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一项比较传统清洁灌肠剂、聚乙二醇电解质散和复方聚乙二醇电解质散用于钡剂灌肠肠道准备的双盲临床试验。

A blinded clinical trial comparing conventional cleansing enema, Pico-salax and Golytely for barium enema bowel preparation.

作者信息

Lai A K, Kwok P C, Man S W, Lau R S, Chan S C

机构信息

Diagnostic Radiology Department, Queen Elizabeth Hospital, Kowloon, Hong Kong.

出版信息

Clin Radiol. 1996 Aug;51(8):566-9. doi: 10.1016/s0009-9260(96)80137-1.

Abstract

UNLABELLED

An evaluator-blinded randomized clinical trial was undertaken to assess the effectiveness and patient acceptance of three bowel cleansing regimens: conventional cleansing enema, Pico-salax and Golytely.

PATIENTS AND METHODS

One hundred and fifty patients, referred for barium enema examination, were allocated to one of the three regimens. Both the radiographers and the radiologists did not know the method of preparation. Radiographers were requested to enter the patients' data, the number of bowel openings, the patients' comments of the preparation and side effects. Films were reviewed independently by two experienced radiologists for the degree of bowel cleanliness and quality of barium coating.

RESULTS

The mean (standard deviation) of bowel opening frequency for the cleansing enema, Pico-Salax and Golytely were 3.6(4.4), 8.3(4.8) and 7.1(4.2), respectively, with less bowel opening in the cleansing enema. There was less nausea associated with the cleansing enema (P = 0.006), more vomiting with Golytely (P = 0.008), less abdominal fullness with Pico-salax (P = 0.0006), less anorectal irritation with Golytely (P = 0.025), and no difference in the abdominal pain amongst three groups. There was no statistically significant difference in the number of bowel openings between the groups. Patients found that Pico-salax tasted better than Golytely (P = 0.0094) and Golytely was less accepted in the amount of fluid intake (P = 0.0018 and P < 0.0002 comparing Golytely with the cleansing enema and Pico-salax). Chi-squared testing showed no statistically significant difference in bowel cleanliness and quality of barium coating among the three preparations.

CONCLUSIONS

There was no difference in the effectiveness of the three regimens. Pico-salax seems the most acceptable because it has the fewest side effects.

摘要

未标注

开展了一项评估者盲法随机临床试验,以评估三种肠道清洁方案(传统清洁灌肠、聚乙二醇电解质散和复方聚乙二醇电解质散)的有效性及患者接受度。

患者与方法

150例因钡灌肠检查前来就诊的患者被分配至三种方案中的一种。放射技师和放射科医生均不知道准备方法。要求放射技师录入患者数据、排便次数、患者对准备过程的评价及副作用。由两名经验丰富的放射科医生独立审查钡剂造影X线片,以评估肠道清洁程度和钡剂涂布质量。

结果

清洁灌肠、聚乙二醇电解质散和复方聚乙二醇电解质散的平均(标准差)排便频率分别为3.6(4.4)、8.3(4.8)和7.1(4.2),清洁灌肠的排便次数较少。清洁灌肠引起的恶心较少(P = 0.006),复方聚乙二醇电解质散引起的呕吐较多(P = 0.008),聚乙二醇电解质散引起的腹部胀满较少(P = 0.0006),复方聚乙二醇电解质散引起的肛门直肠刺激较少(P = 0.025),三组之间腹痛无差异。各组间排便次数无统计学显著差异。患者发现聚乙二醇电解质散的味道比复方聚乙二醇电解质散更好(P = 0.0094),复方聚乙二醇电解质散在液体摄入量方面的接受度较低(与清洁灌肠和聚乙二醇电解质散相比,复方聚乙二醇电解质散的P = 0.0018和P < 0.0002)。卡方检验显示三种制剂在肠道清洁程度和钡剂涂布质量方面无统计学显著差异。

结论

三种方案的有效性无差异。聚乙二醇电解质散似乎是最可接受的,因为其副作用最少。

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