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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 effects of ipilimumab in the treatment of advanced malignancies by Meta-analysis. METHODS: The databases of Pub Med, Cochrane Library, EMBase, Clinical Trials.gov, Wanfang, Zhidu, Vip and other databases were searched for randomized controlled trials (RCTs) on ipilimumab in the treatment of advanced malignancies and screened by inclusion criteria Qualified literature was prepared and evaluated for quality. Meta-analysis was performed using Revman 5.3 software. Results: Four RCTs were finally included and included 2 tumor types, totaling 2,875 patients. Meta-analysis showed that patients with ipilimumab were associated with pruritus (RR = 3.57, 95% CI: 2.40-5.33, P <0.000 01), rash (RR = 3.63, 95% CI (RR = 2.45, 95% CI: 2.12-2.84, P <0.000 01) and colitis (RR = 11.42, 95% CI: 6.13-21.28, P <0.000 01) (RR = 2.22, 95% CI: 0.59 ~ 8.34, P = 0.24), and the incidence of endocrine-related adverse reactions was not significantly different , 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) Inflammation: (RR = 13.32, 95% CI: 0.76 to 233.37, P = 0.08); Adrenocortical hypofunction: (RR = 2.98, 95% CI: 0.73-12.11, P = 0.13)]. CONCLUSION: Ipilimumab is effective in treating advanced malignancies and increases the incidence of immune-related skin and gastrointestinal adverse reactions in patients without increasing the incidence of immune-related aminotransferases and immune-related endocrine adverse reactions.