伊托必利治疗慢性胃炎合并消化不良症状多中心、随机、双盲、平行安慰剂对照研究

目的：通过与安慰剂对照研究，评价伊托必利治疗慢性胃炎合并消化不良症状的疗效和安全性。方法：179例慢性胃炎合并消化不良症状患随机分为2组，双盲法分别接受伊托必利50mg tid或安慰剂tid治疗。疗效评价指标为(1)基线期、治疗1周和2周分别评价上腹胀、上腹不适、早饱、上腹痛、恶心、呕吐或食欲减退的总症状评分和上腹胀和早饱2项主要症状评分(0-3)；(2)胃不透X线标志物排空率；(3)受试和观察的疗效综合评价。同时评价药物不良事件发生情况和安全性。结果：伊托必剩治疗1周和2周后总症状评分和两项主要症状评分、受试和观察的疗效综合评均显优于安慰剂组(P＜0、05)。伊托必利组2周治疗结束时第5小时胃排空率显示伐于安慰剂的趋势，且无显统计学意义(P＝0．058)。伊托必利的不良反应轻微，患耐受良好。结论：伊托必利50mg tid，疗程两周，用于治疗慢性胃炎伴消化不良症状，具有良好的临床疗效及安全性。

Clinical Evaluation of Itopride for Chronic Gastritis with Dyspepsia, - A Multi - Center, Randomized, Paralleled, Placebo - Controlled Trial

Objective: To compare the efficacy and safety of itopride with placebo in patients with chronic gastritis accompanied with dyspeptic symptoms.Methods: One hundred and seventy nine patients with chronic gastritis accompanied with dyspeptic symptoms were randomized and treated in a double blind technique with itopride 50 mg tid, or placebo tid. Parameters to observe included (1) the global symptoms score (epigastric fullness, epigastric discomfort, early satiety, epigastric pain, nausea, vomiting and anorexi-a) and total symptom score of epigastric fullness & early satiety, assessed at baseline and after 1 and 2 weeks of treatment; (2) gastric emptying of radiopaque markers (%); (3) subject and investigator's global satisfactory evaluations on efficency, (4) Safety and adverse events of treatment were assessed. Results: At 1 and 2 weeks, treatment with itopride yielded significantly (all P values < 0.05) better improvement of symptoms scores, subject' s and investigator' s global satisfactory evaluations compared to placebo. As for gastric emptying test, itopride was better than placebo, although the result was not of much statistical significance (P = 0.058). Adverse effects were mild in itopride treated group, and subjects demonstrated a good clinical tolerability. Conclusion: Itopride has a good clinical efficacy and safety when administrated to subjects of chronic gastritis accompanied with dyspeptic symptoms, in 50mg tid for two weeks.