盐酸伊托必利治疗功能性消化不良的临床研究

Effect of itopride hydrochlonde on functional dyspepsia

目的评价盐酸伊托必利治疗功能性消化不良(FD)的疗效及安全性。方法以多潘立酮为对照药,用随机、双盲双模拟、平行对照的试验方法,治疗FD病人42例,其中试验组21例,给予盐酸伊托必利50mg,每日3次;对照组21例,给予多潘立酮10mg,每日3次,疗程4周。治疗前后记录临床症状评分、检测胃排空功能、测定空腹血浆胃动素、胆囊收缩素水平。结果盐酸伊托必利可缓解FD患者的临床症状,改善胃排空功能,提高血浆胃动素水平,且无严重药物不良反应,疗效与多潘立酮相似。结论盐酸伊托必利可安全、有效地治疗FD,其疗效与提高血浆胃动素水平有关。

Objective To evaluate the clinical safety and efficacy of itopride hydrochloride on functional dyspepsia. Methods Domperidone was used as control agent, a randomized and double-blind controlled clinical trial were performed. Forty-two patients with functional dyspepsia were randomized into 2 groups. Fifty itopride hydrochloride (trial group) was given 50 mg 3 times daily and 21 domperidone (control group) 10 mg 3 times daily to the control group, for 4 weeks. At the beginning and end of the treatment, symptom scores, gastric emptying rate and the level of plasma motilin, cholecystokinin were examined, respectively. Results Both itopride hydrochloride and domperidone improved the clinical symptoms, gastric emptying rate and the level of plasma motilin. No serious side effect was found in 2 groups. Conclusion Itopride hydrochloride is an effective and safe medicine in the treatment of functional dyspepsia. The drug effects may correlate with the improvement of the level of motilin.