Guaydier-Souquières G, Kotzki P O, Sabatier J P, Basse-Cathalinat B, Loeb G
CHU Côte de Nacre, Caen, France.
Osteoporos Int. 1996;6(2):171-7. doi: 10.1007/BF01623943.
The efficacy of a monofluorophosphate-calcium combination (MFP-Ca) in increasing lumbar bone mineral density (BMD) was assessed in a prospective double-masked study. Patients (n = 35), who had been treated for 1 year or more with prednisone-equivalent doses > or = 7 mg/day for asthma or other respiratory diseases, were randomly assigned to receive twice a day, for 2 years, either one MFP-Ca tablet [100 mg sodium monofluorophosphate (13.2 mg F-) + 500.5 mg Ca2+] or one Ca tablet (500.5 mg Ca2+). BMD was measured from L2 to L4 using a dual photon absorptiometer. The eligible patients (7 premenopausal women, 21 men), who had no previous vertebral fractures and were aged 46.5 (21-65) years, had received 18 (7.5-60) mg prednisone-equivalent/day and had a mean lumbar BMD of 0.917 +/- 0.141 g/cm2 at baseline (MO); in these 28 patients, the mean increase in lumbar BMD at final assessment was significantly greater in the MFP-Ca group (p = 0.05; Mann-Whitney). There was also a significant difference after 2 years between the two groups (p = 0.05, ANOVA) in favour of MFP-Ca, with an increase in lumbar BMD of 11% (MFP-Ca) compared with 1% (Ca); thus, with MFP-Ca, lumbar BMD increased by an average of approximately 5.5%/year. There was no statistically significant difference between the two groups in doses of corticosteroids used during the 2 study years, rate of vertebral fractures, or frequency of side-effects (which were all minor). No bone fissure was observed. Thus, the daily dose of 200 mg monofluorophosphate (26.4 mg F-) combined with 1 g Ca2+ in patients with long-term corticosteroid-treated respiratory diseases appears to be a safe and efficient way of increasing lumbar BMD, suggesting that its use should be further studied in corticosteroid-induced osteoporosis.
在一项前瞻性双盲研究中评估了单氟磷酸钙组合(MFP-Ca)增加腰椎骨密度(BMD)的疗效。35例因哮喘或其他呼吸系统疾病接受泼尼松等效剂量≥7mg/天治疗1年或更长时间的患者,被随机分配,每天两次,持续2年,分别服用一片MFP-Ca片[100mg单氟磷酸钠(13.2mg氟离子)+500.5mg钙离子]或一片钙片(500.5mg钙离子)。使用双能光子吸收仪测量L2至L4的骨密度。符合条件的患者(7名绝经前女性,21名男性),既往无椎体骨折,年龄46.5(21 - 65)岁,接受泼尼松等效剂量18(7.5 - 60)mg/天,基线(M0)时腰椎平均骨密度为0.917±0.141g/cm²;在这28例患者中,最终评估时MFP-Ca组腰椎骨密度的平均增加显著更大(p = 0.05;Mann-Whitney检验)。两组在2年后也存在显著差异(p = 0.05,方差分析),有利于MFP-Ca,MFP-Ca组腰椎骨密度增加11%,而钙片组为1%;因此,使用MFP-Ca时,腰椎骨密度平均每年增加约5.5%。在2年研究期间,两组在使用的皮质类固醇剂量、椎体骨折发生率或副作用频率(均为轻微副作用)方面无统计学显著差异。未观察到骨裂。因此,对于长期接受皮质类固醇治疗的呼吸系统疾病患者,每日200mg单氟磷酸(26.4mg氟离子)与1g钙离子联合使用似乎是增加腰椎骨密度的一种安全有效的方法,这表明其在皮质类固醇诱导的骨质疏松症中的应用应进一步研究。