替诺福韦治疗成人慢性乙型肝炎的临床综合评价  

Clinical Comprehensive Evaluation of Tenofovir in the Treatment of Adult Chronic Hepatitis B

作　　者：叶溪[1] 刘晓霞[1] 周鹏翔[2,3] 陈晓宇 冯钟文[1] 张莉 YE Xi;LIU Xiaoxia;ZHOU Pengxiang;CHEN Xiaoyu;FENG Zhongwen;ZHANG Li(Guangxi Academy of Medical Sciences,The People′s Hospital of Guangxi Zhuang Autonomous Region,Nanning Guangxi 530021,China;Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China)

机构地区：[1]广西医学科学院,广西壮族自治区人民医院,广西南宁530021 [2]北京大学第三医院,北京100191 [3]北京大学医学部药物评价中心,北京100191

出　　处：《药品评价》2024年第11期1325-1332,共8页Drug Evaluation

基　　金：广西壮族自治区卫生健康委员会药品临床综合评价中心项目(YPPJ001)。

摘　　要：目的 对替诺福韦衍生药物治疗慢性乙型肝炎的临床价值进行综合评价。方法 采用快速评估的方法,基于当前可得证据,围绕替诺福韦治疗慢性乙型肝炎的安全性、有效性、经济性、创新性、适宜性和可及性六个维度,开展临床综合评价。结果 有效性方面,替诺福韦非劣于恩替卡韦,优于拉米夫定、阿德福韦酯和替比夫定;安全性方面,替诺福韦的药物不良反应发生率与恩替卡韦相当,目前尚未发现替诺福韦的耐药情况,并且丙酚替诺福韦和艾米替诺福韦在抑制病毒复制的同时具有骨、肾保护作用;经济性方面,文献结果显示在中国,基于Markov模型下恩替卡韦更具有经济学优势,在母婴传播阻断场景下替诺福韦具有经济学优势;创新性方面,艾米替诺福韦是我国自主研发的抗乙肝药物;适宜性方面,替诺福韦使用方便且便于存储;可及性方面,替诺福韦的价格水平较低、覆盖较广、产能充足、无供应短缺风险,覆盖医疗机构数量及区县不及恩替卡韦;一线治疗药物在纳入集采后,可负担性均较好。结论 替诺福韦的安全性、有效性明确,同时在药物技术特性和药品使用方面具有良好的适宜性;患者可负担性和药品可获得性均较好。Objective To evaluate the clinical value of tenofovir in the treatment of chronic hepatitis B.Methods A rapid evaluation method was used to conduct a comprehensive clinical evaluation based on the currently available evidence,focusing on the six dimensions of safety,effectiveness,economy,innovation,suitability and accessibility of tenofovir in the treatment of chronic hepatitis B.Results In terms of effectiveness,tenofovir was inferior to entecavir and superior to lamivudine,adefovir dipivoxil and tibivudine.In terms of safety,the incidence of adverse drug reactions of tenofovir was similar to that of entecavir.No resistance to tenofovir has been found,and tenofovir alafenamide and tenofovir amibufenamide have bone and kidney protection effects while inhibiting virus replication.In terms of economy,the literature results show that in China,entecavir has more economic advantages based on Markov model,and tenofovir has economic advantages when mother to child transmission is blocked.In terms of innovation,tenofovir amibufenamide is an anti-hepatitis B drug independently developed in China.In terms of suitability,tenofovir is easy to use and easy to store.In terms of accessibility,tenofovir has a lower price level,wider coverage,sufficient production capacity and no risk of supply shortage,and the number of medical institutions and districts covered by tenofovir were less than entecavir.The affordability of first-line treatment drugs was good after they were included in collective collection.Conclusion The safety and efficacy of tenofovir are well-established,and it possesses favorable attributes in terms of its pharmaceutical properties and usage.It's also highly affordable and accessible for patients.

关 键 词：替诺福韦 慢性乙型肝炎 临床综合评价 

分 类 号：R51[医药卫生—内科学]