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新药研发前沿动态 / 医药领域趋势进展

张婷, 杨劲. 对乙酰氨基酚种族差异研究[J]. 药学进展, 2019, 43(3): 194-201.
引用本文: 张婷, 杨劲. 对乙酰氨基酚种族差异研究[J]. 药学进展, 2019, 43(3): 194-201.
ZHANG Ting, YANG Jin. Researches on Ethnic Differences of Acetaminophen[J]. Progress in Pharmaceutical Sciences, 2019, 43(3): 194-201.
Citation: ZHANG Ting, YANG Jin. Researches on Ethnic Differences of Acetaminophen[J]. Progress in Pharmaceutical Sciences, 2019, 43(3): 194-201.

对乙酰氨基酚种族差异研究

Researches on Ethnic Differences of Acetaminophen

  • 摘要: 对乙酰氨基酚是临床上常用的解热镇痛药,但是过量使用会导致肝损伤,我国临床上使用对乙酰氨基酚的剂量通常不超过每天2 g,仅是美国、日本说明书中推荐的最大日剂量的一半。分析了对乙酰氨基酚的种族敏感因素,发现东亚人种的对乙酰氨基酚药物暴露量普遍高于高加索人种,但在每日4 g的剂量下东亚人种肝损伤风险很低,在每6 h给予1 000 mg或每4 h给予650 mg的给药剂量下对乙酰氨基酚能够显著缓解疼痛,改善临床镇痛终点指标。建议在中国的临床实践下开展临床试验,探索每天4 g的剂量在中国人中的有效性和安全性。

     

    Abstract: Acetaminophen is a commonly used antipyretic analgesic in clinical practice, but its excessive use can cause liver damage. The recommended dose of acetaminophen for Chinese patients is usually no more than 2 g·d-1, which is only half of the maximum dose recommended in the US and Japanese version of package insert. We analyzed the ethnic sensitivity factors of acetaminophen and found that the drug exposure of acetaminophen in East Asians was generally higher than that in Caucasians, but the risk of liver damage in East Asians was very low at the maximum dose of 4 g · d-1. The dose regimen of 1 000 mg q6h or 650 mg q4h can significantly relieve pain and improve clinical endpoints of analgesia. We propose that it is necessary to conduct clinical trials to explore the efficacy and safety of 4 g·d-1 in Chinese population.

     

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