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期刊来源：JAMA

文献发表时间：2023-10-14

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2810592

关键点内容如下：

问题

在因急性感染住院的成人中，选择头孢吡肟或哌拉西林-他唑巴坦是否会影响急性肾损伤或神经功能障碍的风险？

调查结果

在2511名因急性感染住院的成人中，随机分配至头孢吡肟组和哌拉西林-他唑巴坦组的患者中，急性肾损伤或死亡的最高阶段无显著差异。随机接受头孢吡肟治疗的患者出现了更多的神经功能障碍，这是次要结果。

意义

在住院成人中，头孢吡肟和哌拉西林-他唑巴坦的急性肾损伤风险无差异，但头孢吡肟的神经功能障碍更常见。

摘要内容如下：

重要性

头孢吡肟和哌拉西林-他唑巴坦通常用于住院成人感染的经验性治疗。尽管哌拉西林-他唑巴坦被假设可导致急性肾损伤，头孢吡肟被假设可导致神经功能障碍，但尚未在随机临床试验中评估其相对安全性。

目的

确定头孢吡肟和哌拉西林-他唑巴坦之间的选择是否会影响急性肾损伤或神经功能障碍的风险。

研究设计和参与者

肾脏结局抗生素选择（ACORN）随机临床试验比较了头孢吡肟与哌拉西林-他唑巴坦在2021年11月10日至2022年10月7日期间在美国急诊科或学术医疗中心的医疗重症监护室就诊后12小时内由临床医生开具抗假单胞菌抗生素医嘱的成人中的应用。随访的最后日期为2022年11月4日。

干预措施

患者以1:1的比例随机接受头孢吡肟或哌拉西林-他唑巴坦治疗。

主要结局和措施

是第14天时急性肾损伤或死亡的最高阶段，按从无急性肾损伤到死亡的5级顺序量表进行测量。两个次要转归是第14天时主要肾脏不良事件的发生率和14天内存活天数以及无谵妄和昏迷的天数。

结果

有2511名患者被纳入主要分析（中位年龄，58岁[IQR，43-69岁]；女性占42.7%；16.3%为非西班牙裔黑人；西班牙裔占5.4%；94.7%的患者在急诊科就诊；77.2%在登记时接受万古霉素治疗）。头孢吡肟组和哌拉西林-他唑巴坦组发生急性肾损伤或死亡的最高阶段无显著差异；共有85名患者（n=1214；7.0%）发生3期急性肾损伤，92例（7.6%）死亡，97例（n=1297；哌拉西林-他唑巴坦组7.5%）发生3期急性肾损伤，78例（6.0%）死亡（比值比为0.95[95%CI为0.80~1.13]，P=0.56）。第14天时，两组的主要肾脏不良事件发生率无差异（头孢吡肟组124例[10.2%]，哌拉西林-他唑巴坦组114例[8.8%]；绝对差异，1.4%[95%CI，-1.0%至3.8%]）。头孢吡肟组的患者存活天数较少，14天内无谵妄和昏迷（平均[SD]，11.9[4.6]天vs哌拉西林-他唑巴坦组的12.2[4.3]天；比值比，0.79[95%CI，0.65至0.95]）。

结论和相关性

在这项随机临床试验的住院成人中，哌拉西林-他唑巴坦治疗不会增加急性肾损伤或死亡的发生率。头孢吡肟治疗导致更多的神经功能障碍。

英文原文如下：

Key Points

Question  Does the choice between cefepime and piperacillin-tazobactam affect the risks of acute kidney injury or neurological dysfunction in adults hospitalized with acute infection?

Findings  Among 2511 adults hospitalized with acute infection, the highest stage of acute kidney injury or death was not significantly different between patients randomized to cefepime and those randomized to piperacillin-tazobactam. Patients randomized to cefepime experienced more neurological dysfunction, a secondary outcome.

Meaning  Among hospitalized adults, the risk of acute kidney injury did not differ between cefepime and piperacillin-tazobactam, but neurological dysfunction was more common with cefepime.

Abstract

Importance  Cefepime and piperacillin-tazobactam are commonly administered to hospitalized adults for empirical treatment of infection. Although piperacillin-tazobactam has been hypothesized to cause acute kidney injury and cefepime has been hypothesized to cause neurological dysfunction, their comparative safety has not been evaluated in a randomized clinical trial.

Objective  To determine whether the choice between cefepime and piperacillin-tazobactam affects the risks of acute kidney injury or neurological dysfunction.

Design, Setting, and Participants  The Antibiotic Choice on Renal Outcomes (ACORN) randomized clinical trial compared cefepime vs piperacillin-tazobactam in adults for whom a clinician initiated an order for antipseudomonal antibiotics within 12 hours of presentation to the hospital in the emergency department or medical intensive care unit at an academic medical center in the US between November 10, 2021, and October 7, 2022. The final date of follow-up was November 4, 2022.

Interventions  Patients were randomized in a 1:1 ratio to cefepime or piperacillin-tazobactam.

Main Outcomes and Measures  The primary outcome was the highest stage of acute kidney injury or death by day 14, measured on a 5-level ordinal scale ranging from no acute kidney injury to death. The 2 secondary outcomes were the incidence of major adverse kidney events at day 14 and the number of days alive and free of delirium and coma within 14 days.

Results  There were 2511 patients included in the primary analysis (median age, 58 years [IQR, 43-69 years]; 42.7% were female; 16.3% were Non-Hispanic Black; 5.4% were Hispanic; 94.7% were enrolled in the emergency department; and 77.2% were receiving vancomycin at enrollment). The highest stage of acute kidney injury or death was not significantly different between the cefepime group and the piperacillin-tazobactam group; there were 85 patients (n = 1214; 7.0%) in the cefepime group with stage 3 acute kidney injury and 92 (7.6%) who died vs 97 patients (n = 1297; 7.5%) in the piperacillin-tazobactam group with stage 3 acute kidney injury and 78 (6.0%) who died (odds ratio, 0.95 [95% CI, 0.80 to 1.13], P = .56). The incidence of major adverse kidney events at day 14 did not differ between groups (124 patients [10.2%] in the cefepime group vs 114 patients [8.8%] in the piperacillin-tazobactam group; absolute difference, 1.4% [95% CI, −1.0% to 3.8%]). Patients in the cefepime group experienced fewer days alive and free of delirium and coma within 14 days (mean [SD], 11.9 [4.6] days vs 12.2 [4.3] days in the piperacillin-tazobactam group; odds ratio, 0.79 [95% CI, 0.65 to 0.95]).

Conclusions and Relevance  Among hospitalized adults in this randomized clinical trial, treatment with piperacillin-tazobactam did not increase the incidence of acute kidney injury or death. Treatment with cefepime resulted in more neurological dysfunction.

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