帕博利珠单抗治疗早期三阴性乳腺癌患者的安全性系统评价

doi:10.3969/j.issn.2095-1264.2024.01.15

首页 > 过刊浏览>2024年第1期 >93-99. DOI:10.3969/j.issn.2095-1264.2024.01.15

帕博利珠单抗治疗早期三阴性乳腺癌患者的安全性系统评价
DOI:
                        10.3969/j.issn.2095-1264.2024.01.15
                    
作者:
                        
                        
                    
作者单位:1.内蒙古科技大学包头医学院药学院，内蒙古 包头，014000;2.内蒙古自治区人民医院 药学处，内蒙古 呼和浩特，010000;3.包头医学院第一附属医院 临床药学室，内蒙古 包头，014000
作者简介:侯斯琦，女，硕士研究生，研究方向：临床药学。
通讯作者:张勇，男，硕士，主任药师，研究方向：临床药理及药物临床试验机构管理。
中图分类号:R737.9
基金项目:内蒙古自治区人民医院院内基金项目（2020YN15）。

The safety of pembrolizumab in the treatment of early triple-negative breast cancer patients: a systematic review

Author:

Affiliation:

1.School of Pharmacy, Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, 014000, Inner Mongolia, China;2.Department of Pharmacy, People's Hospital of Inner Mongolia Autonomous Region, Hohhot, 010000,Inner Mongolia, China;3.The First Affiliated Hospital of Baotou Medical College, Baotou, 014000, Inner Mongolia, China

Fund Project:

摘要

图/表

访问统计

参考文献

相似文献

引证文献

资源附件

文章评论

摘要:

目的通过Meta分析评估帕博利珠单抗（pembrolizumab）治疗早期三阴性乳腺癌（ETNBC）的安全性。方法计算机检索PubMed、Web of science、Cochrane数据库、Embase、clinicaltrials.gov、中国知网、万方和CBM，收集传统化疗联合帕博利珠单抗（试验组）对比传统化疗联合安慰剂（对照组）或紫杉醇联合帕博利珠单抗（试验组）对比紫杉醇联合安慰剂（对照组）的临床试验，检索时间为从建库至2023年4月1日。筛选文献、提取数据和评价质量后，采用RevMan 5.3软件进行统计分析、敏感性分析。结果共纳入3篇文献，合计1 509例患者，试验中结局指标（即3~5级不良事件）主要为腹泻、中性粒细胞减少、贫血、疲乏和皮肤反应。Meta分析结果显示，试验组患者3~5级腹泻（RR=1.83， 95% CI： 0.81~4.12， P=0.15）、中性粒细胞减少症（RR=1.03， 95% CI： 0.88~1.20， P=0.73）、贫血（RR=1.20， 95% CI： 0.92~1.55， P=0.18）、皮肤反应（RR=3.14， 95% CI： 0.28~35.41， P=0.35）的发生率与对照组比较，差异均无统计学意义；试验组疲乏发生率为3.4%，对照组疲乏发生率为1.3%，两组3~5级疲乏的发生率比较，差异有统计学意义（RR=2.21， 95% CI： 1.03~4.76， P=0.04）。结论在常见不良事件方面，使用帕博利珠单抗可能会增加患者发生疲乏的概率，但并不会增加不良事件总体发生率及其他常见不良事件的风险，具有可接受的安全性，在ETNBC患者中耐受性良好。

Abstract:

Objective To evaluate the safety of pembrolizumab in the treatment of early triple-negative breast cancer (ETNBC) by meta-analysis.Methods Computer searches were conducted on PubMed, Web of Science, Cochrane databases, Embase, ClinicalTrials.gov, CNKI, Wanfang, and CBM to collect clinical trials of traditional chemotherapy combined with pembrolizumab (experimental group) compared to traditional chemotherapy combined with placebo (control group) or paclitaxel combined with pembrolizumab (experimental group) compared to paclitaxel combined with placebo (control group). The search period was from database establishment to April 1, 2023. After screening literature, extracting data, and evaluating quality, RevMan 5.3 software was used for statistical analysis and sensitivity analysis.Results A total of 1 509 patients were included in 3 articles. The outcome indicators, which were grade 3~5 adverse events in the trials, mainly inlcuded diarrhea, neutropenia, anemia, fatigue, and skin reactions. The meta-analysis results showed that there was no statistically significant difference in the incidence of grade 3~5 adverse events between the experimental group and the control group, including diarrhea (RR=1.83, 95% CI: 0.81~4.12, P=0.15), neutropenia (RR=1.03, 95% CI: 0.88~1.20, P=0.73), anemia (RR=1.20, 95% CI: 0.92~1.55, P=0.18), and skin reactions (RR=3.14, 95% CI: 0.28~35.41, P=0.35). In terms of fatigue incidence, there was a statistically significant difference between the experimental group and the control group (RR=2.21, 95% CI: 1.03~4.76, P=0.04). The incidence rate of fatigue was 3.4% in the experimental group , but it was 1.3% the control group.Conclusion In terms of common adverse events, the use of pembrolizumab may increase the probability of fatigue in patients, but in terms of overall incidence of adverse events and other common adverse events, it does not increase the risk of adverse events in patients. It has acceptable safety and is well tolerated in ETNBC patients.