Lee Kyung-Hee, Kang Jung-Hun, Oh Ho-Suk, Choi Moon-Ki, Shim Byoung-Yong, Eum Young-Jun, Park Hye-Jeong, Kang Jin-Hyong
Department of Hematology/Oncology, Yeungnam University Hospital, Daegu, Republic of Korea.
Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea.
Pain Res Manag. 2017;2017:9741729. doi: 10.1155/2017/9741729. Epub 2017 Oct 31.
To compare efficacy and safety of intravenous continuous infusion of oxycodone with morphine in patients with cancer pain.
A 5-day, randomized, open-label, exploratory study at 6 sites in the Republic of Korea. Sixty-six adults aged ≥19 years with moderate-to-severe cancer pain (Numeric Rating Scale [NRS] ≥ 4) were enrolled. The study group received intravenous (IV) oxycodone, and the comparator group received IV morphine which were titrated depending on pain intensity. The efficacy endpoint is change in average NRS score from baseline to Day 5. Other assessments included worst, current, and average pain intensity; patient satisfaction; medication dose; and adverse events.
Both groups achieved >50% reduction in average pain intensity: from "moderate" at baseline (oxycodone versus morphine: 6.0 ± 1.8 versus 5.9 ± 1.4) to "mild" at Day 5 (2.5 ± 1.8 versus 2.8 ± 1.6). While this reduction was similar between groups (3.5 ± 2.2 versus 3.1 ± 1.8, value = 0.562), oxycodone achieved faster pain relief (average pain: 3.0 ± 1.6 versus 3.9 ± 1.6, value = 0.020) on Day 2 and significant NRS reductions for worst pain on Day 2 ( value = 0.045) and current pain on Day 2 ( value = 0.035) and Day 5 ( value = 0.020) compared to morphine. Patient satisfaction, adverse events, and adverse drug reactions were similar for both groups.
For Asian patients with cancer pain, IV oxycodone is faster acting and showed similar analgesic efficacy and safety profiles as IV morphine. This trial is registered with Clinicaltrials.gov NCT02660229.
比较静脉持续输注羟考酮与吗啡治疗癌痛患者的疗效和安全性。
在韩国6个地点进行的一项为期5天的随机、开放标签的探索性研究。纳入66名年龄≥19岁、患有中重度癌痛(数字评分量表[NRS]≥4)的成年人。研究组接受静脉注射(IV)羟考酮,对照组接受静脉注射吗啡,并根据疼痛强度进行滴定。疗效终点是从基线到第5天平均NRS评分的变化。其他评估包括最严重、当前和平均疼痛强度;患者满意度;药物剂量;以及不良事件。
两组的平均疼痛强度均降低了>50%:从基线时的“中度”(羟考酮与吗啡:6.0±1.8对5.9±1.4)降至第5天的“轻度”(2.5±1.8对2.8±1.6)。虽然两组之间的这种降低相似(3.5±2.2对3.1±1.8,P值=0.562),但羟考酮在第2天实现了更快的疼痛缓解(平均疼痛:3.0±1.6对3.9±1.6,P值=0.020),并且与吗啡相比,在第2天最严重疼痛的NRS显著降低(P值=0.045),第2天当前疼痛的NRS显著降低(P值=0.035)以及第5天当前疼痛的NRS显著降低(P值=0.020)。两组的患者满意度、不良事件和药物不良反应相似。
对于亚洲癌痛患者,静脉注射羟考酮起效更快,并且显示出与静脉注射吗啡相似的镇痛疗效和安全性。该试验已在Clinicaltrials.gov注册,注册号为NCT02660229。