雷莫卢单抗致肿瘤患者出血风险的荟萃分析

目的:系统评价雷莫卢单抗(Ramucirumab)对肿瘤患者出血风险的影响。方法:全面检索PubMed、ASCO Abstracts、ESMO Abstracts、Embase、ClinicalTrials.gov、CNKI以及万方数据库,查找雷莫卢单抗所有相关的前瞻性随机对照试验(RCTs),采用Revman5.2软件进行Meta分析。结果:纳入13篇随机对照试验,包含6307例肿瘤患者。结果显示与对照组相比,雷莫卢单抗增加了肿瘤患者所有级别出血风险(RR:1.95,95%CI:1.79–2.13,P<0.00001),但没有增加高级别(≥3级)出血风险(RR:1.04,95%CI:0.78–1.39,P=0.79)。在亚组分析中,雷莫卢单抗没有增加非小细胞肺癌患者所有级别(RR:1.28,95%CI:0.95–1.74,P=0.11)以及高级别肺出血风险(RR:1.37,95%CI:0.46–4.09,P=0.57)。此外,在雷莫卢单抗不同剂量组,发生高级别和所有级别的出血风险未见差异。结论:雷莫卢单抗致严重出血的风险较小,由于本研究存在一定的局限性,仍需更多高水平、大样本、多中心的临床随机对照试验加以验证。

Meta-analysis of the risk of bleeding associated with ramucirumab in cancer patients

Objective:To systematically evaluate the relative risk(RR)of bleeding associated with ramucirumab in cancer patients.Methods:Prospective randomized controlled trials(RCTs)of ramucirumab were searched in databases including PubMed,American society of clinical oncology(ASCO)Abstracts,European society of medical oncology(ESMO)Abstracts,Embase,ClinicalTrials.gov,CNKI and Wanfang database.The software RevMan5.2 was used for meta-analysis.Results:A total of 13 RCTs involved 6307 cases of cancer patients were enrolled in this study.Results of meta-analysis showed that compared with the control group,ramucirumab increased the risk of all-grade bleeding(RR:1.95,95%CI:1.79–2.13,P<0.00001),but the risk of≥3 grade bleeding(RR:1.04,95%CI:0.78–1.39,P=0.79)was not increased.Results of sub-group analysis showed that the risks of all-grade bleeding(RR:1.28,95%CI:0.95–1.74,P=0.11)and≥3 grade pulmonary hemorrhage(RR:1.37,95%CI:0.46–4.09,P=0.57)in non-small cell lung cancer(NSCLC)patients were not increased by ramucirumab,and there were no significant differences in the risks of all-grade and≥3 grade bleeding in different dose of ramucirumab.Conclusion:Ramucirumab had a relatively small risk of serious bleeding.Due to the limitations of this study,more high-level,large sample,multicenter clinical randomized controlled trials are still needed to verify.