Department of Endoscopy, Hospital Alemán, 1118 Buenos Aires, Argentina.
World J Gastroenterol. 2013 Aug 21;19(31):5103-10. doi: 10.3748/wjg.v19.i31.5103.
To compare the efficacy of different doses of sodium phosphate (NaP) and polyethylenglicol (PEG) alone or with bisacodyl for colonic cleansing in constipated and non-constipated patients.
Three hundred and forty-nine patients, older than 18 years old, with low risk for renal damage and who were scheduled for outpatient colonoscopy were randomized to receive one of the following preparations (prep): 90 mL of NaP (prep 1); 45 mL of NaP + 20 mg of bisacodyl (prep 2); 4 L of PEG (prep 3) or 2 L of PEG + 20 mg of bisacodyl (prep 4). Randomization was stratified by constipation. Patients, endoscopists, endoscopists' assistants and data analysts were blinded. A blinding challenge was performed to endoscopist in order to reassure blinding. The primary outcome was the efficacy of colonic cleansing using a previous reported scale. Secondary outcomes were tolerability, compliance, side effects, endoscopist perception about the necessity to repeat the study due to an inadequate colonic preparation and patient overall perceptions.
Information about the primary outcome was obtained from 324 patients (93%). There were no significant differences regarding the preparation quality among different groups in the overall analysis. Compliance was higher in the NaP preparations being even higher in half-dose with bisacodyl: 94% (prep 1), 100% (prep 2), 81% (prep 3) and 87% (prep 4) (2 vs 1, 3 and 4, P < 0.01; 1 vs 3, 4, P < 0.05). The combination of bisacodyl with NaP was associated with insomnia (P = 0.04). In non-constipated patients the preparation quality was also similar between different groups, but endoscopist appraisal about the need to repeat the study was more frequent in the half-dose PEG plus bisacodyl than in whole dose NaP preparation: 11% (prep 4) vs 2% (prep 1) (P < 0.05). Compliance in this group was also higher with the NaP preparations: 95% (prep 1), 100% (prep 2) vs 80% (prep 3) (P < 0.05). Bisacodyl was associated with abdominal pain: 13% (prep 1), 31% (prep 2), 21% (prep 3) and 29% (prep 4), (2, 4 vs 1, 2, P < 0.05). In constipated patients the combination of NaP plus bisacodyl presented higher rates of satisfactory colonic cleansing than whole those PEG: 95% (prep 2) vs 66% (prep 3) (P = 0.03). Preparations containing bisacodyl were not associated with adverse effects in constipated patients.
In non-constipated patients, compliance is higher with NaP preparations, and bisacodyl is related to adverse effects. In constipated patients NaP plus bisacodyl is the most effective preparation.
比较不同剂量的磷酸钠(NaP)和聚乙二醇(PEG)单独或与比沙可啶联合用于治疗便秘和非便秘患者的结肠清洁效果。
将 349 名年龄大于 18 岁、有低肾损伤风险且计划行门诊结肠镜检查的患者随机分为以下准备组(prep)之一:90 毫升 NaP(prep 1);45 毫升 NaP+20 毫克比沙可啶(prep 2);4 升 PEG(prep 3)或 2 升 PEG+20 毫克比沙可啶(prep 4)。根据便秘情况对患者进行分层随机分组。患者、内镜医生、内镜医生助手和数据分析师均设盲。对内镜医生进行了盲法挑战,以确保盲法的实施。主要结局是使用先前报道的量表评估结肠清洁效果。次要结局是耐受性、依从性、副作用、内镜医生对因结肠准备不足而需要重复研究的看法以及患者的整体看法。
324 名患者(93%)提供了主要结局信息。在整体分析中,不同组之间的准备质量没有显著差异。在含有比沙可啶的 NaP 制剂中,依从性更高,甚至半剂量的依从性更高:94%(prep 1)、100%(prep 2)、81%(prep 3)和 87%(prep 4)(2 与 1、3 和 4 相比,P<0.01;1 与 3、4 相比,P<0.05)。比沙可啶与 NaP 联合使用与失眠有关(P=0.04)。在非便秘患者中,不同组之间的准备质量也相似,但半剂量 PEG 加比沙可啶组的内镜医生认为需要重复研究的频率更高,而全剂量 NaP 制剂组则较低:11%(prep 4)与 2%(prep 1)(P<0.05)。该组的依从性也更高,含 NaP 制剂的依从性更高:95%(prep 1)、100%(prep 2)与 80%(prep 3)(P<0.05)。比沙可啶与腹痛有关:13%(prep 1)、31%(prep 2)、21%(prep 3)和 29%(prep 4)(2、4 与 1、2 相比,P<0.05)。在便秘患者中,NaP 加比沙可啶的结肠清洁效果满意度高于全 PEG:95%(prep 2)与 66%(prep 3)(P=0.03)。含有比沙可啶的制剂在便秘患者中没有与不良反应相关。
在非便秘患者中,NaP 制剂的依从性更高,比沙可啶与不良反应相关。在便秘患者中,NaP 加比沙可啶是最有效的制剂。