硫培非格司亭注射液预防肿瘤患者化学治疗致中性粒细胞减少的快速卫生技术评估  

Rapid Health Technology Assessment of Mecapegfilgrastim Injection for Prophylaxis of Chemotherapy-Induced Neutropenia in Tumor Patients

作　　者：王陈萍[1] 王丹丹[1] 孟佳佳 刘青青[1] 窦志华[1] WANG Chenping;WANG Dandan;MENG Jiajia;LIU Qingqing;DOU Zhihua(Department of Pharmacy,Nantong Third Hospital Affiliated to Nantong University,Nantong,Jiangsu,China 226006)

机构地区：[1]南通大学附属南通第三医院药学部,江苏南通226006

出　　处：《中国药业》2022年第13期113-116,共4页China Pharmaceuticals

基　　金：江苏省南通市卫生健康委员会青年医学重点人才培养项目[WR2017017]。

摘　　要：目的评价硫培非格司亭注射液预防肿瘤患者化学治疗致中性粒细胞减少(CIN)的有效性、安全性及经济性。方法采用计算机检索PubMed、The Cochrane Library、CRD Web及中国知网、万方等数据库中硫培非格司亭注射液预防肿瘤患者CIN的相关文献,检索时间为自建库起至2021年5月31日。由2名评价员根据纳入标准和排除标准筛选文献,提取资料。采用描述性分析方式对提取的研究内容进行分析和总结,采用快速卫生技术评估药品的有效性、安全性和经济性。结果共检索文献35篇,最终纳入3篇RCT、2篇Meta分析和1篇药物经济学研究。与重组人粒细胞集落刺激因子(rhG-CSF)相比,硫培非格司亭注射液可显著降低≥3级中性粒细胞减少发生率(P=0.013)和化疗第2周期4级中性粒细胞减少发生率[RR=0.37,95%CI(0.21,0.65),P=0.0006)],且可显著缩短化疗第2周期中性粒细胞减少恢复时间、≥3级中性粒细胞减少持续时间和4级中性粒细胞减少持续时间(P<0.001)。硫培非格司亭注射液致骨痛、白细胞增多、血红蛋白下降发生率与rhG-CSF、培非格司亭相似(P>0.05)。与rhG-CSF(惠尔血)相比,硫培非格司亭注射液成本更低(平均治疗成本为35019.35元比39586.24元)、收益更高(质量调整生命年9.99年比9.75年)。结论硫培非格司亭注射液预防肿瘤患者CIN有效性和安全性均良好,在国内具有一定的经济优势。Objective To evaluate the effectiveness,safety and economy of Mecapegfilgrastim Injection for the prophylaxis of chemotherapy-induced neutropenia(CIN)in tumor patients.Methods Relevant studies of Mecapegfilgrastim Injection for the prophylaxis of CIN in the PubMed,The Cochrane Library,CRD Web,CNKI,WanFang and other databases from inception to May 31,2021 were searched.The studies were screened according to the inclusion and exclusion criteria and the data were extracted by two evaluators.The descriptive analysis was used to sort out and summarize the extracted research content.The rapid health technology assessment(HTA)was used to evaluate the effectiveness,safety and economy of drugs.Results Thirty-five studies were searched,and three RCTs,two Meta-analysis and one pharmacoeconomics study were included finally.Compared with recombinant human granulocyte colony-stimulating factor(rhG-CSF),Mecapegfilgrastim Injection could significantly decrease the incidence of grade≥3 neutropenia(P=0.013)and grade 4 neutropenia at the second cycle of chemotherapy[RR=0.37,95%CI(0.21,0.65),P=0.0006)],and it could also significantly shorten the recovery time of neutropenia at the second cycle of chemotherapy,the duration of grade≥3 neutropenia and the duration of grade 4 neutropenia(P<0.001).The incidences of ostalgia,leukocytosis and hemoglobin decrease of Mecapegfilgrastim Injection were similar to those of rhG-CSF and pegfilgrastim(P>0.05).The average treatment costs of Mecapegfilgrastim Injection and rhG-CSF(Gran)were 35019.35 CNY and 39586.24 CNY respectively,the quality-adjusted life years(QALYs)of Mecapegfilgrastim Injection and rhG-CSF(Gran)were 9.99 years and 9.75 years respectively,thus compared with rhG-CSF(Gran),Mecapegfilgrastim Injection had lower treatment cost and higher benefit.Conclusion Mecapegfilgrastim Injection is effective and safe for the prophylaxis of CIN in tumor patients,and it has a certain economic advantage in China.

关 键 词：硫培非格司亭注射液 化学治疗致中性粒细胞减少 有效性 安全性 经济性 快速卫生技术评估 

分 类 号：R969[医药卫生—药理学] R973[医药卫生—药学]