Oliveira L, Wexner S D, Daniel N, DeMarta D, Weiss E G, Nogueras J J, Bernstein M
Department of Colorectal Surgery, Cleveland Clinic Florida, Fort Lauderdale 33309, USA.
Dis Colon Rectum. 1997 May;40(5):585-91. doi: 10.1007/BF02055384.
The aim of this study was to compare the cleansing ability, patient compliance, and safety of two oral solutions for elective colorectal surgery.
All eligible patients were prospectively randomized to receive either 4 l of standard polyethylene glycol (PEG) solution or 90 ml of sodium phosphate (NaP) as mechanical bowel preparation for colorectal surgery. A detailed questionnaire was used to assess patient compliance. In addition, the surgeons, blinded to the preparation, intraoperatively evaluated its quality. Postoperative septic complications were also assessed. The calcium serum level was monitored before and after bowel preparation. Statistical analysis was performed using the Wilcoxon's rank-sum test and Fisher's exact test.
Two hundred patients, well matched for age, gender, and diagnosis, were prospectively randomized to receive either PEG or NaP solutions for elective colorectal surgery. All patients completed all phases of the trial. There was a significant decrease in serum calcium levels after administration of both NaP (mean, 9.3-8.8 mg/dl) and PEG (9.2-8.9 mg/dl), respectively (P < 0.0001), with no clinical sequelae. However, patient tolerance to NaP was superior to PEG: less trouble drinking the preparation (17 vs. 32 percent; P < 0.0002), less abdominal pain (12 vs. 22 percent; P = 0.004), less bloating (7 vs. 28 percent), and less fatigue (8 vs. 17 percent), respectively. Additionally, 65 percent of patients who received the NaP preparation stated they would repeat this preparation again compared with only 25 percent for the PEG group (P < 0.0001). Ninety-five percent of patients who received the NaP solution tolerated 100 percent of the solution compared with only 37 percent of the PEG group (P < 0.0001). For quality of cleansing, surgeons scored NaP as "excellent" or "good" in 87 compared with 76 percent after PEG (P = not significant). Rates of septic and anastomotic complications were 1 percent and 1 percent for NaP and 4 percent and 1 percent for PEG, respectively (P = not significant).
Both oral solutions proved to be equally effective and safe. However, patient tolerance of the small volume of NaP demonstrated a clear advantage over the traditional PEG solution.
本研究旨在比较两种用于择期结直肠手术的口服溶液的清洁能力、患者依从性和安全性。
所有符合条件的患者被前瞻性随机分组，分别接受4升标准聚乙二醇（PEG）溶液或90毫升磷酸钠（NaP）作为结直肠手术的机械性肠道准备。使用详细的问卷评估患者依从性。此外，对准备情况不知情的外科医生在术中评估其质量。还评估了术后感染性并发症。在肠道准备前后监测血清钙水平。使用Wilcoxon秩和检验和Fisher精确检验进行统计分析。
200例年龄、性别和诊断匹配良好的患者被前瞻性随机分组，接受PEG或NaP溶液用于择期结直肠手术。所有患者均完成了试验的所有阶段。给予NaP（平均，9.3 - 8.8毫克/分升）和PEG（9.2 - 8.9毫克/分升）后，血清钙水平均显著下降（P < 0.0001），且无临床后遗症。然而，患者对NaP的耐受性优于PEG：饮用准备溶液时的不适感更少（17%对32%；P < 0.0002），腹痛更少（12%对22%；P = 0.004），腹胀更少（7%对28%），疲劳感更少（8%对17%）。此外，接受NaP准备的患者中有65%表示会再次使用这种准备方法，而PEG组仅为25%（P < 0.0001）。接受NaP溶液的患者中有95%能耐受全部溶液，而PEG组仅为37%（P < 0.0001）。对于清洁质量，外科医生将NaP评为“优秀”或“良好”的比例为87%，而PEG组为76%（P = 无显著差异）。NaP组和PEG组的感染性并发症发生率和吻合口并发症发生率分别为1%和1%以及4%和1%（P = 无显著差异）。
两种口服溶液均被证明同样有效且安全。然而，患者对小剂量NaP的耐受性相对于传统PEG溶液具有明显优势。
