Objective The objective of this article is to evaluate near-infrared spectroscopy (NIRS), a non-invasive technique to assess tissue oxygenation and mitochondrial function, as a diagnostic tool for statin-associated muscle symptoms (SAMS). Methods We verified SAMS in 39 statin-treated patients (23 women) using a double-blind, placebo-controlled, cross-over protocol. Subjects with suspected SAMS were randomised to simvastatin 20 mg/day or placebo for 8 weeks, followed by a 4-week no treatment period and then assigned to the alternative treatment, either simvastatin or placebo. Tissue oxygenation was measured before and after each statin or placebo treatment using NIRS during handgrip exercise at increasing intensities of maximal voluntary contraction (MVC). Results 44% (n=17) of patients were confirmed as having SAMS (11 women) because they reported discomfort only during simvastatin treatment. There were no significant differences in percent change in tissue oxygenation in placebo versus statin at all % MVCs in all subjects. The percent change in tissue oxygenation also did not differ significantly between confirmed and unconfirmed SAMS subjects on statin (−2.4% vs −2.4%, respectively) or placebo treatment (−1.1% vs −9%, respectively). The percent change in tissue oxygenation was reduced after placebo therapy in unconfirmed SAMS subjects (−10.2%) (p≤0.01) suggesting potential measurement variability. Conclusions NIRS in the forearm cannot differentiate between confirmed and unconfirmed SAMS, but further research is needed to assess the usability of NIRS as a diagnostic tool for SAMS. Trial registration number [NCT03653663][1]. Data are available upon reasonable request. The data underlying this article will be shared on reasonable request to the corresponding author. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03653663&atom=%2Fopenhrt%2F11%2F1%2Fe002551.atom

中文翻译：

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患有他汀类药物相关肌肉症状（SAMS）患者的骨骼肌线粒体能力

目的 本文的目的是评估近红外光谱 (NIRS)，一种评估组织氧合和线粒体功能的非侵入性技术，作为他汀类药物相关肌肉症状 (SAMS) 的诊断工具。方法 我们使用双盲、安慰剂对照、交叉方案在 39 名接受他汀类药物治疗的患者（23 名女性）中验证了 SAMS。疑似 SAMS 的受试者被随机分配至辛伐他汀 20 毫克/天或安慰剂组，为期 8 周，随后是 4 周的不治疗期，然后分配至替代治疗组，即辛伐他汀或安慰剂。在每次他汀类药物或安慰剂治疗之前和之后，在增加最大随意收缩 (MVC) 强度的握力训练期间，使用 NIRS 测量组织氧合。结果 44% (n=17) 的患者被确认患有 SAMS（11 名女性），因为她们仅在辛伐他汀治疗期间报告有不适。在所有受试者的所有 % MVC 中，安慰剂与他汀类药物的组织氧合百分比变化没有显着差异。在接受他汀类药物（分别为-2.4％与-2.4％）或安慰剂治疗（分别为-1.1％与-9％）的已确诊和未确诊的SAMS受试者之间，组织氧合百分比变化也没有显着差异。在未经证实的 SAMS 受试者中，安慰剂治疗后组织氧合百分比变化降低 (−10.2%) (p≤0.01)，表明潜在的测量变异性。结论 前臂 NIRS 无法区分确诊和未确诊的 SAMS，但需要进一步研究来评估 NIRS 作为 SAMS 诊断工具的可用性。试用注册号[NCT03653663][1]。数据可根据合理要求提供。本文所依据的数据将根据合理请求分享给通讯作者。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03653663&atom=%2Fopenhrt%2F11%2F1%2Fe002551.atom