Karlstadt R G, Hedrich D A, Asbel-Sethi N R, Palmer R H
SmithKline Beecham Pharmaceuticals, Philadelphia, Pennsylvania.
Clin Ther. 1993 Jan-Feb;15(1):97-106.
The effect of two doses (37.5 mg/hr and 50 mg/hr) of continuously infused cimetidine on gastric acid secretion and pH control over 24 hours was compared with that of placebo in 21 adult males with active duodenal ulcer or scarring from healed duodenal ulcer. This single-center, double-blind, three-way crossover trial consisted of three treatment periods separated by 5- to 7-day washout periods. Gastric contents were continuously aspirated through a nasogastric tube during the second half of each study hour. Volume, pH, and titratable acidity were measured from the aspirates collected during the last 20 minutes of each aspiration period. The median pH, volume (ml), and titratable acidity (mEq/hr) values for the 37.5-mg/hr infusion were 5, 16.0, and 0.24, respectively (P < 0.05 versus placebo). For the 50-mg/hr infusion, the respective values were 5.3, 15.8, and 0.14 (P < 0.05 versus placebo); and for placebo, the values were 1.4, 30.5, and 6.83. The median percent of time that the pH was > or = 4 was 65%, 65%, and 0% for the 37.5-mg/hr, 50-mg/hr, and placebo infusions, respectively (P < 0.05 versus placebo). The 37.5-mg/hr and 50-mg/hr intravenous doses of continuously infused cimetidine are commonly used in the hospital setting to treat intractable ulcers or prevent upper gastrointestinal bleeding in critically ill patients. The results of this study demonstrate that both doses are similarly effective in maintaining intragastric pH and acid secretion at levels generally recognized as being effective.
在21名患有活动性十二指肠溃疡或愈合性十二指肠溃疡瘢痕的成年男性中,比较了两种剂量(37.5毫克/小时和50毫克/小时)持续输注西咪替丁对胃酸分泌和24小时pH值控制的影响与安慰剂的效果。这项单中心、双盲、三向交叉试验包括三个治疗期,中间间隔5至7天的洗脱期。在每个研究小时的后半段,通过鼻胃管持续抽吸胃内容物。从每个抽吸期最后20分钟收集的抽吸物中测量体积、pH值和可滴定酸度。37.5毫克/小时输注的pH值中位数、体积(毫升)和可滴定酸度(毫当量/小时)分别为5、16.0和0.24(与安慰剂相比,P<0.05)。对于50毫克/小时的输注,相应的值分别为5.3、15.8和0.14(与安慰剂相比,P<0.05);对于安慰剂,值分别为1.4、30.5和6.83。对于37.5毫克/小时、50毫克/小时和安慰剂输注,pH值≥4的时间中位数百分比分别为65%、65%和0%(与安慰剂相比,P<0.05)。37.5毫克/小时和50毫克/小时静脉持续输注西咪替丁的剂量常用于医院环境中治疗难治性溃疡或预防重症患者上消化道出血。本研究结果表明,两种剂量在将胃内pH值和酸分泌维持在普遍认为有效的水平方面同样有效。