摘要
目的采用Meta分析方法对安罗替尼治疗广泛期小细胞肺癌(ES-SCLC)的疗效及安全性进行系统评价。方法检索PubMed、Embase、Cochrane Library、知网、万方、维普、中国生物医学文献数据库,查阅自建库至2022年11月公开发表的研究安罗替尼治疗ES-SCLC的全部文献。由另外2名研究员负责独立按照纳排标准进行筛选文献和提取资料后,使用RevMan 5.4软件进行数据的Meta分析。结果共纳入6项随机对照试验进行分析研究,合计302例患者。Meta分析提示安罗替尼能明显延长ES-SCLC的无进展生存期(HR=0.12,95%CI:0.07~0.21,P<0.01),提高客观缓解率(RR=1.48,95%CI:1.15~1.91,P<0.01),改善KPS评分(MD=9.18,95%CI:4.35~14.02,P<0.01),降低NSE值(MD=-8.20,95%CI:-9.15~-7.25,P<0.01)。安全性方面:安罗替尼组相较于对照组,不良反应发生风险增高,但差异无统计学意义(RR=1.11,95%CI:0.91~1.35,P=0.31),高血压发生率(RR=6.63,95%CI:2.44~16.44,P<0.01)及皮疹发生率(RR=3.55,95%CI:1.43~8.78,P<0.01)均高于对照组;其余不良反应如乏力(RR=1.06,95%CI:0.74~1.52,P=0.74)、腹泻(RR=2.28,95%CI:0.56~9.24,P=0.25)、蛋白尿(RR=1.75,95%CI:0.53~5.73,P=0.36)两组比较差异均无统计学意义。结论与安慰剂或空白对照相比,安罗替尼能提高ES-SCLC患者的远期生存和近期疗效,改善生活质量,降低NSE值,其发生高血压及皮疹的风险较高,其余一些不良反应如乏力、腹泻、蛋白尿的发生率与安慰剂/空白对照组相近,患者总体用药耐受程度较好。
Objective To systematically evaluate the efficacy and safety of anlotinib in the treatment of extensive-stage small cell lung cancer(ES-SCLC)by meta-analysis.Methods PubMed,Embase,Cochrane Library,CNKI,Wanfang Data,VIP Database,China Biology Medicine disc were searched for the full literature on studies of anlotinib for the treatment of ES-SCLC published from database establishment to November 2022.Other 2 investigators were responsible for screening the literature and extracting data independently according to the inclusion and exclusion criteria.Revman 5.4 software was used for meta-analysis of the data.Results A total of 6 RCTs were included for analysis studies,with a total of 302 patients.Meta analysis suggested that anlotinib significantly prolonged progression free survival of ES-SCLC(HR=0.12,95%CI:0.07 to 0.21,P<0.01),improved objective response rate(RR=1.48,95%CI:1.15 to 1.91,P<0.01),improved KPS score(MD=9.18,95%CI:4.35 to 14.02,P<0.01),and decreased neuron-specific enolase(NSE)value(MD=-8.20,95%CI:-9.15 to-7.25,P<0.01).Compared to control group,the anlotinib group was associated with a higher risk of adverse events(RR=1.11,95%CI:0.91 to 1.35,P=0.31),but without significant difference,while the incidence of hypertension(RR=6.63,95%CI:2.44 to 16.44,P<0.01)and rash(RR=3.55,95%CI:1.43 to 8.78,P<0.01)increased in anlotinib group.There was no significant difference in the remaining adverse effects,such as fatigue(RR=1.06,95%CI:0.74 to 1.52,P=0.74),diarrhea(RR=2.28,95%CI:0.56 to 9.24,P=0.25),and proteinuria(RR=1.75,95%CI:0.53 to 5.73,P=0.36).Conclusion Anlotinib can raise long-term survival and short-term outcomes,improve quality of life,and reduce NSE values in ES-SCLC patients compared with placebo or blank controls,but it has a higher risk of developing hypertension and rash.The risk of remaining adverse effects such as fatigue,diarrhea,and proteinuria occurred are similar between placebo/blank controls and anlotimib treatment.The patients have a good medication tolerance.
作者
李姝蒙
赵国桢
刘梓燊
张兴涵
张怀锐
杨国旺
LI Shumeng;ZHAO Guozhen;LIU Zishen;ZHANG Xinghan;ZHANG Huairui;YANG Guowang(Beijing University of Chinese Medicine,Beijing 100029,China;不详)
出处
《中国临床研究》
CAS
2023年第6期860-866,共7页
Chinese Journal of Clinical Research
基金
国家重点研发计划(2018YFC1705101)
国家自然科学基金(82174453)
北京市自然科学基金(7222270)。
