Division of Epidemiology and Public Health, Nottingham University, Clinical Sciences Building, City Hospital Campus, Hucknall Road, Nottingham, NG5 1PB, UK.
Dig Dis Sci. 2013 Sep;58(9):2691-704. doi: 10.1007/s10620-013-2705-y. Epub 2013 May 30.
Chronic hepatitis C (HCV) is a significant risk factor for cirrhosis and subsequently hepatocellular carcinoma (HCC). HCV patients with cirrhosis are screened for HCC every 6 months. Surveillance for progression to cirrhosis and consequently access to HCC screening is not standardized. Liver biopsy, the usual test to determine cirrhosis, carries a significant risk of morbidity and associated mortality. Transient ultrasound elastography (fibroscan) is a non-invasive test for cirrhosis.
This study assesses the cost effectiveness of annual surveillance for cirrhosis in patients with chronic HCV and the effect of replacing biopsy with fibroscan to diagnose cirrhosis.
A Markov decision analytic model simulated a hypothetical cohort of 10,000 patients with chronic HCV initially without fibrosis over their lifetime. The cirrhosis surveillance strategies assessed were: no surveillance; current practice; fibroscan in current practice with biopsy to confirm cirrhosis; fibroscan completely replacing biopsy in current practice (definitive); annual biopsy; annual fibroscan with biopsy to confirm cirrhosis; annual definitive fibroscan.
Our results demonstrate that annual definitive fibroscan is the optimal strategy to diagnose cirrhosis. In our study, it diagnosed 20 % more cirrhosis cases than the current strategy, with 549 extra patients per 10,000 accessing screening over a lifetime and, consequently, 76 additional HCC cases diagnosed. The lifetime cost is £98.78 extra per patient compared to the current strategy for 1.72 additional unadjusted life years. Annual fibroscan surveillance of 132 patients results in the diagnosis one additional HCC case over a lifetime. The incremental cost-effectiveness ratio for an annual definitive fibroscan is £6,557.06/quality-adjusted life years gained.
Annual definitive fibroscan may be a cost-effective surveillance strategy to identify cirrhosis in patients with chronic HCV, thereby allowing access of these patients to HCC screening.
慢性丙型肝炎（HCV）是肝硬化和随后发生肝细胞癌（HCC）的重要危险因素。患有肝硬化的 HCV 患者每 6 个月接受一次 HCC 筛查。监测进展为肝硬化并随后获得 HCC 筛查的方法尚未标准化。肝活检是确定肝硬化的常用检查，但具有较高的发病率和相关死亡率。瞬时超声弹性成像（fibroscan）是一种用于肝硬化的非侵入性检查。
本研究评估了对慢性 HCV 患者进行年度肝硬化监测的成本效益，以及用 fibroscan 替代活检来诊断肝硬化的效果。
采用 Markov 决策分析模型模拟了一组 10000 名初始无纤维化的慢性 HCV 患者的终生情况。评估的肝硬化监测策略包括：不进行监测；当前实践；当前实践中使用 fibroscan 并进行活检以确认肝硬化；当前实践中完全用 fibroscan 替代活检（确定性）；每年进行活检；每年进行 fibroscan 并进行活检以确认肝硬化；每年进行确定性 fibroscan。
我们的结果表明，每年进行确定性 fibroscan 是诊断肝硬化的最佳策略。在我们的研究中，与当前策略相比，它诊断出的肝硬化病例增加了 20%，在 10000 名患者的一生中，有 549 名额外患者接受了筛查，因此诊断出了 76 例额外的 HCC 病例。与当前策略相比，每位患者的终生成本增加了 98.78 英镑，获得了 1.72 个未经调整的额外生命年。每年对 132 名患者进行 fibroscan 监测，可在一生中诊断出一个额外的 HCC 病例。年度确定性 fibroscan 的增量成本效益比为每获得 1 个质量调整生命年增加 6557.06 英镑。
年度确定性 fibroscan 可能是一种具有成本效益的监测策略，可用于识别慢性 HCV 患者的肝硬化，从而使这些患者能够接受 HCC 筛查。
