辅酶Q10用于确诊他汀类药物所致肌病患者的随机试验。
A randomized trial of coenzyme Q10 in patients with confirmed statin myopathy.
作者信息
Taylor Beth A, Lorson Lindsay, White C Michael, Thompson Paul D
机构信息
Division of Cardiology, Henry Low Heart Center, Hartford Hospital, Hartford, CT, USA; Department of Health Sciences, University of Hartford, West Hartford, CT, USA; University of Connecticut School of Medicine, Farmington, CT, USA.
Division of Cardiology, Henry Low Heart Center, Hartford Hospital, Hartford, CT, USA.
出版信息
Atherosclerosis. 2015 Feb;238(2):329-35. doi: 10.1016/j.atherosclerosis.2014.12.016. Epub 2014 Dec 17.
BACKGROUND
Coenzyme Q10 (CoQ10) supplementation is the most popular therapy for statin myalgia among both physicians and patients despite limited and conflicting evidence of its efficacy.
OBJECTIVE
This study examined the effect of coenzyme Q10 (CoQ10) supplementation on simvastatin-associated muscle pain, muscle strength and aerobic performance in patients with confirmed statin myalgia.
METHODS
Statin myalgia was confirmed in 120 patients with prior symptoms of statin myalgia using an 8-week randomized, double-blind crossover trial of simvastatin 20 mg/d and placebo. Forty-one subjects developed muscle pain with simvastatin but not with placebo and were randomized to simvastatin 20 mg/d combined with CoQ10 (600 mg/d ubiquinol) or placebo for 8 weeks. Muscle pain (Brief Pain Inventory [BPI]), time to pain onset, arm and leg muscle strength, and maximal oxygen uptake (VO2max) were measured before and after each treatment.
RESULTS
Serum CoQ10 increased from 1.3 ± 0.4 to 5.2 ± 2.3 mcg/mL with simvastatin and CoQ10, but did not increase with simvastatin and placebo (1.3 ± 0.3 to 0.8 ± 0.2) (p < 0.05). BPI pain severity and interference scores increased with simvastatin therapy (both p < 0.01), irrespective of CoQ10 assignment (p = 0.53 and 0.56). There were no changes in muscle strength or VO2max with simvastatin with or without CoQ10 (all p > 0.10). Marginally more subjects reported pain with CoQ10 (14 of 20 vs 7 of 18; p = 0.05). There was no difference in time to pain onset in the CoQ10 (3.0 ± 2.0 weeks) vs. placebo (2.4 ± 2.1 wks) groups (p = 0.55). A similar lack of CoQ10 effect was observed in 24 subjects who were then crossed over to the alternative treatment.
CONCLUSIONS
Only 36% of patients complaining of statin myalgia develop symptoms during a randomized, double-blind crossover of statin vs placebo. CoQ10 supplementation does not reduce muscle pain in patients with statin myalgia. Trial RegistrationNCT01140308; www.clinicaltrials.gov.
背景
尽管辅酶Q10（CoQ10）补充疗法疗效的证据有限且相互矛盾，但在医生和患者中，它仍是治疗他汀类药物引起的肌痛最常用的方法。
目的
本研究探讨补充辅酶Q10（CoQ10）对确诊为他汀类药物引起肌痛的患者的辛伐他汀相关肌肉疼痛、肌肉力量和有氧运动能力的影响。
方法
采用为期8周的20mg/d辛伐他汀与安慰剂随机、双盲交叉试验，对120例有他汀类药物肌痛既往症状的患者确诊他汀类药物肌痛。41名受试者服用辛伐他汀时出现肌肉疼痛，而服用安慰剂时未出现，将其随机分为两组，一组服用20mg/d辛伐他汀联合CoQ10（600mg/d泛醇），另一组服用安慰剂，为期8周。在每次治疗前后测量肌肉疼痛（简短疼痛量表[BPI]）、疼痛发作时间、手臂和腿部肌肉力量以及最大摄氧量（VO2max）。
结果
辛伐他汀与CoQ10联合使用时，血清CoQ10从1.3±0.4mcg/mL增至5.2±2.3mcg/mL，而辛伐他汀与安慰剂联合使用时未增加（从1.3±0.3mcg/mL降至0.8±0.2mcg/mL）（p<0.05）。无论是否分配CoQ10，辛伐他汀治疗后BPI疼痛严重程度和干扰评分均增加（均p<0.01）（p=0.53和0.56）。无论是否使用CoQ10，辛伐他汀治疗后肌肉力量和VO2max均无变化（所有p>0.10）。报告使用CoQ10时疼痛的受试者略多（20例中的14例 vs 18例中的7例；p=0.05）。CoQ10组与安慰剂组的疼痛发作时间无差异（3.0±2.0周 vs 2.4±2.1周）（p=0.55）。在随后交叉接受替代治疗的24名受试者中也观察到类似的CoQ10无效情况。
结论
在他汀类药物与安慰剂的随机双盲交叉试验中，只有36%主诉他汀类药物肌痛的患者出现症状。补充CoQ10不能减轻他汀类药物引起肌痛患者的肌肉疼痛。试验注册号：NCT01140308；www.clinicaltrials.gov。
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