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Prep Kit-C与聚乙二醇电解质散的前瞻性单盲单中心随机对照试验:潜在的炎症性肠病是否会影响耐受性和疗效?

Prospective single-blinded single-center randomized controlled trial of Prep Kit-C and Moviprep: Does underlying inflammatory bowel disease impact tolerability and efficacy?

作者信息

Mohsen Waled, Williams Astrid-Jane, Wark Gabrielle, Sechi Alexandra, Koo Jenn-Hian, Xuan Wei, Bassan Milan, Ng Watson, Connor Susan

机构信息

Department of Digestive Diseases, Gold Coast University Hospital, Gold Coast, 4215, Queensland, Australia.

Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia.

出版信息

World J Gastroenterol. 2021 Mar 21;27(11):1090-1100. doi: 10.3748/wjg.v27.i11.1090.

Abstract

BACKGROUND

Colonoscopy remains the gold standard for detection of colonic disease. An optimal evaluation depends on adequate bowel cleansing. Patients with inflammatory bowel disease (IBD), require frequent endoscopic assessment for both activity and dysplasia assessment. Two commonly used bowel preparations in Australia are Prep Kit-C (Pc) and Moviprep (Mp). Little is known about tolerability, efficacy and safety of split protocols of Mp and Pc in both IBD and non-IBD patients.

AIM

To primary aim was to compare the tolerability, efficacy and safety of split protocols of Mp and Pc in patients having a colonoscopy. The secondary aim was to compare the efficacy, tolerability and safety of either preparation in patients with or without IBD.

METHODS

Patients were randomized to Pc or Mp bowel preparation. Patients completed a questionnaire to assess tolerability. Efficacy was assessed using the Ottawa Bowel Preparation Score. Serum electrolytes and renal function were collected one week prior to colonoscopy and on the day of colonoscopy.

RESULTS

Of 338 patients met the inclusion criteria. Of 168 patients randomized to Mp and 170 to Pc. The efficacy of bowel preparation (mean Ottawa Bowel Preparation Score) was similar between Mp (5.4 ± 2.4) and Pc (5.1 ± 2.1) ( = 0.3). Mean tolerability scores were similar in Mp (11.84 ± 5.4) and Pc (10.99 ± 5.2; = 0.17). 125 patients had IBD (73 had Crohn's Disease and 52 had Ulcerative colitis). Sixty-four IBD patients were allocated to Mp and 61 to Pc. In non-IBD patients, 104 were allocated to Mp and 109 to Pc. The mean tolerability score in the IBD group was lower than the non-IBD group (mean tolerability scores: IBD: 10.3 ± 5.1 and non-IBD: 12.0 ± 5.3; = 0.01). IBD patients described more abdominal pain with Mp when compared with Pc; (Mp: 5.7 ± 4.4 Pc: 3.6 ± 2.6, = 0.046). Serum magnesium level increased with Pc compared with Mp in all patients (mean increase in mmol/L: Mp: 0.03 ± 0.117 and Pc: 0.11 ± 0.106; < 0.0001).

CONCLUSION

In this study, the efficacy, tolerability and safety of Mp and Pc were similar in all patients. However, patients with IBD reported lower tolerability with both preparations. Specifically, IBD patients had more abdominal pain with Mp. These results should be considered when recommending bowel preparation especially to IBD patients.

摘要

背景

结肠镜检查仍是结肠疾病检测的金标准。最佳评估取决于充分的肠道清洁。炎症性肠病(IBD)患者需要频繁进行内镜检查以评估疾病活动度和发育异常情况。澳大利亚常用的两种肠道准备药物是Prep Kit - C(Pc)和Moviprep(Mp)。对于IBD和非IBD患者,关于Mp和Pc的分段方案的耐受性、有效性和安全性知之甚少。

目的

主要目的是比较Mp和Pc分段方案在接受结肠镜检查患者中的耐受性、有效性和安全性。次要目的是比较这两种制剂在有或无IBD患者中的有效性、耐受性和安全性。

方法

患者被随机分配接受Pc或Mp肠道准备。患者完成一份问卷以评估耐受性。使用渥太华肠道准备评分评估有效性。在结肠镜检查前一周和结肠镜检查当天采集血清电解质和肾功能指标。

结果

338例患者符合纳入标准。168例患者被随机分配至Mp组,170例被分配至Pc组。肠道准备的有效性(平均渥太华肠道准备评分)在Mp组(5.4±2.4)和Pc组(5.1±2.1)之间相似(P = 0.3)。Mp组(11.84±5.4)和Pc组(10.99±5.2;P = 0.17)的平均耐受性评分相似。125例患者患有IBD(73例患有克罗恩病,52例患有溃疡性结肠炎)。64例IBD患者被分配至Mp组,61例被分配至Pc组。在非IBD患者中,104例被分配至Mp组,109例被分配至Pc组。IBD组的平均耐受性评分低于非IBD组(平均耐受性评分:IBD组:10.3±5.1,非IBD组:12.0±5.3;P = 0.01)。与Pc相比,IBD患者使用Mp时描述的腹痛更多;(Mp组:5.7±4.4,Pc组:3.6±2.6,P = 0.046)。与Mp相比,所有患者使用Pc后血清镁水平升高(平均升高mmol/L:Mp组:0.03±0.117,Pc组:0.11±0.106;P < 0.0001)。

结论

在本研究中,Mp和Pc在所有患者中的有效性、耐受性和安全性相似。然而,IBD患者报告这两种制剂的耐受性均较低。具体而言,IBD患者使用Mp时腹痛更多。在推荐肠道准备时,尤其是对IBD患者,应考虑这些结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e33c/7985733/2a3096bd2695/WJG-27-1090-g001.jpg

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