Adachi J D, Bell M J, Bensen W G, Bianchi F, Cividino A, Sebaldt R J, Gordon M, Ioannidis G, Goldsmith C
Department of Medicine, St. Joseph's Hospital, McMaster University, Hamilton, Ontario, Canada.
J Rheumatol. 1997 Dec;24(12):2308-13.
To determine the efficacy of sodium fluoride (40 mg/day) in preventing rheumatoid arthritis (RA) induced bone loss, which may lead to osteoporosis.
We conducted an 18 month, randomized, double blind, placebo controlled trial in 38 patients with RA. The primary outcome measure was the difference in the percentage change between groups in lumbar spine bone mineral density (BMD) from baseline values after 18 months of therapy. The secondary outcome measures were the differences in the percentage change between groups in femoral neck, Ward's triangle, trochanter, and total body BMD from baseline after 18 months of therapy.
There was a significant percentage difference (SD) between groups of 6.2% (7.3%) (p = 0.0005) in lumbar spine BMD after 18 months of treatment in favor of the fluoride group. The fluoride group experienced a 5.2% (8.4%) (p = 0.0125) increase, whereas the placebo group showed a 1.0% (4.8%) (p = 0.8015) decrease in lumbar spine BMD after treatment. No significant differences were found for the femoral neck, Ward's triangle, trochanter, and total body BMD in terms of the percentage changes from baseline within each treatment group or in the differences in the degree of change between groups after therapy. Lumbar spine BMD increased in about 80% of patients treated with fluoride (responders) compared to 44% of patients treated with placebo.
The results showed that fluoride therapy was well tolerated and increased vertebral bone mass in patients with RA.
确定氟化钠(每日40毫克)预防类风湿关节炎(RA)所致骨质流失(这可能导致骨质疏松症)的疗效。
我们对38例类风湿关节炎患者进行了一项为期18个月的随机、双盲、安慰剂对照试验。主要结局指标是治疗18个月后,两组腰椎骨矿物质密度(BMD)相对于基线值的百分比变化差异。次要结局指标是治疗18个月后,两组股骨颈、沃德三角区、大转子和全身骨密度相对于基线的百分比变化差异。
治疗18个月后,腰椎骨密度两组间存在显著的百分比差异(标准差),为6.2%(7.3%)(p = 0.0005),氟化钠组占优。治疗后,氟化钠组腰椎骨密度增加了5.2%(8.4%)(p = 0.0125),而安慰剂组则下降了1.0%(4.8%)(p = 0.8015)。在每个治疗组内,股骨颈、沃德三角区、大转子和全身骨密度相对于基线的百分比变化,以及治疗后两组间变化程度的差异均无显著差异。与44%接受安慰剂治疗的患者相比,约80%接受氟化钠治疗的患者(反应者)腰椎骨密度增加。
结果表明,氟化钠治疗耐受性良好,可增加类风湿关节炎患者的椎骨骨量。