de Groot G H, de Both P S
Department of Internal Medicine, Rode Kruis Ziekenhuis, Beverwijk, the Netherlands.
Aliment Pharmacol Ther. 1997 Feb;11(1):193-9. doi: 10.1046/j.1365-2036.1997.117288000.x.
Functional dyspepsia is recognized as a common disorder in clinical practice. The aim of this study was to determine the efficacy and adverse effects of cisapride compared to a placebo in patients from a general practice with functional dyspepsia (FD). Secondly we investigated whether Helicobacter pylori-positive FD patients present with specific symptoms and determined the efficacy of cisapride for FD patients with H. pylori.
In a placebo-controlled double-blind study, patients were randomized to receive fixed doses of either cisapride (10 mg three times daily) or placebo. Symptoms were evaluated after 2 and 4 weeks of treatment. The selection of FD patients,collection of data, and evaluation of symptoms as well as adverse effects were performed by general practitioners. Dyspeptic patients were referred to the Gastroenterology Department in order to exclude ulcers, oesophagitis, pancreatitis and gallstones. Biopsies of gastric mucosa were taken for histological examination and H. pylori culture.
121 patients entered this study (61 took cisapride, 60 placebo). There were 113 patients (56 cisapride, 57 placebo) available for analysis of the efficacy and 120 patients (61 cisapride, 59 placebo) for evaluation of adverse effects.In total 102 biopsies were tested for the presence of gastritis by histological examination. There were 30 H. pylori-positive cultures among 111 patients.
After 4 weeks a statistically significant reduction in symptoms was found, but it was similar in the two groups. No symptoms specific for H. pylori-positive patients were found. There was not a significant difference in the response to cisapride between H. pylori-positive and H. pylori-negative patients. The difference in overall (63%) response in the cisapride group and the 44% response in the placebo group did not reach statistical significance.
No significant difference was found between placebo and cisapride in the treatment of FD in general practice. H. pylori-positive patients did not present with specific symptoms nor did they exhibit a different response to cisapride.
功能性消化不良在临床实践中被认为是一种常见疾病。本研究的目的是确定西沙必利与安慰剂相比，对普通诊所中功能性消化不良（FD）患者的疗效和不良反应。其次，我们调查了幽门螺杆菌阳性的FD患者是否有特定症状，并确定了西沙必利对幽门螺杆菌阳性的FD患者的疗效。
在一项安慰剂对照双盲研究中，患者被随机分配接受固定剂量的西沙必利（每日三次，每次10毫克）或安慰剂。治疗2周和4周后评估症状。FD患者的选择、数据收集、症状评估以及不良反应评估均由全科医生进行。消化不良患者被转诊至胃肠病科以排除溃疡、食管炎、胰腺炎和胆结石。取胃黏膜活检进行组织学检查和幽门螺杆菌培养。
121名患者进入本研究（61名服用西沙必利，60名服用安慰剂）。有113名患者（56名服用西沙必利，57名服用安慰剂）可用于疗效分析，120名患者（61名服用西沙必利，59名服用安慰剂）可用于不良反应评估。总共对102份活检组织进行了组织学检查以检测胃炎的存在。111名患者中有30份幽门螺杆菌培养阳性。
4周后发现症状有统计学意义的减轻，但两组相似。未发现幽门螺杆菌阳性患者的特定症状。幽门螺杆菌阳性和阴性患者对西沙必利的反应没有显著差异。西沙必利组总体反应率（63%）与安慰剂组反应率（44%）之间的差异未达到统计学意义。
在普通诊所治疗FD时，安慰剂和西沙必利之间未发现显著差异。幽门螺杆菌阳性患者没有特定症状，对西沙必利的反应也没有不同。
