發(fā)布時間：2021-08-28 13:27

　　目的:系統(tǒng)性評價程序性死亡因子1/程序性死亡因子1配體（PD-1/PD-L1）抑制劑對比常規(guī)療法治療癌癥的有效性和安全性。方法:計算機全面檢索PubMed、MEDLINE、EMBASE數(shù)據(jù)庫,收集PD-1/PD-L1抑制劑治療癌癥的文獻研究,檢索時間為2000年1月1日至2019年6月30日。兩位研究人員獨立收集和整理資料,評價納入文獻研究的偏倚風險,應用Review Manager 5.3軟件對納入研究進行數(shù)據(jù)整理。結果:最終納入11項隨機對照試驗,共6 295例研究對象,其中PD-1/PD-L1抑制劑試驗組3 220例,常規(guī)療法藥物對照組3 075例。Meta分析結果顯示,PD-1/PD-L1抑制劑試驗組的客觀反應率（ORR）[RR=1. 87,95%CI（1. 33,2. 64）,P<0. 001]、完全緩解率（CR）[RR=2. 45,95%CI（1. 27,4. 73）,P<0. 001]和部分緩解率（PR）[RR=1. 81,95%CI（1. 28,2. 54）,P<0. 001]優(yōu)于常規(guī)療法對照組,結果均有統(tǒng)計學差異;在疾病控制率（DCR）[RR=1. ... 

【文章來源】：現(xiàn)代腫瘤醫(yī)學. 2020,28(10)

【文章頁數(shù)】：8 頁

【部分圖文】：

文獻篩選流程圖及結果

10項RCT報告了3-5級不良反應發(fā)生率,可提取數(shù)據(jù),異質(zhì)性檢驗分析結果表現(xiàn)出明顯的異質(zhì)性(χ2=181.94,P<0.000 01,I2=95%),故采用隨機效應模型進行分析,其合并效應量RR=0.44,95%CI(0.28,0.68),差異有統(tǒng)計學意義(Z=3.63,P=0.000 3),說明PD-1/PD-L1抑制劑試驗組在治療癌癥方面出現(xiàn)的3-5級不良反應發(fā)生率低于常規(guī)療法對照組,結果提示PD-1/PD-L1抑制劑對癌癥患者具有更高的安全性(圖9)。2.4 文獻發(fā)表偏倚

表3 納入文獻的質(zhì)量評價Tab.3 Quality evaluation of the included studies Included studies Study design Blind method Allocation concealment Data integrity Selective reporting Other sources of bias Achim Rittmeyer 2016 RCT Open-label Not described Unclear Unclear Unclear Antoni Ribas 2015 RCT Open-label Not described 10 people quit Unclear Unclear Bellmunt 2017 RCT Open-label Not described 21 people quit Unclear Unclear Caroline Robert 2015 RCT Open-label Not described 7 people quit Unclear Unclear Caroline Robert 2015 RCT Open-label Not described 23 people quit Unclear Unclear H Borghaei 2015 RCT Open-label Not described 27 people quit Unclear Unclear Jacob Schachter 2017 RCT Open-label Not described 23 people quit Unclear Unclear Jeffrey S Weber 2015 RCT Open-label Not described 35 people quit Unclear Unclear Julie Brahmer 2015 RCT Open-label Not described 12 people quit Unclear Unclear RJ Motzer 2015 RCT Open-label Not described 18 people quit Unclear Unclear Thomas Powles 2018 RCT Open-label Not described 29 people quit Unclear Unclear2.3.2 CR


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