易普利姆玛治疗晚期恶性肿瘤的免疫相关不良反应的Meta分析  

Meta-analysis of immune-related adverse events of ipilimumab for advanced malignant tumors

作　　者：夏太玉 陈川[2] 任庆兰[2] 

机构地区：[1]重庆市大足区人民医院肿瘤科,重庆402360 [2]重庆医科大学附属第一医院肿瘤科,重庆400016

出　　处：《中国新药杂志》2016年第13期1555-1560,共6页Chinese Journal of New Drugs

摘　　要：目的：采用Meta分析方法评价易普利姆玛治疗晚期恶性肿瘤的免疫相关不良反应。方法：检索Pub Med,Cochrane Library,EMBase,Clinical Trials.gov,万方、知网、维普等数据库,搜索关于易普利姆玛治疗晚期恶性肿瘤的随机对照试验（RCTs）,按纳入排除标准筛选出合格的文献并对其进行质量评价,应用Revman 5.3软件进行Meta分析。结果：最终纳入4篇RCTs,包含2种肿瘤类型,共2 875例患者。Meta分析结果显示,与对照组相比,易普利姆玛组患者免疫相关性瘙痒（RR=3.57,95%CI：2.40-5.33,P〈0.000 01）、皮疹（RR=3.63,95%CI：2.90-4.55,P〈0.000 01）、腹泻（RR=2.45,95%CI：2.12-2.84,P〈0.000 01）和结肠炎（RR=11.42,95%CI：6.13-21.28,P〈0.000 01）的发生率较高,而免疫相关性转氨酶增高、内分泌相关不良反应的发生率无显著性差异[丙氨酸氨基转移酶：（RR=2.22,95%CI：0.59-8.34,P=0.24）;天门冬氨酸氨基转移酶：（RR=2.37,95%CI：0.58-9.66,P=0.23）;甲状腺功能减退：（RR=4.70,95%CI：0.98-22.39,P=0.05）;垂体炎：（RR=13.32,95%CI：0.76-233.37,P=0.08）;肾上腺皮质功能减退：（RR=2.98,95%CI：0.73-12.11,P=0.13）]。结论：易普利姆玛治疗晚期恶性肿瘤,增加患者免疫相关性皮肤和胃肠道不良反应发生率,而不增加免疫相关性转氨酶增高和免疫相关性内分泌不良反应发生率。Objective： To evaluate the immune-related adverse events of ipilimumab for advanced malignant 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 ipilimumab for advanced malignant tumors were collected. All the literatures retrieved were screened according to the inclusion and exclusion criteria. The software Rev Man 5. 3 was used for meta-analysis. Results： Four RCTs with2 different types of malignancies and 2 875 patients were included in this meta-analysis. The results of metaanalysis suggested that the immune-related cutaneous and gastrointestinal side-effects showed significant differences between the 2 groups in pruritus（ RR = 3. 57,95% CI： 2. 40 - 5. 33,P 0. 000 01）,rash（ RR = 3. 63,95% CI：2. 90 - 4. 55,P 0. 000 01）,diarrhea（ RR = 2. 45,95% CI： 2. 12 - 2. 84,P 0. 000 01）,colitis（ RR = 11. 42,95% CI： 6. 13 - 21. 28,P 0. 000 01）. However,there were no significant differences in increase of aminopherase and endocrine-related adverse events [alanine aminotransferase（ RR = 2. 22,95% CI： 0. 59 - 8. 34,P = 0. 24）,aspartate aminotransferase（ RR = 2. 37,95% CI： 0. 58 - 9. 66,P = 0. 23）,hypothyroidism（ RR = 4. 70,95% CI：0. 98 - 22. 39,P = 0. 05）,hypophysitis（ RR = 13. 32,95% CI： 0. 76 - 233. 37,P = 0. 08）,hypoadrenocorticism（ RR = 2. 98,95% CI： 0. 73 - 12. 11,P = 0. 13） ]. Conclusion： Ipilimumab is associated with a significantly increased risk of immune-related cutaneous and gastrointestinal side-effects in malignant tumor sufferers,withoutraising risk of elevation of aminopherase and incidence of endocrine-related adverse events.

关 键 词：易普利姆玛 恶性肿瘤 META分析 不良反应 

分 类 号：R979.1[医药卫生—药品]