帕洛诺司琼预防成人化疗所致恶心呕吐随机对照试验Meta分析  

Comparative efficacy and safety of palonosetron with the first 5-HT3 receptor antagonists for the chemotherapy-induced nausea and vomiting in Chinese patients:a Meta-analysis

作　　者：董良[1] 李海金[1] 赵建刚[1] 葛丽娜[1] 王伟英[1] 

机构地区：[1]中国医科大学绍兴医院肿瘤内科,浙江绍兴312030

出　　处：《中华肿瘤防治杂志》2014年第18期1461-1467,共7页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的：对帕洛诺司琼预防中国成人恶性肿瘤患者化疗所致的恶心呕吐的疗效和不良反应进行Meta分析。方法：计算机检索Cochrane图书馆、PubMed、EMbase、VIP、CNKI和CBM等电子数据库，查找应用帕洛诺司琼与第1代5-HT3受体拮抗剂预防中国成人化疗所致恶心呕吐的随机对照试验（randomizedcontrolledtrial，RCT）。对符合条件的RCT，进行质量评价和资料提取，采用RevMan5．2软件进行Meta分析，并采用推荐分级的评价、制定与评估（gradesofrecommendationsassessment，developmentandevaluation，GRADE）系统对证据质量和等级推荐进行分级。结果：共纳入10个RCT，共计接受中高度致吐性化疗患者1774例。Meta分析显示，与第1代5-HT3受体拮抗剂比较，帕洛诺司琼预防急性化疗所致恶性呕吐有效率（RR=1．08，95％CI：1．02～1．15，P=0．02）、迟发性化疗所致恶性呕吐有效率（RR=1．34，95％CI：1．21～1．48，P〈0．001）和全程化疗所致恶性呕吐有效率（RR=1．23，95％CI：1．09～1．40，P=0．001）均具有明显优势，且主要不良反应头痛（RR=0．91，95％CI：0．55～1．52，P=0．72）和便秘（RR=1．00，95％CI：0．66～1．53，P=0．99）差异无统计学意义。GRADE系统评价结果显示，证据级别均为低级别，推荐等级为弱推荐。结论：帕洛诺司琼预防成人化疗所致恶心呕吐安全、有效；帕洛诺司琼可优先考虑用于预防中高度致吐性化疗方案的恶心呕吐。OBJECTIVE： To evaluate the efficacy and safety of palonosetron with the first 5-HT3 receptor antago- nists for the chemotherapy-induced nausea and vomiting （CINV） in Chinese patients. METHODS： Randomized controlled trials （RCTs） on palonosetron with the first 5-HT3 receptor antagonists for the chemotherapy-induced nausea and vomiting in Chinese patients were searched in the Cochrane Library,PubMed, EMbase, VIP, CNKI,CBMdisc and other elec tronic databases. The quality of RCTs was evaluated and the data were extracted;meta-analysis were performed with Rev Man 5.2 software,and GRADE System was used to rate the level of evidence and strength of recommendation. RESULTS： Among the 10 RCTs involving 1 774 cases,Meta-analysis showed statistically significant differences in favor of palonose- tron compared with first 5 HT3 receptor antagonists in prevention of acute CINV（RR： 1.08,95 %CI： 1.02-1.15, P= 0.02） ,delayed CINV（RR：I. 34,95GCI：1.21--1.48,P〈0. 001） ,and overall phase of CINV（RR：1. 23,95%CI：1.09 1.40,P：0. 001）,while the main adverse events such as headache（RR=0.91,95%CI：0.55--1.52,P=0.72） and constipation（RR = 1.00,95 % CI： 0.66-1.53, P = 0.99） were not different between the two groups. Based on GRADE, the level of evidence was Grade C,and the strength of recommendation was weak. CONCLUSION： Palonosetron is highly effective and safety in preventing CINV in Chinese patients, and can be a prefer choice in preventing nausea and vomiting in the days after administration of moderately or highly emetogenic chemotherapy agents.

关 键 词：帕洛诺司琼 5-HT3受体拮抗剂 化疗所致恶心呕吐 META分析 

分 类 号：R730.53[医药卫生—肿瘤]