Cash Brooks D, Lacy Brian E
Dr. Cash is an Associate Professor of Medicine at the Uniformed Services University of Health Sciences and also serves as Chief of the Gastroenterology Division and Colon Health Initiative at the Naval Medical Center in Bethesda, Md. Dr. Lacy is an Associate Professor of Medicine and is also the Director of the GI Motility Laboratory at the Dartmouth-Hitchcock Medical Center, Lebanon, NH.
Gastroenterol Hepatol (N Y). 2006 Oct;2(10):736-749.
Constipation is a common, often chronic, gastrointestinal disorder that can negatively impact the lives of those it affects and can be difficult to treat satisfactorily. The objective of this systematic review is to identify and analyze the available published literature on US Food and Drug Administration-approved prescription therapies for adults with constipation (episodic and chronic) and to assess their place in therapy, based on the methodologic strength and results of identified clinical trials. Ovid MEDLINE, PubMed, and EMBASE databases were used to search the published literature. Studies were included if they were randomized and prospective, conducted in adults (age ≥18), published as full-length manuscripts in English, and compared the test agent with placebo or a comparator(s). Studies were excluded if they involved patients with constipation attributed to secondary causes. Because fully published manuscripts from phase III efficacy trials involving the recently approved medication lubiprostone were not available, a manual search was performed of abstracts from the two annual major gastroenterology meetings (American College of Gastroenterology and Digestive Disease Week) from the past 4 years. Data on study design; number, age, and sex of patients; duration of treatment period; primary efficacy variable; secondary efficacy variables; adverse events; and discontinuations because of adverse events were abstracted from eligible articles. Eligible studies were assessed using well-established recommendations and a preformatted standardized form. A scoring system, with scores ranging from 1 to 15, was used to individually and separately assess the methodologic quality of the studies. Results of this analysis indicate a general lack of methodologically high-quality clinical trials supporting the use of lactulose and PEG 3350 to treat patients with chronic constipation, but data support their use in acute, episodic constipation. Conversely, high-quality evidence for tegaserod and lubiprostone in patients with chronic constipation does exist, though conclusions regarding the role in therapy for lubiprostone are still in development.
便秘是一种常见的、通常为慢性的胃肠道疾病，会对患者的生活产生负面影响，且难以得到令人满意的治疗。本系统评价的目的是识别和分析美国食品药品监督管理局批准的用于治疗成人便秘（偶发性和慢性）的处方疗法的已发表文献，并根据已识别临床试验的方法学优势和结果评估它们在治疗中的地位。使用Ovid MEDLINE、PubMed和EMBASE数据库检索已发表文献。纳入的研究需为随机前瞻性研究，研究对象为成年人（年龄≥18岁），以英文全文发表，且将受试药物与安慰剂或对照药物进行比较。如果研究涉及继发原因导致的便秘患者，则予以排除。由于涉及最近批准的药物鲁比前列酮的III期疗效试验的完整发表手稿不可得，因此对过去4年两次年度主要胃肠病学会议（美国胃肠病学会和消化系统疾病周）的摘要进行了手动检索。从符合条件的文章中提取关于研究设计、患者数量、年龄和性别、治疗期持续时间、主要疗效变量、次要疗效变量、不良事件以及因不良事件而停药的数据。使用既定的建议和预先格式化的标准化表格对符合条件的研究进行评估。采用评分系统（分数范围为1至15）分别单独评估研究的方法学质量。该分析结果表明，总体上缺乏方法学上高质量的临床试验来支持使用乳果糖和聚乙二醇3350治疗慢性便秘患者，但数据支持它们用于急性偶发性便秘。相反，对于替加色罗和鲁比前列酮治疗慢性便秘患者确实存在高质量证据，尽管关于鲁比前列酮在治疗中的作用的结论仍在形成中。
