Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Clin Ther. 2020 Mar;42(3):488-498.e8. doi: 10.1016/j.clinthera.2020.01.008. Epub 2020 Feb 8.
Acid-suppressive medications are widely used in non-intensive care unit (non-ICU) patients for stress ulcer (SU) prophylaxis. However, SU prophylaxis in this population is still controversial. The purpose of this study was to systematically evaluate the efficacy and tolerability of these agents for SU prophylaxis in non-ICU patients.
Electronic databases including Cochrane, ClinicalTrials.gov, Ovid-Medline, Embase, Chinese CNKI, and Wanfang Data were systematically searched on July 10, 2019, for randomized controlled trials (RCTs) that evaluated acid-suppressive medications in non-ICU patients. Network meta-analysis and pairwise meta-analysis were performed to calculate odds ratios (ORs) and 95% CIs. A random-effects model was used for generating pooled estimates. The primary outcome was occurrence of SU bleeding, and the adverse drug events (ADEs) were described as the secondary outcome.
A total of 17 RCTs involving 1985 patients were eligible. Meta-analysis results indicated that the occurrence of SU bleeding was significantly decreased with all acid-suppressive medications compared with placebos (gastric mucosa protectants, OR = 0.29 [95% CI, 0.14-0.61]; H2-receptor antagonists, OR = 0.3 [95% CI, 0.18-0.50]; proton pump inhibitors [PPIs]: OR = 0.08 [95% CI, 0.04-0.16]). The occurrence of SU bleeding was significantly decreased with PPIs compared with gastric mucosa protectants (OR = 0.29; 95% CI, 0.12-0.72) and H2-receptor antagonists (OR = 0.28; 95% CI, 0.16-0.48). There was no significant difference between any 2 classes of PPIs on SU bleeding or any 2 acid-suppressive medications on ADEs.
PPIs could significantly decrease SU bleeding risk without increasing ADEs than other acid-suppressive medications for SU prophylaxis in non-ICU patients. However, RCTs of high quality were required to confirm the findings of this investigation.
抑酸药物广泛用于非重症监护病房（非 ICU）患者应激性溃疡（SU）的预防。然而，此类人群的 SU 预防仍存在争议。本研究旨在系统评价这些药物预防非 ICU 患者 SU 的疗效和耐受性。
系统检索 Cochrane、ClinicalTrials.gov、Ovid-Medline、Embase、中国知网（CNKI）和万方数据于 2019 年 7 月 10 日收录的评价非 ICU 患者抑酸药物的随机对照试验（RCT），进行网络荟萃分析和两两荟萃分析，计算比值比（OR）及其 95%置信区间（CI）。采用随机效应模型进行汇总估计。主要结局为 SU 出血的发生，不良药物事件（ADE）为次要结局。
共纳入 17 项 RCT，涉及 1985 例患者。Meta 分析结果表明，与安慰剂相比，所有抑酸药物均显著降低 SU 出血的发生（胃黏膜保护剂：OR=0.29，95%CI：0.140.61；H2 受体拮抗剂：OR=0.30，95%CI：0.180.50；质子泵抑制剂[PPI]：OR=0.08，95%CI：0.040.16）。与胃黏膜保护剂（OR=0.29，95%CI：0.120.72）和 H2 受体拮抗剂（OR=0.28，95%CI：0.16~0.48）相比，PPI 显著降低 SU 出血的发生。两种 PPI 类药物在 SU 出血或两种抑酸药物在 ADE 方面无显著差异。
与其他抑酸药物相比，PPI 可显著降低非 ICU 患者 SU 出血风险，且不增加 ADE。但仍需高质量 RCT 来证实本研究结果。
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