羟考酮和吗啡是治疗中度至重度癌症疼痛的常用药物。患者自控皮下镇痛（PCSA）是管理癌症疼痛的有效技术。然而，目前对羟考酮的PCSA用于缓解癌症疼痛的疗效和安全性的研究较少。本研究旨在探讨羟考酮引起的PCSA在中度至重度癌症疼痛短期疗效和安全性方面的情况。这是一项单中心、随机、主动对照、双盲试验（从2019年4月至2021年8月）。根据PCSA进行药物给药，将60例中度至重度癌症疼痛患者按1:1随机分配到羟考酮组或吗啡组。主要观察指标为72小时内通过数字评分量表（NRS）测量的疼痛强度。次要观察指标包括基线、15分钟、30分钟、2小时、8小时、24小时和48小时NRS测量的疼痛强度。还记录了破裂性疼痛（BTP）的发生情况、疼痛对生活质量的影响（使用简明疼痛指数[BPI]评估）、日常额外使用阿片类药物的量以及不良事件的发生率。不良事件包括恶心、呕吐、头晕、便秘和呼吸抑制。在四川大学华西医院共纳入了57例患者（羟考酮组28例，吗啡组29例）。羟考酮组和吗啡组在基线时的平均（标准差[SD]）NRS分别为7.8（1.7）和7.6（1.7），72小时后分别为3.4（1.8）和3.2（1.5）。两组的术后NRS较基线明显降低。羟考酮组30分钟时的平均（SD）NRS显著低于吗啡组（3.9（2.6） vs. 5.3（2.1），P=0.035）。两组在48小时和72小时的BTP发生率与相应的基线相比显著降低（P < 0.05），并且两组之间没有显著差异。两组在PCSA后24小时和72小时的BPI总分和子项得分与基线相比均显著降低。两组之间的每日额外阿片类药物使用量比较无统计学显著差异。两组间恶心、呕吐、头晕和便秘的发生率也没有显著差异（P > 0.05）。本研究发现羟考酮和吗啡的PCSA均能有效而安全地缓解短期中度至重度癌症疼痛。值得注意的是，羟考酮的PCSA起效更快。版权所有 © 2023年 Elsevier Inc. 发表。

Hydromorphone and morphine are the common drugs used for the treatment of moderate to severe cancer pain. Patient controlled subcutaneous analgesia (PCSA) is an effective technique to manage cancer pain. However, few studies have been conducted to show the efficacy and safety of PCSA of hydromorphone for the relief of cancer pain.To explore the short-term efficacy and safety of PCSA elicited by hydromorphone for moderate to severe cancer pain.This was a single-center, randomized, active-controlled, double-blind trial (from April 2019 to August 2021). Sixty patients with moderate to severe cancer pain were randomized (1:1) to hydromorphone or morphine groups according to drug delivery by PCSA. The primary outcome was the pain intensity measured by a numerical rating scale (NRS) at 72 h. Secondary outcomes included pain intensity measured by NRS at baseline, 15 min, 30 min, 2 h, 8 h, 24 h and 48 h. The daily occurrence of breakthrough pain (BTP), impact of pain on quality of life measured by the brief pain inventory (BPI), the daily additional consumption of opioids and the incidence of adverse events were also recorded. Adverse events included nausea, vomiting, dizziness, constipation and respiratory depression.A total of 57 patients (28 patients in the hydromorphone group and 29 patients in the morphine group) in the West China Hospital of Sichuan University were investigated. The mean (standard deviation [SD]) NRS in the two groups at baseline was 7.8 (1.7) in the hydromorphone group and 7.6 (1.7) in the morphine group, and at 72 h were 3.4 (1.8) and 3.2 (1.5), respectively. The postoperative NRS in both groups was decreased significantly compared to baseline. The mean (SD) NRS at 30 min in the hydromorphone group was significantly lower than in the morphine group (3.9 (2.6) vs. 5.3 (2.1), P = 0.035). The daily occurrence of BTP in both groups at 48 h and 72 h decreased significantly compared to the corresponding baseline (P < 0.05), and there was no significant difference between the two groups. The total scores and sub-item scores of BPI at 24 h and 72 h after PCSA in both groups decreased significantly from baseline. A comparison of daily additional consumption of opioids between the two groups revealed no statistically significant difference. There were no significant differences in the incidences of nausea, vomiting, dizziness or constipation between the two groups (P > 0.05).This study found that the PCSA of both hydromorphone and morphine could effectively and safely relieve short-term moderate to severe cancer pain. Of note, the PCSA of hydromorphone took effect more quickly than that of morphine.Copyright © 2023. Published by Elsevier Inc.