Department of Internal Medicine, Hiroshima City Hospital, Hiroshima, Japan; Department of Gastroenterology, Kurashiki Central Hospital, Okayama, Japan.
Department of Gastroenterology, Kurashiki Central Hospital, Okayama, Japan.
Clin Gastroenterol Hepatol. 2017 Nov;15(11):1782-1790.e4. doi: 10.1016/j.cgh.2016.10.041. Epub 2016 Dec 23.
BACKGROUND & AIMS: Hepatic venous pressure gradient can predict mortality and hepatic decompensation in patients with cirrhosis. Measurement of hepatic venous pressure gradient requires an invasive procedure; therefore, prognostic markers are needed that do not require invasive procedures. We investigated whether measurements of spleen stiffness, made by acoustic radiation force impulse (ARFI) imaging, associated with mortality and decompensation in patients with cirrhosis, compared with liver stiffness and other markers. METHODS: We measured spleen stiffness in 393 patients diagnosed with cirrhosis (based on histologic or physical, laboratory, and radiologic findings) at a hospital in Japan from September 2010 through August 2013 (280 patients with compensated and 113 patients with decompensated cirrhosis). Patients underwent biochemical, ARFI, ultrasonography, and endoscopy evaluations every 3 or 6 months to screen for liver-related complications until their death, liver transplantation, or the end of the study period (October 2015). The primary outcome was the accuracy of spleen stiffness in predicting mortality and decompensation, measured by Cox proportional hazards model analysis. We compared spleen stiffness with other noninvasive parameters using the Harrell's C-index analysis. RESULTS: During a median follow-up period of 44.6 months, 67 patients died and 35 patients developed hepatic decompensation. In the multivariate analysis, spleen stiffness was an independent parameter associated with mortality, after adjustment for levels of alanine aminotransferase and serum sodium, and the model for end-stage liver disease score (P < .001). Spleen stiffness was associated independently with decompensation after adjustment for Child-Pugh score and model for end-stage liver disease score (P < .001). Spleen stiffness predicted mortality and decompensation with greater accuracy than other parameters (C-indexes for predicting mortality and decompensation were 0.824 and 0.843, respectively). A spleen stiffness cut-off value of 3.43 m/s identified the death of patients with a 95.3% negative predictive value and 75.8% accuracy. A spleen stiffness cut-off value of 3.25 m/s identified patients with decompensation with a 98.8% negative predictive value and 68.9% accuracy. CONCLUSIONS: Spleen stiffness, measured by ARFI imaging, can predict death of patients with cirrhosis with almost 76% accuracy and hepatic decompensation with almost 70% accuracy. It might be a useful noninvasive test to predict patient outcome. UMIN Clinical Trials Registry no. UMIN000004363.
背景与目的：肝静脉压力梯度可预测肝硬化患者的死亡率和肝功能失代偿。肝静脉压力梯度的测量需要一种有创的程序；因此，需要不需要有创程序的预后标志物。我们研究了通过声辐射力脉冲（ARFI）成像测量的脾脏硬度是否与死亡率和肝硬化患者的肝功能失代偿有关，与肝硬度和其他标志物相比。
方法：我们在日本的一家医院测量了 393 名诊断为肝硬化的患者（基于组织学或物理、实验室和影像学发现）的脾脏硬度，这些患者在 2010 年 9 月至 2013 年 8 月期间就诊（280 例代偿性肝硬化患者和 113 例失代偿性肝硬化患者）。患者每 3 或 6 个月接受一次生化、ARFI、超声和内镜评估，以筛查肝脏相关并发症，直到他们死亡、进行肝移植或研究结束（2015 年 10 月）。主要结局是通过 Cox 比例风险模型分析评估的脾脏硬度预测死亡率和肝功能失代偿的准确性。我们使用 Harrell 的 C 指数分析比较了脾脏硬度与其他非侵入性参数。
结果：在中位随访 44.6 个月期间，67 名患者死亡，35 名患者发生肝功能失代偿。多变量分析显示，调整丙氨酸氨基转移酶和血清钠水平以及终末期肝病模型评分后，脾脏硬度是与死亡率相关的独立参数（P <.001）。调整 Child-Pugh 评分和终末期肝病模型评分后，脾脏硬度与肝功能失代偿独立相关（P <.001）。脾脏硬度预测死亡率和肝功能失代偿的准确性优于其他参数（预测死亡率和肝功能失代偿的 C 指数分别为 0.824 和 0.843）。脾脏硬度截断值为 3.43 m/s 时，患者死亡的阴性预测值为 95.3%，准确率为 75.8%。脾脏硬度截断值为 3.25 m/s 时，患者发生肝功能失代偿的阴性预测值为 98.8%，准确率为 68.9%。
结论：通过 ARFI 成像测量的脾脏硬度可以预测肝硬化患者的死亡率，准确率约为 76%，预测肝功能失代偿的准确率约为 70%。它可能是一种有用的非侵入性检测方法，可用于预测患者预后。UMIN 临床研究注册号 UMIN000004363。
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