Litovitz T, Clancy C, Korberly B, Temple A R, Mann K V
National Capital Poison Center, Washington, DC 20016, USA.
J Toxicol Clin Toxicol. 1997;35(1):11-9. doi: 10.3109/15563659709001159.
Loperamide was approved for nonprescription use in 1988. While efficacy is well documented, there are few data on loperamide overdose and management.
Eight poison centers participated in a prospective study enrolling 216 patients.
Where the amount ingested was known, it ranged from 0.03 to 0.94 mg/kg. One- to 3-year-olds were involved in 57.9% of ingestions. Ingestion was unintentional in 182 cases (84.3%), including 59 patients with therapeutic errors (27.3% of all cases). Dispensing cup errors were implicated in 23 cases; 15 patients assumed the dispensing cup was the unit of measure. No symptoms developed in 63.0%; 27.8% had related symptoms. No related symptoms were life-threatening, and no fatalities occurred. The most frequent symptoms were drowsiness (15.7%), vomiting (4.2%), and abdominal pain or burning (3.7%). The frequency of related symptoms was compared in patients receiving the most frequently utilized decontamination modalities: ipecac alone, activated charcoal alone, lavage and activated charcoal, and ipecac and activated charcoal. Compared to the 112 patients who received no decontamination, only the ipecac-treated group demonstrated a significant reduction in the frequency of related symptoms; 13.9% of patients given ipecac alone (without other gastric decontamination) had related symptoms compared to 33.0% of patients who received no decontamination. Three patients received naloxone for CNS symptoms related to loperamide; two responded and the response of the third was unknown.
Within the range of doses implicated in this study (up to 0.94 mg/kg), there were no life threatening clinical effects and no fatalities. Development of a management protocol is complicated by the absence of a predictable clinical response in each dose range. The data suggest that children over six months with single acute ingestions up to 0.4 mg/kg, and possibly higher, can be safely managed at home, without gastric decontamination.
洛哌丁胺于1988年被批准非处方使用。虽然其疗效已有充分记录，但关于洛哌丁胺过量及处理的数据却很少。
8个中毒控制中心参与了一项前瞻性研究，共纳入216例患者。
已知摄入剂量范围为0.03至0.94毫克/千克。1至3岁儿童占摄入病例的57.9%。182例（84.3%）摄入为无意摄入，其中59例患者存在治疗失误（占所有病例的27.3%）。23例涉及配药杯失误；15例患者以为配药杯是计量单位。63.0%的患者未出现症状；27.8%的患者出现相关症状。无相关症状危及生命，也未发生死亡。最常见的症状为嗜睡（15.7%）、呕吐（4.2%）以及腹痛或烧灼感（3.7%）。对接受最常用去污方式的患者的相关症状发生频率进行了比较：单独使用吐根糖浆、单独使用活性炭、洗胃加活性炭以及吐根糖浆加活性炭。与112例未进行去污的患者相比，只有接受吐根糖浆治疗的组相关症状发生频率显著降低；单独使用吐根糖浆（未进行其他胃部去污）的患者中有13.9%出现相关症状，而未进行去污的患者中有33.0%出现相关症状。3例患者因与洛哌丁胺相关的中枢神经系统症状接受了纳洛酮治疗；2例有反应，第3例的反应未知。
在本研究涉及的剂量范围内（最高0.94毫克/千克），未出现危及生命的临床效应，也未发生死亡。由于每个剂量范围内缺乏可预测的临床反应，制定处理方案变得复杂。数据表明，单次急性摄入剂量达0.4毫克/千克甚至更高的6个月以上儿童可在家中安全处理，无需进行胃部去污。
