Prucalopride improves bowel function and colonic transit time in patients with chronic constipation: an integrated analysis.
Prucalopride improves bowel function and colonic transit time in patients with chronic constipation: an integrated analysis.
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DOI：
10.1038/ajg.2014.74
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发表时间：
2014-06
影响因子：
9.8
通讯作者：
Kerstens, Rene
中科院分区：
文献类型：
--
作者：
Emmanuel, Anton;Cools, Marina;Vandeplassche, Lieve;Kerstens, Rene
便秘通常以结肠传输缓慢为特征，但结肠传输时间（CTT）与症状之间的关系尚不清楚。本研究的目的是调查 5-羟色胺受体 4 激动剂普卡必利对 CTT 的影响，并评估 CTT 与症状之间的关系。这是对普卡必利治疗慢性便秘患者的三项随机、安慰剂对照、2 期剂量探索试验的综合分析（ClinicalTrials.gov 标识符：NCT00617513；NCT00631813；和 NCT00596596）。在治疗开始和结束（4 或 12 周）时使用不透射线标记物分析 CTT 测量结果。在这些就诊中，患者评估了症状的存在和严重程度。总共有 280 名患者在治疗前和治疗结束时进行了 CTT 测量，并被纳入分析。他们的平均年龄为 43 岁，其中 93% 是女性，便秘的平均持续时间为 19 年。每日一次使用普卡必利 2mg (n=98) 和 4mg (n=70) 治疗后，CTT 分别降低 12.0h（95% 置信区间 (CI)：–18.9，–5.1）和 13.9h（95% CI：–20.5，–7.4）；安慰剂组 (n=112) 的 CTT 增加 0.5 小时 (95% CI: –4.5, 5.5)。试验结束时，与正常 CTT 患者相比，慢速或极慢 CTT（>48小时）患者的比例较高，包括腹胀/胀气/膨胀和紧张等症状被评为严重或非常严重。慢性便秘患者的 CTT 增加与症状严重程度增加之间存在明显的关系。普卡必利治疗可加速这些个体的 CTT。
Constipation is often characterized by slow colonic transit, but the relationship between colonic transit time (CTT) and symptoms is unclear. The aims of this study were to investigate the effect of prucalopride, a 5-hydroxytryptamine receptor-4 agonist, on CTT and assess the relationship between CTT and symptoms. This was an integrated analysis of three randomized, placebo-controlled, phase 2 dose-finding trials of prucalopride in patients with chronic constipation (ClinicalTrials.gov identifiers: NCT00617513; NCT00631813; and NCT00596596). Measurements of CTT were analyzed using radio-opaque markers at the start and end (4 or 12 weeks) of treatment. At these visits, patients assessed the presence and severity of their symptoms. In total, 280 patients had CTT measurements before and at the end of treatment and were included in the analysis. Their mean age was 43 years, 93% were women, and mean duration of constipation was 19 years. After a once daily treatment with prucalopride 2 mg (n=98) and 4 mg (n=70), CTT was reduced by 12.0 h (95% confidence interval (CI): –18.9, –5.1) and 13.9 h (95% CI: –20.5, –7.4), respectively; CTT increased by 0.5 h (95% CI: –4.5, 5.5) with placebo (n=112). At the end of the trial, symptoms including bloating/flatulence/distension and straining were rated as severe or very severe by a higher proportion of patients with slow or very slow CTT (>48 h) than by those with normal CTT. There was a clear relationship between increased CTT and increased symptom severity in patients with chronic constipation. Treatment with prucalopride accelerated CTT in these individuals.
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影响因子：
29.4
作者：
Metcalf, Amanda M.;Phillips, Sidney F.;Wolff, Bruce G.
通讯作者：
Wolff, Bruce G.
影响因子：
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作者：
Bharucha, Adil E.;Seide, Barbara M.;Melton, L. Joseph, III
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Melton, L. Joseph, III
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作者：
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作者：
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通讯作者：
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158.5
作者：
Camilleri, Michael;Kerstens, Rene;Vandeplassche, Lieve
通讯作者：
Vandeplassche, Lieve