评估静脉注射硫酸镁预防秋水仙碱诱发急性肾损伤的效果:一项开放标签、安慰剂对照、随机区组临床试验。

IF 3.1 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Sareh Hosseini, Ilad Alavi Darzam, Mahdi Amirdosara, Masoud Zangi, Zahra Sahraei
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引用次数: 0

摘要

尽管秋水仙碱具有已知的肾毒性,但它已重新成为最后的抗生素。本研究旨在确定硫酸镁(Mg)在可乐定治疗期间的潜在肾保护作用。本研究是一项开放标签、安慰剂对照、整群随机临床试验,于 2023 年 1 月至 2024 年 2 月进行,共有 87 名符合可乐定治疗条件的患者参与。患者被随机分配到接受硫酸镁(16 mEq 加入 100 mL 生理盐水中)或 100 mL 生理盐水作为安慰剂,然后再服用每次剂量的秋水仙碱。研究的主要结果是在接受秋水仙碱治疗的第一周内急性肾损伤(AKI)的发生率,次要结果包括秋水仙碱剂量调整、重症监护室和住院时间以及总死亡率。该研究已在伊朗临床试验注册中心注册(IRCT20130917014693N15;2023-01-12)。共有 87 名患者(镁组 46 人,对照组 41 人)完成了研究。在接受可乐定治疗的第一周,镁组有 14 名患者(30.43%)和对照组有 21 名患者(51.21%)发生了 AKI(P = 0.048)。虽然在未经调整的 Cox 回归模型中,两组间的 AKI 发生率无统计学差异(HR =0.51,95% CI =0.26-1.01,P =0.057),但在调整了混杂因素后,差异显著(HR =0.40,95% CI =0.18-0.86,P =0.021)。镁组和对照组的住院时间分别为(48.62±18.82)天和(44.82±20.23)天(P=0.373)。镁组 46 名患者中有 25 人(54.34%)最终死亡,对照组 41 名患者中有 24 人(58.53%)最终死亡(P=0.694)。本研究表明,硫酸镁可显著降低 AKI 发生率,预防低镁血症,优化用药剂量,提高可乐定治疗期间的患者安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluating the effects of intravenous magnesium sulfate for prevention of colistin induced acute kidney injury: an open-label, placebo-controlled, block randomized clinical trial.

Colistin, has reinstated as a last-resort antibiotic despite its known nephrotoxicity. The aim of this study was to determine the potential nephroprotective effects of Magnesium (Mg) Sulfate during colistin therapy. This study was an open-label, placebo-controlled, block-randomized clinical trial conducted from January 2023 to February 2024 involving 87 patients eligible for colistin therapy. Patients were randomly assigned to receive either Mg sulfate (16 mEq in 100 mL of normal saline) or 100 mL of normal saline as placebo before each dose of colistin. The primary outcome of the study was the incidence of Acute Kidney Injury (AKI) during the first week of colistin therapy, while the secondary outcomes included colistin dose adjustments, length of stay in the ICU and hospital, and overall mortality. This study was registered in The Iranian Registry of Clinical Trials (IRCT20130917014693N15; 2023-01-12). A total of 87 patients (46 in Mg and 41 in control group) completed the study. Fourteen patients (30.43%) in the Mg group and twenty-one patients (51.21%) in the control group developed AKI during the first week of colistin therapy (p = 0.048). Although AKI incidence was not statistically different between the groups in unadjusted Cox regression model (HR =0.51, 95% CI =0.26-1.01, P =0.057), it became significant after adjusting for confounding factors (HR =0.40,95% CI =0.18-0.86, P =0.021). The length of hospital stay was 48.62 ± 18.82 and 44.82 ± 20.23 days for Mg and control groups respectively (p=0.373). In the Mg group, 25 out of 46 patients (54.34 %) and in the control group, 24 out of 41 patients (58.53%) eventually expired (p=0.694). This study indicates that Mg sulfate significantly reduces AKI rates and prevents hypomagnesemia, optimizing dosing and enhancing patient safety during colistin therapy.

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来源期刊
CiteScore
6.20
自引率
5.60%
发文量
142
审稿时长
4-8 weeks
期刊介绍: Naunyn-Schmiedeberg''s Archives of Pharmacology was founded in 1873 by B. Naunyn, O. Schmiedeberg and E. Klebs as Archiv für experimentelle Pathologie und Pharmakologie, is the offical journal of the German Society of Experimental and Clinical Pharmacology and Toxicology (Deutsche Gesellschaft für experimentelle und klinische Pharmakologie und Toxikologie, DGPT) and the Sphingolipid Club. The journal publishes invited reviews, original articles, short communications and meeting reports and appears monthly. Naunyn-Schmiedeberg''s Archives of Pharmacology welcomes manuscripts for consideration of publication that report new and significant information on drug action and toxicity of chemical compounds. Thus, its scope covers all fields of experimental and clinical pharmacology as well as toxicology and includes studies in the fields of neuropharmacology and cardiovascular pharmacology as well as those describing drug actions at the cellular, biochemical and molecular levels. Moreover, submission of clinical trials with healthy volunteers or patients is encouraged. Short communications provide a means for rapid publication of significant findings of current interest that represent a conceptual advance in the field.
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