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口服磷酸钠溶液:用作结肠清洁剂的综述。

Oral sodium phosphate solution: a review of its use as a colorectal cleanser.

作者信息

Curran Monique P, Plosker Greg L

机构信息

Adis International Limited, Auckland, New Zealand.

出版信息

Drugs. 2004;64(15):1697-714. doi: 10.2165/00003495-200464150-00009.

Abstract

UNLABELLED

Oral sodium phosphate solution (Fleet Phospho-soda, Casen-Fleet Fosfosoda is a low-volume, hyperosmotic agent used as part of a colorectal-cleansing preparation for surgery, x-ray or endoscopic examination. The efficacy and tolerability of oral sodium phosphate solution was generally similar to, or significantly better than, that of polyethylene glycol (PEG) or other colorectal cleansing regimens in patients preparing for colonoscopy, colorectal surgery or other colorectal-related procedures. Generally, oral sodium phosphate solution was significantly more acceptable to patients than PEG or other regimens. The use of this solution should be considered in most patients (with the exception of those with contraindications) requiring colorectal cleansing. PHARMACOLOGICAL PROPERTIES: After the first and second 45 mL dose of oral sodium phosphate solution, the mean time to onset of bowel activity was 1.7 and 0.7 hours and the mean duration of activity was 4.6 and 2.9 hours. Bowel activity ceased within 4 hours of administration of the second dose in 83% of patients. Elevations in serum phosphorus and falls in serum total and ionised calcium from baseline occurred during the 24 hours after administration of oral sodium phosphate solution in seven healthy volunteers. These changes were not associated with significant changes in clinical assessments. The decrease in serum potassium levels after administration of oral sodium phosphate solution was negatively correlated with baseline intracellular potassium levels.

THERAPEUTIC USE

A regimen that administered the first dose of sodium phosphate on the previous evening and a second dose on the morning of the procedure (10-12 hours apart) was significantly more effective than PEG-based regimens for colorectal cleansing in preparation for colonoscopy, sigmoidoscopy or colorectal surgery. A regimen that administered both doses of oral sodium phosphate on the day prior to the procedure offered no colorectal cleansing advantage over PEG-based regimens and was significantly less effective than an oral sodium phosphate solution regimen that administered one dose on the previous evening and a second dose on the morning of the procedure. Oral sodium phosphate solution was generally as effective as other colorectal cleansing solutions (including magnesium citrate-containing regimens with sodium picosulfate). The direct costs of a diagnostic colonic examination with oral sodium phosphate solution were less than those with PEG (US465 dollars vs US503 dollars per patient; 1995 values), according to data from a US study. Oral sodium phosphate solution was significantly more effective than a commercially available tablet formulation as a colorectal cleanser prior to colonoscopy (data from one study only).

TOLERABILITY

Oral sodium phosphate solution administered as two 45 mL doses (generally 10-12 hours apart) was well tolerated in well designed trials in which adults with major comorbid conditions were excluded. Sodium phosphate-associated adverse events were mostly gastrointestinal (including abdominal pain/cramping, abdominal fullness and/or bloating, anal or perianal irritation or soreness, nausea, vomiting or hunger pains), although dizziness, weakness/fatigue, thirst, chest pain, chills, headache and sleep loss were also reported. Faecal incontinence was commonly reported in the elderly. Three doses (administered 10 minutes apart) of 15 mL of oral sodium phosphate solution, each diluted in 250 mL of clear fluid was associated with less vomiting than one 45 mL dose of the solution diluted in 250 mL of clear fluid (data from one study). In patients without major comorbid conditions, oral sodium phosphate has been associated with transient and clinically inconsequential changes in intravascular volume and electrolyte disturbances. Serious electrolyte disturbances have been associated with oral sodium phosphate administration in patients in whom sodium phosphate is contraindicated or should be use with caution (the elderly and those with bowel obstructions, small intestinal disorders, poor gut motilderly and those with bowel obstructions, small intestinal disorders, poor gut motility, renal insufficiency, cardiovascular disease or taking concomitant medication) or in patients ingesting more than the recommended dosage. Changes in the colonic mucosa have been reported in patients treated with oral sodium phosphate solution; however, the exact role of this agent in the appearance of these changes has not been fully clarified. The tolerability profile of oral sodium phosphate solution was similar to, or significantly better than, that of PEG or other colorectal cleansing regimens. Oral sodium phosphate solution was generally significantly more acceptable than PEG or other colorectal cleansing regimens. Oral sodium phosphate solution had similar tolerability, but was considered to be more acceptable than commercially available oral sodium phosphate tablets prior to colonoscopy (data from one study).

摘要

未标注

口服磷酸钠溶液(Fleet Phospho - soda、Casen - Fleet Fosfosoda)是一种小容量、高渗性制剂,用作手术、X线或内镜检查的结肠清洁准备用药的一部分。在准备结肠镜检查、结肠手术或其他结肠相关手术的患者中,口服磷酸钠溶液的疗效和耐受性通常与聚乙二醇(PEG)或其他结肠清洁方案相似,或显著优于它们。一般来说,口服磷酸钠溶液比PEG或其他方案更易为患者接受。对于大多数需要进行结肠清洁的患者(有禁忌证者除外),应考虑使用该溶液。

药理特性

在口服45 mL第一剂和第二剂磷酸钠溶液后,肠道活动开始的平均时间分别为1.7小时和0.7小时,活动的平均持续时间分别为4.6小时和2.9小时。83%的患者在服用第二剂后4小时内肠道活动停止。7名健康志愿者在服用口服磷酸钠溶液后的24小时内,血清磷升高,血清总钙和离子钙从基线水平下降。这些变化与临床评估中的显著变化无关。口服磷酸钠溶液后血清钾水平的降低与基线细胞内钾水平呈负相关。

治疗用途

对于结肠镜检查、乙状结肠镜检查或结肠手术准备中的结肠清洁,在前一晚服用第一剂磷酸钠且在检查当天上午服用第二剂(间隔10 - 12小时)的方案比基于PEG的方案显著更有效。在检查前一天服用两剂口服磷酸钠的方案与基于PEG的方案相比,在结肠清洁方面没有优势,且明显不如在前一晚服用一剂且在检查当天上午服用第二剂的口服磷酸钠溶液方案有效。口服磷酸钠溶液通常与其他结肠清洁溶液(包括含枸橼酸镁和匹可硫酸钠的方案)效果相同。根据美国一项研究的数据,使用口服磷酸钠溶液进行诊断性结肠检查的直接成本低于使用PEG(每位患者分别为465美元和503美元;1995年数值)。作为结肠镜检查前的结肠清洁剂,口服磷酸钠溶液比市售片剂制剂显著更有效(仅来自一项研究的数据)。

耐受性

在精心设计的试验中,排除患有主要合并症的成年人后,以两个45 mL剂量(通常间隔10 - 12小时)服用口服磷酸钠溶液耐受性良好。与磷酸钠相关的不良事件大多为胃肠道反应(包括腹痛/绞痛、腹部胀满和/或腹胀、肛门或肛周刺激或疼痛、恶心、呕吐或饥饿痛),不过也有头晕、虚弱/疲劳、口渴、胸痛、寒战、头痛和失眠的报告。老年人中常见大便失禁。与将45 mL一剂的溶液稀释于250 mL清澈液体中相比,将15 mL口服磷酸钠溶液分三剂(间隔10分钟)、每剂稀释于250 mL清澈液体中引起的呕吐较少(来自一项研究的数据)。在没有主要合并症的患者中,口服磷酸钠与血管内容量的短暂且临床上无关紧要的变化以及电解质紊乱有关。在禁忌使用或应谨慎使用磷酸钠的患者(老年人以及患有肠梗阻、小肠疾病、肠道蠕动不良、肾功能不全、心血管疾病或正在服用合并用药的患者)中,或在摄入超过推荐剂量的患者中,口服磷酸钠与严重电解质紊乱有关。接受口服磷酸钠溶液治疗的患者中报告有结肠黏膜变化;然而,该制剂在这些变化出现中的确切作用尚未完全阐明。口服磷酸钠溶液的耐受性特征与PEG或其他结肠清洁方案相似,或显著优于它们。口服磷酸钠溶液通常比PEG或其他结肠清洁方案更易为患者接受。在结肠镜检查前,口服磷酸钠溶液具有相似的耐受性,但被认为比市售口服磷酸钠片剂更易为患者接受(仅来自一项研究的数据)。

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