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舌下含服莨菪碱喷雾剂作为结肠镜检查的术前用药:一项随机双盲安慰剂对照试验。

Sublingual hyoscyamine spray as premedication for colonoscopy: a randomized double-blinded placebo-controlled trial.

作者信息

Chaptini Louis A, Janec Eileen M, Seltzer Gregory, Peikin Steven, Elfant Adam B

机构信息

Division of Gastroenterology and Liver Diseases, Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, Cooper University Hospital, Camden, NJ 08103, USA.

出版信息

Am J Surg. 2008 Jul;196(1):51-5. doi: 10.1016/j.amjsurg.2007.06.030. Epub 2008 Apr 24.

Abstract

BACKGROUND

Colonic motility and spasm during colonoscopy may affect duration and quality of the examination as well as patient comfort during and after the procedure. Previous studies assessing the utility of antispasmodic agents in colonoscopy demonstrated conflicting results. The aim of this study was to determine the effect of sublingual hyoscyamine spray (IB-Stat, Inkine Pharmaceutical) on the performance of colonoscopy.

METHODS

One hundred patients undergoing elective colonoscopy were randomized in a double-blind study to receive .25 mg sublingual hyoscyamine spray (n = 50: 25 men and 25 women, mean age 60) or placebo spray (n = 50: 23 men and 27 women, mean age 56) 15 to 30 minutes before the procedure. Parameters measured included time required to reach the cecum, total procedure time, endoscopist perception of colonic motility and difficulty of the procedure, and patient assessment of discomfort after the procedure. The latter parameters were measured using a 100-mm visual analog scale. A single endoscopist performed all of the procedures.

RESULTS

After adjustment for age, procedural difficulty scores and colonic motility scores were significantly lower in the hyoscyamine group compared with placebo (differences of 5.589 mm [P = .047] and 5.685 mm [P = .040], respectively). Mean time to cecal intubation and percentage of patients with discomfort were slightly lower in the hyoscyamine group (5.68 minutes/48%) compared with placebo (5.92 minutes/57.1%), although the differences were not statistically significant (P = .57 and P = .36, respectively).

CONCLUSIONS

Procedural difficulty and colonic motility scores were significantly lower in subjects who received sublingual hyoscyamine before colonoscopy.

摘要

背景

结肠镜检查期间的结肠动力和痉挛可能会影响检查的时长和质量,以及检查过程中和检查后的患者舒适度。先前评估抗痉挛药物在结肠镜检查中效用的研究结果相互矛盾。本研究的目的是确定舌下含服东莨菪碱喷雾剂(IB-Stat,英金制药公司)对结肠镜检查操作的影响。

方法

在一项双盲研究中,将100例行择期结肠镜检查的患者随机分为两组,在检查前15至30分钟,一组接受0.25毫克舌下含服东莨菪碱喷雾剂(n = 50:25名男性和25名女性,平均年龄60岁),另一组接受安慰剂喷雾剂(n = 50:23名男性和27名女性,平均年龄56岁)。测量的参数包括到达盲肠所需的时间、总操作时间、内镜医师对结肠动力和操作难度的感知,以及患者对检查后不适的评估。后一项参数使用100毫米视觉模拟量表进行测量。所有操作均由一名内镜医师完成。

结果

在对年龄进行调整后,与安慰剂组相比,东莨菪碱组的操作难度评分和结肠动力评分显著更低(差异分别为5.589毫米[P = 0.047]和5.685毫米[P = 0.040])。与安慰剂组(5.92分钟/57.1%)相比,东莨菪碱组到达盲肠插管的平均时间和出现不适的患者百分比略低(5.68分钟/48%),尽管差异无统计学意义(分别为P = 0.57和P = 0.36)。

结论

在结肠镜检查前接受舌下含服东莨菪碱的受试者的操作难度和结肠动力评分显著更低。

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