背景:尽管低维生素D水平与他汀类药物相关的肌肉症状(SAMS)有关,目前尚不清楚补充维生素D是否能改善症状.
目的:我们进行了系统评价,以评估补充维生素D与SAMS消退的关系。
方法:我们搜索了Medline(PubMed),Embase和Cochrane图书馆至2021年12月12日。包括报道成人SAMS患者补充维生素D之间关联的全长文章。
结果:我们确定了8项介入研究,包括669名参与者。大多数参与者是白种人,参与者的平均年龄为59.5至64.8岁。这些研究招募了初始平均治疗前维生素D水平为17.8至22.0ng/mL的患者。随访时间为2至24个月,治疗后平均维生素D水平为34.3至56.0ng/mL。我们发现,在7项研究中,606名患者中有509名(83.9%)患者补充维生素D与他汀类药物耐受性改善相关,这些研究报告了补充后的患者人数(95%CI=0.81-0.87,I2=72%n=7)。没有一项研究是随机对照试验(RCT),因此不能排除维生素D的安慰剂效应。他汀类药物的Nocebo效应也未通过任何研究进行评估。
结论:轻度-中度维生素D不足患者补充维生素D与SAMS的改善有关。然而,定量疗效分析是不可能的,这种观察到的关联可能被nocebo和安慰剂效应混淆.需要RCT来最终评估补充维生素D在改善SAMS中的效用。
BACKGROUND: Although low vitamin D levels are associated with statin-associated muscle symptoms (SAMS), it remains unclear if vitamin D supplementation leads to symptom improvement.
OBJECTIVE: We performed a systematic
review to evaluate the association of vitamin D supplementation with resolution of SAMS.
METHODS: We searched Medline (PubMed), Embase and Cochrane Library till 12 December 2021. Full length articles that reported on the association between vitamin D supplementation in adult patients with SAMS were included.
RESULTS: We identified 8 interventional studies comprising 669 participants. Majority of the participants were of Caucasian ethnicity and the mean age of participants ranged from 59.5 to 64.8 years old. The studies recruited patients with initial mean pre-treatment vitamin D levels ranging from 17.8 to 22.0ng/mL. Follow up duration ranged from 2 to 24 months and mean post-treatment vitamin D levels ranged from 34.3 to 56.0ng/mL. We found that vitamin D supplementation was associated with improved statin tolerance in 509 out of 606 (83.9%) patients across the 7 studies which reported patient numbers after supplementation (95% CI = 0.81-0.87, I2 = 72% n = 7). None of the studies were randomized controlled trials (RCTs) and hence placebo effect of vitamin D could not be ruled out. Nocebo effect of statin was also not assessed by any of the studies.
CONCLUSIONS: Vitamin D supplementation in patients with mild-moderate vitamin D insufficiency was associated with improvement of SAMS. However, quantitative efficacy analysis was not possible and this observed association is likely confounded by nocebo and placebo effects. RCTs are required to conclusively assess the utility of vitamin D supplementation in improving SAMS.