| 摘要: |
| ［摘要］ 目的 通过快速卫生技术评估（HTA）方法比较替诺福韦（TDF）与其他口服核苷（酸）类似物（NAs）在阻断乙型肝炎病毒(HBV)母婴传播的有效性、安全性和经济性，为临床合理用药提供参考。方法 系统检索PubMed、Embase和the Cochrane Library等英文数据库，以及中国知网（CNKI）、万方医学网和维普网等中文数据库，同时检索国内外HTA机构官方网站及相关数据库。对TDF阻断HBV母婴传播的临床有效性和安全性的综合性HTA报告、系统评价（SR）/Meta分析以及药物经济学（PE）研究进行汇总分析。结果 共纳入15篇文献，其中SR/Meta分析11篇、PE研究4篇。有效性评价结果显示，TDF在抑制母亲HBV病毒复制、阻断HBV母婴传播等有效性指标优于拉米夫定（LAM）和替比夫定（LDT）。安全性评价结果显示，TDF的不良反应发生率与LAM和LDT比较差异无统计学意义（P>0.05）。经济性评价显示，TDF在中国和南非具有经济学优势。结论 TDF阻断HBV母婴传播有效性优于LAM和LDT，安全性与其他NAs相当，在我国具有经济学优势。 |
| 关键词: 替诺福韦 乙型肝炎病毒 母婴传播 核苷（酸）类似物 卫生技术评估 孕妇 |
| DOI：10.3969/j.issn.1674-3806.2025.08.14 |
| 分类号:R 978.7 |
| 基金项目:广西卫生健康委药品临床综合评价课题（编号：YPPJ001） |
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| Rapid health technology assessment of the effectiveness, safety and economy of tenofovir disoproxil fumarate in blocking mother-to-child transmission of HBV |
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TAN Sitao, LIU Xiaoxia, HUANG Hai, ZHANG Li, HE Ying, CHEN Xiaoyu
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Department of Clinical Pharmacy, the People′s Hospital of Guangxi Zhuang Autonomous Region(Guangxi Academy of Medical Sciences), Nanning 530021, China
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| Abstract: |
| ［Abstract］ Objective To compare the effectiveness, safety and economy of tenofovir disoproxil fumarate(TDF) and other oral nucleos(t)ide analogues(NAs) in blocking mother-to-child transmission of hepatitis B virus(HBV) by using rapid health technology assessment(HTA) method, and to provide reference for rational administration of medication in clinic. Methods The English databases including PubMed, Embase and the Cochrane Library, and the Chinese databases including China National Knowledge Infrastructure(CNKI), Wanfang Med Online and VIP were systematically searched. At the same time, the official websites and related databases of HTA agencies at home and abroad were searched. The comprehensive HTA reports, systematic review(SR)/Meta-analysis and pharmaceutical economics(PE) studies on the clinical effectiveness and safety of TDF blocking mother-to-child transmission of HBV were summarized and analyzed. Results A total of 15 papers were included, including 11 papers on SR/Meta analysis and 4 papers on PE studies. The results of effectiveness evaluation showed that TDF was superior to lamivudine(LAM) and telbivudine(LDT) in the effectiveness indicators of inhibiting maternal HBV replication and preventing mother-to-child transmission of HBV. The results of safety evaluation showed that there was no significant difference in the incidence of adverse reactions between TDF and LAM as well as between TDF and LDT(P>0.05). The economic evaluation revealed that TDF had economic advantages in China and South Africa. Conclusion The effectiveness of TDF in blocking mother-to-child transmission of HBV is superior to that of LAM and LDT, and the safety of TDF is comparable to that of the other NAs. TDF has economic advantages in China. |
| Key words: Tenofovir disoproxil fumarate(TDF) Hepatitis B virus(HBV) Mother-to-child transmission Nucleos(t)ide analogues(NAs) Health technology assessment(HTA) Pregnant woman |
