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标准剂量白蛋白输注 6 小时以上治疗自发性细菌性腹膜炎的耐受性:一项随机对照试验。

Tolerance of standard dose albumin infused over 6 hrs for treatment of spontaneous bacterial peritonitis-A randomized controlled trial.

机构信息

Department of Hepatology and Liver Transplantation, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110 070, India.

Department of Radiology, Institute of Liver and Biliary Sciences, D 1 Vasant Kunj, New Delhi, 110 070, India.

出版信息

Indian J Gastroenterol. 2023 Aug;42(4):505-516. doi: 10.1007/s12664-023-01389-x. Epub 2023 Jul 8.

Abstract

BACKGROUND AND AIMS

Twenty per cent albumin (1.5 g/kg at diagnosis and 1 g/kg on day three, infused over six-hour duration) is recommended particularly in high-risk spontaneous bacterial peritonitis (SBP). Whether reduced dose albumin infusion is as effective as the standard dose albumin infusion is not clear. The aim of this study was to compare standard dose albumin infusion with reduced dose albumin infusion in acute kidney injury (AKI) development or progression in patients with cirrhosis and high-risk SBP.

METHODS

Sixty-three patients were randomized to the standard dose albumin arm (n = 31) and reduced dose albumin arm (n = 32, 0.75 g/kg at diagnosis and 0.5 g/kg 48 h later). The albumin was infused over six-hour duration in both groups. When the patient developed respiratory distress, the albumin infusion was stopped and that dose (i.e. of day one or day three) was not restarted and no attempt was made to finish the whole dose of that day. However, the next dose was started at the pre-calculated infusion rate if there was no evidence of respiratory distress at the start of next infusion.

RESULTS

All 31 patients in standard dose and two (6.25%) in the reduced dose group developed symptomatic circulatory overload (p < 0.001), with infusions being stopped prematurely. The actual albumin dose received on day one was similar in both groups and only slightly higher in the standard dose group on day three. Resolution of SBP, progression of AKI to higher stage, in-hospital mortality and 28 days' mortality were similar in both groups.

CONCLUSIONS

For treatment of SBP, standard dose albumin infusion (1.5 g/kg at diagnosis and 1 g/kg 48 hours later) infused over six hours is not tolerated by Indian patients. The effectiveness of standard dose albumin infused over more prolonged periods, as compared to reduced dose albumin, should be evaluated in further studies.

TRIAL REGISTRATION

Clinical Trials.gov Identifier: NCT04273373 .

摘要

背景与目的

20%白蛋白(诊断时 1.5g/kg,第 3 天 1g/kg,输注 6 小时)尤其推荐用于高危自发性细菌性腹膜炎(SBP)。目前尚不清楚减少剂量白蛋白输注是否与标准剂量白蛋白输注同样有效。本研究旨在比较标准剂量白蛋白输注与减少剂量白蛋白输注在肝硬化伴高危 SBP 患者中急性肾损伤(AKI)发展或进展中的作用。

方法

63 名患者随机分为标准剂量白蛋白组(n=31)和减少剂量白蛋白组(n=32,诊断时 0.75g/kg,48 小时后 0.5g/kg)。两组白蛋白均输注 6 小时。当患者出现呼吸困难时,停止输注白蛋白,且当日不再继续输注该剂量(即第 1 天或第 3 天的剂量),且不再尝试完成当日剩余剂量。然而,如果下一次输注开始时没有出现呼吸困难的证据,则按照预先计算的输注速度开始输注下一次剂量。

结果

标准剂量组 31 名患者和减少剂量组 2 名(6.25%)患者均出现症状性循环超负荷(p<0.001),且输注提前停止。两组第 1 天实际接受的白蛋白剂量相似,而标准剂量组第 3 天的剂量略高。两组 SBP 缓解率、AKI 向更高阶段进展率、住院死亡率和 28 天死亡率均相似。

结论

对于 SBP 的治疗,印度患者无法耐受标准剂量白蛋白输注(诊断时 1.5g/kg,48 小时后 1g/kg,输注 6 小时)。应进一步研究在更长时间内输注标准剂量白蛋白与减少剂量白蛋白相比的有效性。

临床试验注册号

ClinicalTrials.gov Identifier:NCT04273373。

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