Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
Digestion. 2012;86(2):114-21. doi: 10.1159/000339111. Epub 2012 Jul 27.
BACKGROUND/AIMS: In this crossover study, we investigated whether nizatidine, a H(2)-receptor antagonist, can alleviate clinical symptoms and gastric emptying in patients with Rome III-based functional dyspepsia (FD) with or without impaired gastric emptying. METHODS: We enrolled 30 patients presenting with FD symptoms (epigastric pain syndrome, n = 6; postprandial distress syndrome, n = 24). Rome III-based FD patients were treated with nizatidine (300 mg/day) or placebo for 4 weeks in a crossover trial. Gastric motility was mainly evaluated with the T(max) value using the (13)C-acetate breath test. Meal-related symptoms were defined as postprandial fullness and early satiation. Gastroesophageal symptom was defined as a burning feeling rising from the stomach or lower chest up toward the neck. Acylated- and desacylated ghrelin levels were evaluated by the ELISA method. Clinical symptoms, gastric emptying and ghrelin levels were evaluated at three different points during the study (pretreatment, after 4 weeks former treatment and after 4 weeks later treatment). The primary end point of this study was to determine whether nizatidine would improve clinical symptoms and gastric emptying in FD patients with or without impaired gastric emptying via affecting ghrelin levels. RESULTS: Meal-related symptoms of the patients treated with nizatidine improved significantly (21/30; 70%) compared to those treated with placebo (3/30; 10%). In addition, nizatidine treatment also significantly improved gastroesophageal symptoms (16/30; 53%) compared to those treated with placebo (0/30; 0%). Nizatidine treatment in patients with FD accompanied by impaired gastric emptying significantly improved clinical symptoms and T(max) value as a marker of gastric emptying (10/11, 91%; 9/11, 82%) compared to placebo therapy, respectively. There were no significant differences in ghrelin levels between nizatidine treatment and placebo therapy. CONCLUSION: Nizatidine administration significantly improved both gastric emptying and clinical symptoms in FD patients with impaired gastric emptying.
背景/目的：在这项交叉研究中，我们调查了 H2 受体拮抗剂尼扎替丁是否可以缓解基于罗马 III 标准的功能性消化不良（FD）患者的临床症状和胃排空，无论这些患者是否存在胃排空受损。
方法：我们招募了 30 名出现 FD 症状（上腹痛综合征，n=6；餐后不适综合征，n=24）的患者。这些患者接受尼扎替丁（300mg/天）或安慰剂交叉治疗 4 周。主要通过 13C-乙酸呼气试验评估胃动力，用 Tmax 值评估。与进餐相关的症状定义为餐后饱胀和早饱。胃食管症状定义为从胃部或下胸部向上蔓延至颈部的烧灼感。酰化和去酰化 ghrelin 水平通过 ELISA 方法评估。在研究的三个不同时间点（治疗前、治疗 4 周前和治疗 4 周后）评估临床症状、胃排空和 ghrelin 水平。本研究的主要终点是确定尼扎替丁是否会通过影响 ghrelin 水平来改善 FD 患者伴或不伴胃排空受损的临床症状和胃排空。
结果：与安慰剂治疗相比，尼扎替丁治疗组患者的与进餐相关的症状显著改善（21/30；70%）。此外，尼扎替丁治疗还显著改善了胃食管症状（16/30；53%），而安慰剂治疗则没有改善（0/30；0%）。尼扎替丁治疗伴有胃排空受损的 FD 患者，胃排空的标志物 Tmax 值和临床症状显著改善（11 例中的 10 例，91%；11 例中的 9 例，82%），而安慰剂治疗则没有改善。尼扎替丁治疗和安慰剂治疗之间 ghrelin 水平没有显著差异。
结论：尼扎替丁治疗可显著改善伴有胃排空受损的 FD 患者的胃排空和临床症状。
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