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去甲肾上腺素在肝肾综合征 - 急性肾损伤患者中比米多君/奥曲肽更有效:一项随机对照试验

Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial.

作者信息

El-Desoki Mahmoud Eman Ibrahim, Abdelaziz Doaa H, Abd-Elsalam Sherief, Mansour Noha O

机构信息

Intensive Care Medicine, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.

Department of Clinical Pharmacy, The National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.

出版信息

Front Pharmacol. 2021 Jul 2;12:675948. doi: 10.3389/fphar.2021.675948. eCollection 2021.

Abstract

Terlipressin is the first-line pharmacological treatment for hepatorenal syndrome. When terlipressin is unavailable, midodrine/octreotide or norepinephrine, with albumin, represent the alternative treatments. The comparative efficacy of these alternative regimens remains unclear. To compare the efficacy of midodrine/octreotide to that of norepinephrine for the treatment of patients with hepatorenal syndrome. In the intensive care setting, sixty patients with hepatorenal syndrome were randomized to initially receive either 0.5 mg/h of norepinephrine (maximum 3 mg/h) or 5 mg of oral midodrine three times/day (maximum 12.5 mg three times/day) plus octreotide (100 μg/6 h) as subcutaneous injection (maximum 200 μg/6 h), together with albumin (20-40 g/day). Treatment was allowed for a maximum of 10 days. Survival was analyzed for up to 30 days. The primary efficacy outcome was the proportion of patients who achieved full response, defined as the return of serum creatinine to a value within 0.3 mg/dl of the baseline at the end of treatment. There was a significantly higher rate of full response in the norepinephrine group (15/26, 57.60%) than the midodrine/octreotide group (5/25, 20%) ( = 0.006). Eleven (42.30%) patients in the norepinephrine group and 6 (24%) in the midodrine/octreotide group survived ( = 0.166). Norepinephrine plus albumin is significantly more effective than midodrine and octreotide plus albumin in improving renal function in patients with hepatorenal syndrome. (ClinicalTrials.gov, identifier: NCT03455322). https://clinicaltrials.gov/ct2/show/NCT03455322?cond = Hepatorenal+Syndrome&cntry = EG&draw = 2&rank = 1.

摘要

特利加压素是肝肾综合征的一线药物治疗。当无法获得特利加压素时,米多君/奥曲肽或去甲肾上腺素联合白蛋白可作为替代治疗。这些替代方案的相对疗效仍不明确。为比较米多君/奥曲肽与去甲肾上腺素治疗肝肾综合征患者的疗效。在重症监护环境中,60例肝肾综合征患者被随机分组,初始分别接受0.5mg/h的去甲肾上腺素(最大剂量3mg/h)或每日3次口服5mg米多君(最大剂量每日3次12.5mg)加奥曲肽(100μg/6小时)皮下注射(最大剂量200μg/6小时),同时给予白蛋白(20 - 40g/天)。治疗最长持续10天。分析30天内的生存率。主要疗效指标是达到完全缓解的患者比例,完全缓解定义为治疗结束时血清肌酐恢复到基线值±0.3mg/dl范围内。去甲肾上腺素组的完全缓解率(15/26,57.60%)显著高于米多君/奥曲肽组(5/25,20%)(P = 0.006)。去甲肾上腺素组有11例(42.30%)患者存活,米多君/奥曲肽组有6例(24%)患者存活(P = 0.166)。去甲肾上腺素联合白蛋白在改善肝肾综合征患者肾功能方面显著优于米多君和奥曲肽联合白蛋白。(ClinicalTrials.gov标识符:NCT03455322)。https://clinicaltrials.gov/ct2/show/NCT03455322?cond = Hepatorenal+Syndrome&cntry = EG&draw = 2&rank = 1

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e0e/8283260/d9f46972107c/fphar-12-675948-g001.jpg

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