利那洛肽治疗便秘型肠易激综合征患者严重腹部症状的效果。
Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation.
机构信息
Section of Gastroenterology and Hepatology, Georgia Regents University, Augusta, Georgia.
Gastroenterology Division, Houston Methodist Hospital and Weill Cornell Medical College, Houston, Texas.
出版信息
Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.
BACKGROUND & AIMS: Patients with irritable bowel syndrome with constipation (IBS-C) have abdominal symptoms that vary in severity. Linaclotide, a guanylate cyclase-C agonist, improves abdominal and bowel symptoms in these patients. We examined the prevalence of severe abdominal symptoms in patients with IBS-C and assessed the effects of linaclotide on abdominal symptoms, global measures, and quality of life (QOL).
METHODS
In two phase 3 trials, patients who met modified Rome II criteria for IBS-C were randomly assigned to groups given oral, once-daily linaclotide (290 μg) or placebo for 12 weeks. During the baseline (2 weeks prior to treatment) and treatment periods, patients rated abdominal pain, discomfort, bloating, fullness, and cramping daily (from 0 = none to 10 = very severe). Linaclotide's effects on abdominal symptoms, global measures, and IBS-related QOL were assessed in subpopulations of patients who rated specific individual abdominal symptoms as severe (≥ 7.0) at baseline.
RESULTS
In the intent-to-treat population (1602 patients; 797 receiving placebo and 805 receiving linaclotide), baseline prevalence values for severe abdominal symptoms were 44% for bloating, 44% for fullness, 32% for discomfort, 23% for pain, and 22% for cramping, with considerable overlap among symptoms. In patients with severe symptoms, linaclotide reduced all abdominal symptoms; mean changes from baseline severity scores ranged from -2.7 to -3.4 for linaclotide vs -1.4 to -1.9 for placebo (P < .0001). Linaclotide improved global measures (P < .0001) and IBS-QOL scores (P < .01) compared with placebo. Diarrhea was the most common adverse event of linaclotide in patients with severe abdominal symptoms (18.8%-21.0%).
CONCLUSIONS
Of 5 severe abdominal symptoms assessed, bloating and fullness were most prevalent in patients with IBS-C. Linaclotide significantly improved all abdominal symptoms, global measures, and IBS-QOL in subpopulations of IBS-C patients with severe abdominal symptoms. Clinicaltrials.gov
NUMBERS
NCT00938717, NCT00948818.
背景与目的
便秘型肠易激综合征（IBS-C）患者的腹部症状严重程度不一。利那洛肽是一种鸟苷酸环化酶-C 激动剂，可改善此类患者的腹部和肠道症状。我们调查了 IBS-C 患者严重腹部症状的发生率，并评估了利那洛肽对腹部症状、总体评估指标和生活质量（QOL）的影响。
方法
在两项 3 期临床试验中，符合改良罗马 II 标准的 IBS-C 患者被随机分配至接受口服、每日一次利那洛肽（290μg）或安慰剂治疗 12 周的组。在基线（治疗前 2 周）和治疗期间，患者每日（从 0 分=无到 10 分=非常严重）对腹痛、不适、腹胀、饱胀和痉挛进行评分。在基线时将特定的单个腹部症状评为严重（≥7.0）的患者亚群中，评估利那洛肽对腹部症状、总体评估指标和与 IBS 相关的 QOL 的影响。
结果
在意向治疗人群（1602 例患者；797 例接受安慰剂，805 例接受利那洛肽）中，基线时严重腹部症状的发生率分别为：腹胀 44%、饱胀 44%、不适 32%、疼痛 23%和痉挛 22%，各症状之间存在较大重叠。在有严重症状的患者中，利那洛肽减轻了所有腹部症状；利那洛肽与安慰剂相比，从基线严重程度评分的平均变化范围为-2.7 至-3.4（P<0.0001）。与安慰剂相比，利那洛肽改善了总体评估指标（P<0.0001）和 IBS-QOL 评分（P<0.01）。在有严重腹部症状的患者中，腹泻是利那洛肽最常见的不良事件（18.8%-21.0%）。
结论
在评估的 5 种严重腹部症状中，腹胀和饱胀在 IBS-C 患者中最为常见。利那洛肽可显著改善有严重腹部症状的 IBS-C 患者的所有腹部症状、总体评估指标和 IBS-QOL。临床试验.gov
注册号
NCT00938717，NCT00948818。
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