An extended study of indomethacin. I. Clinical pharmacology.
An extended study of indomethacin. I. Clinical pharmacology.
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吲哚美辛的扩展研究。
DOI：
10.1001/jama.1966.03100070075022
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发表时间：
1966
期刊：
影响因子：
--
通讯作者：
N. Rothermich
中科院分区：
文献类型：
--
作者：
N. Rothermich
在234例患者的长期治疗试验和6例患者的大剂量急性毒性试验中，研究了吲哚美辛对人体的影响。副作用仅限于中枢神经系统（CNS），症状为头痛、眩晕、头晕目眩和感觉障碍，以及胃肠道系统，症状为上腹痛、痉挛和消化性溃疡。CNS副作用相当频繁，总发生率达到47.1%，20%的患者严重到需要停药。这些副作用是暂时性的，没有残留或后遗症，停药后立即消失。胃肠道症状不太常见，只有12.5%的患者严重到需要停药。副作用的高发生率受到本实验研究中使用的极高剂量的影响;临床治疗中的发生率将低得多。未发现其他并发症或副作用。
The effects of indomethacin were studied in the human on long-term therapy in 234 patient-trials and on largedose, acute toxicity trials in six patients. Side effects were limited to the central nervous system (CNS), with symptoms of headache, vertigo, light-headedness, and disturbed sensorium, and to the gastrointestinal system, with symptoms of epigastric pain, cramping, and peptic ulceration. The CNS side effects were quite frequent, reaching a total incidence of 47.1% and were severe enough in 20% to require discontinuance of the drug. These side effects are of a transient nature without residuals or sequelae and disappear promptly on cessation of the drug. The gastrointestinal symptoms were less frequent, and in only 12.5% were they severe enough to warrant cessation of the drug. The high incidence of side effects was influenced by the exceptionally high doses used in this experimental study; the incidence in clinical therapy would be much lower. No other complications or side effects could be detected.