Patil Sanjeev, Holt Graeme, Raby Nigel, McLellan Alastair R, Smith Karen, O'Kane Sarah, Beastall Graham, Crossan James F
Department of Orthopaedic and Trauma Surgery, Southern General Hospital, 1345 Govan Road, Glasgow, G51 4TF, United Kingdom.
J Orthop Res. 2009 Mar;27(3):281-5. doi: 10.1002/jor.20572.
Although statins are widely prescribed as cholesterol-lowering drugs, a number of studies suggest that these compounds may have anabolic effects on bone. Our aim was to assess whether simvastatin affects the rate of fracture healing in humans. A prospective, double-blind, randomized controlled trial was performed. Individuals who had sustained an undisplaced, extra-articular fracture of the distal radial metaphysis were recruited from a trauma clinic. Patients were randomized to receive simvastatin 20 mg once daily or a placebo. Regular clinical and radiological follow-up was undertaken for a 12 week period. Dual-energy X-ray absorptiometry assessment of bone mineral density was conducted at 2 and 12 weeks postinjury. Biochemical markers of bone turnover were assayed during the study period. Time to fracture union was defined as the time to cortical bridging in four cortices on plain radiographs. In addition, the rate of trabecular union was assessed. Eighty patients were recruited, of which 62 completed the study (31 in each group). Study cohorts were matched for age and gender. For patients receiving simvastatin therapy, the mean time to fracture union was 71.6 days (SD 22.2 days, SEM 3.8 days). This compared to 71.3 days (SD 21.3, SEM 4.1 days) for the control cohort (p = 0.6481). There was no significant difference between bone mineral density or bone biochemical markers between groups (p > 0.05). Despite promising results from in vivo and in vitro animal studies, simvastatin at a treatment dose of 20 mg once daily does not affect the rate of fracture healing in humans.
尽管他汀类药物作为降胆固醇药物被广泛使用，但多项研究表明，这些化合物可能对骨骼有合成代谢作用。我们的目的是评估辛伐他汀是否会影响人类骨折愈合的速度。进行了一项前瞻性、双盲、随机对照试验。从创伤诊所招募了桡骨远端干骺端无移位、关节外骨折的个体。患者被随机分为每日一次接受20毫克辛伐他汀或安慰剂治疗。进行了为期12周的定期临床和放射学随访。在受伤后2周和12周进行双能X线吸收法骨密度评估。在研究期间测定骨转换的生化标志物。骨折愈合时间定义为X线平片上四个皮质出现皮质桥接的时间。此外，还评估了小梁愈合的速度。共招募了80名患者，其中62名完成了研究（每组31名）。研究队列在年龄和性别上相匹配。接受辛伐他汀治疗的患者，骨折愈合的平均时间为71.6天（标准差22.2天，标准误3.8天）。相比之下，对照组为71.3天（标准差21.3，标准误4.1天）（p = 0.6481）。两组之间的骨密度或骨生化标志物没有显著差异（p > 0.05）。尽管体内和体外动物研究取得了有前景的结果，但每日一次20毫克治疗剂量的辛伐他汀并不影响人类骨折愈合的速度。
