预防性治疗急性静脉曲张出血性脑病：乳果糖与无乳果糖的随机对照试验。
Prophylaxis of hepatic encephalopathy in acute variceal bleed: a randomized controlled trial of lactulose versus no lactulose.
机构信息
Department of Gastroenterology, G. B. Pant Hospital, New Delhi, India.
出版信息
J Gastroenterol Hepatol. 2011 Jun;26(6):996-1003. doi: 10.1111/j.1440-1746.2010.06596.x.
BACKGROUND AND AIMS
Acute variceal bleed (AVB) is an important precipitating factor for development of hepatic encephalopathy (HE). However, there is paucity of data on the role of lactulose for prevention of HE after AVB. We evaluated the role of lactulose for prophylaxis of HE after AVB.
METHODS
Consecutive patients of cirrhosis with AVB enrolled. Patients included if >18 years old and had no HE at the time of presentation. Patients were randomized to receive lactulose (Group-L) or no lactulose (Group-P) along with standard treatment of AVB as per Baveno 4 guidelines. Primary endpoint was development of overt HE as per West Haven criteria within 120 h of randomization.
RESULTS
Seventy patients were randomized into group-L (Gp-L, n = 35) and group-P (Gp-P, n = 35). There was no significant difference in baseline characteristics between the two groups. Characteristics of variceal bleed were also similar (Gp-L vs Gp-P [mean arterial pressure 81.0 ± 10.5 vs 79.5 ± 9.9 mmHg], Hb [8.4 ± 1.5 vs 9.3 ± 2.3 g/dL], blood transfusion requirement [1.6 ± 1.1 vs 1.3 ± 0.9 units], time to endoscopy [6.3 ± 2.8 vs 7.0 ± 3.1 h], and esophageal source of bleed [92% vs 88%]). Nineteen (27%) patients developed HE; five patients (14%) in Gp-L and 14 patients (40%) in Gp-P, P = 0.03. The median grade of HE was 2 (range 2-4) and median time interval of development of HE after randomization was 2 days (range 1-4). Nine patients (13%) died; three (8.5%) patients in Gp-L and six (17%) patients in Gp-P, P = 0.23. Patients who developed HE had significantly higher baseline Child-Turcotte-Pugh score score (10.2 ± 1.2 vs 9.4 ± 1.4 P = 0.04), model for end stage liver disease score (18.2 ± 3.9 vs 15.4 ± 4.5 P = 0.02), arterial ammonia level (112.2 ± 22.7 vs 94.8 ± 17.6 umol/L, P = 0.001), baseline total leukocyte count (10,505.2 ± 8911.9 vs 5784.3 ± 3387.0 P = 0.002), total bilirubin (3.4 ± 1.3 vs 2.1 ± 1.8 mg%, P = 0.008) as compared to patients who did not develop HE. On multivariate analysis only baseline arterial ammonia, blood requirement during hospital stay and lactulose therapy were predictors of development of HE.
CONCLUSIONS
Lactulose is effective in prevention of HE in patients with cirrhosis and acute variceal bleed.
背景与目的
急性静脉曲张出血（AVB）是肝性脑病（HE）发展的重要诱发因素。然而，关于乳果糖在预防 AVB 后 HE 方面的作用的数据很少。我们评估了乳果糖在预防 AVB 后 HE 中的作用。
方法
连续纳入肝硬化伴 AVB 的患者。纳入标准为>18 岁，且在出现时无 HE。患者随机分为接受乳果糖（组-L）或不接受乳果糖（组-P）组，并根据 Baveno 4 指南接受 AVB 的标准治疗。主要终点是在随机分组后 120 小时内根据 West Haven 标准发生显性 HE。
结果
70 例患者被随机分为组-L（Gp-L，n=35）和组-P（Gp-P，n=35）。两组间基线特征无显著差异。静脉曲张出血的特征也相似（Gp-L 与 Gp-P[平均动脉压 81.0±10.5 与 79.5±9.9mmHg]，Hb[8.4±1.5 与 9.3±2.3g/dL]，输血需求[1.6±1.1 与 1.3±0.9 单位]，内镜检查时间[6.3±2.8 与 7.0±3.1 小时]，出血来源为食管[92%与 88%]）。19 例（27%）患者发生 HE；组-L 中有 5 例（14%），组-P 中有 14 例（40%），P=0.03。HE 的中位严重程度为 2 级（范围 2-4），随机分组后发生 HE 的中位时间间隔为 2 天（范围 1-4）。9 例（13%）患者死亡；组-L 中有 3 例（8.5%），组-P 中有 6 例（17%），P=0.23。发生 HE 的患者基线 Child-Turcotte-Pugh 评分（10.2±1.2 与 9.4±1.4，P=0.04）、终末期肝病模型评分（18.2±3.9 与 15.4±4.5，P=0.02）、动脉血氨水平（112.2±22.7 与 94.8±17.6μmol/L，P=0.001）、基线总白细胞计数（10505.2±8911.9 与 5784.3±3387.0，P=0.002）和总胆红素（3.4±1.3 与 2.1±1.8mg%，P=0.008）均显著高于未发生 HE 的患者。多变量分析显示，只有基线动脉血氨、住院期间的血需求和乳果糖治疗是发生 HE 的预测因素。
结论
乳果糖可有效预防肝硬化伴急性静脉曲张出血患者的 HE。
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