Sawant Prabha, Das H S, Desai Nutan, Kalokhe S, Patil S
Dept. of Gastroenterology, LTM Medical College and LTM General Hospital, Sion, Mumbai, 400 022, India.
J Assoc Physicians India. 2004 Aug;52:626-8.
Prokinetic drugs are widely used for treatment of non-ulcer dyspepsia (NUD).
To assess the efficacy and tolerability of a new prokinetic agent, itopride hydrochloride in patients of NUD and compare it with domperidone.
Fifty-six patients who fulfilled the inclusion and exclusion criteria were enrolled in the study. Patients underwent upper gastrointestinal endoscopy to rule out organic pathology as a cause for their symptoms. The patient's symptoms were graded on a 4-point scale (0 to 3) at the beginning of treatment and at the end of Week-one and Week-two Patients were randomly allocated to receive either one tablet of itopride hydrochloride 50mg three times daily or one tablet of domperidone 10mg three times daily for two weeks. Pre-treatment and post-treatment hemogram, liver function and renal function tests, prolactin level and ECG were done in all patients. The response to therapy was evaluated by assessing the relief of symptoms at the end of two weeks on a 5-point scale. Statistical analysis was done using two-tailed paired t-test; Wilcoxon matched pairs ranks sum test, Mann-Whitney-U test and chi-square test as applicable.
Of the fifty-five patients enrolled in the study (age range of 18-60 yrs, median age of 35yrs), 26 were males and twenty nine were females. They had a median duration of symptoms for 4 weeks. Twenty-seven patients received itopride and 28 received domperidone. One patient did not follow up in the domperidone group, thus 54 patients were evaluable for analysis. Moderate to complete symptomatic relief was observed in 22 (81%) patients in the itopride group and 19 patients (70%) in the domperidone group (p > 0.05, NS). Both the drugs were well tolerated and neither caused prolongation of QT interval nor any abnormality in any serum biochemistry values.
Therapy with itopride resulted in good symptomatic relief, was safe, well tolerated and comparable in efficacy to domperidone in relieving the symptoms of NUD. By virtue of its efficacy and tolerability, it could be an ideal choice for providing symptomatic relief to patients suffering from non-ulcer dyspepsia.
促动力药物广泛用于治疗非溃疡性消化不良（NUD）。
评估一种新型促动力剂盐酸伊托必利对NUD患者的疗效和耐受性，并与多潘立酮进行比较。
56例符合纳入和排除标准的患者纳入本研究。患者接受上消化道内镜检查以排除作为其症状原因的器质性病变。在治疗开始时以及第一周和第二周结束时，根据4分制（0至3分）对患者症状进行分级。患者被随机分配接受每日三次、每次一片50mg盐酸伊托必利或每日三次、每次一片10mg多潘立酮，持续两周。对所有患者进行治疗前和治疗后的血常规、肝功能和肾功能检查、催乳素水平及心电图检查。通过在两周结束时根据5分制评估症状缓解情况来评价治疗反应。根据适用情况，使用双尾配对t检验、Wilcoxon配对秩和检验、Mann-Whitney-U检验和卡方检验进行统计分析。
在纳入研究的55例患者（年龄范围18 - 60岁，中位年龄35岁）中，26例为男性，29例为女性。他们的症状中位持续时间为4周。27例患者接受伊托必利治疗，28例接受多潘立酮治疗。多潘立酮组有1例患者未随访，因此54例患者可进行分析。伊托必利组22例（81%）患者和多潘立酮组19例（70%）患者观察到中度至完全症状缓解（p>0.05，无统计学差异）。两种药物耐受性均良好，均未导致QT间期延长或任何血清生化值异常。
伊托必利治疗能有效缓解症状，安全且耐受性良好，在缓解NUD症状方面疗效与多潘立酮相当。凭借其疗效和耐受性，它可能是为非溃疡性消化不良患者提供症状缓解的理想选择。
