Ben-Menachem T, Fogel R, Patel R V, Touchette M, Zarowitz B J, Hadzijahic N, Divine G, Verter J, Bresalier R S
Division of Gastroenterology, Henry Ford Hospital, Detroit, MI 48202.
Ann Intern Med. 1994 Oct 15;121(8):568-75. doi: 10.7326/0003-4819-121-8-199410150-00003.
To determine the efficacy and safety of cimetidine and sucralfate prophylaxis for stress-related gastrointestinal hemorrhage in patients admitted to a medical intensive care unit.
Medical intensive care unit of a nonprofit, university-affiliated teaching hospital.
300 patients admitted to the medical intensive care unit during a 10-month period.
Randomized, controlled, single-blind clinical trial.
Patients were assigned to receive no prophylaxis (control), 1 g sucralfate given orally every 6 hours, or continuous intravenous cimetidine titrated to maintain gastric pH at 4.0, intervention was maintained until the occurrence of clinically severe hemorrhage, onset of drug-related complications, death, or discharge from the medical intensive care unit.
The primary outcome measure was the incidence of clinically severe hemorrhage from endoscopically verified stress-related gastritis. Other outcome measures were transfusion requirements, duration of medical intensive care unit stay, incidence of nosocomial pneumonia, adverse drug reactions, and death.
100 patients were randomly assigned to each treatment. The three groups were similar with regard to demographic characteristics, intensive care unit admission diagnoses, and APACHE II scores. Stress-related hemorrhage was seen in 6% of control participants and in 5% of those receiving sucralfate or cimetidine (relative risk compared with control, 0.83 for each group; 95% CI, 0.26 to 2.64; P = 0.75). No statistically significant differences were found for transfusion requirements, duration of medical intensive care unit stay, and mortality rates among the three groups. Nosocomial pneumonia was diagnosed in 6%, 12%, and 13% of controls, sucralfate recipients, and cimetidine recipients, respectively (sucralfate: relative risk, 2.0 [CI, 0.79 to 5.01], P = 0.14; cimetidine: relative risk, 2.2 [CI, 0.88 to 5.33], P = 0.09). Prophylaxis caused no definite adverse drug reactions.
The observed effects of cimetidine and sucralfate on the incidence and severity of hemorrhage from stress-related gastritis were not significant when compared with no treatment. Routine prophylaxis with these agents for patients entering the medical intensive care unit does not seem warranted.
确定西咪替丁和硫糖铝预防入住内科重症监护病房患者应激性胃肠道出血的疗效和安全性。
一家非营利性大学附属医院的内科重症监护病房。
10个月期间入住内科重症监护病房的300例患者。
随机、对照、单盲临床试验。
患者被分配接受不预防（对照组）、每6小时口服1克硫糖铝，或持续静脉输注西咪替丁并调整剂量以维持胃pH值在4.0，干预措施持续至发生临床严重出血、出现药物相关并发症、死亡或从内科重症监护病房出院。
主要观察指标是经内镜证实的应激性胃炎导致的临床严重出血的发生率。其他观察指标包括输血需求、内科重症监护病房住院时间、医院获得性肺炎的发生率、药物不良反应和死亡。
每组随机分配100例患者。三组在人口统计学特征、重症监护病房入院诊断和急性生理与慢性健康状况评分系统II（APACHE II）评分方面相似。对照组6%的参与者以及接受硫糖铝或西咪替丁治疗的参与者中5%出现应激性出血（与对照组相比的相对风险，每组均为0.83；95%可信区间，0.26至2.64；P = 0.75）。三组在输血需求、内科重症监护病房住院时间和死亡率方面未发现统计学上的显著差异。对照组、硫糖铝治疗组和西咪替丁治疗组医院获得性肺炎的诊断率分别为6%、12%和13%（硫糖铝：相对风险，2.0[可信区间，0.79至5.01]，P = 0.14；西咪替丁：相对风险，2.2[可信区间，0.88至5.33]，P = 0.09）。预防措施未引起明确的药物不良反应。
与不治疗相比，观察到的西咪替丁和硫糖铝对应激性胃炎出血发生率和严重程度的影响不显著。对于入住内科重症监护病房的患者，似乎没有必要常规使用这些药物进行预防。
