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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Pub Med、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。
Objective To evaluate the efficacy and safety of oxycodone hydrochloride sustained-release tablets for oral and rectal administration in the treatment of moderate to severe cancer pain. Methods Randomized controlled trials (RCTs) of oral and rectal administration of oxycodone hydrochloride tablets for treating moderate to severe cancer pain were searched by Pub Med, Cochrane Library, CNKI, VIP, CBM and Wanfang database. Years are self-built library until March 2016. Literature quality evaluation reference Cochrane reviews system manual. Results A total of 10 studies were included, with a total of 642 patients. The primary outcome measures were clinical efficacy and the secondary outcome measures were adverse reactions (nausea, vomiting, constipation, drowsiness). Due to the poor quality of the included studies and the publication bias, only descriptive analyzes were conducted. The results of systematic reviews showed that the clinical efficacy of oxycodone hydrochloride sustained-release tablets rectal administration in the treatment of moderate and severe cancer pain was no difference compared with oral administration, and the incidence of nausea and vomiting, constipation and drowsiness were lower. Conclusions Oxycodone Hydrochloride Sustained Release Tablets Oral and rectal administration have the same effect in the treatment of moderate and severe cancer pain, and the incidence of rectal adverse drug reactions is lower, but the quality and quantity of the study should be limited in the future More large samples, high-quality RCT to be verified.