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对上海第六制药厂和辽原制药厂研制的两批法莫替丁(FT)作了临床耐量与抑酸试验。在20例(男19、女1)健康志愿者耐量试验表明:在20mg,40mg、60mg和80mg/日四组中连服7天,均无全身不良反应,对心、肝、肾无明显毒性反应。仅少数受试者出现腹胀、纳差等消化道症状。在10mg至40mg/日剂量组中,BAO抑制率分别为64.75％与80.93％,且呈明显的剂量与抑酸之递增效应;PAO之抑制率分别为75.39％与84.98％,本试验提示FT有良好的抑酸胃酸分泌作用,使用时有较大的安全性。
Two batches of famotidine (FT) developed by Shanghai No.6 Pharmaceutical Factory and Liaoyuan Pharmaceutical Factory were tested for clinical tolerance and acid suppression. In 20 volunteers (male 19, female 1), the volunteers’ tolerance test showed that there was no systemic adverse reaction even in the four groups of 20mg, 40mg, 60mg and 80mg / day for 7 days and no obvious toxicity to heart, liver and kidney reaction. Only a few subjects had bloating, anorexia and other gastrointestinal symptoms. BAO inhibitory rates were 64.75% and 80.93% in 10mg to 40mg / day dose group, respectively, with obvious dose and acid suppression increasing effect. The inhibitory rates of PAO were 75.39% and 84.98% Good inhibition of gastric acid secretion, the use of greater safety.