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首页> 外文期刊>Journal of International Medical Research >Adequate Relief as an Endpoint in Clinical Trials in Irritable Bowel Syndrome
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Adequate Relief as an Endpoint in Clinical Trials in Irritable Bowel Syndrome

机译：充分缓解作为肠易激综合症临床试验的终点

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Irritable bowel syndrome is characterized by recurrent abdominal pain and altered bowel function. In designing studies to evaluate new treatments for this disease, however, it is difficult to select appropriate endpoints to reflect improvement in the range of symptoms of the syndrome. In the present study we evaluated the parameter of adequate relief of abdominal pain and discomfort, as perceived by the patients, as a key endpoint for efficacy in the treatment of patients with irritable bowel syndrome. Abdominal pain and bowel function data were collected daily from 370 patients with the disease during treatment with placebo or a novel potent 5HT3 receptor antagonist. Once every 7 days adequate relief of pain and discomfort was assessed. Quality-of-life data were collected using self-administered questionnaires. The endpoint of adequate relief was significantly (P < 0.05) correlated with improvement in pain severity scores, percentage of pain-free days, percentage of days with urgency, improvement in stool frequency and consistency, and quality-of-life parameters. Adequate relief of pain and discomfort is significantly correlated with changes in multiple parameters associated with irritable bowel syndrome and can be used as an endpoint for assessing response to therapy in these patients.
机译：肠易激综合征的特征是反复出现腹痛和肠功能改变。但是，在设计评估该疾病新疗法的研究时，很难选择合适的终点指标来反映该综合征症状范围的改善。在本研究中，我们评估了患者感觉到的足以缓解腹部疼痛和不适的参数，将其作为治疗肠易激综合症疗效的关键指标。在安慰剂或新型有效5HT3受体拮抗剂治疗期间，每天从370名患有该病的患者中收集腹部疼痛和肠功能数据。每7天评估一次疼痛和不适的充分缓解。使用自我管理的问卷收集生活质量数据。充分缓解的终点显着（P <0.05）与疼痛严重程度评分，无痛天数百分比，有急症天数百分比，大便次数和稠度改善以及生活质量参数改善相关。疼痛和不适的充分缓解与与肠易激综合症相关的多个参数的变化显着相关，并且可以用作评估这些患者对治疗反应的终点。

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