率的组间差异（P = 0.32）。
与口服羟考酮片相比，氢吗啡酮PCSA用于癌痛患者可缩短滴定持续时间（<0.001），且未显著增加不良事件（P = 0.32）。
