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全肠道灌洗对乙酰氨基酚制剂药代动力学及不透射线标记物在胃肠道推进的影响。

Effect of whole bowel irrigation on the pharmacokinetics of an acetaminophen formulation and progression of radiopaque markers through the gastrointestinal tract.

作者信息

Ly Binh T, Schneir Aaron B, Clark Richard F

机构信息

Division of Medical Toxicology, Department of Emergency Medicine, University of California-San Diego Medical Center, California Poison Control System, San Diego Division, San Diego, CA 92103-8925, USA.

出版信息

Ann Emerg Med. 2004 Feb;43(2):189-95. doi: 10.1016/s0196-0644(03)00720-0.

Abstract

STUDY OBJECTIVES

We describe the effects of whole bowel irrigation on a delayed-release acetaminophen preparation. We compare the mechanical effect of whole bowel irrigation on the progression of radiopaque markers through the gastrointestinal tract between an experimental and a control group.

METHODS

We performed a 2-armed, prospective, randomized, crossover volunteer study. In the experimental phase, subjects were administered a delayed-release acetaminophen preparation (75 mg/kg) along with a capsule containing radiopaque markers. We initiated whole bowel irrigation at 30 minutes after ingestion and continued until the rectal effluent was clear. Serum acetaminophen concentrations were measured at baseline and from 0.5 to 8 hours. Abdominal radiographs were obtained at the completion of whole bowel irrigation. In the control phase, whole bowel irrigation was not performed. The primary outcome measure was the effect on the area under the acetaminophen concentration versus time curve (AUC) between the 2 groups.

RESULTS

Ten subjects participated in the study. We found an 11.5% reduction in the AUC, with the majority of the effect occurring in the delayed-release portion of the curve after the 2-hour mark. This reduction, however, was not statistically significant. Radiographs obtained at the end of whole bowel irrigation revealed radiopaque markers sequestered in the right hemicolon in 8 of 10 subjects. No discernible pattern was noted in the control arm.

CONCLUSION

The effect of whole bowel irrigation on reduction of AUC for delayed-release acetaminophen preparation was not statistically significant. Whole bowel irrigation did appear to have a mechanical effect on the progression of radiopaque markers through the gastrointestinal tract, but the clinical significance of this finding is not clear.

摘要

研究目的

我们描述了全肠道灌洗对缓释对乙酰氨基酚制剂的影响。我们比较了实验组和对照组中全肠道灌洗对不透射线标记物在胃肠道中推进的机械作用。

方法

我们进行了一项双臂、前瞻性、随机、交叉志愿者研究。在实验阶段,给受试者服用缓释对乙酰氨基酚制剂(75毫克/千克)以及一粒含有不透射线标记物的胶囊。在摄入后30分钟开始全肠道灌洗,并持续至直肠流出物变清。在基线以及0.5至8小时期间测量血清对乙酰氨基酚浓度。在全肠道灌洗结束时拍摄腹部X光片。在对照阶段,不进行全肠道灌洗。主要结局指标是两组之间对乙酰氨基酚浓度-时间曲线下面积(AUC)的影响。

结果

10名受试者参与了该研究。我们发现AUC降低了11.5%,大部分影响发生在2小时标记之后曲线的缓释部分。然而,这种降低没有统计学意义。全肠道灌洗结束时拍摄的X光片显示,10名受试者中有8人在右半结肠中有不透射线标记物滞留。在对照组未观察到明显模式。

结论

全肠道灌洗对缓释对乙酰氨基酚制剂AUC降低的影响没有统计学意义。全肠道灌洗似乎确实对不透射线标记物在胃肠道中的推进有机械作用,但这一发现的临床意义尚不清楚。

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