摘要
目的:利用快速卫生技术评估(HTA)工具对白蛋白结合型紫杉醇(nab-PTX)治疗乳腺癌的有效性、安全性及经济性进行评估,为药物选择提供循证依据。方法:检索PubMed、Cochrane Library、中国知网、万方数据库及卫生技术评估网站,纳入nab-PTX治疗乳腺癌的系统评价/Meta分析、HTA和药物经济学研究,采用描述性分析对研究结论进行分类分析。结果:共纳入5篇系统评价/Meta分析、8篇药物经济学研究。与传统紫杉类药物相比,nab-PTX可提高新辅助化疗(NAC)的乳腺癌患者的病理完全缓解率(pCR)[OR=1.39,95%CI(1.16,1.67),P<0.001]和无事件生存期(EFS)[HR=0.69,95%CI(0.57,0.85),P<0.001];但两者在转移性乳腺癌(MBC)患者的总生存期(OS)、无进展生存期(PFS)、客观缓解率(ORR)和疾病控制率(DCR)上差异则无统计学意义。安全性方面,nab-PTX提高了MBC患者3~4级感觉神经毒性的发生率[OR=1.89,95%CI(1.36,2.61),P<0.001],增加了NAC的乳腺癌患者中性粒细胞减少发生率[OR=1.52,95%CI(1.23,1.88),P<0.001]、感觉神经毒性发生率[OR=2.17,95%CI(1.38,3.40),P<0.001]、皮疹发生率[OR=1.46,95%CI(1.18,1.80),P<0.001]以及疲劳发生率[OR=1.28,95%CI(1.04,1.56),P=0.02]。药物经济学研究显示,nab-PTX相对于传统紫杉类药物可提高MBC患者的质量调整生命年,更具有经济性。结论:nab-PTX可提高NAC的乳腺癌患者的pCR,但在MBC的有效性上并无显著优势,且不良反应更为多见;采用nab-PTX治疗MBC比传统紫杉类药物可能更具成本-效用优势。
OBJECTIVE:To evaluate the effectiveness,safety and economy of albumin-bound paclitaxel(nab-PTX)in the treatment of breast cancer by using rapid health technology assessment(HTA),and to provide evidence-based reference for drug selection.METHODS:Retrieved from PubMed,the Cochrane Library,CNKI,Wangfang database and other databases,systematic evaluation/Meta-analysis,HTA and pharmacoeconomic studies about nab-PTX in the treatment of breast cancer were included;the conclusions were classified and analyzed by using descriptive analysis.RESULTS:A total of 5 systematic reviews/Meta-analysis,8 pharmacoeconomic studies were included in this study.Compared with conventional taxanes,nab-PTX increased pathological complete response(pCR)rate[OR=1.39,95%CI(1.16,1.67),P<0.001]and event-free survival(EFS)[HR=0.69,95%CI(0.57,0.85),P<0.001]in neoadjuvant chemotherapy(NAC)-treated breast cancer patients.However,there were no significant differences in overall survival(OS),progression-free survival(PFS),objective response rate(ORR)and disease control rate(DCR)in metastatic breast cancer(MBC)patients between 2 groups.In the terms of safety,nab-PTX increased the incidence of grade 3-4 sensory neuropathy[OR=1.89,95%CI(1.36,2.61),P<0.001]in MBC patients,and increased the incidence of neutropenia[OR=1.52,95%CI(1.23,1.88,P<0.001],sensory neuropathy[OR=2.17,95%CI(1.38,3.40),P<0.001],rash[OR=1.46,95%CI(1.18,1.80),P<0.001]and fatigue[OR=1.28,95%CI(1.04,1.56),P=0.02]in NAC-treated breast cancer patients.Pharmacoeconomic studies showed that nab-PTX could improve the quality adjusted life years of MBC patients compared with traditional taxanes,and it was a economical option.CONCLUSIONS:Nab-PTX enhances p CR in NAC-treated breast cancer patients,but has no significant advantage in the effectiveness of MBC patients,and increases the occurrence of ADR.Nab-PTX may have a cost-utility advantage over conventional taxanes for MBC.
作者
江洁美
王亚露
杨春兰
冯丽娟
陈若男
曹曦
门鹏
杨毅恒
翟所迪
夏泉
JIANG Jiemei;WANG Yalu;YANG Chunlan;FENG Lijuan;CHEN Ruonan;CAO Xi;MEN Peng;YANG Yiheng;ZHAI Suodi;XIA Quan(Dept.of Pharmacy,the First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Grade 3 Pharmaceutical Chemistry Laboratory of State Administration of Traditional Chinese Medicine,Hefei 230022,China;School of Pharmacy,Anhui Medical University,Hefei 230032,China;Dept.of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Center for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China)
出处
《中国药房》
CAS
北大核心
2021年第13期1611-1616,共6页
China Pharmacy
基金
安徽省自然科学基金资助项目(No.2008085QH398)。
