Department of Oncology, Unit of Pain and Palliative Care Research, Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Department of Oncology, Unit of Cancer Epidemiology, Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
J Pain Symptom Manage. 2019 May;57(5):899-908.e6. doi: 10.1016/j.jpainsymman.2019.02.009. Epub 2019 Feb 16.
Opioids are frequently used for the treatment of moderate-to-severe pain and their use may produce a number of unwanted adverse events (AEs).
The objective of this study was to understand the burden of opioid-induced AEs in cancer patients with pain after the introduction of strong opioids (WHO Step III).
This is a cohort study derived from a randomized controlled trial involving 498 cancer patients with pain who received strong opioids. During 28-day follow-up, we analyzed frequency, intensity, and changes over time of the main opioid-induced AEs; the influence of previous pain therapy on AEs; and the relationships between the presence of AEs and analgesic response.
After starting strong opioids, dry mouth, nausea, and vomiting immediately increased and persisted over time, constipation continued to increase, while drowsiness and confusion tended to decrease. Patients previously treated with weak opioids had more frequent and severe AEs. While at all observation points the percentage of patients without AEs was 37%-39%, considering all the five scheduled visits, from Day 3 to Day 28, 17% of patients never experienced any AEs, while 48% of patients had four or more concomitant AEs. Patients with no AEs experienced significantly lower pain intensity.
Opioid introduction induces various AEs that persist over time and worse patients' symptomatology. Moreover, there seems to be a different expression of the opioid toxicity among patients, and a possible interaction between AEs and the analgesic response. The balance between the opioids analgesic effect and induced toxicity is fundamental in deciding the best management for pain in cancer patients.
阿片类药物常用于治疗中重度疼痛，其使用可能会产生许多不良的不良反应（AE）。
本研究旨在了解在引入强阿片类药物（WHO 第 III 步）后，疼痛的癌症患者中阿片类药物引起的不良反应的负担。
这是一项来自涉及 498 名疼痛的癌症患者的随机对照试验的队列研究，他们接受了强阿片类药物治疗。在 28 天的随访期间，我们分析了主要阿片类药物引起的 AE 的频率、强度和随时间的变化；既往疼痛治疗对 AE 的影响；以及 AE 的存在与镇痛反应之间的关系。
在开始使用强阿片类药物后，口干、恶心和呕吐立即增加并持续存在，便秘持续增加，而嗜睡和混乱则趋于减少。以前接受弱阿片类药物治疗的患者出现更频繁和严重的 AE。虽然在所有观察点无 AE 的患者比例为 37%-39%，但考虑到所有五个预定就诊时间，从第 3 天到第 28 天，17%的患者从未出现任何 AE，而 48%的患者有四个或更多的同时发生的 AE。无 AE 的患者疼痛强度明显较低。
阿片类药物的引入会引起各种不良反应，这些不良反应会持续存在并加重患者的症状。此外，患者之间似乎存在阿片类药物毒性的不同表现，以及 AE 和镇痛反应之间可能存在相互作用。在决定癌症患者疼痛的最佳管理方案时，阿片类药物的镇痛效果和诱导的毒性之间的平衡至关重要。
