替莫唑胺联合干扰素-α治疗晚期恶性黑色素瘤的疗效与安全性Meta分析  

Efficacy and safety of temozolomide combined with interferon-αin the treatment of advanced malignant melanoma:a metaanalysis

作　　者：肖渝 夏萍 张漾杰 肖砚斌 康建平 朱昱衡 Xiao Yu;Xia Ping;Zhang Yangjie(Department of Orthopedics,Yunnan Cancer Hospital,Kunming 650118)

机构地区：[1]云南省肿瘤医院昆明医科大学第三附属医院骨外二科,云南昆明650118 [2]昆明医科大学第一附属医院干部医疗心内科,云南昆明650032

出　　处：《中国现代医药杂志》2022年第2期1-7,共7页Modern Medicine Journal of China

基　　金：国家自然科学基金(编号:81760495)。

摘　　要：目的通过Meta分析比较替莫唑胺(Temozolomide,TMZ)联合干扰素-α或TMZ单药治疗晚期恶性黑色素瘤的疗效和安全性。方法检索PubMed、Cochrane Library、Ovid、中国知网、万方、维普数据库自建库以来至2021年8月公开发表的采用TMZ治疗晚期恶性黑色素瘤的研究文献,依据纳入和排除标准选择文献并进行质量评估和数据提取,使用RevMan5.4软件行Meta分析。结果共纳入4篇文献,均为高质量随机对照试验(RCT)研究。4篇文献入选客观缓解率分析,实验组高于对照组[OR=2.23,95%CI(1.44,3.47),P<0.05];4篇文献入选控制率分析,两组间无统计学差异[OR=1.37,95%CI(0.95,1.98),P>0.05];2篇文献入选无进展生存期分析,两组间无统计学差异[HR=1.14,95%CI(1.00,1.30),P>0.05];4篇文献入选白细胞减少分析,组间存在异质性,经亚组分析发现,研究中限定用药周期对研究结果存在影响;3篇文献入选血小板减少分析,对照组较实验组血小板减少出现更少[OR=4.51,95%CI(2.44,8.34),P<0.05];2篇文献纳入血红蛋白减少分析,两组间无统计学差异[OR=1.61,95%CI(0.87,3.01),P>0.05];3篇文献纳入恶心呕吐症状分析,两组间无统计学差异[OR=0.85,95%CI(0.46,1.60),P>0.05];3篇文献纳入肝损伤分析,两组间无统计学差异[OR=1.39,95%CI(0.67,2.88),P>0.05]。结论TMZ联合干扰素-α治疗晚期恶性黑色素瘤较TMZ单药可在不明显增加化疗副反应的前提下提高疾病的客观缓解率,但未能证明联合治疗方案能够提升患者的疾病控制率或延长无进展生存期。Objective To compare the efficacy and safety of temozolomide(TMZ)combined with interferon-α(IFN-α)or TMZ mono in the treatment of advanced malignant melanoma through meta-analysis.Methods Databases including PubMed,Cochrane Library,Ovid,CNKI,Wanfang and VIP were searched for studies about TMZ in the treatment of advanced malignant melanoma from the establishment of the database to Aug 2021.The literatures were selected according to the inclusion and exclusion criteria,and the quality evaluation were performed.RevMan5.4 software was used for meta-analysis.Results A total of four literatures were included,and all were high quality randomized controlled trials(RCT).Four RCTs were selected for objective response rate(ORR)analysis,and the ORR of the experimental group was higher than that of the control group[OR=2.23,95%CI(1.44,3.47),P<0.05];four RCTs were selected for control rate(CR)analysis,and there was no statistical difference between the two groups[OR=1.37,95%CI(0.95,1.98),P>0.05];two RCTs were selected for progression-free survival(PFS)analysis,and there was no statistically significant difference between the two groups[HR=1.14,95%CI(1.00,1.30),P>0.05];the leukopenia analysis of the four literatures showed that there was heterogeneity between the groups.The subgroup analysis showed that the specific medication cycle in the study had an impact on the results.Three items were selected for thrombocytopenia analysis,and the occurrence of thrombocytopenia in the control group was less than that in the experimental group[OR=4.51,95%CI(2.44,8.34),P<0.05];two RCTs were selected for hemoglobin reduction analysis,and there was no statistical difference between the two groups[OR=1.61,95%CI(0.87,3.01),P>0.05];three RCTs were selected for nausea and vomiting symptoms,and there was no statistical difference between the two groups[OR=0.85,95%CI(0.46,1.60),P>0.05];three RCTs were selected for liver injury analysis,and there was no statistical difference between the two groups[OR=1.39,95%CI(0.67,2.88),P>0.05].Conclusion The

关 键 词：恶性黑色素瘤 替莫唑胺 干扰素-Α META分析 

分 类 号：R739.5[医药卫生—肿瘤]