目的评估胸腺法新(thymalfasin,Tα1)作为乙型肝炎病毒(hepatitis B virus,HBV)相关肝细胞癌(hepatocellular carcinoma,HCC)术后辅助治疗的疗效及安全性,并对术后使用 Tα1 进行成本效用分析。方法回顾性收集 2007 年 2 月—2015 年 12 月于四川大学华西医院、成都军区总院和中山大学附属第三医院接受肝切除术的 HBV 相关 HCC 的患者,分成 Tα1 组和观察组,采用 Kaplan-Meier 法及对数秩检验,评估 Tα1 治疗起至死亡的总生存期、无复发生存期及安全性;建立马尔可夫模型,计算与观察组相比 Tα1 术后辅助治疗的质量调整生命年(quality-adjusted life years,QALY)及增量成本效用比(incremental cost-effectiveness ratio,ICER)。成本数据来源于上述 3 家医院医院信息系统和电话随访,健康效用值数据主要来源于既往已发表的文献,敏感性分析用于探究关键变量对于结果的影响。结果共纳入 208 例 HCC 患者,其中 48 例术后接受 Tα1 治疗(Tα1 组),160 例仅随访观察(观察组),两组基线资料差异无统计学意义。Tα1 组和观察组的中位总生存期分别为 102.0 个月[95% 置信区间(confidence interval,CI)(74.8,129.2)个月]和 81.6 个月[(95%CI(65.7,97.6)个月],差异有统计学意义(P=0.047);中位无复发生存期分别为 66.7 个月[95%CI(17.3,116.1)个月]和 37.4 个月[95%CI(28.7,46.2)个月],差异有统计学意义(P=0.044)。治疗期间,无Ⅲ-Ⅳ级不良反应及致死性不良反应。Tα1 组对比观察组的 ICER 为 108 050.02 元/QALY,该 ICER 值小于意愿支付(177 785.25 元/QALY)。结论Tα1 作为术后 HBV 相关 HCC 患者的辅助治疗可改善患者的预后,且费用在我国目前能够接受的水平范围内,故该方案与观察组相比具备成本效用优势。

ObjectiveTo evaluate the efficacy and cost-effectiveness of thymalfasin (Tα1) as an adjuvant therapy for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after surgery.MethodsPatients with HBV-related HCC who underwent hepatectomy from February 2007 to December 2015 in West China Hospital of Sichuan University, Chengdu Military General Hospital, or the Third Affiliated Hospital of Sun Yat-sen University were retrospectively collected and divided into the Tα1 group and the observation group. Log-rank test and Kaplan-Meier curve were used to assess the overall survival, recurrence-free survival, and safety of patients. A Markov model was used to calculate the quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) of the Tα1 group compared with the observation group. Cost data was from the hospital information system of the three hospitals. Utility scores mainly came from published data. Sensitivity analyses were applied to explore the impact of essential variables.ResultsA total of 208 patients with HCC after liver resection were enrolled, among them 48 received Tα1 treatment (the Tα1 group) and 160 were only followed up (the observation group). There was no significant difference between the two groups in the baseline characteristics. The median overall survival of the Tα1 group and the observation group was 102.0 months [95% confidence interval (CI) (74.8, 129.2) months] and 81.6 months [95%CI (65.7, 97.6) months], respectively, and the difference was statisitically significant (P=0.047); the median recurrence-free survival was 66.7 months [95%CI (17.3, 116.1) months] and 37.4 months [95%CI (28.7, 46.2) months], respectively, and the difference was statistically significant (P=0.044). There were no grade Ⅲ-Ⅳ adverse events and no treatment-related death occurred. The ICER of Tα1 group was ¥108 050.02/QALY, which was less than the willingness to pay (¥177 785.25/QALY).ConclusionsTα1, as an adjuvant therapy for HBV-related HCC patients, can improve the prognosis of the patients, and the cost is within the acceptable level in our country, so this strategy is likely to be a cost-effective option compared with the observation group.

关键词: 胸腺法新; 肝细胞癌; 辅助治疗; 无复发生存; 总生存; 成本效用; 敏感性分析

Key words: Thymalfasin; Hepatocellular carcinoma; Adjuvant therapy; Recurrence-free survival; Overall survival; Cost-effectiveness; Sensitive analyses

引用本文: 王新源, 文凤, 朱永强, 凌云彪, 李秋. 肝细胞癌术后胸腺法新治疗的临床观察及成本效用分析. 华西医学, 2018, 33(12): 1471-1478. doi: 10.7507/1002-0179.201811022 复制

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