Agnusdei D, Adami S, Cervetti R, Crepaldi G, Di Munno O, Fantasia L, Isaia G C, Letizia G, Ortolani S, Passeri M
Institute of Internal Medicine, University of Siena, Italy.
Bone Miner. 1992 Oct;19 Suppl 1:S43-8. doi: 10.1016/0169-6009(92)90865-b.
Recently it has been demonstrated that ipriflavone (IP), an isoflavone derivative, is able to increase bone mass in patients with established postmenopausal osteoporosis (PMO). Here we present a preliminary report of a 2-year multicenter, double-blind, placebo-controlled clinical study performed in order to evaluate the efficacy and tolerability of IP in PMO. A large number of patients with PMO, referred to 12 Italian centers, was randomly divided into 2 groups and treated with oral IP (600 mg/day) or placebo (Pl). All patients received an oral Ca supplement (1 g/day). One hundred and twenty six patients completed 1 year of the study. Bone mineral density (BMD) of the distal radius, measured by DPA, serum osteocalcin (BGP), and urinary hydroxyproline excretion (HOP/Cr), were measured before and after 12 months. After 12 months, a significant increase in BMD was observed in the IP-treated group (P < 0.05). IP determined a reduction of HOP/Cr, while in Pl-treated patients a significant increase of this index, as well as of BGP, was observed. After 12 months the difference between the two groups resulted significant (P < 0.05) for BGP. The drug was well tolerated and the patients' compliance to the oral treatment resulted excellent. The results of this study indicate that IP is able to increase bone mass in patients with PMO.
最近有研究表明，异黄酮衍生物依普黄酮（IP）能够增加已确诊的绝经后骨质疏松症（PMO）患者的骨量。在此，我们给出一项为期2年的多中心、双盲、安慰剂对照临床研究的初步报告，该研究旨在评估依普黄酮治疗PMO的疗效和耐受性。大量来自12个意大利中心的PMO患者被随机分为两组，分别接受口服依普黄酮（600毫克/天）或安慰剂（Pl）治疗。所有患者均接受口服钙剂补充（1克/天）。126名患者完成了为期1年的研究。在12个月前后，通过双能X线吸收法（DPA）测量桡骨远端的骨密度（BMD），检测血清骨钙素（BGP）以及尿羟脯氨酸排泄率（HOP/Cr）。12个月后，依普黄酮治疗组的骨密度显著增加（P < 0.05）。依普黄酮使HOP/Cr降低，而在接受安慰剂治疗的患者中，该指标以及BGP均显著升高。12个月后，两组之间BGP的差异具有统计学意义（P < 0.05）。该药物耐受性良好，患者对口服治疗的依从性极佳。本研究结果表明，依普黄酮能够增加PMO患者的骨量。
