4种治疗慢性乙型肝炎核苷(酸)类似物的临床综合评价OA

OBJECTIVE To conduct a comprehensive clinical evaluation of four nucleoside(acid)analogues that have been approved and marketed in China,such as entecavir,tenofovir disoproxil fumarate,tenofovir alafenamide fumarate,and tenofovir amibufenamide.METHODS According to the Guideline for the Administration of Clinical Comprehensive Evaluation of Drugs(2021 edition,trial implementation),a comprehensive search was conducted across databases including CNKI,Wanfang Data,VIP,PubMed,the Cochrane Library,Embase,as well as relevant official websites.Drug package inserts,guidelines,consensus statements,and relevant literature for the four drugs were collected and subjected to a comprehensive evaluation across six dimensions:safety,efficacy,cost-effectiveness,innovativeness,suitability,and accessibility.RESULTS The scores for entecavir in terms of safety,efficacy,cost-effectiveness,innovativeness,suitability,and accessibility-along with its comprehensive score-were 13,14,13,10,18,and 6,totaling 74 points.For tenofovir disoproxil fumarate,the respective scores were 13,17,18,8,18,and 7,totaling 81 points.For tenofovir alafenamide fumarate,the scores were 14,20,12,8,18,and 5,totaling 77 points.Finally,for tenofovir amibufenamide,the scores were 10.5,17,10,6,15,and 4,totaling 62.5 points.CONCLUSIONS Tenofovir disoproxil fumarate,with the highest score,is recommended as the first-line option,suitable for adults,children,and pregnant women.However,caution is warranted for potential renal impairment.Tenofovir alafenamide fumarate is recommended as a second-line alternative,particularly for individuals at high risk for bone and renal damage.Entecavir has a score similar to tenofovir alafenamide fumarate but requires dosing on an empty stomach and dose adjustment based on renal function of patients.Tenofovir amibufenamide received the lowest score and is considered a weak recommendation.The clinical application of these nucleoside(acid)analogues should be individualized based on the patient's age,physiological status,and risk factors.