Abstract：
BACKGROUND: Statins are the leading lipid-lowering drugs, reducing blood cholesterol by controlling its synthesis. Side effects are linked to the use of statins, in particular statin-associated muscle symptoms (SAMS). Some data suggest that vitamin D supplementation could reduce SAMS.
OBJECTIVE: The purpose of this study was to evaluate the potential benefits of vitamin D supplementation in a randomized controlled trial.
METHODS: Men (n = 23) and women (n = 15) (50.5 ± 7.7 years [mean ± SD]) in primary cardiovascular prevention, self-reporting or not SAMS, were recruited. Following 2 months of statin withdrawal, patients were randomized to supplementation (vitamin D or placebo). After 1 month of supplementation, statins were reintroduced. Before and 2 months after drug reintroduction, muscle damage (creatine kinase and myoglobin) was measured. Force (F), endurance (E) and power (P) of the leg extensors (ext) and flexors (fle) and handgrip strength (FHG) were also measured with isokinetic and handheld dynamometers, respectively. The Short Form 36 Health Survey (SF-36) questionnaire and a visual analog scale (VAS) were administrated to assess participants\' self-reported health-related quality of life and SAMS intensity, respectively. Repeated-measures analysis was used to investigate the effects of time, supplementation, and their interaction, according to the presence of SAMS.
RESULTS: Despite no change for objective measures, subjective measures worsened after reintroduction of statins, independent of supplementation (VAS, SF-36 mental component score, all p < 0.05). However, no interaction between time and supplementation according to the presence of SAMS was observed for any variables.
CONCLUSIONS: Vitamin D supplementation does not appear to mitigate SAMS.
OBJECTIVE: The purpose of this study was to evaluate the potential benefits of vitamin D supplementation in a randomized controlled trial.
METHODS: Men (n = 23) and women (n = 15) (50.5 ± 7.7 years [mean ± SD]) in primary cardiovascular prevention, self-reporting or not SAMS, were recruited. Following 2 months of statin withdrawal, patients were randomized to supplementation (vitamin D or placebo). After 1 month of supplementation, statins were reintroduced. Before and 2 months after drug reintroduction, muscle damage (creatine kinase and myoglobin) was measured. Force (F), endurance (E) and power (P) of the leg extensors (ext) and flexors (fle) and handgrip strength (FHG) were also measured with isokinetic and handheld dynamometers, respectively. The Short Form 36 Health Survey (SF-36) questionnaire and a visual analog scale (VAS) were administrated to assess participants\' self-reported health-related quality of life and SAMS intensity, respectively. Repeated-measures analysis was used to investigate the effects of time, supplementation, and their interaction, according to the presence of SAMS.
RESULTS: Despite no change for objective measures, subjective measures worsened after reintroduction of statins, independent of supplementation (VAS, SF-36 mental component score, all p < 0.05). However, no interaction between time and supplementation according to the presence of SAMS was observed for any variables.
CONCLUSIONS: Vitamin D supplementation does not appear to mitigate SAMS.
摘要：
背景：他汀类药物是主要的降脂药物，通过控制其合成来降低血液胆固醇。副作用与他汀类药物的使用有关,特别是他汀类药物相关的肌肉症状(SAMS)。一些数据表明补充维生素D可以减少SAMS。
目的：本研究的目的是在一项随机对照试验中评估补充维生素D的潜在益处。
方法：男性（n=23）和女性（n=15）（50.5±7.7年[平均值±SD]）在初级心血管预防中，自我报告或不SAMS，被招募。停用他汀类药物2个月后，患者被随机分配接受补充治疗(维生素D或安慰剂).补充1个月后，他汀类药物被重新引入。在重新引入药物之前和之后2个月，测量肌肉损伤（肌酸激酶和肌红蛋白）。力(F),腿部伸肌（ext）和屈肌（fle）的耐力（E）和力量（P）以及握力（FHG）也用等速和手持式测力计进行了测量，分别。采用简短表格36健康调查问卷（SF-36）和视觉模拟量表（VAS）评估参与者自我报告的健康相关生活质量和SAMS强度，分别。重复测量分析用于调查时间的影响，补充,和他们的互动，根据SAMS的存在。
结果：尽管客观指标没有变化，重新引入他汀类药物后主观测量恶化，独立于补充(VAS，SF-36心理成分评分，所有p<0.05)。然而,对于任何变量,没有观察到时间和根据SAMS存在的补充之间的相互作用.
结论：补充维生素D似乎不能缓解SAMS。
目的：本研究的目的是在一项随机对照试验中评估补充维生素D的潜在益处。
方法：男性（n=23）和女性（n=15）（50.5±7.7年[平均值±SD]）在初级心血管预防中，自我报告或不SAMS，被招募。停用他汀类药物2个月后，患者被随机分配接受补充治疗(维生素D或安慰剂).补充1个月后，他汀类药物被重新引入。在重新引入药物之前和之后2个月，测量肌肉损伤（肌酸激酶和肌红蛋白）。力(F),腿部伸肌（ext）和屈肌（fle）的耐力（E）和力量（P）以及握力（FHG）也用等速和手持式测力计进行了测量，分别。采用简短表格36健康调查问卷（SF-36）和视觉模拟量表（VAS）评估参与者自我报告的健康相关生活质量和SAMS强度，分别。重复测量分析用于调查时间的影响，补充,和他们的互动，根据SAMS的存在。
结果：尽管客观指标没有变化，重新引入他汀类药物后主观测量恶化，独立于补充(VAS，SF-36心理成分评分，所有p<0.05)。然而,对于任何变量,没有观察到时间和根据SAMS存在的补充之间的相互作用.
结论：补充维生素D似乎不能缓解SAMS。
