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评价盐酸伊托必利治疗功能性消化不良的安全性及有效性。方法：本多中心临床试验以多潘立酮为对照，采用随机、双百平行对照的试验方法，本项临床试验共入选病例２０８例，其中入选盐酸伊托必利组１０５例，临床疗效评价病例１００例，安全性评价病例１０１例．入选多潘立酮组１０３例，临床疗效评价病例１０１例，安全性评价１０３例。盐酸伊托必利和多潘立酮的剂量分别为５０ｍｇ和 １０ｍｇ，每日三次，餐前口服，疗程２周。随机抽取５８例患者分别在治疗前后采用钡条祛进行胃排空和小肠转运时间的测定。结果：盐酸伊托必利可使ＦＤ患者诸多的消化道症状消失或得到明显改善，其疗效与多潘立酮相似（Ｐ＞０．０５）；盐酸伊托必利可以显著改善胃排空功能，与多潘立酮相比差异有显著性（Ｐ＜０．０５），同时亦可使小肠转运时间明显缩短，但与吗丁琳比较差异无显著性。药物不良反应发生率分别为１．９８％和３．９２％，二者比较差异无显著性（Ｐ＞０．０５）。结论：盐酸伊托必利是一种安全、有效的胃肠道促动力药。
To evaluate the efficacy and safety of itopride hydrochloride in the treatment of functional dyspepsia. Methods: The multi-center clinical trial of domperidone as a control, randomized, two hundred parallel control test method, the clinical trials were selected 208 cases, of which 105 cases of itopromide hydrochloride group, clinical evaluation of 100 cases , Safety evaluation of 101 cases. 103 cases were selected domperidone group, 101 cases of clinical efficacy evaluation, safety evaluation of 103 cases. Itopride hydrochloride and domperidone dose were 50mg and 10mg, three times a day, before meals, oral treatment for 2 weeks. 58 patients were randomly selected before and after treatment with barium removal of gastric emptying and intestinal transit time determination. Results: Itopride hydrochloride could relieve many gastrointestinal symptoms or improve the symptoms of FD patients. The efficacy was similar to that of domperidone (P> 0.05). Itopride hydrochloride could significantly improve gastric emptying function, Compared with the difference was significant (P <0.05), but also can significantly shorten the transit time of the small intestine, but compared with you Ding Lin no significant difference. Adverse drug reaction rates were 1.98% and 3.92%, respectively, with no significant difference (P> 0.05). Conclusion: Itopride hydrochloride is a safe and effective gastrointestinal motility drug.