Department of Gastroenterology, SMS Medical College & Hospital, Jaipur, Rajasthan, 302004, India.
, House No. 109, Shiv Vihar, VKI, Infront of road number 5, Sikar Road, Jaipur, 302039, India.
Sci Rep. 2024 May 24;14(1):11862. doi: 10.1038/s41598-024-62293-8.
Hepatic encephalopathy (HE), a morbid ordeal affecting chronic liver disease patients always insists for the search of a rational, superior & infallible agent beyond the time-proven standards i.e., Lactulose & Rifaximin. In this RCT, we compared the efficacy of intravenous (IV) L-ornithine-L-aspartate(LOLA) versus Oral LOLA in patients with chronic liver disease(CLD) enduring overt Hepatic Encephalopathy(OHE). 40 CLD patients with OHE were randomly assigned IV or oral LOLA in a 1:1 ratio. Patients were graded for HE and monitored for serum ammonia levels from day 1 to day 5. The aim was to compare IV versus oral LOLA efficacy in HE grades improvement and its correlation with ammonia levels. The study was registered with clinical trials registry-India, CTRI/2020/12/029943. Baseline characteristics of patients in both groups were similar. The mean difference in ammonia levels from day 1 to day 5 was 55.4 ± 32.58 µmol/L in the IV LOLA group and 60.75 ± 13.82 µmol/L in the oral LOLA group (p = 0.511). Significant reductions in ammonia levels were observed from day 1 to day 5 within each group (p < 0.001). HE grade & ammonia correlated positively in both groups. LOLA, regardless of administration route, has demonstrated efficacy in OHE.
肝性脑病（HE）是一种影响慢性肝病患者的病态病症，一直以来都在寻找一种合理、优越且可靠的药物，超越已被证实的乳果糖和利福昔明标准。在这项 RCT 中，我们比较了静脉（IV）L-鸟氨酸-L-天冬氨酸（LOLA）与口服 LOLA 治疗慢性肝病（CLD）伴显性肝性脑病（OHE）患者的疗效。40 例 OHE 的 CLD 患者按 1:1 的比例随机分为 IV 或口服 LOLA 组。患者根据 HE 分级，并在第 1 天至第 5 天监测血清氨水平。目的是比较 IV 与口服 LOLA 在改善 HE 分级方面的疗效及其与氨水平的相关性。该研究已在印度临床试验注册处注册，注册号为 CTRI/2020/12/029943。两组患者的基线特征相似。IV LOLA 组从第 1 天到第 5 天的平均氨水平差异为 55.4±32.58µmol/L，口服 LOLA 组为 60.75±13.82µmol/L（p=0.511）。两组内从第 1 天到第 5 天的氨水平均显著降低（p<0.001）。HE 分级与氨水平在两组内均呈正相关。无论给药途径如何，LOLA 对 OHE 均有效。
