功能性消化不良症中的伊托普里德:两个多中心,随机,双盲,安慰剂对照试验的开放标签,一年的治疗随访
Bert Broeders1, Jan Tack2, Nicholas J Talley3
1Translational Research Center for Gastrointestinal Disorders, Leuven, Belgium.
Therapeutic advances in gastroenterology
|February 24, 2025
概括
伊托普里德是一种安全有效的功能性消化不良 (FD) 的长期治疗方法,高达三分之二的患者保持了12个月的症状缓解. 这种 prokinetic 剂在 FD 患者中表现出良好的耐受性和服从性.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 功能性消化不良 (FD) 是一种普遍存在的胃肠道疾病,有效的治疗选择有限.
- 伊托普里德是一种 prokinetic 剂,通过多巴胺D2受体对抗和乙胆酶抑制起作用.
- 虽然已在多个国家获得FD的批准,但以前无法获得itopride有效性和安全性的长期数据.
研究的目的:
- 评估伊托普里德的长期安全性和评估伊托普里德在被诊断为功能性消化不良的患者中的潜在有效性.
- 为了收集有关患者在长期治疗伊托普里德时的治疗结果和耐受性的扩展数据.
主要方法:
- 进行了一项开放式的长期药物有效性研究.
- 参与者包括18-65岁的男性和女性,患有FD (罗马II标准),并没有通过内镜检测发现的结构上部胃肠道疾病.
- 患者在初始双盲治疗期后过渡到开放式延长期.
主要成果:
- 共有798名患者至少接受了一剂;69.0%完成6个月和36.8%完成12个月的治疗.
- 医生评估的应答率稳步增加,在52周达到77.9%.
- 药物表现出良好的服药性 (>95%),可接受的胃肠道副作用,并且没有临床上显著的益生素升高或心电图变化.
结论:
- 在患有功能性消化不良的患者中,伊托普里德被发现是安全的,并且可以在长达12个月的时间内耐受良好.
- 大约三分之二的患者在整个12个月的治疗期间似乎维持了症状的好处.
- 这项研究支持长期使用伊托普里德作为功能性消化不良的可行治疗选择.
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