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药师主导的干预措施在中国重症监护病房减少应激性溃疡预防的抑酸治疗的有效性:一项多中心、阶梯式楔形、整群随机对照试验

Effectiveness of a Pharmacist-Led Intervention to Reduce Acid Suppression Therapy for Stress Ulcer Prophylaxis in ICUs in China: A Multicenter, Stepped-Wedge, Cluster-Randomized Controlled Trial.

作者信息

Li Hailong, Zeng Linan, Xu Peipei, Olsen Keith, Granholm Anders, Jin Xiaodong, Zhang Lingli, Guyatt Gordon

机构信息

Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.

Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.

出版信息

Crit Care Med. 2025 Jan 31;53(4):e805-16. doi: 10.1097/CCM.0000000000006589.

Abstract

OBJECTIVES

This study aimed to evaluate the effectiveness of a pharmacist-led intervention in decreasing the overuse of stress ulcer prophylaxis (SUP) compared with the usual care for adult patients in Chinese ICUs.

DESIGN

Pragmatic, multicenter, stepped-wedge, cluster-randomized controlled trial.

SETTING

Twenty-six ICUs in China from October 2022 to March 2023.

PATIENTS

We enrolled 2199 patients 18 years old or older who were newly admitted to the participating ICUs.

INTERVENTIONS

Using the Medical Research Council framework for developing and evaluating complex intervention measures, a multidisciplinary team (Scenarios, Improving and Refining Interventions, Constructing, Refining and Testing Research Theories, Incorporating Stakeholders, Identifying Important Uncertainties, and Economics Considerations) designed a multifaceted intervention.

MEASUREMENTS AND MAIN RESULTS

The primary outcomes were the proportion of patients receiving SUP and that with overt gastrointestinal bleeding. We conducted intention-to-treat analyses using generalized linear mixed models to adjust for potential confounders (age, sex, and acute physiology and chronic health evaluation II score) with random effects for the site. The proportion of patients receiving SUP in the intervention group was lower than that in the control group (45.5% vs. 49.5%; odds ratio [OR], 0.81; 95% CI, 0.68-0.96; p = 0.017). The proportion of patients with overt gastrointestinal bleeding was similar (3.7% vs. 4.0%; OR, 1.05; 95% CI, 0.65-2.85; p = 0.81).

CONCLUSIONS

The pharmacist-led intervention reduced the proportion of patients receiving SUP in the ICUs, without significantly affecting the proportion of patients with overt gastrointestinal bleeding. These findings will help guide ICU medical decision-making.

摘要

目的

本研究旨在评估与中国重症监护病房(ICU)成年患者的常规护理相比,由药剂师主导的干预措施在减少应激性溃疡预防(SUP)过度使用方面的有效性。

设计

实用、多中心、阶梯式楔形、整群随机对照试验。

地点

2022年10月至2023年3月期间中国的26个ICU。

患者

我们纳入了2199名18岁及以上新入住参与研究ICU的患者。

干预措施

使用医学研究理事会制定和评估复杂干预措施的框架,一个多学科团队(情景、改进和完善干预措施、构建、完善和测试研究理论、纳入利益相关者、识别重要不确定性以及经济考量)设计了一项多方面的干预措施。

测量指标和主要结果

主要结局是接受SUP的患者比例以及显性胃肠道出血患者的比例。我们使用广义线性混合模型进行意向性分析,以调整潜在混杂因素(年龄、性别以及急性生理学与慢性健康状况评价II评分),并对研究地点进行随机效应分析。干预组接受SUP的患者比例低于对照组(45.5%对49.5%;优势比[OR],0.81;95%置信区间[CI],0.68 - 0.96;p = 0.017)。显性胃肠道出血患者的比例相似(3.7%对4.0%;OR,1.05;95% CI,0.65 - 2.85;p = 0.81)。

结论

由药剂师主导的干预措施降低了ICU中接受SUP的患者比例,且未显著影响显性胃肠道出血患者的比例。这些研究结果将有助于指导ICU的医疗决策。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/87cd/11952691/91e139cf4f16/ccm-53-e805-g001.jpg

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