López-Herce J, Dorao P, Elola P, Delgado M A, Ruza F, Madero R
Pediatric Intensive Care Unit, La Paz Children's Hospital, Madrid, Spain.
Crit Care Med. 1992 Aug;20(8):1082-9. doi: 10.1097/00003246-199208000-00003.
To determine the occurrence of upper gastrointestinal hemorrhage in critically ill children, and the efficacy of prophylaxis with almagate (antacid), ranitidine, and sucralfate.
Prospective, randomized, controlled trial.
Pediatric ICU of a tertiary care pediatric hospital.
During a 2-yr study period, 165 patients with one or more upper gastrointestinal hemorrhage risk factors were randomized into one of four groups. Twenty-five patients were excluded because of protocol violations. A total of 140 patients completed the study, with 35 patients in each group.
Patients received no treatment in the control group. The antacid group received almagate 0.25 to 0.5 mL/kg every 2 hrs by nasogastric tube. The ranitidine group received 1.5 mg/kg every 6 hrs iv. The sucralfate group received 0.5 to 1 g every 6 hrs by nasogastric tube.
Gastric pH and macroscopic bleeding were determined every 2 hrs in all patients until the end of the study. Macroscopic bleeding was classified as nonhemorrhage, slight, or important. Microscopic gastric bleeding was researched with guaiac testing in 72 patients (680 samples). The severity of illness was evaluated by using the Therapeutic Intervention Scoring System, Physiologic Stability Index, and the Multiorgan System Failure scores. The risk of upper gastrointestinal hemorrhage was evaluated by the Zinner and Tryba indices, and was modified for children.
The occurrence rate of important upper gastrointestinal hemorrhage was higher (by 20%) in the control group than in the rest of the groups (5.7%), p less than .01. There were no differences between the other groups (almagate 5.7%, ranitidine 8.5%, and sucralfate 2.8%). There was a statistically significant correlation between the occurrence rate of important upper gastrointestinal hemorrhage, the scores of severity of illness indices (Therapeutic Intervention Scoring System, Physiologic Stability Index, and the Multiorgan System Failure scoring system), the risk of upper gastrointestinal hemorrhage indices (Zinner and Tryba), and mortality rate. The Zinner index better classified the patients in relation to the onset of important upper gastrointestinal hemorrhage (sensitivity 76.9%, specificity 85.8%).
Upper gastrointestinal hemorrhage is an important complication in critically ill children. Prophylaxis with almagate, ranitidine, or sucralfate reduces the occurrence rate of clinically important gastrointestinal hemorrhage.
确定危重症儿童上消化道出血的发生率,以及铝碳酸镁(抗酸剂)、雷尼替丁和硫糖铝预防上消化道出血的疗效。
前瞻性、随机、对照试验。
一家三级儿科医院的儿科重症监护病房。
在为期2年的研究期间,165例有一项或多项上消化道出血危险因素的患者被随机分为四组。25例患者因违反方案被排除。共有140例患者完成研究,每组35例。
对照组患者不接受治疗。抗酸剂组通过鼻胃管每2小时给予铝碳酸镁0.25至0.5 mL/kg。雷尼替丁组每6小时静脉注射1.5 mg/kg。硫糖铝组通过鼻胃管每6小时给予0.5至1 g。
在所有患者中,每2小时测定胃pH值和肉眼可见出血情况,直至研究结束。肉眼可见出血分为无出血、轻度或重度。72例患者(680份样本)通过愈创木脂试验研究镜下胃出血情况。采用治疗干预评分系统、生理稳定性指数和多器官系统衰竭评分评估疾病严重程度。采用Zinner和Tryba指数评估上消化道出血风险,并针对儿童进行了修改。
对照组严重上消化道出血发生率高于其他组(5.7%)20%,P<0.01。其他组之间无差异(铝碳酸镁组5.7%,雷尼替丁组8.5%,硫糖铝组2.8%)。严重上消化道出血发生率、疾病严重程度指数评分(治疗干预评分系统、生理稳定性指数和多器官系统衰竭评分系统)、上消化道出血风险指数(Zinner和Tryba)与死亡率之间存在统计学显著相关性。Zinner指数在区分严重上消化道出血发病方面对患者的分类效果更好(敏感性76.9%,特异性85.8%)。
上消化道出血是危重症儿童的重要并发症。铝碳酸镁、雷尼替丁或硫糖铝预防可降低临床上重要的胃肠道出血发生率。