Mayama T, Yokota M, Shimatani I, Ohyagi H
Pharmaceutical Information & Regulatory Affairs, Meiji Seika Kaisha, Ltd., Tokyo, Japan.
Int J Clin Pharmacol Ther Toxicol. 1993 Feb;31(2):77-82.
For about 6 years after the marketing of oral formulations of fosfomycin calcium (FOM-Ca) in December, 1980, we collected the data on 35,481 cases and analyzed it regarding safety. Primary side-effects consisted mainly in gastrointestinal disturbances, damage to skin and adnexa, liver and bile duct disorders. Specifically, diarrhea, nausea, abdominal pain, anorexia, eruption and increased serum transaminase were frequent. Serious and newly detected side-effects after marketing were pseudomembranous colitis and melena, one case each. As for the oral administration of FOM-Ca to 83 patients hypertensive to beta-lactams, gastrointestinal side-effects were seen but none of them developed hypersensitivity, an allergic reaction.
1980年12月磷霉素钙口服制剂上市后的约6年时间里，我们收集了35481例病例的数据，并对其安全性进行了分析。主要副作用主要包括胃肠道不适、皮肤及附件损害、肝胆疾病。具体而言，腹泻、恶心、腹痛、厌食、皮疹及血清转氨酶升高较为常见。上市后严重且新发现的副作用为伪膜性结肠炎和黑便，各1例。对于83例对β-内酰胺类药物过敏的患者口服磷霉素钙，观察到有胃肠道副作用，但均未发生超敏反应（一种过敏反应）。
