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目的观察反复摄入3种柑桔类果汁对阿托伐他汀(ATV)在健康受试者体内药动学的影响。方法采用4周期交叉自身对照试验设计,洗脱期为2周。24名健康受试者随机分为4组,每组6人,分别给予220 mL葡萄柚汁,220 mL橙汁,220 mL桔汁和220 mL水,1 d 3次,共服用2 d。于第3天分别用220 mL葡萄柚汁,220 mL橙汁,220 mL桔汁和220 mL水送服单剂量10 mg ATV片,服药后0.5和1.5 h再分别服用220 mL葡萄柚汁,220 mL橙汁,220 mL桔汁和220 mL水,于服药后48 h内检测ATV血浆浓度。结果与对照组水相比,服用葡萄柚汁使阿托伐他汀酸的AUC0-∞增加8%(P>0.05),ρmax降低8%(P>0.05);服用橙汁使阿托伐他汀酸的AUC0-∞降低10%(P>0.05),ρmax降低27%(P>0.05);服用桔汁使阿托伐他汀酸的AUC0-∞降低13%(P>0.05),ρmax降低15%(P>0.05)。结论3种果汁未显著影响健康受试者体内ATV的药动学过程。
Objective To observe the effects of repeated ingestion of three citrus juices on the pharmacokinetics of atorvastatin (ATV) in healthy volunteers. Methods Four-cycle crossover self-controlled trial design, the elution period of 2 weeks. Twenty-four healthy subjects were randomly divided into 4 groups of 6 persons each. They were given 220 mL of grapefruit juice, 220 mL of orange juice, 220 mL of orange juice and 220 mL of water respectively for 3 days for 2 days. On the third day, 220 mL grapefruit juice, 220 mL orange juice, 220 mL orange juice and 220 mL water were respectively administered to a single dose of 10 mg ATV tablets. After 0.5 and 1.5 h, 220 mL grapefruit juice and 220 mL Orange juice, 220 mL orange juice and 220 mL water, and ATV plasma concentrations were measured within 48 h after taking the drug. Results Compared with the control group, the AUC0-∞ of atorvastatin acid was increased by 8% (P> 0.05) and ρmax by 8% (P> 0.05) when grapefruit juice was taken. Compared with the control group, AUC0-∞ decreased by 10% (P> 0.05) and ρmax decreased by 27% (P> 0.05). AUC0-∞ of atorvastatin acid decreased by 13% (P> 0.05) > 0.05). Conclusion The three juices did not significantly affect the pharmacokinetics of ATV in healthy subjects.