Lippuner K
Osteoporosis Policlinic, University Hospital of Berne, 3010, Berne, Switzerland.
Eur Spine J. 2003 Oct;12 Suppl 2(Suppl 2):S132-41. doi: 10.1007/s00586-003-0608-x. Epub 2003 Sep 17.
Although osteoporosis is a systemic disease, vertebral fractures due to spinal bone loss are a frequent, sometimes early and often neglected complication of the disease, generally associated with considerable disability and pain. As osteoporotic vertebral fractures are an important predictor of future fracture risk, including at the hip, medical management is targeted at reducing fracture risk. A literature search for randomized, double-blind, prospective, controlled clinical studies addressing medical treatment possibilities of vertebral fractures in postmenopausal Caucasian women was performed on the leading medical databases. For each publication, the number of patients with at least one new vertebral fracture and the number of randomized patients by treatment arm was retrieved. The relative risk (RR) and the number needed to treat (NNT, i.e. the number of patients to be treated to avoid one radiological vertebral fracture over the duration of the study), together with the respective 95% confidence intervals (95%CI) were calculated for each study. Treatment of steroid-induced osteoporosis and treatment of osteoporosis in men were reviewed separately, based on the low number of publications available. Forty-five publications matched with the search criteria, allowing for analysis of 15 different substances tested regarding their anti-fracture efficacy at the vertebral level. Bisphosphonates, mainly alendronate and risedronate, were reported to have consistently reduced the risk of a vertebral fracture over up to 50 months of treatment in four (alendronate) and two (risedronate) publications. Raloxifene reduced vertebral fracture risk in one study over 36 months, which was confirmed by 48 months' follow-up data. Parathormone (PTH) showed a drastic reduction in vertebral fracture risk in early studies, while calcitonin may also be a treatment option to reduce fracture risk. For other substances published data are conflicting (calcitriol, fluoride) or insufficient to conclude about efficacy (calcium, clodronate, etidronate, hormone replacement therapy, pamidronate, strontium, tiludronate, vitamin D). The low NNTs for the leading substances (ranges: 15-64 for alendronate, 8-26 for risedronate, 23 for calcitonin and 28-31 for raloxifene) confirm that effective and efficient drug interventions for treatment and prevention of osteoporotic vertebral fractures are available. Bisphosphonates have demonstrated similar efficacy in treatment and prevention of steroid-induced and male osteoporosis as in postmenopausal osteoporosis. The selection of the appropriate drug for treatment of vertebral osteoporosis from among a bisphosphonate (alendronate or risedronate), PTH, calcitonin or raloxifene will mainly depend on the efficacy, tolerability and safety profile, together with the patient's willingness to comply with a long-term treatment. Although reduction of vertebral fracture risk is an important criterion for decision making, drugs with proven additional fracture risk reduction at all clinically relevant sites (especially at the hip) should be the preferred options.
尽管骨质疏松症是一种全身性疾病,但因脊柱骨质流失导致的椎体骨折却是该疾病常见、有时较早出现且常被忽视的并发症,通常会伴有严重的残疾和疼痛。由于骨质疏松性椎体骨折是未来骨折风险(包括髋部骨折风险)的重要预测指标,因此药物治疗的目标是降低骨折风险。我们在主要医学数据库中进行了文献检索,以查找针对绝经后白人女性椎体骨折药物治疗可能性的随机、双盲、前瞻性对照临床研究。对于每篇出版物,检索了至少有一处新椎体骨折的患者数量以及按治疗组随机分组的患者数量。计算了每项研究的相对风险(RR)和需治疗人数(NNT,即在研究期间为避免一例放射学椎体骨折所需治疗的患者数量)以及各自的95%置信区间(95%CI)。基于现有出版物数量较少,分别对类固醇诱导的骨质疏松症治疗和男性骨质疏松症治疗进行了综述。45篇出版物符合检索标准,从而能够分析15种不同物质在椎体水平上的抗骨折疗效。双膦酸盐,主要是阿仑膦酸盐和利塞膦酸盐,在四项(阿仑膦酸盐)和两项(利塞膦酸盐)出版物中报道,在长达50个月的治疗中持续降低了椎体骨折风险。雷洛昔芬在一项为期36个月的研究中降低了椎体骨折风险,48个月的随访数据证实了这一点。甲状旁腺激素(PTH)在早期研究中显示椎体骨折风险大幅降低,而降钙素也可能是降低骨折风险的一种治疗选择。对于其他物质,已发表的数据相互矛盾(骨化三醇、氟化物)或不足以得出疗效结论(钙、氯屈膦酸盐、依替膦酸盐、激素替代疗法、帕米膦酸盐、锶、替鲁膦酸盐、维生素D)。主要药物的低NNTs(范围:阿仑膦酸盐为15 - 64,利塞膦酸盐为8 - 26,降钙素为23,雷洛昔芬为28 - 31)证实,有有效的药物干预措施可用于治疗和预防骨质疏松性椎体骨折。双膦酸盐在治疗和预防类固醇诱导的骨质疏松症以及男性骨质疏松症方面已证明与绝经后骨质疏松症具有相似的疗效。从双膦酸盐(阿仑膦酸盐或利塞膦酸盐)、PTH、降钙素或雷洛昔芬中选择治疗椎体骨质疏松症的合适药物,将主要取决于疗效、耐受性和安全性概况,以及患者对长期治疗的依从意愿。尽管降低椎体骨折风险是决策的重要标准,但在所有临床相关部位(尤其是髋部)已证明能额外降低骨折风险的药物应是首选。