Pak C Y, Sakhaee K, Adams-Huet B, Piziak V, Peterson R D, Poindexter J R
University of Texas Southwestern Medical Center, Dallas, USA.
Ann Intern Med. 1995 Sep 15;123(6):401-8. doi: 10.7326/0003-4819-123-6-199509150-00001.
To test whether slow-release sodium fluoride inhibits spinal fractures and is safe to use.
Placebo-controlled randomized trial.
Slow-release sodium fluoride, 25 mg twice daily, in four 14-month cycles (12 months receiving sodium fluoride followed by 2 months not receiving it) compared with placebo. Calcium citrate, 400 mg calcium twice daily, continuously in both groups.
48 of 54 patients who received sodium fluoride and 51 of 56 patients who received placebo completed at least 1 year of the study. All patients had postmenopausal osteoporosis.
Compared with the placebo group, the fluoride group had a lower individual vertebral fracture rate (0.064 +/- 0.182 per patient-year compared with 0.205 +/- 0.297 per patient-year; P = 0.002), a higher unadjusted fracture-free rate (85.4% compared with 56.9%; P = 0.001), and a greater survival estimate (relative risk, 0.3 [95% CI, 0.12 to 0.76]) for new fractures. The recurrent spinal fracture rate did not differ between the two groups. The fluoride group had a substantial increase in L2-L4 bone mass of 4% to 5% per year for 4 years, a mean increase in femoral neck bone density of 2.38% +/- 3.33% per year, and no change in radial shaft bone density. The frequency with which minor side effects and appendicular fractures occurred was similar in the two groups; no patients developed microfractures or gastric ulcers.
Slow-release sodium fluoride and calcium citrate administered for 4 years inhibits new vertebral fractures (but not recurrent fractures), augments spinal and femoral neck bone mass, and is safe to use.
测试缓释氟化钠是否能抑制脊柱骨折以及使用是否安全。
安慰剂对照随机试验。
与安慰剂相比，缓释氟化钠，每日两次，每次25毫克，共四个14个月周期（12个月服用氟化钠，随后2个月不服用）。两组均持续每日两次服用400毫克柠檬酸钙。
接受氟化钠治疗的54例患者中有48例、接受安慰剂治疗的56例患者中有51例完成了至少1年的研究。所有患者均患有绝经后骨质疏松症。
与安慰剂组相比，氟化物组的个体椎体骨折率较低（每位患者每年0.064±0.182，而安慰剂组为0.205±0.297；P = 0.002），未调整的无骨折率较高（85.4% 对比56.9%；P = 0.001），新发骨折的生存估计更高（相对风险，0.3 [95% CI，0.12至0.76]）。两组的复发性脊柱骨折率无差异。氟化物组4年内L2-L4骨量每年大幅增加4%至5%，股骨颈骨密度每年平均增加2.38%±3.33%，桡骨干骨密度无变化。两组轻微副作用和四肢骨折的发生频率相似；没有患者发生微骨折或胃溃疡。
服用4年的缓释氟化钠和柠檬酸钙可抑制新发椎体骨折（但不能抑制复发性骨折），增加脊柱和股骨颈骨量，且使用安全。
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