Itopride在功能性消化不良:结果两三期多中心,随机,双盲,安慰剂对照试验。

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策略Talley新泽西,J, Ptak T,古普塔R, Giguere M

Itopride在功能性消化不良:结果两三期多中心,随机,双盲,安慰剂对照试验。

肠道。2008年6月,57 (6):740 - 6。Epub 2007年10月26日。

PubMed ID

17965059 (在PubMed

]

文摘

背景:功能性消化不良(FD)是一种常见的疾病,但目前没有有效的药物治疗。Itopride, prokinetic批准在几个国家,显示有前途的功效在FD IIb阶段试验。本研究的目的是测试这种药物在FD的疗效和安全性。方法:进行了两个相似的安慰剂对照临床试验(国际和北美)。18 - 65岁的男性和女性,诊断为FD(罗马II)和没有任何相关的结构性疾病的(通过胃镜检查)招募了。幽门螺旋杆菌都是负面的,如果存在,心痛不能超过每周一个小段。检查后,病人被随机itopride每日三次,每次100毫克或相同的安慰剂。co-primary终点是:(1)全球患者疗效的评估(GPA);和(2)利兹消化不良问卷(LDQ)。症状进行评估在星期2,4,8。 Secondary measures of efficacy included Nepean Dyspepsia Index (NDI) quality of life. RESULTS: The GPA responder rates at week 8 on itopride versus placebo were similar in both trials (45.2% vs 45.6% and 37.8 vs 35.4%, respectively; p = NS). A significant benefit of itopride over placebo was observed for the LDQ responders in the International (62% vs 52.7%, p = 0.04) but not the North American trial (46.9% vs 44.8%). The safety and tolerability profile were comparable with placebo, with the exception of prolactin elevations, which occurred more frequently on itopride (18/579) than placebo (1/591). CONCLUSION: In this population with FD, itopride did not show a difference in symptom response from placebo.

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药物

Itopride