盐酸羟考酮缓释片口服和直肠给药治疗中重度癌痛有效性和安全性的系统评价

Systematic Review of the Therapeutic Efficacy and Safety of Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Severe Cancer Pain by Oral and Rectal Administration

关键词:  盐酸羟考酮缓释片  癌痛  直肠给药  系统评价

Key words:  oxycodone hydrochloride sustained-release tablets  cancer pain  rectal administration  systematic review

摘要:

目的 系统评价盐酸羟考酮缓释片口服和直肠给药治疗中、重度癌痛的有效性和安全性。方法 计算机检索PubMed、Cochrane图书馆、CNKI、VIP、CBM、万方等数据库公开发表的盐酸羟考酮缓释片口服和直肠给药治疗中、重度癌痛的随机对照试验（RCT），检索年限均为自建库至2016年3月。文献质量评价参照Cochrane系统评价员手册。结果 共纳入10项研究，合计642例患者，主要结局指标为临床疗效，次要结局指标为不良反应（恶心呕吐、便秘、嗜睡）。由于纳入研究质量不高且存在发表偏倚，因此只做描述性分析。系统评价结果显示，盐酸羟考酮缓释片直肠给药治疗中、重度癌痛的临床疗效与口服给药相较无差异，且恶心呕吐、便秘和嗜睡的发生率更低。结论 盐酸羟考酮缓释片口服与直肠给药治疗中、重度癌痛具有相同的疗效，且直肠给药不良反应发生率更低，但受限于纳入研究的质量和数量，尚需今后开展更多大样本、高质量的RCT加以验证。

Abstract:

OBJECTIVE To systematically review the efficacy and safety of Oxycodone hydrochloride sustained-release tablets in the treatment of severe cancer pain by oral and rectal administration. METHODS Retrieved from PubMed, Cochrane Library, CNKI, VIP, CBM and Wanfang database, randomized controlled trails (RCT) about oxycodone by oral and rectal administration in the treatment of severe cancer pain were included from establishment to March 2016 and comprehensively evaluated. Literature quality was evaluated according to Cochrane system evaluation manual. RESULTS A total of 10 RCTs involving 642 patients were included in this study. The primary end point was clinical efficacy, and the secondary end point was adverse reactions (nausea and vomiting, astriction, drowsiness). This study only made description analysis without a quantitative analysis, because the included studies had low quality and publication bias. The results of systematic review showed that there was no significant difference between rectal administration and oral administration on the clinical efficacy with oxycodone hydrochloride sustained-release tablets. And oxycodone hydrochloride sustained-release tablets were associated with less nausea and vomiting, astriction, drowsiness by rectal administration. CONCLUSION The efficacy of oxycodone hydrochloride sustained-release tablets rectal administration may be similar to oral administration for severe cancer pain, and the adverse events of rectal administration is lower. Because of the limited quantity and quality of currently-available research, the aforementioned conclusion should be verified by strictly-designed and large-scale sample RCTs.