Title盐酸多柔比星脂质体注射液用于多种肿瘤治疗的卫生技术评估
Other TitlesHealth technology assessment of pegylated liposomal doxorubicin for cancer chemotherapy
Authors张琪
张萌萌
翟所迪
Affiliation北京大学第三医院药剂科
北京大学医学部药物评价中心
Keywords多柔比星脂质体
多美素
肿瘤治疗
卫生技术评估
临床用药
pegylated liposomal doxorubicin
duomeisu
cancer chemotherapy
health technology assessment
medical treatment
Issue Date2019
Publisher中国新药杂志
Abstract目的:评估盐酸多柔比星脂质体注射液(pegylated liposomal doxorubicin,PLD)用于多种肿瘤治疗的有效性、安全性和经济性,为医保决策和临床用药提供证据支持。方法:按照纳入排除标准,系统检索已发表的卫生技术评估(HTA)报告、系统评价/Meta分析、随机对照试验(RCTs)、药物经济学分析,并评价研究质量。对RCTs进行荟萃分析,对其他研究结果进行定性分析。结果:共纳入7项系统评价/Meta分析、23项RCT研究和6项经济学研究。PLD在肿瘤治疗中应用广泛:对于艾滋病相关的卡波氏肉瘤(AIDS-KS)、乳腺癌、多发性骨髓瘤、软组织及骨肉瘤、急性淋巴细胞白血病及非鼻咽头颈部肿瘤患者,PLD对总生存期(OS)的延长与对照药物相比无统计学差异,但可显著延长晚期胃癌患者的无进展生存期(PFS)与OS。PLD耐受性良好,大多数毒性反应的发生与对照组无统计学差异。与蒽环类药物、紫杉醇等其他化疗药物相比,PLD可显著降低心脏毒性、血液学毒性、脱发、乏力等不良事件的发生率,但会增加手足综合征的发生率。国外经济学评价结果显示,在AIDS-KS患者中,PLD的经济性优于柔红霉素脂质体,劣于紫杉醇。结论:PLD治疗AIDS-KS具有良好的有效性、安全性,在乳腺癌、胃癌治疗中可能有效,在国内的经济性仍需进一步研究证实。
Objective: To support decision-making in insurance coverage and clinical practice by evaluating the efficacy,safety and economic efficiency of pegylated liposomal doxorubicin( PLD) for cancer therapy. Methods:Published HTA reports,systematic reviews/Meta-analyses,RCTs and pharmacoeconomic studies were retrieved according to defined inclusion criteria,of which quality was assessed. Included RCTs were pooled through metaanalysis,while other studies were analyzed qualitatively. Results: 7 systematic review/meta-analyses,23 RCTs and 6 economic evaluations were included. PLD was widely used and evaluated in a variety of malignant tumors.The OS was not significantly different between PLD group and the control group in breast cancer,AIDS-KS,multiple myeloma,soft tissue sarcoma,acute lymphoblastic leukemia and non-nasopharyngeal head and neck cancer.However,the improvement by PLD in PFS and OS was significant in gastric cancer. In these malignant tumors,the occurrence of most adverse events was similar,while PLD was associated with significantly less cardiac toxicity,hematological toxicity,alopecia and fatigue,and more hand-foot syndrome. Foreign economic evaluation results show that PLD is more economical than liposomal daunorubicin in the treatment of AIDS-KS,while less than paclitaxel.Conclusion: PLD has favorable profiles in the efficacy,safety in the treatment of AIDS-KS,and it might be effective in gastric cancer and breast cancer. Its economy in China still needs more studies in the future to confirm.
URIhttp://hdl.handle.net/20.500.11897/562457
ISSN1003-3734
Indexed中文核心期刊要目总览(PKU)
Appears in Collections:第三医院

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