Fogacci Federica, Rizzo Manfredi, Krogager Christoffer, Kennedy Cormac, Georges Coralie M G, Knežević Tamara, Liberopoulos Evangelos, Vallée Alexandre, Pérez-Martínez Pablo, Wenstedt Eliane F E, Šatrauskienė Agnė, Vrablík Michal, Cicero Arrigo F G
Hypertension and Cardiovascular Risk Factors Research Group, Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, 40138 Bologna, Italy.
Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), School of Medicine, University of Palermo, 90127 Palermo, Italy.
Antioxidants (Basel). 2020 Oct 19;9(10):1011. doi: 10.3390/antiox9101011.
Alpha-lipoic acid (ALA) is a natural short-chain fatty acid that has attracted great attention in recent years as an antioxidant molecule. However, some concerns have been recently raised regarding its safety profile. To address the issue, we aimed to assess ALA safety profile through a systematic review of the literature and a meta-analysis of the available randomized placebo-controlled clinical studies. The literature search included EMBASE, PubMed Medline, SCOPUS, Google Scholar, and ISI Web of Science by Clarivate databases up to 15th August 2020. Data were pooled from 71 clinical studies, comprising 155 treatment arms, which included 4749 subjects with 2558 subjects treated with ALA and 2294 assigned to placebo. A meta-analysis of extracted data suggested that supplementation with ALA was not associated with an increased risk of any treatment-emergent adverse event (all > 0.05). ALA supplementation was safe, even in subsets of studies categorized according to smoking habit, cardiovascular disease, presence of diabetes, pregnancy status, neurological disorders, rheumatic affections, severe renal impairment, and status of children/adolescents at baseline.
α-硫辛酸（ALA）是一种天然的短链脂肪酸，近年来作为一种抗氧化分子备受关注。然而，最近人们对其安全性提出了一些担忧。为解决这一问题，我们旨在通过对文献的系统回顾和对现有随机安慰剂对照临床研究的荟萃分析来评估ALA的安全性。文献检索包括截至2020年8月15日的EMBASE、PubMed Medline、SCOPUS、谷歌学术以及科睿唯安数据库中的ISI Web of Science。数据来自71项临床研究，共155个治疗组，其中包括4749名受试者，2558名接受ALA治疗，2294名被分配接受安慰剂治疗。对提取数据的荟萃分析表明，补充ALA与任何治疗中出现的不良事件风险增加无关（所有P>0.05）。即使在根据吸烟习惯、心血管疾病、糖尿病状况、妊娠状态、神经疾病、风湿性疾病、严重肾功能损害以及基线时儿童/青少年状态分类的研究亚组中，补充ALA也是安全的。
