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在印度尼西亚进行的一项多中心随机对照试验中,对于I级和II级登革出血热住院成人患者,与乳酸林格液相比,早期使用5%白蛋白显示出对血管完整性和功能的更好控制。

Early intervention of 5% albumin shown superior control of vascular integrity and function compared to ringer's lactatein hospitalized adult with grade I & II Dengue hemorrhagic fever: a multicenter randomized controlled trial in Indonesia.

作者信息

Bur Rika, Suwarto Suhendro, Pohan Herdiman Theodorus, Prihartono Joedo, Harahap Alida Roswita, Dewi Beti Ernawati, Sadikin Mohamad, Rachman Andhika, Yusuf Hadi

机构信息

Division of Tropical and Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Harapan Kita National Women and Children Health Center, Jakarta, 11420, Indonesia.

Division of Tropical and Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, 10430, Indonesia.

出版信息

Trop Dis Travel Med Vaccines. 2024 Oct 1;10(1):20. doi: 10.1186/s40794-024-00230-3.

Abstract

BACKGROUND

Dengue virus remains a major public health problem with one of the hallmark pathologies is the vascular leakage caused by endothelial dysfunction which can lead to Dengue Hemorrhagic Fever (DHF) manifestation. In the status quo, no specific therapy has been discovered but rather heavily relies on judicious and frequent monitoring of intravenous fluids administration. The current guideline has discussed the roles of fluid therapy during the Dengue Shock Syndrome (DSS) stage, however, administration of early fluid intervention for DHF grade I and II remains uncharted territory. In addition, the choice and timing of colloid administration remains underexplored. As one of the widely available colloids, 5% albumin has known physiological properties that potentially minimize plasma leakage. Therefore, this study aimed to evaluate the benefit of early intervention of 5% albumin in adults with DHF in the hope of preventing the lethal progression to DSS and further, shorten the length of stay (LOS) for patients.

METHODS

We conducted a multicenter, open-labeled, randomized controlled trial in Jakarta and Banten to compare the effect of early intervention with 5% albumin in adult patients with DHF compared to Ringer's Lactate (RL). Statistical analyses were conducted using unpaired t-test and Mann-Whitney for normally and abnormally distributed data respectively.

RESULTS

Adult patients with a diagnosis of DHF grade I and II that being hospitalized to receive the early intervention of 5% albumin had significantly lower levels of hemoconcentration 4, 12, and 24 h (p = 0.002, 0.001, 0.003, respectively), higher platelet counts 4 h (p = 0.036), higher serum albumin levels 48 h (p = 0.036), lower proteinuria 24 and 48 h post-albumin administration (p < 0.001, < 0.001, respectively), and shorter LOS (p < 0.001) when compared to the RL group.

CONCLUSION

Early intervention of 5% albumin showed better control on vascular integrity and function compared to ringer lactate in hospitalized adults with grade I & II DHF, thus halting the progression of DHF into DSS and other related complications which leads to faster recovery and shorter length of stay.

TRIAL REGISTRATION

The study was registered to www.

CLINICALTRIAL

gov with trial registration number NCT04076254, and registration date October 31st 2016.

摘要

背景

登革病毒仍然是一个主要的公共卫生问题,其标志性病理之一是由内皮功能障碍引起的血管渗漏,这可能导致登革出血热(DHF)的表现。目前,尚未发现特异性治疗方法,而是严重依赖于对静脉输液管理进行明智且频繁的监测。当前指南讨论了在登革休克综合征(DSS)阶段液体疗法的作用,然而,对于DHF I级和II级的早期液体干预管理仍未明确。此外,胶体的选择和使用时机仍未得到充分研究。作为广泛可用的胶体之一,5%白蛋白具有已知的生理特性,有可能使血浆渗漏最小化。因此,本研究旨在评估5%白蛋白早期干预对成年DHF患者的益处,以期预防致命进展为DSS,并进一步缩短患者的住院时间(LOS)。

方法

我们在雅加达和万丹进行了一项多中心、开放标签、随机对照试验,以比较5%白蛋白早期干预与乳酸林格液(RL)对成年DHF患者的效果。分别使用不成对t检验和曼-惠特尼检验对正态分布和非正态分布的数据进行统计分析。

结果

诊断为DHF I级和II级并住院接受5%白蛋白早期干预的成年患者,在4、12和24小时时的血液浓缩水平显著更低(分别为p = 0.002、0.001、0.003),4小时时血小板计数更高(p = 0.036),48小时时血清白蛋白水平更高(p = 0.036),白蛋白给药后24和48小时蛋白尿更低(分别为p < 0.001、< 0.001),与RL组相比住院时间更短(p < 0.001)。

结论

与乳酸林格液相比,5%白蛋白早期干预对I级和II级DHF住院成年患者的血管完整性和功能显示出更好的控制,从而阻止DHF进展为DSS及其他相关并发症,实现更快康复和更短住院时间。

试验注册

该研究已在www.CLINICALTRIAL.gov上注册,试验注册号为NCT04076254,注册日期为2016年10月31日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e675/11443621/47b41a9d8441/40794_2024_230_Fig1_HTML.jpg

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