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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者随机分为2组,双盲法分别接受伊托必利5smg 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)受试者和观察者的疗效综合评价。同时评价药物不良事件发生情况和安全性。结果:伊托必利治疗1周和2周后总症状评分和两项主要症状评分、受试者和观察者的疗效综合评均显著优于安慰剂组(P<0.05)。伊托必利组2周治疗结束时第5小时胃排空率显示优于安慰剂的趋势,虽无显著统计学意义(P=0.058)。伊托必利的不良反应轻微,患者耐受良好。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。
OBJECTIVE: To evaluate the efficacy and safety of itopride in treating chronic gastritis complicated with dyspepsia by comparing with placebo. Methods: One hundred and seventy-nine patients with chronic gastritis complicated with dyspepsia were randomly divided into two groups. The double-blind patients were treated with Itopride 5smg tid or placebo tid. Evaluation of efficacy indicators (1) at baseline, 1 week and 2 weeks of treatment, respectively, evaluation of abdominal distention, abdominal discomfort, fullness, upper abdominal pain, nausea, vomiting or loss of appetite, the total symptom score and abdominal distention and early satiety 2 main Symptom score (0-3); (2) Gastric impermeable X-ray marker emptying rate; (3) Comprehensive evaluation of the efficacy of subjects and observers. At the same time evaluate the occurrence and safety of adverse drug events. Results: The total symptom score and the two main symptom scores of itopride after 1 week and 2 weeks were significantly better than those of the placebo group (P <0.05). The 5-hour gastric emptying rate at the end of the 2 weeks treatment in the itopride group was superior to placebo, although not statistically significant (P = 0.058). Itopride had mild adverse reactions and patients were well tolerated. Conclusion: Itopride 50mg tid, two weeks of treatment, for the treatment of chronic gastritis with dyspepsia symptoms, has good clinical efficacy and safety.