Phillips J O, Metzler M H, Palmieri M T, Huckfeldt R E, Dahl N G
Department of Surgery, University of Missouri-Columbia 65212, USA.
Crit Care Med. 1996 Nov;24(11):1793-800. doi: 10.1097/00003246-199611000-00006.
To determine the efficacy, safety, and cost of simplified omeprazole suspension in mechanically ventilated critically ill patients who have at least one additional risk factor for stress-related mucosal damage.
Prospective, open-label study.
Surgical intensive care and burn unit at a university tertiary care center.
Seventy-five adult, mechanically ventilated patients with at least one additional risk factor for stress-related mucosal damage.
Patients received 20 mL of simplified omeprazole suspension (containing 40 mg of omeprazole) initially, followed by a second 20-mL dose 6 to 8 hrs later, then 10 mL (20 mg) daily. Simplified omeprazole suspension was administered through a nasogastric tube, followed by 5 to 10 mL of tap water. The nasogastric tube was clamped for 1 to 2 hrs after each administration.
The primary outcome measure was clinically significant gastrointestinal bleeding determined by endoscopic evaluation, nasogastric aspirate examination, or heme-positive coffee ground material that did not clear with lavage, which was associated with at least a 5% decrease in hematocrit. Secondary efficacy measures were gastric pH measured 4 hrs after omeprazole was first administered, mean gastric pH after omeprazole was started, and the lowest gastric pH during omeprazole therapy. Safety-related outcomes included the occurrence rate of adverse events and pneumonia. No patient experienced clinically significant upper gastrointestinal bleeding after receiving omeprazole suspension. The 4-hr postomeprazole mean gastric pH was 7.1, the mean gastric pH after starting omeprazole was 6.8, and the mean lowest pH after starting omeprazole was 5.6. The occurrence rate of pneumonia was 12%. No patient in this high-risk population experienced an adverse event or a drug interaction that was attributable to omeprazole.
Simplified omeprazole suspension prevented clinically significant upper gastrointestinal bleeding and maintained gastric pH of > 5.5 in mechanically ventilated critical care patients without producing toxicity.
确定简化奥美拉唑混悬液在至少有一项应激相关黏膜损伤额外危险因素的机械通气重症患者中的疗效、安全性和成本。
前瞻性、开放标签研究。
一所大学三级医疗中心的外科重症监护病房和烧伤病房。
75名成年机械通气患者，至少有一项应激相关黏膜损伤额外危险因素。
患者最初接受20毫升简化奥美拉唑混悬液（含40毫克奥美拉唑），6至8小时后再给予20毫升剂量，然后每日10毫升（20毫克）。简化奥美拉唑混悬液通过鼻胃管给药，随后注入5至10毫升自来水。每次给药后鼻胃管夹闭1至2小时。
主要结局指标是通过内镜评估、鼻胃抽吸物检查或洗胃后未清除的潜血阳性咖啡渣样物质确定的具有临床意义的胃肠道出血，这与血细胞比容至少降低5%相关。次要疗效指标是首次给予奥美拉唑后4小时测量的胃pH值、开始使用奥美拉唑后的平均胃pH值以及奥美拉唑治疗期间的最低胃pH值。与安全性相关的结局包括不良事件和肺炎的发生率。接受奥美拉唑混悬液后，无患者发生具有临床意义的上消化道出血。奥美拉唑给药后4小时的平均胃pH值为7.
