Mangel A W, Hahn B A, Heath A T, Northcutt A R, Kong S, Dukes G E, McSorley D
Department of Gastroenterology Clinical Research, Glaxo Wellcome Inc., Research Triangle Park, NC, USA.
J Int Med Res. 1998 Mar-Apr;26(2):76-81. doi: 10.1177/030006059802600203.
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.
肠易激综合征的特点是反复出现腹痛和肠道功能改变。然而，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一系列症状的改善情况。在本研究中，我们评估了患者所感知的腹痛和不适充分缓解这一参数，将其作为治疗肠易激综合征患者疗效的关键终点指标。在370例该疾病患者接受安慰剂或新型强效5-羟色胺3（5HT3）受体拮抗剂治疗期间，每天收集腹痛和肠道功能数据。每7天评估一次疼痛和不适的充分缓解情况。使用自行填写的问卷收集生活质量数据。疼痛和不适充分缓解这一终点指标与疼痛严重程度评分的改善、无痛天数百分比、有便急症状天数百分比、排便频率和大便性状的改善以及生活质量参数显著相关（P < 0.05）。疼痛和不适的充分缓解与肠易激综合征相关的多个参数变化显著相关，可作为评估这些患者治疗反应的终点指标。
