Horikawa Akira, Miyakoshi Naohisa, Shimada Yoichi, Sugimura Yusuke, Kodama Hiroyuki
South Akita Orthopedic Clinic, Seiwakai, 96-2 Kaidousita, Syowa-Ookubo, Katagami, 018-1401 Japan.
Department of Orthopedic Surgery, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543 Japan.
Springerplus. 2015 Nov 5;4:675. doi: 10.1186/s40064-015-1474-9. eCollection 2015.
It has recently been reported that bisphosphonates are the most common treatment for osteoporotic patients. However, they are many problems, including poor bioavailability and adherence, as well as adverse drug reactions. Therefore, intravenous administration of bisphosphonates has been developed to resolve these problems. In Japan today, alendronate and ibandronate have been approved for intravenous administration, and they have advantages, such as good adherence and better gastrointestinal tolerability, compared to oral administration. We attempted to confirm the effects of administration of intravenous alendronate, which is not inferior to oral administration, for osteoporotic patients in earlier research. 200 consecutive Japanese over 70 years-old postmenopausal women who visited the first author's orthopedic clinic and had femoral neck or lumbar spine bone mineral density (BMD) values more than 2.5 SD lower than the reference values were randomly enrolled in this study. 100 subjects were recruited for administration of intravenous alendronates because of their poor adherence, no respond of treatment status, and gastrointestinal adverse effects. Furthermore, 10 of these subjects were excluded due to discontinuation, and a total of 90 subjects were eligible for the intravenous group. The remaining 50 patients received oral alendronate. The present study also showed no significant difference between intravenous and oral administration with respect to BMD, biochemical bone turnover markers, and the incidence of fractures. These results show that intravenous administration of alendronate is not inferior to oral alendronate for the treatment of osteoporosis. Therefore, intravenous administration of alendronate can be recommended if patients do not tolerate or adhere to oral bisphosphonates.
最近有报道称,双膦酸盐是骨质疏松症患者最常用的治疗方法。然而,它们存在许多问题,包括生物利用度差、依从性差以及药物不良反应。因此,已开发出双膦酸盐的静脉给药方式来解决这些问题。在当今的日本,阿仑膦酸钠和伊班膦酸钠已被批准用于静脉给药,与口服给药相比,它们具有诸如依从性好和胃肠道耐受性更好等优点。在早期研究中,我们试图证实静脉注射阿仑膦酸钠对骨质疏松症患者的疗效并不亚于口服给药。200名连续就诊于第一作者骨科诊所的70岁以上日本绝经后女性被随机纳入本研究,这些女性的股骨颈或腰椎骨密度(BMD)值比参考值低2.5个标准差以上。100名受试者因依从性差、治疗无反应状态和胃肠道不良反应而被招募接受静脉注射双膦酸盐。此外,其中10名受试者因停药而被排除,共有90名受试者符合静脉注射组的条件。其余50名患者接受口服阿仑膦酸钠。本研究还表明,在骨密度、生化骨转换标志物和骨折发生率方面,静脉注射和口服给药之间没有显著差异。这些结果表明,静脉注射阿仑膦酸钠在治疗骨质疏松症方面并不亚于口服阿仑膦酸钠。因此,如果患者不能耐受或不依从口服双膦酸盐,可以推荐静脉注射阿仑膦酸钠。