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目的从患者角度比较替比夫定(Ld T)优化疗法与恩替卡韦(ETV)常规疗法治疗HBe Ag阳性慢性乙型肝炎患者的用药费用差异,为临床探讨有效且经济的治疗方案提供循证支持。方法建立一个5年的预算影响模型(Budget Impact Model,BIM)用于比较Ld T优化治疗方案与ETV单药常规治疗方案的用药费用。以来自中国多中心临床试验的治疗应答率、HBe Ag转换率和耐药率作为疗效指标,按相关治疗方案涉及的原研药品各地平均中标价测算用药费用,并对药品价格进行敏感性分析,以测试模型结果的稳定性。结果根据临床研究数据和中标均价,两种治疗方案5年的治疗费用预算分别为71 269.27元和73 562.29元。结论 Ld T优化治疗与ETV常规治疗相比,疗效相似且费用略低,为我国慢性乙型肝炎患者治疗提供了更多的选择。
OBJECTIVE: To compare the cost-effectiveness of treatment with HBeAg-positive chronic hepatitis B patients with conventional therapy of telbivudine (LdT) and entecavir (ETV) and to provide evidence-based support for effective and economical treatment of clinical trials. Methods A 5-year Budget Impact Model (BIM) was set up to compare the cost-effectiveness of Ld T-optimized regimens with conventional ETV monotherapy. The treatment response rate, HBeAg conversion rate and drug resistance rate from multicentre clinical trials in China were taken as efficacy indexes. The drug cost was calculated according to the average bidding price of the original research drug involved in the relevant treatment plan, and the sensitivity analysis was conducted on the drug price Test the stability of the model results. Results According to the clinical research data and the average bid price, the five-year treatment costs of the two treatment plans were estimated at 71,269.27 yuan and 73 562.29 yuan respectively. Conclusion Compared with ETV routine therapy, Ld T optimized therapy has similar curative effect and lower cost, which provides more choices for the treatment of chronic hepatitis B patients in our country.