英国伦敦卫生与热带医学院Liam Smeeth团队研究了他汀类药物治疗与肌肉症状的相关性。2021年2月25日，《英国医学杂志》发表了该成果。
为了确定他汀类药物对先前服用他汀类药物时出现肌肉症状人群的影响，2016年12月至2018年4月，研究组在英国的50个初级保健点进行了一系列随机、安慰剂对照的n/1试验。
研究组招募了200名因为肌肉症状而最近停止或正在考虑停止他汀类药物治疗的参与者，将其随机分组，分别接受6个双盲疗程（每个疗程两个月），每天服用20 mg阿托伐他汀或安慰剂治疗。在每个治疗期结束时，参与者用视觉模拟量表（0-10）来评定他们的肌肉症状。初步分析比较了他汀类药物和安慰剂治疗期间的症状评分。
最终有151名参与者提供了至少一个他汀类药物治疗周期和一个安慰剂治疗周期的症状评分，并被纳入初步分析。总体而言，他汀类药物与安慰剂治疗期间的肌肉症状得分没有显著差异。在他汀类药物治疗期间，有18名受试者（9%）因肌肉不耐受症状而停药，而在安慰剂治疗期间，有13名受试者（7%）因肌肉不耐受症状而停药。完成试验的三分之二的人报告重新开始他汀类药物的长期治疗。
研究结果表明，与安慰剂相比，对于先前报告服用他汀类药物时出现严重肌肉症状的受试者，服用20 mg阿托伐他汀对肌肉症状没有总体影响，完成试验的大多数人打算重新开始他汀类药物的治疗。
附：英文原文
Author: Emily Herrett, Elizabeth Williamson, Kieran Brack, Danielle Beaumont, Alexander Perkins, Andrew Thayne, Haleema Shakur-Still, Ian Roberts, Danielle Prowse, Ben Goldacre, Tjeerd van Staa, Thomas M MacDonald, Jane Armitage, Jon Wimborne, Paula Melrose, Jayshireen Singh, Lucy Brooks, Michael Moore, Maurice Hoffman, Liam Smeeth
Issue&Volume: 2021/02/24
Abstract:
Objective To establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins.
Design Series of randomised, placebo controlled n-of-1 trials.
Setting Primary care across 50 sites in the United Kingdom, December 2016 to April 2018.
Participants 200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms.
Interventions Participants were randomised to a sequence of six double blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo.
Main outcome measures At the end of each treatment period, participants rated their muscle symptoms on a visual analogue scale (0-10). The primary analysis compared symptom scores in the statin and placebo periods.
Results 151 participants provided symptoms scores for at least one statin period and one placebo period and were included in the primary analysis. Overall, no difference in muscle symptom scores was found between the statin and placebo periods (mean difference statin minus placebo 0.11, 95% confidence interval 0.36 to 0.14; P=0.40)). Withdrawals because of intolerable muscle symptoms were 18 participants (9%) during a statin period and 13 (7%) during a placebo period. Two thirds of those completing the trial reported restarting long term treatment with statins.
Conclusions No overall effect of atorvastatin 20 mg on muscle symptoms compared with placebo was found in participants who had previously reported severe muscle symptoms when taking statins. Most people completing the trial intended to restart treatment with statins. N-of-1 trials can assess drug effects at the group level and guide individual treatment.
DOI: 10.1136/bmj.n135
Source: https://www.bmj.com/content/372/bmj.n135
BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
官方网址：http://www.bmj.com/
投稿链接：https://mc.manuscriptcentral.com/bmj
本期文章：《英国医学杂志》：Online/在线发表
