芬太尼透皮贴剂对比硫酸吗啡控释片治疗中重度癌痛的系统评价

Systematic Review on Fentanyl Transdermal System vs Morphine Sulfate Controlled- Release Tablets for Treating Moderate to Severe Cancer Pain

目的系统评价芬太尼透皮贴剂对比硫酸吗啡控释片治疗国人中重度癌痛的疗效性与安全性。方法计算机检索中国医院知识总库(CHKD)、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普中文数据库(VIP)、万方数据库从建库至2014年12月相关随机对照试验(RCT),对纳入的研究进行偏倚风险分析,并用Rev Man 5.14统计软件对数据进行Meta分析。结果共纳入14项RCT,包括1 371例患者。Meta分析结果显示,硫酸吗啡控释片组与芬太尼透皮贴剂组有效率相似[OR=1.05,95%CI(0.72,1.54),P=0.81];呕吐、便秘、嗜睡、尿潴留、呼吸抑制发生率较低[OR=0.28,95%CI(0.18,0.43),P<0.000 01;OR=0.18,95%CI(0.13,0.24),P<0.000 01;OR=0.42,95%CI(0.27,0.64),P<0.000 1;OR=0.24,95%CI(0.15,0.39),P<0.000 01;OR=0.34,95%CI(0.14,0.87),P=0.02];过敏反应发生率较高[OR=5.22,95%CI(1.98,13.76),P=0.000 8]。结论芬太尼透皮贴剂与硫酸吗啡控释片治疗国人中重度癌痛时,疗效等同,但不良反应发生率芬太尼透皮贴剂较低。因纳入研究质量不高、样本量较小,此结论尚需更多大样本、高质量的RCT予以证实。

Objective To systematically evaluate tbe effectiveness and safety of Fentanyl Transdermal System vs Morpbine Sulfate Con-trolled-Release Tablets for treating moderate to severe cancer pain. Methods Tbe randomized controlled trials（RCTs） were retrieved from tbe databases of CHKD,CBM,CNKI and VIP from tbeir establisbment to December 2014 by computer. Tbe included RCTs were performed tbe bias risk analysis and tbe meta analysis was conducted by using tbe RevMan 5. 14 software. Results 14 RCTs involving 1 377 patients were ultimately identified. Tbe meta analyses results sbowed tbat tbe effective rate of Fentany Transdermal System group was similar to tbe Morpbine Sulfate Controlled-Release Tablets group [ OR=1. 05,95% CI（0. 72,1. 54）,P=0. 81 ];tbe occurrence rates of vomiting,constipation,drowsiness,retention of urine and respiratory inbibition in tbe Fentany Transdermal System group were lower [ OR=0. 28,95% CI（0. 18,0. 43）,P 〈 0. 000 01;OR=0. 18,95% CI（0. 13,0. 24）,P 〈 0. 000 01;OR=0. 42,95% CI（0. 27,0. 64）, P 〈 0. 000 1;OR=0. 24,95% CI（0. 15,0. 39）,P 〈 0. 000 01;OR=0. 34,95% CI（0. 14,0. 87）,P=0. 02 ];tbe occurrence rate of allergic reactions in tbe Fentany Transdermal System group was bigber [ OR=5. 22,95% CI（1. 98,13. 76）,P=0. 000 8 ] . Conclusion Fentany Transdermal System and Morpbine Sulfate Controlled-Release Tablets bave tbe same effect for treating moderate to severe can-cer pain,but tbe incidence of adverse reactions of Fentany Transdermal System is lower. However,due to tbe quality of included RCTs and small sample amount,more large sample size,bigb-quality RCTs are needed to verify tbe reswlt.