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同一天准备聚乙二醇电解质散加柠檬酸镁与当天行结肠镜检查肠道准备的疗效和安全性:多中心、单臂、开放标签研究。

Efficacy and safety of same-day preparation with sodium picosulfate plus magnesium citrate on the day of colonoscopy for bowel preparation: Multicenter, single-arm, open-label study.

机构信息

Department of Internal Medicine, Division of Gastroenterology, Kobe University Graduate School of Medicine, Kobe, Japan.

Division of Gastroenterology, International Clinical Cancer Research Center, Kobe University, Kobe, Japan.

出版信息

J Gastroenterol Hepatol. 2024 Oct;39(10):2151-2157. doi: 10.1111/jgh.16660. Epub 2024 Jun 20.

Abstract

BACKGROUND AND AIM

Sodium picosulfate plus magnesium citrate (SP + MC) is a well-tolerated bowel preparation agent. However, Japan currently approves only two methods of taking SP + MC: the day-before and split-dose preparation, without approval of same-day preparations. This study aimed to evaluate the efficacy and safety of same-day SP + MC preparations.

METHODS

This was a multicenter, single-arm, nonrandomized, open-label study. We enrolled 145 Japanese patients between June and December 2023. The patients received two sachets of SP + MC dissolved in 300 ml of water and 1200 mL or more of clear liquid on the day of colonoscopy. Bowel cleansing efficacy, adverse events (AEs), and patient satisfaction were evaluated.

RESULTS

Of the enrolled patients, 137 underwent colonoscopy according to our protocol. Bowel preparation was adequate in 133 patients (97.1%). The mean total Boston Bowel Preparation Score was 8.3 ± 1.2. Five patients experienced AEs (3.6%): two (1.5%), abdominal pain; one (0.73%), ischemic enteritis; one (0.73%), vomiting or nausea; and one (0.73%), headache. All AEs were treated conservatively. None of the patients exhibited abnormal blood test results or clinical symptoms after receiving SP + MC. Regarding patient satisfaction, all patients were able to take SP + MC as directed; 136 (99.2%) expressed a preference for this bowel preparation for future colonoscopies.

CONCLUSION

The same-day SP + MC preparation showed high bowel-cleansing efficacy and satisfaction in Japanese patients without serious AEs.

摘要

背景与目的

聚乙二醇 4000 钠散联合枸橼酸镁(SP+MC)是一种耐受性良好的肠道准备药物。然而,日本目前仅批准 SP+MC 的两种服用方法:前一天和分剂量准备,而不批准同日准备。本研究旨在评估同日 SP+MC 准备的疗效和安全性。

方法

这是一项多中心、单臂、非随机、开放标签研究。我们在 2023 年 6 月至 12 月期间招募了 145 名日本患者。患者在结肠镜检查当天将两袋 SP+MC 溶解在 300ml 水中,并饮用 1200ml 或更多的澄清液体。评估肠道清洁效果、不良事件(AE)和患者满意度。

结果

在纳入的患者中,有 137 名根据我们的方案进行了结肠镜检查。133 名患者(97.1%)的肠道准备充分。总波士顿肠道准备评分的平均值为 8.3±1.2。五名患者发生了 AE(3.6%):两名(1.5%)腹痛;一名(0.73%)缺血性肠炎;一名(0.73%)呕吐或恶心;一名(0.73%)头痛。所有 AE 均经保守治疗。接受 SP+MC 后,无患者出现异常的血液检查结果或临床症状。关于患者满意度,所有患者均能按指示服用 SP+MC;136 名(99.2%)表示他们更喜欢这种肠道准备用于未来的结肠镜检查。

结论

在日本患者中,同日 SP+MC 准备显示出较高的肠道清洁效果和满意度,且无严重 AE。

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