盐酸羟考酮控释片阴道给药治疗癌性疼痛的临床研究

背景与目的：盐酸羟考酮控释片是治疗中重度癌性疼痛的强阿片类口服镇痛药，部分患者由于持续的恶心、呕吐、意识障碍或吞咽困难等，常使其口服应用受到限制。本研究目的是观察盐酸羟考酮控释片阴道给药方式治疗中重度癌性疼痛的疗效及不良反应，为口服药物困难的女性患者提供新选择。方法：36例不能口服药物中重度癌痛女性患者采用盐酸羟考酮控释片阴道给药方式治疗，以往未使用阿片类止痛药物者，初始盐酸羟考酮控释片剂量为10mg，每12h用药一次，剂量滴定参考口服给药方法：对凶不能继续口服盐酸羟考酮控释片而改用阴道给药方式者，继续原来剂量阴道给药。结果：36例患者中完全缓解6例，明显缓解20例，中度缓解和轻度缓解各4例，未缓解2例；中度以上疼痛缓解率为83．3％。中位起效时间为49min；中位镇痛时间为13．8h。主要不良反应为阴道烧灼感（9例，25．0％），无因不良反应而中止治疗者。结论：盐酸羟考酮控释片阴道给药方式安全、有效、方便，在口服药物困难的女性患者是一种可选择的给药方式。

Effect of vaginal administration of controlled-release oxycodone on cancer pain

Background and Objective：Controlled-release oxycodone is an ora？ly administered strong opioid analgesic for moderate to severe cancer pain. Sometimes, its oral administration has to be stopped because of continuous nausea, vomiting, conscious disturbance, or inability to swallow. This study was to investigate analgesic effect of vaginal administration of controlled-release oxycodone on cancer pain and observe adverse events to provide a new choice for female patients who can not tolerate the adverse events caused by oral administration. Methods. Controlled-release oxycodone tablets were vaginally administered to 36 female patients with moderate to severe cancer pain. The initial dose was 10 mg every 12 h to patients who had never taken opioid analgesics; former dose continued to patients switching to vaginal route from oral route. Results：Among the 36 patients, six had complete relief of cancer pain, 20 had significant relief, four had moderate relief, and four had slight relief, two had no relief. The relief rate of cancer pain was 83.3%. The mean time for onset of analgesic effect was 49 min; the mean duration of analgesic effect was 13.8 h. Main adverse event was vaginal burning sensation in nine （25.0%） patients. No patient discontinued vaginal administration because of adverse events. Conclusion： The vaginal administration of controlled-release oxycodone is a safe,effective and simple means of managing cancer pain in female patients who can not tolerate the adverse events caused by oral administration.