弱阿片药物与低剂量强阿片药物治疗中度癌痛的Meta分析与GRADE评价

Meta-analysis and GRADE profile of weak opioids versus low dose strong opioids in the treatment of moderate cancer pain

目的:评价弱阿片类药物(Weak Opioids,WO)与低剂量强阿片类药物(Low-Dose Strong Opioids,LDSO)治疗中度癌痛的有效性和安全性。方法:以"吗啡","羟考酮","曲马多","可待因","中度癌痛"为关键词对Pubmed、EMbase、Cochrane Library、中国知网、万方、维普等数据库进行检索。以临床疗效为主要结局、毒副反应(恶心呕吐,嗜睡,厌食和便秘)为次要结局,采用软件Review Manager 5.3对数据进行处理,并采用软件GRADE profiler 3.6对结果证据质量进行评级。结果:纳入4项随机对照研究,共计708例患者。结果表明LDSO对中度癌痛的控制要优于WO[OR=3.50,95%CI(2.39 to 5.13),P<0.000 01]。而在毒副反应方面,两组的恶心呕吐[OR=0.92,95%CI(0.59 to 1.42),P=0.69]、嗜睡[OR=1.23,95%CI(0.74 to 2.05),P=0.42]、厌食[OR=1.19,95%CI(0.59 to 2.37),P=0.63]以及便秘[OR=1.34,95%CI(0.87 to 2.07),P=0.19]均无显著性差异。缓解率和各毒副反应的GRADE证据评价级均为中级。结论:在治疗中度癌痛中,LDSO的疗效优于WO,且耐受性良好,提示临床可以采用弱化二阶梯方案,将LDSO用于治疗中度癌痛。

OBJECTIVE To evaluate the efficacy and safety of weak opioids and low dose strong opioids in the treatment of moderate cancer pain.METHODS Electronic databases of Pubmed,EMbase,Cochrane Library,CNKI,Wan Fang and VIP were searched with the key words including morphine,oxycodone,tramadol,codeine and moderate cancer pain.Primary endpoint was clinical efficacy and the secondary endpoint were side effects（nausea/vomiting,drowsiness,anorexia and constipation）.Review Manager 5.3 was used to perform the meta-analysis,GRADE quality of evidence system was used to assess the results of metaanalysis.RESULTS Four randomized controlled trials（RCTs）with a total of 708 patients were included.Meta-analysis results indicated that LDSO was superior in pain relief[OR=3.50,95% CI（2.39 to 5.13）,P0.000 01]compared with WO,and the two arms had no significant difference in nausea/vomiting[OR=0.92,95% CI（0.59 to 1.42）,P=0.69],drowsiness[OR=1.23,95% CI（0.74 to 2.05）,P=0.42],anorexia[OR=1.19,95% CI（0.59 to 2.37）,P=0.63]or constipation [OR=1.34,95% CI（0.87 to 2.07）,P=0.19]between the two arms.The evidence of pain relief and side effects were moderate as assessed by GRADE quality of evidence system.CONCLUSION LDSO is superior in pain relief than WO in the treatment of moderate cancer pain and well tolerated,which indicates that LDSO is a viable treatment for patients with moderate cancer pain.