新型口服硫酸盐溶液用于结肠镜肠道准备的Ⅲ期随机对照研究
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1.国家消化系统疾病临床医学研究中心,首都医科大学附属北京友谊医院消化内科;2.天津医科大学总医院消化科;3.复旦大学附属中山医院消化科;4.中山大学附属第一医院消化科;5.江苏省人民医院消化科

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Oral sulfate solution versus polyethylene glycol for colonoscopy bowel preparation: a randomized controlled study in phase Ⅲ
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    摘要:

    目的 探讨口服硫酸盐溶液(oral sulfate solution,OSS)与聚乙二醇(polyethylene glycol,PEG)电解质散用于结肠镜检查前肠道准备的疗效。方法 全国9家中心纳入283例受试者随机应用OSS(143例)和PEG(140例)2 d分次方案进行肠道准备,进行了结肠镜检查并接受评估。主要研究终点为肠道准备成功率[独立评审中心评估波士顿肠道准备评分量表(Boston bowel preparation scale,BBPS)评分≥6分],次要研究终点包括BBPS总分和分肠段评分、研究者对肠道准备的满意度(5分制Likert量表评估),以及通过调查问卷评估患者满意度,采用Sharma量表评估患者耐受性并比较两组的依从性和安全性。结果 OSS组和PEG组肠道准备成功率分别为100.0%和99.3%[校正后差异0.7%(95%CI:-5.3%~6.7%),非劣效检验,P<0.001]。OSS组BBPS评分总分显著高于PEG组(8.1分比7.7分,P<0.001),所有分肠段BBPS也高于PEG组(右半结肠:2.4分比2.3分,P=0.002;横结肠:2.8分比2.7分,P=0.018;左半结肠:2.8分比2.7分,P=0.007)。OSS组研究者Likert评分明显高于PEG组(2.6分比2.3分,P<0.001)。OSS组总体依从性和PEG相当,但第2次给药依从性显著高于PEG(90.9%比82.6%,P=0.039)。两组患者满意度、Sharma量表评分以及出现耐受性相关症状受试者比例未见明显差异。两组安全性相当,不良事件均为轻中度。结论 OSS用于肠道准备效果和PEG相当,其具有较高的全肠段BBPS评分和研究者满意度,分次给药时患者依从性较PEG更好,耐受性和安全性与PEG相当。

    Abstract:

    Objective To compare the efficacy of oral sulfate solution (OSS) and polyethylene glycol (PEG) electrolyte powder for colonoscopy bowel preparation. Methods A total of 283 randomized patients from 9 centers in China taking OSS (n=143) or PEG (n=140) using two‑day split bowel preparation regimen received colonoscopy and assessment. The primary index was the bowel preparation success rate [global Boston bowel preparation scale (BBPS)≥ 6 by independent assessment center]. Secondary indices included BBPS global and segmental scores, investigator satisfaction (5‑point Likert scale) with the quality of bowel preparation, patient satisfaction assessed by questionnaires, and patient tolerance assessed by Sharma scale. Compliance and safety were compared between the two groups. Results The bowel preparation success rates were 100.0% for OSS and 99.3% for PEG [adjusted difference 0.7% (95%CI: -5.3% - 6.7%), P<0.001 for non-inferiority]. The BBPS global score in OSS group was significantly higher than that in PEG group (8.1 VS 7.7, P<0.001). The segment BBPS scores were also higher in OSS group than those in PEG group for all 3 segments (right colon: 2.4 VS 2.3, P=0.002; transverse colon: 2.8 VS 2.7, P=0.018; left colon: 2.8 VS 2.7, P=0.007). Investigator Likert score in the OSS group was significantly higher than that in the PEG group (2.6 VS 2.3, P<0.001). There was no significant difference in compliance between OSS and PEG, except for the second dose (90.9% VS 82.6%, P=0.039). There was no significant difference in patient satisfaction, Sharma score or proportion of patients with tolerance-related symptoms between the two groups. Safety was comparable between the two groups, and all adverse events were mild to moderate. Conclusion OSS has comparable efficacy with PEG, with higher BBPS scores in all segments, better investigator satisfaction, better compliance in split dose, and comparable patient tolerance and safety.

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宗 晔,孟凡冬,吴咏冬,等.新型口服硫酸盐溶液用于结肠镜肠道准备的Ⅲ期随机对照研究[J].中华消化内镜杂志,2022,39(4):261-266.

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  • 收稿日期:2021-01-20
  • 最后修改日期:2022-03-15
  • 录用日期:2021-02-25
  • 在线发布日期: 2022-03-31
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