a Department of General Surgery , Zhongshan Hospital, Fudan University , Shanghai , PR China.
b Haikou City People's Hospital , Haikou City , Hainan , PR China.
Curr Med Res Opin. 2018 Aug;34(8):1449-1455. doi: 10.1080/03007995.2018.1464132. Epub 2018 Apr 20.
To assess the efficacy and safety of esomeprazole in preventing upper gastrointestinal (GI) bleeding in critically ill Chinese patients, using cimetidine as an active comparator.
A pre-specified non-inferiority limit (5%) was used to compare rates of significant upper GI bleeding in this randomized, double-blind, parallel-group, phase 3 study across 27 intensive care units in China. Secondary endpoints included safety and tolerability measures. Patients required mechanical ventilation and had at least one additional risk factor for stress ulcer bleeding. Patients were randomized to receive either active esomeprazole 40 mg, as a 30-min intravenous (IV) infusion twice daily, and an IV placebo cimetidine infusion or active cimetidine 50 mg/h, as a continuous infusion following an initial bolus of 300 mg, and placebo esomeprazole injections, given up to 14 days. Patients were blinded using this double-dummy technique.
Of 274 patients, 2.7% with esomeprazole and 4.6% with cimetidine had significant upper GI bleeding (bright red blood in the gastric tube not clearing after lavage or persistent Gastroccult-positive "coffee grounds" material). Non-inferiority of esomeprazole to cimetidine was demonstrated. The safety profiles of both drugs were similar and as expected in critically ill patients.
Esomeprazole is effective in preventing upper GI bleeding in critically ill Chinese patients, as demonstrated by the non-inferiority analysis using cimetidine as an active control.
ClinicalTrials.gov identifier NCT02157376.
评估埃索美拉唑预防中国危重症患者上消化道出血的疗效和安全性，采用西咪替丁作为活性对照。
本研究采用预先设定的非劣效性界限（5%），对 27 家中国重症监护病房开展的这项随机、双盲、平行组、3 期研究中，显著上消化道出血发生率进行比较。次要终点包括安全性和耐受性指标。患者需接受机械通气，且至少存在 1 项应激性溃疡出血的附加风险因素。患者被随机分组，分别接受以下治疗：每日 2 次、每次 30 分钟静脉（IV）输注 40mg 埃索美拉唑，以及 IV 安慰剂西咪替丁输注；或初始推注 300mg 后持续输注 50mg/h 西咪替丁，以及安慰剂埃索美拉唑注射，最多给药 14 天。采用双盲技术对患者进行盲法处理。
在 274 例患者中，埃索美拉唑组和西咪替丁组分别有 2.7%和 4.6%的患者发生显著上消化道出血（灌洗后胃管内仍有鲜红血液、且持续胃管潜血阳性“咖啡渣样”物质）。研究结果证实埃索美拉唑不劣于西咪替丁。两种药物在重症患者中的安全性特征相似，且与预期结果一致。
埃索美拉唑可有效预防中国危重症患者上消化道出血，该结论通过以西咪替丁作为活性对照的非劣效性分析得出。
ClinicalTrials.gov 标识符 NCT02157376。
