盐酸羟考酮缓释片滴定治疗中度癌痛的临床研究

Clinical Study of Titration Treatment for Moderate Cancer Pain with Oxycodone Hydrochloride Sustained-release Tablets

目的：研究盐酸羟考酮缓释片对中度癌痛患者进行剂量滴定及维持治疗的疗效和不良反应。方法：选取70例无阿片类药使用史的中度癌痛患者,按1∶1分为两组。A组采用盐酸羟考酮缓释片10 mg作为起始剂量进行滴定,B组采用吗啡即释片5-10 mg进行滴定;达到部分缓解或完全缓解后,分别给予盐酸羟考酮缓释片和硫酸吗啡缓释片维持治疗。比较两组的疼痛缓解率和不良反应发生率。结果：服药1 h后A组有效率为62.9%,B组为37.1%,两组比较差异有统计学意义（P〈0.05）;12 h时A组的有效率为80.0%,B组为57.1%,两组比较差异有统计学意义（P〈0.05）;24、48、72 h时两组有效率相近,差异均无统计学意义（P〉0.05）。两组的不良反应主要为便秘、头晕、恶心、呕吐、嗜睡及厌食等,A组的便秘和恶心发生率明显低于B组,两组比较差异均有统计学意义（P〈0.05）;其他不良反应发生率比较差异无统计学意义（P〉0.05）。结论：盐酸羟考酮缓释片滴定治疗中度癌痛起效快,且便秘、恶心的发生率低,可以作为中度癌痛滴定治疗的首选药。

OBJECTIVE： To study therapeutic efficacy and adverse reactions advantage of titration and maintenance therapy of Oxycodone hydrochloride sustained-release tablets for moderate cancer pain. METHODS： 70 moderate cancer pain patients without opioids history were collected and divided into 2 groups according to the proportion of 1：1. Group A received Oxycodone hydrochlo- ride sustained-release tablets with initial dose of 10 mg, and group B received Morphine immediate-release tablets 5-10 mg for titra- tion. Patients who achieved partial remission or complete remission were respectively treated with Oxycodone hydrochloride sus- tained-release tablets and Morphine sulfate sustained-release tablets as maintenance therapy. The rate of pain relief and the incidence of ADR were compared between 2 groups. RESULTS： 1 h after medication, the effective rate was 62.9% in group A and 37.1% in group B, there was significant difference between 2 groups （P〈0.05） ; 12 h after medication, the effective rate was 80.0% in group A and 57.1% in group B, there was also significant difference between 2 groups （P〈0.05） ; 24 h, 48 h and 72 h after medi- cation, there was no statistical significance between 2 groups （P〉0.05）. The main ADR were constipation, dizziness, nausea, vomiting, lethargy and anorexia. The incidence of constipation and nausea in group A was significantly lower than in group B, there was significant difference between 2 groups （P〈0.05） ; there was no statistical significance in the incidence of other ADR （P〉0.05）. CONCLUSIONS： Titration therapy of Oxycodone hydrochloride sustained-release tablets has rapid onset for moderate cancer pain, and demonstrate low incidence of constipation and nausea; therefore, it is the first choice for moderate cancer pain.