Investigating the effects of Liushen Capsules on the metabolome of seasonal influenza: A randomized clinical trial.
Investigating the effects of Liushen Capsules on the metabolome of seasonal influenza: A randomized clinical trial.
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DOI：
10.3389/fphar.2022.968182
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发表时间：
2022
影响因子：
5.6
通讯作者：
Yang, Zifeng
中科院分区：
文献类型：
--
作者：
Ma, Qinhai;Chen, Ruihan;Lei, Biao;Ye, Feng;Li, Zhengtu;Zhan, Yangqing;Liu, Bin;Yang, Zifeng
关键词：
研究背景：中药是预防流感感染的有效策略。六神胶囊在体内外均能抑制流感病毒增殖，显著减轻病毒诱导的炎症反应，改善急性肺损伤。然而，LS在临床试验中的有效性和安全性，以及LS在调节患者代谢物中的作用尚不清楚。 材料与方法：本研究采用随机、双盲、安慰剂对照的临床试验设计。所有参与者均于2019年12月至2020年11月期间入组。通过主要疗效终点（曲线下面积（AUC）分析）和次要终点（每种症状的个体评分、症状缓解和炎症因子发生率）评估疗效和安全性。采用RT-PCR检测患者血清中炎症因子水平，采用非靶向代谢组学超高效液相色谱-串联质谱（LC-MS）鉴定代谢产物。 结果如下：来自广州中医药大学附属第二医院和广州医科大学附属第一医院的81名受试者完成了完整研究。干预14天后，LS组总症状评分曲线下面积（AUC）显著小于安慰剂组（p < 0.001）。LS组咽喉痛、咳嗽和鼻塞的缓解情况明显优于安慰剂组。LS组症状缓解或完全缓解的时间和次数明显优于安慰剂组。LS组临床治疗的不良反应略高于安慰剂组，但无统计学差异。LS干预14 d后，流感感染者血清中IL-1 ra、Eotaxin、IFN-γ、IL-6、IL-10、IL-13、SCF和TRAIL水平较安慰剂组显著降低。观察到LS开始和结束组之间的血清代谢谱存在显著差异。进一步的相关性分析显示甘油磷脂、鞘脂脂肪酰与过度炎症和临床症状之间存在潜在的调节串扰。重要的是，它可能与磷脂、脂肪酸、花生四烯酸和淀粉-tRNA合成途径代谢途径密切相关。 结论：研究显示，LS无临床显著不良反应，接受LS治疗的患者的流感样炎症和炎症反应有显著改善。进一步分析表明，LS可显著纠正患者血清代谢物谱中的代谢紊乱。这为LS治疗流感的潜在机制提供了新的见解。
Background: Traditional Chinese Medicines (TCMs) are effective strategies for preventing influenza infection. Liushen Capsules can inhibit influenza virus proliferation, significantly mitigate virus-induced inflammation and improve acute lung injury in vitro or in vivo. However, the efficacy and safety of LS in clinical trials, and the role of LS in regulating metabolites in patients are not well known. Materials and methods: A randomized, double-blind, placebo-controlled clinical trial was designed in this study. All participants were enrolled between December 2019 and November 2020. The efficacy and safety were assessed by primary efficacy endpoint ((area under the curve (AUC) analysis)) and secondary endpoint (individual scores for each symptom, remission of symptoms, and rates of inflammatory factors). The serum samples were collected from patients to detect the levels of inflammatory factors using RT-PCR and to identify metabolites using a non-targeted metabolomics ultra-performance liquid chromatography-tandem mass spectrometry (LC-MS). Results: 81 participants from The Second Affiliated Hospital of Guangzhou University of Chinese Medicine and the First Affiliated Hospital of Guangzhou Medical University were completed the full study. After 14 days of intervention, the area under the curve (AUC) of the total symptom scores in LS group was significantly smaller than that in Placebo group (p < 0.001). Alleviation of sore throat, cough and nasal congestion in the LS group was significantly better than that in the Placebo group. The time and number to alleviation of symptoms or complete alleviation of symptoms in LS group was significantly better than that in Placebo group. The adverse effects of clinical therapy were slightly higher in LS group than in Placebo group, but there was no statistical difference. After 14 days of LS intervention, the levels of IL-1ra, Eotaxin, IFN-γ, IL-6, IL-10, IL-13, SCF and TRAIL in serum of participants with influenza infection were significantly decreased compared with Placebo group. It was observed that there were significant differences in the serum metabolic profiles between start- and end- LS groups. Further correlation analysis showed a potential regulatory crosstalk between glycerophospholipids, sphingolipids fatty acyls and excessive inflammation and clinical symptoms. Importantly, it may be closely related to phospholipid, fatty acid, arachidonic acid and amyl-tRNA synthesis pathway metabolic pathways. Conclusion: The study showed there were no clinically significant adverse effects on LS, and a significant improvement in influenza-like symptomatology and inflammatory response in patients treated with LS. Further analysis showed that LS could significantly correct the metabolic disorders in the serum metabolite profile of the patients. This provided new insights into the potential mechanism of LS for the treatment of influenza.
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影响因子：
3.7
作者：
Dong G;Peng C;Luo J;Wang C;Han L;Wu B;Ji G;He H
通讯作者：
He H
影响因子：
6.1
作者：
Lin, Shuhai;Liu, Ning;Cai, Zongwei
通讯作者：
Cai, Zongwei
DOI：
10.1016/j.bbadis.2015.08.021
发表时间：
2015-11
期刊：
Biochimica et biophysica acta
影响因子：
--
作者：
Tarasenko TN;Singh LN;Chatterji-Len M;Zerfas PM;Cusmano-Ozog K;McGuire PJ
通讯作者：
McGuire PJ
影响因子：
5.1
作者：
Gowda GA;Zhang S;Gu H;Asiago V;Shanaiah N;Raftery D
通讯作者：
Raftery D
影响因子：
5.4
作者：
Ma, Qinhai;Huang, Wenbo;Yang, Zifeng
通讯作者：
Yang, Zifeng