阿卡波糖治疗功能性消化不良餐后相关症状的安慰剂对照试验。

OBJECTIVE

To determine the efficacy of acotiamide, an acetylcholinesterase inhibitor, in patients with functional dyspepsia (FD) in a 4-week trial.

METHODS

A multicentre, randomised, placebo-controlled, parallel-group, phase III trial was carried out, in which patients with FD received 100 mg of acotiamide or placebo three times a day for 4 weeks, with 4 weeks post-treatment follow-up. The primary efficacy end points were global assessment of overall treatment efficacy (OTE) and elimination rate of all three meal-related symptoms (postprandial fullness, upper abdominal bloating and early satiation), as derived from daily diaries. Secondary efficacy end points were individual symptom scores and quality of life. Adverse events were monitored.

RESULTS

52.2% of those receiving acotiamide and 34.8% in the placebo group (p<0.001) were classified as responders according to a global assessment of OTE. Over 4 weeks, the elimination rate for all three meal-related symptoms was 15.3% among patients receiving acotiamide compared with 9.0% in the placebo group (p=0.004). The significant benefit of acotiamide over placebo in OTE and elimination rate was maintained during the 4 week post-treatment follow-up. All other secondary efficacy end points, including quality of life, were significantly improved with 100 mg of acotiamide as compared with placebo. The number needed to treat was 6 for OTE and 16 for symptom elimination rate. The incidence of adverse events was similar between the acotiamide group and placebo group and no significant cardiovascular effects due to treatment were seen.

CONCLUSIONS

Over 4 weeks, acotiamide significantly improved symptom severity and eliminated meal-related symptoms in patients with FD.

TRIAL REGISTRATION NUMBER

http://ClinicalTrials.gov number, NCT00761358.

目的

在为期 4 周的试验中，确定乙酰胆碱酯酶抑制剂阿考替胺在功能性消化不良（FD）患者中的疗效。

方法

进行了一项多中心、随机、安慰剂对照、平行分组、III 期试验，FD 患者接受 100mg 阿考替胺或安慰剂，每天 3 次，共 4 周，治疗后 4 周随访。主要疗效终点为总体治疗疗效（OTE）的总体评估和三种与进餐相关症状（餐后饱胀、上腹胀满和早饱）的消除率，来自每日日记。次要疗效终点为各症状评分和生活质量。监测不良事件。

结果

根据 OTE 的总体评估，接受阿考替胺治疗的患者中有 52.2%，安慰剂组中有 34.8%（p<0.001）被归类为应答者。在 4 周期间，与安慰剂组相比，接受阿考替胺治疗的患者的所有三种与进餐相关症状的消除率为 15.3%，安慰剂组为 9.0%（p=0.004）。在治疗后 4 周的随访期间，阿考替胺在 OTE 和消除率方面的显著获益与安慰剂相比得以维持。与安慰剂相比，阿考替胺在 OTE 和消除率方面的所有其他次要疗效终点，包括生活质量，均显著改善。需要治疗的病例数（NNT）为 OTE 为 6，症状消除率为 16。阿考替胺组与安慰剂组的不良事件发生率相似，未观察到因治疗导致的明显心血管效应。