羟考酮控释片作为止痛背景用药在中重度癌痛滴定中的临床观察

目的 评价羟考酮控释片在中重度癌痛滴定中的有效性和安全性。方法 81例既往未接受阿片类药物治疗的中重度癌痛（疼痛评分＞3）患者随机分成2组：A组（42例）接受吗啡即释片10 mg q4 h滴定；B组（39例）接受羟考酮控释片10 mg q12 h为背景止痛药的滴定。后按照NCCN疼痛治疗指南的要求滴定，24 h后2组均根据吗啡使用总量调整羟考酮控释片用量。观察期为24 h，服药后1 h开始根据疼痛数字评价量表（NRS）进行评分，比较两组疗效和不良反应的发生率。结果 24 h观察期内吗啡即释片组的疼痛缓解率为82.9％，羟考酮控释片组为87.2％；滴定4 h，吗啡即释片组的疼痛缓解率为58.3％，羟考酮控释片组为77.0％，两组差异有统计学意义（P＜0.05）；滴定12 h,两组疼痛缓解率接近，差异无统计学意义（P>0.05）。两组患者主要不良反应为便秘、恶心呕吐、头晕、口干、嗜睡、尿潴留，经过对症处理均可耐受。结论 羟考酮控释片作为止痛背景用药在中重度癌痛滴定中与吗啡即释片的疗效及安全性相当，但止痛治疗的稳定性更佳。

Effect of oxycodone controlled-release tablets in titration of moderate or severe cancer pain for background

Objective To evaluate the efficacy and safety of oxycodone hydrochloride controlled release tablets in titration of moderate or severe caner pain for background. Methods Eighty-one patients suffering from moderate or severe cancer pain without history of opioid were divided into two groups： Group A（42 cases） used short acting morphine tablets 10 mg per 4 h to start titration； Group B（39 cases） used oxycodone hydrochloride controlled release tablets 10 mg per12 h as background， then patients received titration following NCCN pain’s guide. After 24 h total opioid dose and translation to oxycodone hydrochloride controlled release tablets at last were calculated and cumulated. Meanwhile， the efficacy and safety of two groups within 24 hours observation period were compared. Results The total efficiency was 82.9％ in group A and 87.2％ in group B. Four hours after titrating， pain relieving objective response rate of group A decreased sharply into 58.3％ while group B up to 77.0％ with statistically significant differences（P＜0.05）. Twelve hours after titrating, the pain relieving objective response rates were similar in two groups, and the difference was no statistically significance（P>0.05). The main adverse reactions of two groups were including constipation， nausea and vomiting， dizziness， dry mouth， drowsiness and dysuria， which could be relieved by symptomatic treatment. Conclusion Oxycodone hydrochloride controlled release tablets are effective and safty in relieving moderate or severe cancer pain steady in titration as background.