Valente M, Bufalino L, Castiglione G N, D'Angelo R, Mancuso A, Galoppi P, Zichella L
1st Obstetrics and Gynecological Department, La Sapienza University, Rome, Italy.
Calcif Tissue Int. 1994 May;54(5):377-80. doi: 10.1007/BF00305522.
Ipriflavone (IP) (7-isopropoxyisoflavone), a synthetic isoflavone derivative, is active in both inhibiting bone resorption and enhancing osteoblast function. This property suggested its clinical use in the treatment of involutional osteoporosis, and in the prevention of postmenopausal bone mass loss. Forty postmenopausal women with low bone mineral content were enrolled and randomly treated for 12 months with IP 600 mg/day or placebo (PL), according to a double-blind, parallel group design. All patients wee also given an oral calcium supplementation (1 g/day). Bone mineral density (BMD) was measured at the spine (L2-L4) by dual-energy X-ray absorptiometry and at the distal radius by single-photon absorptiometry. Bone metabolism markers (serum calcium, phosphate, osteocalcin, and alkaline phosphatase, and urinary calcium, phosphate, and hydroxyproline) were assessed at the same times. After 12 months, a reduction of BMD was evidenced in the PL-treated group, at both the spine (-2.2%, P < 0.01 vs baseline) and the forearm (-1.2%). In the IP-treated group, an increase of BMD was obtained (+1.2%, P < 0.01 vs placebo, at the spine; +3%, not significant, at the forearm). Bone markers were in the normal range for postmenopausal women; no statistically significant modifications were observed during the treatment period. Three patients were withdrawn from the treatment in the IP-treated group, and two in the PL-treated group for gastrointestinal disturbances. In the other women, the tolerance of the drug was good and the compliance with the oral treatment was excellent.
依普黄酮（IP）（7-异丙氧基异黄酮）是一种合成异黄酮衍生物，在抑制骨吸收和增强成骨细胞功能方面均具有活性。这一特性表明其可用于临床治疗绝经后骨质疏松症以及预防绝经后骨质流失。根据双盲平行组设计，招募了40名低骨矿物质含量的绝经后女性，随机给予她们每天600毫克依普黄酮或安慰剂（PL），治疗12个月。所有患者还接受了口服钙剂补充（每天1克）。通过双能X线吸收法测量脊柱（L2-L4）的骨矿物质密度（BMD），通过单光子吸收法测量桡骨远端的骨矿物质密度。同时评估骨代谢标志物（血清钙、磷、骨钙素和碱性磷酸酶，以及尿钙、磷和羟脯氨酸）。12个月后，安慰剂治疗组的脊柱（-2.2%，与基线相比P<0.01）和前臂（-1.2%）的骨矿物质密度均有所降低。在依普黄酮治疗组，脊柱的骨矿物质密度有所增加（+%，与安慰剂相比P<0.01；前臂增加3%，无统计学意义）。骨标志物处于绝经后女性的正常范围内；治疗期间未观察到统计学上的显著变化。依普黄酮治疗组有3名患者因胃肠道不适退出治疗，安慰剂治疗组有2名患者退出。在其他女性中，药物耐受性良好，口服治疗的依从性极佳。
