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痰热清注射液对健康志愿者肠道微生物群的影响。

Effects of Tanreqing injection on the gut microbiota in healthy volunteers.

机构信息

Clinical Research Center, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Clinical Laboratory, Zhoupu Hospital, Shanghai University of Medicine and Health Sciences, Shanghai, China.

出版信息

Front Cell Infect Microbiol. 2024 Oct 4;14:1428476. doi: 10.3389/fcimb.2024.1428476. eCollection 2024.

Abstract

OBJECTIVES

Many studies have confirmed that antibacterial agents can disrupt the human gut microbiota. In China, Tanreqing injection (TRQ) is a drug with antibacterial activity that is widely used in the treatment of respiratory infections. However, its specific influence on gut microbiota remains unclear. This study aimed to investigate the effect of TRQ on the gut microbiota of healthy volunteers.

METHODS

Twelve healthy adults received 20 ml of TRQ intravenously daily for 7 consecutive days. At six timepoints (Pre, on D1, D3, D5, D7 and follow-up visit) fecal samples were collected and analyzed using 16S rRNA gene sequencing.

RESULTS

Eleven people were included in the analysis finally. TRQ did not significantly alter gut microbiota diversity or richness (Shannon and Simpson and Chao1 index) in healthy people during the intervention. Gut microbial structure was stable (weighted and unweighted Unifrac). Using a machine learning method based on PLS-DA analysis, the separation trend on D7 at the genus level was found, returning to baseline two days after discontinuation. The abundance of major genus fluctuated on D7 compared with that prior to treatment, including an increase of unclassified_f_Enterobacteriaceae (13.0611%), a decrease of and (6.887%, 10.487%). Functional prediction analysis did not reveal any significant difference.

CONCLUSIONS

Our study showed short-term use of TRQ at conventional doses may not cause perturbations to the gut microbiota in healthy adults. This finding provides some useful information for the safe use of TRQ in the treatment of respiratory infections.

CLINICAL TRIAL REGISTRATION

https://www.medicalresearch.org.cn/, identifier MR-31-24-014367.

摘要

目的

许多研究证实,抗菌药物会破坏人体肠道微生物群。在中国,痰热清注射液(TRQ)是一种具有抗菌活性的药物,广泛用于治疗呼吸道感染。然而,其对肠道微生物群的确切影响尚不清楚。本研究旨在探讨 TRQ 对健康志愿者肠道微生物群的影响。

方法

12 名健康成年人连续 7 天每天静脉注射 20ml TRQ。在 6 个时间点(预、第 1 天、第 3 天、第 5 天、第 7 天和随访)采集粪便样本,并用 16S rRNA 基因测序进行分析。

结果

最终有 11 人纳入分析。TRQ 未显著改变健康人在干预期间的肠道微生物多样性或丰富度(Shannon 和 Simpson 和 Chao1 指数)。肠道微生物结构稳定(加权和非加权 Unifrac)。使用基于 PLS-DA 分析的机器学习方法,在第 7 天发现了属水平的分离趋势,停药后两天恢复基线。与治疗前相比,第 7 天主要属的丰度发生波动,包括未分类_f_肠杆菌科(13.0611%)增加, 和 (6.887%,10.487%)减少。功能预测分析未发现任何显著差异。

结论

本研究表明,常规剂量短期使用 TRQ 可能不会引起健康成年人肠道微生物群的紊乱。这一发现为 TRQ 在治疗呼吸道感染中的安全使用提供了一些有用的信息。

临床试验注册

https://www.medicalresearch.org.cn/,标识符 MR-31-24-014367。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f96/11486765/987114292556/fcimb-14-1428476-g001.jpg

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