Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study
Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study
复制标题
DOI：
10.1016/s1090-3801(98)90020-9
复制
发表时间：
1998-01-01
期刊：
影响因子：
--
通讯作者：
Reder, RF
中科院分区：
文献类型：
--
作者：
Mucci-LoRusso, P;Berman, BS;Reder, RF
口服羟考酮和吗啡的控释制剂都是适用于中度至重度疼痛的镇痛药。将它们与癌症疼痛患者进行比较，随机分组，每12小时使用控释羟考酮（n = 48）或控释吗啡（n = 52）进行双盲治疗，持续12天。83%的羟考酮控释患者和81%的吗啡控释患者在2天内（中位数）实现稳定镇痛。滴定至稳定镇痛后，各组疼痛强度（0 =无至3 =严重）较基线下降（p <或等于0.005），羟考酮控释组疼痛强度从1.9（0.1）降至1.3(0.1)，平均（SE），吗啡控释组疼痛强度从1.6（0.1）降至1.0(0.1)（组间无显著差异）。两组均报告了典型的阿片类药物不良反应。仅控释吗啡组出现幻觉（n = 2）。控释羟考酮对“瘙痒”和“抓伤”的视觉模拟评分（VAS）较低（p小于或等于0.044），稳态血浆浓度的峰谷波动也较低（p = 0.004）。羟考酮（0.7）的血药浓度与剂量的相关性较吗啡（0.3）强（p = 0.026）。羟考酮组疼痛强度（VAS）与血药浓度呈正相关（p = 0.046）。吗啡-6-葡糖苷浓度与尿素氮、肌酐水平呈正相关（p = 0.0001）。控释羟考酮在缓解慢性癌症相关疼痛方面与控释吗啡一样有效，并且很容易根据个体对疼痛控制的需求进行滴定。虽然不良经历相似，但控释羟考酮与瘙痒减轻和无幻觉有关。控释羟考酮为中重度癌症相关疼痛的治疗提供了一种合理的替代控释吗啡的方法。
Controlled-release oral formulations of oxycodone and morphine are both suitable analgesics for moderate to severe pain. They were compared in cancer-pain patients randomized to double-blind treatment with controlled-release oxycodone (n = 48) or controlled-release morphine (n = 52) every 12 h for up to 12 days. Stable analgesia was achieved by 83% of controlled-release oxycodone and 81% of controlled-release morphine patients in 2 days (median). Following titration to stable analgesia, pain intensity (0 = none to 3 = severe) decreased from baseline within each group (p less than or equal to 0.005), from 1.9 (0.1) to 1.3 (0.1), mean (SE), with controlled-release oxycodone, and from 1.6 (0.1) to 1.0 (0.1) with controlled-release morphine (no significant between-group differences). Typical opioid adverse experiences were reported in both groups. Hallucinations were reported only with controlled-release morphine (n = 2). Visual analog scores (VAS) for 'itchy' and 'scratching' were lower with controlled-release oxycodone (p less than or equal to 0.044), as was peak-to-trough fluctuation in steady-state plasma concentration (p = 0.004). The correlation between plasma concentration and dose was stronger (p = 0.026) for oxycodone (0.7) than morphine (0.3). The relationship between pain intensity (VAS) and plasma concentration was more positive for oxycodone (p = 0.046). There was a positive relationship between morphine-6-glucuronide concentrations and urea nitrogen and creatinine levels (p = 0.0001). Controlled-release oxycodone was as effective as controlled-release morphine in relieving chronic cancer-related pain, and as easily titrated to the individual's need for pain control. While adverse experiences were similar, controlled-release oxycodone was associated with less itching and no hallucinations. Controlled-release oxycodone provides a rational alternative to controlled-release morphine for the management of moderate to severe cancer-related pain.