BACKGROUND:Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. OBJECTIVE:The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. METHODS:This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. RESULTS:In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p < 0.001). The treatment response rates in patients who fulfilled Rome I, II and III criteria for FD were 33.68%, 34.71% and 35.50%, respectively, after 1 week of treatment; 52.82%, 54.61% and 56.51%, respectively, after 2 weeks; 66.67%, 67.23% and 68.64%, respectively, after 3 weeks; and 72.82%, 73.54% and 75.15%, respectively, after 4 weeks. Response rates were significantly different at 1 week versus 4 weeks of treatment. Nine patients (1.54%) had adverse events: four were probably related to the study drug, three were possibly related and two were not related. Of the nine patients with adverse events, two discontinued the study drug, two suspended (i.e. temporarily discontinued the drug until the adverse event subsided) the study drug, and five continued the study drug. Seven of the nine patients with adverse events had adverse reactions (defined as adverse events considered causally related to the study drug): two improved, three recovered and two showed no change. No adverse reactions were serious enough to warrant discontinuation of therapy. CONCLUSION:Itopride was an effective and well tolerated drug in the management of FD in this patient population.

译文

背景:促动力药通常用于功能性消化不良(FD)的对症治疗。与使用诸如甲氧氯普胺,多潘立酮,西沙必利和莫沙必利等现有的动力学相关的安全性或功效问题,意味着需要一种有效且耐受性良好的促运动剂。依托必利是一种新型的促运动剂,具有双重作用方式,良好的安全性和在安慰剂对照试验中已证明的疗效。
目的:本研究的目的是评估伊托必利在FD治疗中的有效性和安全性。
方法:这是在中国各地的私人门诊进行的一项前瞻性,多中心,上市后的观察性研究。该研究包括年龄≥18岁的有症状FD患者。饭前4周,每天3次给患者开50 mg伊托必利处方,此后有2周的随访期不服用伊托必利。分析从完成4周治疗的患者获得的有效性和耐受性数据。 4周后的治疗反应率通过患者总体评估来衡量;将治疗结束时的得分与基线得分进行比较。在4周后还测量了基于症状评分的缓解率,有效治疗被定义为≥50%的症状改善。
结果:总共587例FD患者入组。 4周治疗前后总症状评分的平均值±SD差异为-5.62±3.27,与基线相比降低了69.23±26.53%(p <0.001)。治疗1周后,符合罗马I,II和III FD标准的患者的治疗反应率分别为33.68%,34.71%和35.50%。 2周后分别为52.82%,54.61%和56.51%; 3周后分别为66.67%,67.23%和68.64%; 4周后分别为72.82%,73.54%和75.15%。治疗1周和4周的缓解率显着不同。 9名患者(1.54%)发生不良事件:4例可能与研究药物有关,3例可能相关,2例无关。在这9名有不良事件的患者中,有2名停用了研究药物,有2名被暂停(即暂时停止使用该药物直到不良事件消退),还有5名继续了该研究药物。在9名发生不良事件的患者中,有7名发生了不良反应(定义为与研究药物因果相关的不良事件):2例得到改善,3例得到了恢复,2例没有变化。没有不良反应严重到足以终止治疗的程度。
结论:伊托必利是该患者人群FD治疗的有效且耐受性良好的药物。

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