罗拉吡坦联合5-羟色胺3受体拮抗药和地塞米松防治化疗相关性恶心呕吐的系统评价

Rolapitant Combined with 5-HT_3 Receptor Antagonist and Dexamethasone for the Prevention and Treatment of Chemotherapy-induced Nausea and Vomiting:A Systematic Review

目的:系统评价罗拉吡坦联合5-羟色胺3受体拮抗药和地塞米松防治化疗相关性恶心呕吐的疗效和安全性,为临床提供循证参考。方法:计算机检索中国期刊全文数据库、中文科技期刊数据库、万方数据库、PubMed、EMBase、Cochrane图书馆,收集罗拉吡坦联合5-羟色胺3受体拮抗药和地塞米松(试验组)对比安慰剂联合5-羟色胺3受体拮抗药和地塞米松(对照组)防治化疗相关性恶心呕吐的随机对照试验(RCT),提取资料并按照Cochrane系统评价员手册5.1.0推荐的偏倚风险评价工具和标准评价质量后,采用RevMan 5.3统计软件进行Meta分析。结果:共纳入3篇文献(4项RCT),合计2 583例患者。Meta分析结果显示,试验组患者完全缓解率[急性期:RR=1.10,95%CI(1.02,1.19),P=0.01;延迟期:RR=1.18,95%CI(1.11,1.25),P<0.001;总体期:RR=1.19,95%CI(1.12,1.26),P<0.001]、呕吐生活功能指数>108分患者占比[RR=1.10,95%CI(1.04,1.16),P<0.001]均显著高于对照组,差异均有统计学意义;两组患者不良反应发生率比较,差异无统计学意义[RR=1.10,95%CI(0.82,1.47),P=0.52]。结论:罗拉吡坦联合5-羟色胺3受体拮抗药和地塞米松能有效防治化疗相关性恶心呕吐,提高患者生存质量,且安全性较好。

OBJECTIVE： To evaluate the effectiveness and safety of rolapitant combined with 5-HT3 receptor antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting systematically, and to provide evidence-based reference in clinic. METHODS： Retrieved from CJFD, VIP, Wanfang Database, PubMed, EMBase and Cochrane Library, randomized controlled trials （RCTs） about rolapitant＋5-HT3 receptor antagonist＋ dexamethasone （trial group） vs. placebo combined with 5-HT3 receptor antagonist＋dexamethasone （control group） for the prevention of chemotherapy-induced nausea and vomiting. Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0. RESULTS： A total of 3 literatures were included, involving 4 RCTs and 2 583 patients. The results of Meta-analysis were as follows： complete remission rate [acute stage： RR=1.10,95%CI（1.02, 1.19）,P=0.01;delay stage： RR= 1.18,95% CI （1.11,1.25）, P〈0.001 ; overall stage： RR= 1.19, 95% CI （1.12, 1.26）, P〈0.001] and the proportion of patients with functional indexes of vomiting living〉 108 [RR= 1.10,95% CI（1.04, 1.16）,P〈0.001] in trial group were significantly higher than control group, with statistical significance. There was no statistical significance in the incidence of ADR between 2 groups[RR= 1.10,95 % CI （0.82, 1.47）, P=0.52]. CONCLUSIONS： Rolapitant combined with 5-HT3 receptor antagonist and dexamethasone can effectively prevent and relieve chemotherapy-induced nausea and vomiting, and improve the quality of life with good safety.