多次递增口服剂量二甲基-APD对骨代谢动力学及安全性的初步研究

Preliminary study of multiple increasing oral doses of dimethyl-APD on bone metabolism dynamics and safety profile.

作者信息

Vega E, Mautalen C, Roldán E J, Pérez Lloret A

机构信息

Section of Bone Diseases, Hospital de Clinicas, University of Buenos Aires, Córdoba, Argentina.

出版信息

Drugs Exp Clin Res. 1994;20(3):103-8.

PMID:7956716

Abstract

A random block study, with 50, 100, 200 and 400 mg of 3-dimethylamino-1-hydroxypropylidene-1, 1-bisphosphonate or dimethyl APD and 300, 600 and 900 mg of 3-amino-1-hydroxypropylidene-1, 1-bisphosphonate or pamidronate (APD), in daily oral doses, showed that all doses were active when assessed in patients with Paget's bone disease. Dimethyl APD administration was followed by an increase in 1.25 (HO)2D levels, an effect that must be confirmed. Neither severe side effects nor significant laboratory abnormalities were detected despite some decrease in white blood cell count seen with the higher dose of APD. Gastrointestinal tolerance of dimethyl APD was acceptable but further investigation is required.

摘要

一项随机区组研究，每日口服剂量分别为50、100、200和400毫克的3-二甲基氨基-1-羟基亚丙基-1,1-双膦酸盐或二甲基APD，以及300、600和900毫克的3-氨基-1-羟基亚丙基-1,1-双膦酸盐或帕米膦酸盐（APD），结果表明，在评估佩吉特骨病患者时，所有剂量均有活性。服用二甲基APD后1,25(OH)₂D水平升高，这一效应有待证实。尽管高剂量APD会使白细胞计数有所下降，但未检测到严重副作用或显著的实验室异常。二甲基APD的胃肠道耐受性尚可，但仍需进一步研究。