Grazio Simeon, Grubišić Frane, Knež Vladimir, Kavanagh Hana Skala, Nemčić Tomislav
Reumatizam. 2016;63(1):20-3.
In the etiology of non-malignant pain, a significant proportion is constituted by patients with pain originating in the musculoskeletal system. The use of strong opioids in the treatment of non-malignant pain is still controversial. Therefore, the aim of this study was to establish the efficacy and safety of oxycodone with a controlled release of the active substance (CR) in the treatment of patients with chronic, not well-controlled musculoskeletal pain. Here we present our preliminary results. In this prospective, open, single-center study conducted at a rheumatology center we enrolled consecutive patients with musculoskeletal pain due to a variety of musculoskeletal diseases (osteoarthritis, pain in the lower back, spondyloarthritis), who suffered from moderate to severe pain despite previous analgesic therapy (with NSAIDs, weak opioids, or a fixed combination of paracetamol and weak opioids). Patients were switched to therapy with oxycodone CR and followed for 14 days. The starting dose of oxycodone CR was 10 mg, and later the dose was adapted as necessary. The primary endpoint was to assess the effectiveness of oxycodone CR on pain intensity, and the secondary goal was to assess the efficiency on the general health of the patient (both on a horizontal visual analogue scale, VAS 0 = best, 10 = worst). Fifteen patients (12 women, 3 men), with a mean age of 61 ± 12 years and a diagnosis of osteoarthritis, pain in the lower back, or inflammatory arthritis, were included in the study. The duration of pain was 41 ± 12 months. The average intensity of pain before oxycodone CR treatment was 7.87 ± 2.28 (range 7-10), and at the end of the study it was 5.92 ± 2.43 (range 4-9) (p=0.069). General health was rated 7.27 ± 2.14 (range 3-10) before the start and 6.00 ± 1.53 (range 3-9) at the end of the study (p=0.028). In one patient the treatment was discontinued due to dizziness and nausea, and one patient voluntarily left the study because of fear and the subjective impression of no adequate pain control after 2 days of treatment. The oxycodone side-effect profile was as expected. Results of our preliminary study show that in patients with chronic non-malignant pain which is not well controlled by simple analgesics, NSAIDs, and weak opioids, treatment with oxycodone CR contributed to a significant reduction in the level of pain and improved the general health of the subjects.
在非恶性疼痛的病因中，相当一部分是由肌肉骨骼系统疼痛的患者构成。在非恶性疼痛治疗中使用强效阿片类药物仍存在争议。因此，本研究的目的是确定活性物质控释（CR）羟考酮在治疗慢性、控制不佳的肌肉骨骼疼痛患者中的疗效和安全性。在此我们展示我们的初步结果。在一家风湿病中心进行的这项前瞻性、开放性、单中心研究中，我们纳入了因各种肌肉骨骼疾病（骨关节炎、下背痛、脊柱关节炎）而患有肌肉骨骼疼痛的连续患者，这些患者尽管之前接受了镇痛治疗（使用非甾体抗炎药、弱阿片类药物或对乙酰氨基酚与弱阿片类药物的固定组合），仍遭受中度至重度疼痛。患者改用羟考酮控释片治疗并随访14天。羟考酮控释片的起始剂量为10毫克，随后根据需要调整剂量。主要终点是评估羟考酮控释片对疼痛强度的有效性，次要目标是评估对患者总体健康状况的效果（均采用水平视觉模拟量表，VAS 0 = 最佳，10 = 最差）。15名患者（12名女性，3名男性）纳入研究，平均年龄61±12岁，诊断为骨关节炎、下背痛或炎性关节炎。疼痛持续时间为41±12个月。在使用羟考酮控释片治疗前，疼痛平均强度为7.87±2.28（范围7 - 10），研究结束时为5.92±2.43（范围4 - 9）（p = 0.069）。研究开始前总体健康评分为7.27±2.14（范围3 - 10），研究结束时为6.00±1.53（范围3 - 9）（p = 0.028）。1例患者因头晕和恶心停药，1例患者在治疗2天后因恐惧和主观感觉疼痛控制不佳而自愿退出研究。羟考酮的副作用情况与预期相符。我们初步研究的结果表明，在单纯镇痛药、非甾体抗炎药和弱阿片类药物控制不佳的慢性非恶性疼痛患者中，使用羟考酮控释片治疗有助于显著降低疼痛水平并改善受试者的总体健康状况。
