摘要
目的评价健康人体对药用炭肠溶片的耐受性和安全性。方法44例健康受试者随机分入6个单次给药组和连续给药组。单次给药组分别口服药用炭肠溶片0.5g、2g、4g、6g、8g和10g。连续给药组口服药用炭肠溶片3g/次,3次/d,服用14天。观察受试者临床症状、生命体征、实验室检查等变化情况。结果4g、6g、8g组各有1例出现轻度一过性消化道症状,10g组出现1例一过性白细胞降低,3周后恢复正常。连续给药组有2例出现轻度一过性消化道症状。甲状腺功能检查显示甲状腺素有降低的趋势。结论健康受试者对药用炭肠溶片的最大耐受剂量为10g,在此剂量范围内安全性好。采用每次3g,每天3次的连续给方式,受试者药耐受性较好。
Objective To evaluate the safety and tolerance of medicinal charcoal enteric-coated tablets in healthy volunteers. Methods A total of 44 healthy volunteers were randomly divided into 6 single-dose groups （0.5 g, 2 g, 4 g, 6 g, 8 g and 10 g） and a multiple-dose group （3 g, 3 times a day, for 14 days）. The safety profile and tolerance were evaluated by observing symptoms, vital signs, and laboratory tests. Results No serious adverse event was reported for any volunteer. Abdominal distension occurred in 2 volunteers in the 4 g dose group and the 6 g dose group. One volunteer in the 8 g dose group experienced nausea and vomiting. Transient decrease in white blood cell count was observed in one volunteer in the 10 g dose group. Abdominal distension occurred in 2 volunteers of the multiple-dose group. Conclusion Based on our findings, the maximum tolerated dose of medicinal charcoal enteric-coated tablets in Chinese healthy volunteers is 10 g. The recommended dose for subsequent clinical trials is 3 g, 3 times a day.
出处
《中国循证医学杂志》
CSCD
2009年第2期204-206,共3页
Chinese Journal of Evidence-based Medicine
关键词
药用炭
肠溶片
耐受性
甲状腺功能亢进
I期临床研究
Medicinal charcoal
Enteric-coated tablet
Tolerance
Hyperthyroidism
Phase Ⅰ study
