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大剂量番泻叶与传统聚乙二醇电解质溶液灌洗用于择期结肠镜检查肠道准备的比较:一项前瞻性、随机、研究者设盲试验

High-dose senna compared with conventional PEG-ES lavage as bowel preparation for elective colonoscopy: a prospective, randomized, investigator-blinded trial.

作者信息

Radaelli Franco, Meucci Gianmichele, Imperiali Gianni, Spinzi Giancarlo, Strocchi Enrico, Terruzzi Vittorio, Minoli Giorgio

机构信息

Division of Gastroenterology, Valduce Hospital, Como, Italy.

出版信息

Am J Gastroenterol. 2005 Dec;100(12):2674-80. doi: 10.1111/j.1572-0241.2005.00335.x.

Abstract

OBJECTIVE

To compare the efficacy and patient acceptance of an oral high dose of senna to conventional polyethylene glycol-electrolyte lavage solution (PEG-ES) in adults undergoing elective colonoscopy.

METHODS

Consecutive outpatients referred for elective colonoscopy were prospectively randomly assigned to receive, the day before the procedure, either 24 tablets of 12 mg senna, divided into two doses at 1 p.m. and 9 p.m. (senna group, n=191), or standard 4-L PEG-ES (PEG-ES group, n=92). The overall quality of colon cleansing (primary outcome measure) and cleansing in the right colon were evaluated using the Aronchick scoring scale (1=excellent to 4=inadequate) by the investigator/endoscopist who was blinded to the treatment assignment. Patient acceptance and the safety of the preparation were assessed by a nurse, using a structured questionnaire covering compliance with the dosing, overall tolerance of the preparation (1=none or mild discomfort to 4=severely distressing), and adverse events.

RESULTS

The quality of colon cleansing, overall tolerance of the preparation, and compliance were significantly better with senna; overall cleansing was excellent or good in 90.6% of patients in the senna group and in 79.7% in the PEG-ES group (p= 0.003). The percentage of procedures rescheduled because of insufficient colon cleansing was 7.3% in the PEG-ES group and 2.6% in the senna group (p=0.035). Multivariate logistic regression modeling showed the PEG-ES preparation as negative independent predictor of unsuccessful bowel cleansing. The incidence of adverse reactions was similar in the two groups; patients who received senna experienced significantly less nausea and vomiting, but more abdominal pain.

CONCLUSIONS

An oral high dose of senna is a valid alternative to standard PEG-ES for outpatient colonoscopy preparation.

摘要

目的

比较口服高剂量番泻叶与传统聚乙二醇电解质灌洗液(PEG-ES)对择期行结肠镜检查的成年人的疗效及患者接受度。

方法

将连续转诊来行择期结肠镜检查的门诊患者前瞻性随机分组,在检查前一天,一组服用24片12毫克的番泻叶,于下午1点和晚上9点分两次服用(番泻叶组,n = 191),另一组服用标准的4升PEG-ES(PEG-ES组,n = 92)。由对治疗分组不知情的研究者/内镜医师使用Aronchick评分量表(1 = 优秀至4 = 不足)评估结肠清洁的总体质量(主要结局指标)以及右半结肠的清洁情况。由护士使用结构化问卷评估患者对准备工作的接受度和安全性,问卷内容包括服药依从性、对准备工作的总体耐受性(1 = 无或轻度不适至4 = 极度痛苦)以及不良事件。

结果

番泻叶组的结肠清洁质量、对准备工作的总体耐受性和依从性明显更好;番泻叶组90.6%的患者总体清洁情况为优秀或良好,PEG-ES组为79.7%(p = 0.003)。因结肠清洁不足而重新安排检查的比例,PEG-ES组为7.3%,番泻叶组为2.6%(p = 0.035)。多变量逻辑回归模型显示,PEG-ES准备是肠道清洁不成功的负性独立预测因素。两组不良反应的发生率相似;服用番泻叶的患者恶心和呕吐明显较少,但腹痛较多。

结论

口服高剂量番泻叶是门诊结肠镜检查准备工作中标准PEG-ES的有效替代方法。

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