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磷酸钠片与聚乙二醇溶液用于结肠镜检查肠道准备的随机对照试验

Randomized controlled trial of sodium phosphate tablets vs polyethylene glycol solution for colonoscopy bowel cleansing.

作者信息

Jung Yoon Suk, Lee Chang Kyun, Kim Hyo Jong, Eun Chang Soo, Han Dong Soo, Park Dong Il

机构信息

Yoon Suk Jung, Dong Il Park, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 110-746, South Korea.

出版信息

World J Gastroenterol. 2014 Nov 14;20(42):15845-51. doi: 10.3748/wjg.v20.i42.15845.

Abstract

AIM

To compare efficacy, patient compliance, acceptability, satisfaction, safety, and adenoma detection rate of sodium phosphate tablets (NaP, CLICOLON(TM)) to a standard 4 L polyethylene glycol (PEG) solution for bowel cleansing for adults undergoing colonoscopy.

METHODS

In this multicenter, randomized, prospective, investigator-blind study, the relatively young (19-60 years) healthy outpatients without comorbidity were randomly assigned to one of two arms. All colonoscopy were scheduled in the morning. The NaP group was asked to take 4 tablets, 5 times the evening before and 4 tablets, 3 times early on the morning of the colonoscopy. The PEG group was asked to ingest 2 L of solution the evening before and 2 L early in the morning of the procedure. Adequacy of bowel preparation was scored using the Boston bowel preparation scale.

RESULTS

No significant differences were observed between the NaP group (n = 158) and PEG group (n = 162) in bowel cleansing quality (adequate preparation 93.0% vs 92.6%, P = 0.877), patient compliance (P = 0.228), overall adverse events (63.3% vs 69.1%, P = 0.269), or adenoma detection rate (34.8% vs 35.2%, P = 0.944). Patient acceptability, satisfaction, and patient rating of taste were higher in the NaP group than in the PEG group (P < 0.001).

CONCLUSION

NaP tablets, compared with PEG solution, produced equivalent colon cleansing, did not cause more side effects, and had better patient acceptability and satisfaction in the relatively young (age < 60 years) healthy individuals without comorbidity. An oral tablet formulation could make bowel preparation less burdensome, resulting in greater patient participation in screening programs.

摘要

目的

比较磷酸钠片(NaP,CLICOLON™)与标准4L聚乙二醇(PEG)溶液用于成人结肠镜检查肠道准备时的疗效、患者依从性、可接受性、满意度、安全性及腺瘤检出率。

方法

在这项多中心、随机、前瞻性、研究者盲法研究中,将相对年轻(19 - 60岁)且无合并症的健康门诊患者随机分为两组。所有结肠镜检查均安排在上午进行。NaP组患者被要求在结肠镜检查前一晚分5次服用4片药,检查当天清晨分3次服用4片药。PEG组患者被要求在检查前一晚摄入2L溶液,检查当天清晨再摄入2L溶液。使用波士顿肠道准备量表对肠道准备的充分程度进行评分。

结果

NaP组(n = 158)和PEG组(n = 162)在肠道清洁质量(充分准备率93.0%对92.6%,P = 0.877)、患者依从性(P = 0.228)、总体不良事件(63.3%对69.1%,P = 0.269)或腺瘤检出率(34.8%对35.2%,P = 0.944)方面均未观察到显著差异。NaP组患者的可接受性、满意度及口感评分均高于PEG组(P < 0.001)。

结论

与PEG溶液相比,磷酸钠片在相对年轻(年龄< 60岁)且无合并症的健康个体中能产生同等的结肠清洁效果,不会引起更多副作用,且患者接受性和满意度更高。口服片剂剂型可使肠道准备负担减轻,从而提高患者参与筛查项目的积极性。

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