盐酸羟考酮控释片治疗慢性颈椎源性疼痛急性发作的疗效和安全性

THE EFFICACY AND SAFETY OF OXYCODONE HYDROCHLORIDE CONTROLLED-RELEASE TABLETS ON MANAGING ACUTE PAIN EPISODES IN PATIENTS WITH CHRONIC NECK PAIN

目的：本研究探讨盐酸羟考酮控释片（oxycodone hydrochloride controlled-release tablets）作为首选用药对慢性颈椎源性疼痛急性发作的治疗效果、副反应和安全性。方法：慢性颈椎源性疼痛急性发作中到重度疼痛患者共116例，随机分为实验组（盐酸羟考酮控释片组）和对照组（安慰剂组）。连续应用盐酸羟考酮控释片（5～10mg／q12h）和安慰剂1至4周。监测用药后第1天，3天，1周，2周，3周和4周疼痛发作频率（次／天）、疼痛强度（VAS）、生活质量、睡眠质量、不良反应发生率。实验结束时监测有无戒断症状不良反应、SF-36。结果：盐酸羟考酮控释片组用药后第3天即可以明显降低疼痛的发作率和VAS（P〈0．05～0．01）。第1周后生活质量有明显改善（P〈0．01）。第3天和以后各周睡眠质量明显改善（P〈0．05～0．01）。不良反应第1周多见，第4周各不良反应基本消失。实验结束时SF-36大部分项目有明显好转（P〈0．05～0．01）。所有患者未出现停药戒断不良反应。结论：盐酸羟考酮控释片对慢性疼痛急性发作的镇痛效果迅速、肯定，可以考虑作为临床治疗慢性颈椎源性疼痛急性发作的一线首选药物之一。

Objective： To evaluate the efficacy and side effects of oxycodone hydrochloride controlled-release tablets（Oxy-CR） as first ladder drug on chronic neck pain with acute pain episodes. Methods： 116 patients were involved in this study. Oxy-CR, 5 - 10 mg was given orally to oxycodone hydrochloride contrdled-release tablets group （ n = 58） every 12 hours from 1 to 4 weeks. The placebo was given orally to placebo group （n = 58 ） every 12 hours for the same weeks. Demographic information, frequency of pain occurrence, pain scores on VAS, scores of QOL （ Quality of Life） , QOS （ Quality of Sleeping） , and adverse effects were measured, at day 1, day 3, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment. Withdrawal symptoms were monitored during the entire study period. SF-36 were administered at the end of study. Results ： Compared to baseline and placebo group, the frequency of pain episodes and the scores of the VAS were decreased significantly from the third day of oxycodone application （P 〈 0.01 -0.05 ） and the most effective pain relief was reached from one week after treatment. Significant improvements on QOL and QOS were found from the third day after treatment （P 〈 0.05 - 0.01 ）. The side-effect rate was higher in CR oxycodone group than that in placebo group after 1 week and 2 week treatment. Withdrawal symptoms did not emerge in the study. The oxycodone made a positive difference in relation to most SF- 36 domains at the end of study（P 〈0.05 -0.01 ）. Conclusion： Oxy-CR could be an important option as the first ladder drug for the management of chronic neck pain patient with refractory and frequent acute episodes while failed responding to non-opioid conservative management.