中国免疫学杂志2024,Vol.40Issue(1) :138-143,中插1-中插7.DOI:10.3969/j.issn.1000-484X.2024.01.021

PD-1抑制剂对比化疗或伊匹单抗治疗晚期黑色素瘤安全性和有效性的Meta分析

Safety and efficacy of PD-1 inhibitors versus chemotherapy or ipilimumab in advanced melanoma:Meta-analysis

林志冰 毛雅珍 周晓燕 林晓丹 徐桂秋 林伟 林雨虹
中国免疫学杂志2024,Vol.40Issue(1) :138-143,中插1-中插7.DOI:10.3969/j.issn.1000-484X.2024.01.021

PD-1抑制剂对比化疗或伊匹单抗治疗晚期黑色素瘤安全性和有效性的Meta分析

Safety and efficacy of PD-1 inhibitors versus chemotherapy or ipilimumab in advanced melanoma:Meta-analysis

林志冰 1毛雅珍 1周晓燕 1林晓丹 1徐桂秋 1林伟 1林雨虹1
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作者信息

  • 1. 福建医科大学附属福州市第一医院检验科,福州 350009
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摘要

目的:分析PD-1抑制剂对比化疗或伊匹单抗治疗晚期黑色素瘤的安全性和有效性.方法:检索PubMed、中国知网(CNKI)、维普和万方数据库,收集PD-1抑制剂治疗晚期黑色素瘤的随机对照试验,检索时限均从建库至2022年5月1日.由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.4和STATA16软件进行Meta分析.结果:共纳入7项研究.Meta分析结果显示:①安全性:PD-1抑制剂治疗相较于化疗有更少的不良反应事件,尤其是血液系统;PD-1抑制剂联合伊匹单抗相较于伊匹单抗单用有更多的不良反应事件,尤其别是肝功能指标;PD-1抑制剂和伊匹单抗治疗的总不良反应事件发生率差异无统计学意义.②有效性:PD-1抑制剂对比化疗或伊匹单抗治疗的PFS、OS和ORR分别为HR=0.54,95%CI(0.45,0.62),P<0.05、HR=0.69,95%CI(0.58,0.80),P=0.03和OR=3.16,95%CI(2.59,3.86),P<0.05.结论:PD-1抑制剂治疗晚期黑色素瘤具有较好的有效性,但不同的联合方式和不同的对照治疗有不同的安全表现.受纳入研究的数量和质量限制,需要更多研究证据予以佐证.

Abstract

Objective:To analyze the safety and efficacy of PD-1 inhibitors versus chemotherapy or ipilimumab in advanced melanoma.Methods:PubMed,CNKI,VIP and Wanfang databases were searched to collect randomised controlled trials of PD-1 inhibi-tors in treatment of advanced melanoma.The search time was from the establishment of the database to May 1,2022.Two reviewers independently screened the literature,extracted data,and assessed risk of bias of included studies.Meta-analysis was performed using RevMan5.4 and STATA16 software.Results:A total of 7 studies were included.Meta-analysis results show that:①Safety:Compared with chemotherapy,PD-1 inhibitor treatment had fewer adverse events,especially in the blood system;compared with ipilimumab alone,PD-1 inhibitor combined with ipilimumab had more adverse events,especially liver function indicators;there was no signifi-cant difference in the incidence of total adverse events between PD-1 inhibitor monotherapy and ipilimumab monotherapy.②Efficacy:The PFS,OS and ORR of PD-1 inhibitor versus chemotherapy or ipilimumab were HR=0.54,95%CI(0.45,0.62),P<0.05,HR= 0.69,95%CI(0.58,0.80),P=0.03 and OR=3.16,95%CI(2.59,3.86),P<0.05,respectively.Conclusion:PD-1 inhibitors have good efficacy in treatment of advanced melanoma,while different combination methods and different control treatments may have different efficacy.Limited by the quantity and quality of included studies,more research evidence is needed to support this.

关键词

PD-1/纳武单抗/派姆单抗/伊匹单抗/晚期黑色素瘤/Meta分析

Key words

PD-1/Nivolumab/Pembrolizumab/Ipilimumab/Advanced melanoma/Meta-analysis

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基金项目

福建省卫生健康青年科研课题(2019-1-81)

福建医科大学启航基金(2020QH1259)

出版年

2024
中国免疫学杂志
中国免疫学会,吉林省医学期刊社

中国免疫学杂志

CSTPCD北大核心
影响因子:0.926
ISSN:1000-484X
参考文献量1
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