Hoy Sheridan M, Scott Lesley J, Wagstaff Antona J
Wolters Kluwer Health, Adis, Auckland, New Zealand.
Drugs. 2009;69(1):123-36. doi: 10.2165/00003495-200969010-00009.
Oral sodium picosulfate/magnesium citrate (CitraFleet; Picolax), consisting of sodium picosulfate (a stimulant laxative) and magnesium citrate (an osmotic laxative), is approved for use in adults (CitraFleet; Picolax) and/or adolescents and children (Picolax) as a colorectal cleansing agent prior to any diagnostic procedure (e.g. colonoscopy or x-ray examination) requiring a clean bowel and/or surgery. It is dispensed in powder form (sodium picosulfate 0.01 g, magnesium oxide 3.5 g, citric acid 12.0 g per sachet), with the magnesium oxide and citric acid components forming magnesium citrate when the powder is dissolved in water. In adult patients, two sachets of sodium picosulfate/magnesium citrate was at least as effective and well tolerated as oral magnesium citrate 17.7 or 35.4 g, or oral polyethylene glycol 236 g in adult patients undergoing a double-contrast barium enema procedure in three large, randomized, comparative clinical studies. In contrast, sodium picosulfate/magnesium citrate was less effective than a sodium phosphate enema preparation in two studies in patients undergoing flexible sigmoidoscopy. A similar number of patients receiving two sachets of sodium picosulfate/magnesium citrate or two 45 mL doses of oral sodium phosphate the day before a double-contrast barium enema procedure achieved satisfactory barium coating and none/minimal faecal residue in one study. However, the data from three of these studies should be interpreted with caution because the administrative regimens used differed from that recommended. Sodium picosulfate/magnesium citrate is also an effective and generally well tolerated colorectal cleansing agent in children and adolescents; the preparation was more effective than oral bisacodyl 0.01 or 0.02 g plus a sodium phosphate enema preparation in this population. Further research is thus required to accurately position sodium picosulfate/magnesium citrate and fully establish its efficacy and tolerability prior to various exploratory or surgical procedures. Nevertheless, oral sodium picosulfate/magnesium citrate provides a useful option in the preparation of the colon and rectum in adults, adolescents and children undergoing any diagnostic procedure (e.g. colonoscopy or x-ray examination) requiring a clean bowel and/or surgery. Oral sodium picosulfate/magnesium citrate acts locally in the colon as both a stimulant laxative, by increasing the frequency and the force of peristalsis (sodium picosulfate component), and an osmotic laxative, by retaining fluids in the colon (magnesium citrate component), to clear the colon and rectum of faecal contents. It is not absorbed in any detectable quantities. Sodium picosulfate is a prodrug: it is hydrolyzed by bacteria in the colon to the active metabolite 4,4'-dihydroxydiphenyl-(2-pyridyl)methane. Sodium picosulfate/magnesium citrate may be associated with a dehydrating effect, as evidenced by a reduction in bodyweight and increased haemoglobin levels; some at-risk patients may experience postural hypotension and older patients may require additional electrolytes. In three large (n >100), randomized, single-blind clinical studies, two sachets of oral sodium picosulfate/magnesium citrate was at least as effective as oral magnesium citrate 17.7 or 35.4 g, or oral polyethylene glycol 236 g as a colorectal cleansing agent in adult patients undergoing a double-contrast barium enema procedure. In contrast, sodium picosulfate/magnesium citrate was less effective than a sodium phosphate enema preparation in two studies in patients undergoing flexible sigmoidoscopy. A similar number of patients receiving two sachets of sodium picosulfate/magnesium citrate or two 45 mL doses of oral sodium phosphate the day before a double-contrast barium enema procedure achieved satisfactory barium coating and none/minimal faecal residue in one study. However, the data from three of these studies should be interpreted with caution because the administrative regimens used differed from that recommended. In children and adolescents, sodium picosulfate/magnesium citrate was significantly more effective as a colorectal cleansing agent than oral bisacodyl 0.01 or 0.02 g plus a sodium phosphate enema preparation in a randomized, single-blind study; dosages were adjusted for age in this study. Oral sodium picosulfate/magnesium citrate is generally well tolerated in adult patients undergoing various investigational colorectal procedures. Adverse events were generally mild to moderate in intensity and mainly gastrointestinal in nature (e.g. abdominal cramps/pain, nausea); other common treatment-emergent adverse events included disturbance of daily activity, headache and sleep disturbance. This combination is at least as well tolerated as oral sodium phosphate or oral polyethylene glycol, with moderate/severe nausea and vomiting occurring less frequently in sodium picosulfate/magnesium citrate recipients than in those receiving oral sodium phosphate, and abdominal bloating/pain and nausea developing less often with sodium picosulfate/magnesium citrate than polyethylene glycol therapy. The incidence of abdominal pain and sleep disturbance in sodium picosulfate/magnesium citrate versus oral magnesium citrate recipients was similar in one study, but significantly lower with sodium picosulfate/magnesium citrate in another. While the incidence of most adverse events was similar in recipients of sodium picosulfate/magnesium citrate and a sodium phosphate enema preparation, more patients receiving sodium picosulfate/magnesium citrate reported moderate/severe flatulence, incontinence and sleep disturbance, and more patients receiving the enema preparation reported rectal soreness. The tolerability profile of sodium picosulfate/magnesium citrate in patients aged >70 years is reportedly similar to that in patients aged <70 years. Abdominal pain also occurred less frequently with sodium picosulfate/magnesium citrate than with oral bisacodyl plus a sodium phosphate enema preparation in children and adolescents.
口服比沙可啶钠/枸橼酸镁(CitraFleet;Picolax),由比沙可啶钠(一种刺激性泻药)和枸橼酸镁(一种渗透性泻药)组成,已被批准用于成人(CitraFleet;Picolax)和/或青少年及儿童(Picolax),作为在任何需要清洁肠道的诊断程序(如结肠镜检查或X光检查)和/或手术前的结肠清洁剂。它以粉末形式分发(每袋含比沙可啶钠0.01g、氧化镁3.5g、柠檬酸12.0g),当粉末溶于水时,氧化镁和柠檬酸成分形成枸橼酸镁。在三项大型、随机、对照临床研究中,对于接受双重对比钡灌肠检查的成年患者,两袋比沙可啶钠/枸橼酸镁的效果和耐受性至少与口服17.7g或35.4g枸橼酸镁或口服236g聚乙二醇相当。相比之下,在两项针对接受乙状结肠镜检查患者的研究中,比沙可啶钠/枸橼酸镁的效果不如磷酸钠灌肠剂。在一项研究中,在双重对比钡灌肠检查前一天,接受两袋比沙可啶钠/枸橼酸镁或两剂45mL口服磷酸钠的患者中,达到满意钡剂涂布且无/极少粪便残留的人数相似。然而,这些研究中的三项数据应谨慎解读,因为所采用的给药方案与推荐方案不同。比沙可啶钠/枸橼酸镁在儿童和青少年中也是一种有效且一般耐受性良好的结肠清洁剂;在该人群中,该制剂比口服0.01g或0.02g比沙可啶加磷酸钠灌肠剂更有效。因此,需要进一步研究以准确确定比沙可啶钠/枸橼酸镁的定位,并在各种探索性或手术程序之前充分确定其疗效和耐受性。尽管如此,口服比沙可啶钠/枸橼酸镁为接受任何需要清洁肠道的诊断程序(如结肠镜检查或X光检查)和/或手术的成人、青少年和儿童的结肠和直肠准备提供了一种有用的选择。口服比沙可啶钠/枸橼酸镁在结肠局部起作用,既是一种刺激性泻药,通过增加蠕动频率和力度(比沙可啶钠成分),又是一种渗透性泻药,通过在结肠中保留液体(枸橼酸镁成分),以清除结肠和直肠中的粪便内容物。它不会被检测到有任何量的吸收。比沙可啶钠是一种前体药物:它在结肠中被细菌水解为活性代谢物4,4'-二羟基二苯基-(2-吡啶基)甲烷。比沙可啶钠/枸橼酸镁可能与脱水作用有关,体重减轻和血红蛋白水平升高证明了这一点;一些高危患者可能会出现体位性低血压,老年患者可能需要补充额外的电解质。在三项大型(n>100)、随机、单盲临床研究中,对于接受双重对比钡灌肠检查的成年患者,两袋口服比沙可啶钠/枸橼酸镁作为结肠清洁剂的效果至少与口服17.7g或35.4g枸橼酸镁或口服236g聚乙二醇相当。相比之下,在两项针对接受乙状结肠镜检查患者的研究中,比沙可啶钠/枸橼酸镁的效果不如磷酸钠灌肠剂。在一项研究中,在双重对比钡灌肠检查前一天,接受两袋比沙可啶钠/枸橼酸镁或两剂45mL口服磷酸钠的患者中,达到满意钡剂涂布且无/极少粪便残留的人数相似。然而,这些研究中的三项数据应谨慎解读,因为所采用的给药方案与推荐方案不同。在一项随机、单盲研究中,对于儿童和青少年,比沙可啶钠/枸橼酸镁作为结肠清洁剂比口服0.01g或0.02g比沙可啶加磷酸钠灌肠剂显著更有效;该研究中根据年龄调整了剂量。口服比沙可啶钠/枸橼酸镁在接受各种结肠研究程序的成年患者中一般耐受性良好。不良事件的强度一般为轻度至中度,主要为胃肠道性质(如腹部绞痛/疼痛、恶心);其他常见的治疗中出现的不良事件包括日常活动障碍、头痛和睡眠障碍。这种组合的耐受性至少与口服磷酸钠或口服聚乙二醇相当,接受比沙可啶钠/枸橼酸镁的患者中中度/重度恶心和呕吐的发生率低于接受口服磷酸钠的患者,比沙可啶钠/枸橼酸镁治疗时腹胀/疼痛和恶心的发生频率低于聚乙二醇治疗。在一项研究中,比沙可啶钠/枸橼酸镁与口服枸橼酸镁的患者中腹痛和睡眠障碍的发生率相似,但在另一项研究中,比沙可啶钠/枸橼酸镁的发生率显著更低。虽然比沙可啶钠/枸橼酸镁和磷酸钠灌肠剂的接受者中大多数不良事件的发生率相似,但接受比沙可啶钠/枸橼酸镁的患者中报告中度/重度肠胃胀气、失禁和睡眠障碍的更多,接受灌肠剂的患者中报告直肠酸痛的更多。据报道,年龄>70岁患者中比沙可啶钠/枸橼酸镁的耐受性与年龄<70岁患者相似。在儿童和青少年中,比沙可啶钠/枸橼酸镁引起的腹痛也比口服比沙可啶加磷酸钠灌肠剂更少。