硫培非格司亭预防癌症患者化疗后中性粒细胞减少的有效性和安全性评价

A systematic review on efficacy and safety of mecapegfilgrastim as prophylaxis for chemotherapy⁃induced neutropenia

目的系统评价硫培非格司亭(HHPG-19K)预防癌症患者化疗后中性粒细胞减少的有效性和安全性,旨为临床提供循证参考。方法计算机检索Cochrane Library、Pub Med、EMBase、Clinical trials、中国生物医学文献、维普、万方、中国临床试验注册中心(各数据库检索时间均从建库至2020年3月31日)数据库中有关硫培非格司亭的原始研究,经过两位研究者独立完成文献筛选、数据提取和质量评价,使用Rev Man 5.3进行Meta分析。结果 4篇RCT文献被纳入,共671例患者。Meta分析结果显示,硫培非格司亭显著降低化疗第2周期(RR=0.37,95%CI:0.21~0.65)Ⅳ度及以上粒细胞减少的发生率但在化疗第1周期差异无统计学意义,第1周期(RR=0.56,95%CI:0.31~1.00);但在降低FN发生率方面无差异(RR=0.42,95%CI:0.15~1.19);硫培非格司亭不增加骨痛的发生率(RR=1.10,95%CI:0.48~2.51)。描述性分析结果显示,与安慰剂相比硫培非格司亭可显著缩短化疗第1周期组Ⅲ度粒细胞减少持续的时间(P <0.000 1),但与rhG-CSF效果相当。结论硫培非格司亭预防化疗后粒细胞减少效果优于安慰剂;硫培非格司亭预防化疗第2周期Ⅳ度及以上粒细胞减少的有效性优于rhG-CSF,但预防第1周期Ⅳ度及以上粒细胞减少及FN发生的有效性与rhG-CSF相当;安全性与rhG-CSF相当。

Objective To assess the effectiveness and safety of mecapegfilgrastimas(HHPG⁃19K)in preventing neutropenia after chemotherapy in cancer patients systematically,aiming to provide evidence⁃based reference for clinical treatment.Methods The original research on mecapegfilgrastimas in the database from Cochrane Library,PubMed,EMBase,ClinicalTrials.gov,CBM,CNKI,VIP,Wanfang and ChiCTR was retrieved.The studies on mecapegfilgrastimas forprophylaxis of chemotherapy⁃induced neutropenia were collected.Literature screening and methodological quality assessment were completed by two reviewers independently.Meta⁃analysis was performed using the RevMan 5.3 software.Results Four RCTs were included,involving 671 patients whowere finally enrolled in this study.The Meta analysis revealedmecapegfilgrastimas significantly decreased the incidence of grade≥4 neutropenia at cycle two(RR=0.37,95%CI:0.21~0.65)and there was no significant differences at cycle one(RR=0.56,95%CI:0.31~1.00).There were no significant differences in the incidence rate of FN(RR=0.42,95%CI:0.15~1.19)andbone pain(RR=1.10,95%CI:0.48~2.51)between mecapegfilgrastimas group and the control group.The descriptive analysis showed that mecapegfilgrastimas markedly shortenedin the mean duration of grade≥3 neutropenia at cycle one(P<0.0001)as compared with placebo.The efficacy of mecapegfilgrastim was equivalent to that of rhG⁃CSF.Conclusions Mecapegfilgrastim is superior to placebo in preventing chemotherapy⁃induced neutropenia.The efficacy of mecapegfilgrastim is better than that of rhG⁃CSF in prevention of the incidence of grade≥4 neutropenia atchemotherapy cycletwo.Mecapegfilgrastim has the similar efficacy torhG⁃CSF in prophylaxis ofthe incidence of grade≥4 neutropenia at cycle one or theoccurrence of FN.The safety of mecapegfilgrastim is similar to that of rhG⁃CSF.