含雷莫卢单抗方案治疗晚期实体瘤安全性的Meta分析  

Meta- analysis on safety of ramucirumab involved regimen for advanced solid tumors

作　　者：陈川[1] 刘明月[1] 夏太玉 龚理[1] 任庆兰[1] 

机构地区：[1]重庆医科大学附属第一医院肿瘤科,重庆400016

出　　处：《中国新药与临床杂志》2016年第1期64-70,共7页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的采用Meta分析法比较含雷莫卢单抗方案和不含雷莫卢单抗方案治疗晚期实体瘤的安全性。方法检索PubMed、Cochrane Library、EMBase、ClinicalTrials．gov、万方、知网、维普等数据库，查找含雷莫卢单抗方案治疗晚期实体瘤的随机对照试验（RCTs），按纳入、排除标准进行筛选并进行质量评价，应用Revman5．3软件进行Meta分析，评价指标为≥3级不良反应。结果最终纳入7篇RCTs，共计6种实体瘤，包含5194例患者。分析结果显示，与不含雷莫卢单抗方案相比，在≥3级不良反应方面，含雷莫卢单抗方案增加了患者高血压（RR=3．75，95％CI：2．83～4．96，P〈0．00001）、胃肠道穿孔（RR：3．37，95％CI：1．51～7．54，P=0．003）的发生率。腹泻（RR=1．30，95％CI：0．98—1．73，P=0．70）、静脉血栓栓塞事件（RR=0．78，95％CI：0.55～1．10，P=0．16）、动脉血栓栓塞事件（RR=1．07，95％CI：0．61—1．88，P=0．81）、出血／血肿（RR=1．07，95％CI：0．77～1．48，P=0．70）的发生率无显著差异。结论与不含雷莫卢单抗方案相比，含雷莫卢单抗方案治疗晚期实体瘤患者≥3级的不良反应发生率增加，高血压、胃肠道穿孔相对风险分别增加了2．75倍、2．37倍，但并不增加腹泻、出血／血肿、动静脉血栓栓塞事件的发生率。AIM To compare the safety of ramucirumab involved regimen and non-ramucirumab involved regimen for advanced solid tumors by meta- analysis. METHODS Databases including Pubmed, Cochrane Library, EMBase, ClinicalTrials.gov databases, Wanfang, CNKI and VIP were searched. Randomized controlled trials （RCTs） focusing on ramucirumab involved regimen for advanced solid tumors were collected. All the literatures retrieved were screened according to inclusion and exclusion criteria. The software RevMan 5.3 was used for meta-analysis. The outcomes included adverse effect （grade ≥3）. RESULTS Seven RCTs with 6 different types of malignancies and 5 194 patients were included in this meta- analysis. The results of meta- analysis suggested that the grade ≥3 toxicity analysis showed significant differences between the 2 groups in hypertension （RR = 3.75, 95%CI： 2.83 - 4.96, P 〈 0.000 01）, gastrointestinal perforation （RR = 3.37, 95%CI： 1.51 - 7.54, P = 0.003）. However, there were no significant differences in diarrhea （RR = 1.30, 95%CI： 0.98- 1.73, P = 0.70）, venous thromboembolism （RR = 0.78, 95%CI： 0.55- 1.10, P= 0.16）, arterial thromboembolism （RR = 1.07, 95%CI： 0.61- 1.88, P= 0.81）, bleeding/hemorrhage （RR = 1.07, 95%CI： 0.77 - 1.48, P = 0.70）. CONCLUSION Compared with non- ramueirumab involved regimen, ramucirumab involved regimen can increase incidence of the grade ≥3 toxicity in patients with advanced solid tumors. The relative risk of hypertension and gastrointestinal perforation increase 2.75 times and 2.37 times without raising risk of diarrhea, venous thromboembolism, arterial thromboembolism, bleeding/hemorrhage.

关 键 词：雷莫卢单抗 实体瘤 META分析 安全 

分 类 号：R730.53[医药卫生—肿瘤] R979.19[医药卫生—临床医学]