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首页> 外文期刊>Expert opinion on drug metabolism & toxicology >Lubiprostone: Pharmacokinetic, pharmacodynamic, safety and regulatory aspects in the treatment of constipation-predominant irritable bowel syndrome
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Lubiprostone: Pharmacokinetic, pharmacodynamic, safety and regulatory aspects in the treatment of constipation-predominant irritable bowel syndrome

机译：鲁比前列酮：治疗以便秘为主的肠易激综合征的药代动力学，药效学，安全性和调节方面

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摘要

Introduction: Lubiprostone acts locally (apical membrane of human intestinal epithelial cells) as a highly selective type-2 chloride channel activator. It was approved in the USA for chronic idiopathic constipation (January 2006) and in women aged ≥ 18 years suffering from irritable bowel syndrome with constipation (IBS-C) (April 2008). So far, the only other pro-secretory medication approved in IBS-C and currently available in USA and Europe (since August and November 2012, respectively) is linaclotide. Areas covered: This review outlines the regulatory history, pharmacokinetic, pharmacodynamic and safety data in the treatment of IBS-C with a European perspective. It is based on publicly available data, namely, published literature, drug labels and the FDA's spontaneous reporting system. Expert opinion: Although interesting pharmacodynamic data suggest that lubiprostone may have additional mechanisms of action, its beneficial effects in IBS-C must be confirmed in the actual clinical scenario taking into account the new version of European Medicines Agency's guideline. This is especially important with regard to duration of studies (recommended to be at least 6 months) to adequately assess long-term sustained efficacy, withdrawal, rebound and safety. Further research is warranted in uncertain areas (i.e., males, pediatric and elderly patients). On the basis of current data, it is still too early to draw definite conclusions on the overall risk - benefit balance for IBS-C.
机译：简介：鲁比前列酮在局部（人肠上皮细胞的顶膜）起着高度选择性的2型氯离子通道激活剂的作用。它在美国被批准用于慢性特发性便秘（2006年1月）以及年龄≥18岁且患有便秘的肠易激综合征的女性（IBS-C）（2008年4月）。迄今为止，利那洛肽是IBS-C批准并目前在美国和欧洲（分别自2012年8月和2012年11月以来）可用的其他促分泌药物。涵盖领域：本综述从欧洲角度概述了IBS-C治疗中的监管历史，药代动力学，药效动力学和安全性数据。它基于公开可用的数据，即公开的文献，药物标签和FDA的自发报告系统。专家意见：尽管有趣的药效学数据表明鲁比前列酮可能具有其他作用机制，但必须在实际临床情况中考虑新版欧洲药品管理局的指南，确认其对IBS-C的有益作用。对于研究持续时间（建议至少6个月）以充分评估长期持续疗效，戒断，反弹和安全性而言，这一点尤其重要。在不确定的地区（即男性，儿科和老年患者）有必要进行进一步的研究。根据当前数据，就IBS-C的总体风险-收益平衡得出明确的结论还为时过早。

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