Department of Intensive Care, 4131, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Syst Rev. 2017 Jun 24;6(1):118. doi: 10.1186/s13643-017-0509-4.
Stress ulcer prophylaxis is considered standard of care in many critically ill patients in the intensive care unit (ICU). However, the quality of evidence supporting this has recently been questioned, and clinical equipoise exists. Whether there is overall benefit or harm of stress ulcer prophylaxis in adult hospitalised acutely ill patients is unknown. Accordingly, we aim to assess patient-important benefits and harms of stress ulcer prophylaxis versus placebo or no treatment in adult hospitalised acutely ill patients with high risk of gastrointestinal bleeding irrespective of hospital setting.
METHODS/DESIGN: We will conduct a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis and assess use of proton pump inhibitors (PPIs) or histamine-2-receptor antagonists (H2RAs) in any dose, formulation and duration. We will accept placebo or no prophylaxis as control interventions. The participants will be adult hospitalised acutely ill patients with high risk of gastrointestinal bleeding. We will systematically search the Cochrane Library, MEDLINE, EMBASE, Science Citation Index, BIOSIS and Epistemonikos for relevant literature. We will follow the recommendations by the Cochrane Collaboration and the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. The risk of systematic errors (bias) and random errors will be assessed, and the overall quality of evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
There is a need for a high-quality systematic review to summarise the benefits and harms of stress ulcer prophylaxis in hospitalised patients to inform practice and future research. Although stress ulcer prophylaxis is used worldwide, no firm evidence for benefit or harm as compared to placebo or no treatments has been established. Critical illness is a continuum not limited to the ICU setting, which is why it is important to assess the benefits and harms of stress ulcer prophylaxis in a wider perspective than exclusively in ICU patients.
PROSPERO CRD42017055676.
在重症监护病房（ICU）中，应激性溃疡预防被认为是许多危重病患者的标准治疗方法。然而，最近对支持这一做法的证据质量提出了质疑，并且存在临床均衡。应激性溃疡预防是否对住院急性病患者整体有益或有害尚不清楚。因此，我们旨在评估应激性溃疡预防与安慰剂或不治疗相比，在无论医院环境如何，有胃肠道出血高风险的住院急性病成年患者中的患者重要获益和危害。
方法/设计：我们将对随机临床试验进行系统评价，进行荟萃分析和试验序贯分析，并评估任何剂量、剂型和持续时间使用质子泵抑制剂（PPIs）或组胺 2 受体拮抗剂（H2RAs）。我们将接受安慰剂或不进行预防作为对照干预。参与者将是有胃肠道出血高风险的住院急性病成年患者。我们将系统地搜索 Cochrane 图书馆、MEDLINE、EMBASE、科学引文索引、BIOSIS 和 Epistemonikos 中的相关文献。我们将遵循 Cochrane 协作和系统评价和荟萃分析的 Preferred Reporting Items（PRISMA）声明的建议。将评估系统误差（偏倚）和随机误差的风险，并使用推荐评估、制定与评价（GRADE）方法评估证据的整体质量。
需要进行高质量的系统评价，以总结应激性溃疡预防在住院患者中的获益和危害，为实践和未来的研究提供信息。尽管应激性溃疡预防在全球范围内使用，但与安慰剂或不治疗相比，尚未确定其获益或危害的确凿证据。危重病是一个连续体，不限于 ICU 环境，因此，从比 ICU 患者更广泛的角度评估应激性溃疡预防的获益和危害非常重要。
PROSPERO CRD42017055676。
