Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: A multicenter double-blind randomized controlled trial

Carrimycin is a potential immune-regulating agent for sepsis in patients with tumors. In this study, we investigated its effects on inflammation and immune function in tumor patients with sepsis. In total, 120 participants were randomized to receive either carrimycin treatment (400 mg/day) (n = 62)...

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Main Authors: Chuanchuan Nan, Xiaowu Zhang, Wei Huang, Biao Zhu, Jianghong Zhao, Song Lu, Lewu Xian, Kaizhong Liu, Gang Ma, Wei Yang, Mingguang Huang, Dongmin Zhou, Ming Zhang, Yan Duan, Guixin Wu, Zhengying Jiang, Li Zhang, Xinrong He, Yuhong Chen, Xuezhong Xing, Changsong Wang, Donghao Wang, Kaijiang Yu
Format: Article
Language:English
Published: Elsevier 2023-12-01
Series:Pharmacological Research
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S104366182300347X
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author Chuanchuan Nan
Xiaowu Zhang
Wei Huang
Biao Zhu
Jianghong Zhao
Song Lu
Lewu Xian
Kaizhong Liu
Gang Ma
Wei Yang
Mingguang Huang
Dongmin Zhou
Ming Zhang
Yan Duan
Guixin Wu
Zhengying Jiang
Li Zhang
Xinrong He
Yuhong Chen
Xuezhong Xing
Changsong Wang
Donghao Wang
Kaijiang Yu
author_facet Chuanchuan Nan
Xiaowu Zhang
Wei Huang
Biao Zhu
Jianghong Zhao
Song Lu
Lewu Xian
Kaizhong Liu
Gang Ma
Wei Yang
Mingguang Huang
Dongmin Zhou
Ming Zhang
Yan Duan
Guixin Wu
Zhengying Jiang
Li Zhang
Xinrong He
Yuhong Chen
Xuezhong Xing
Changsong Wang
Donghao Wang
Kaijiang Yu
author_sort Chuanchuan Nan
collection DOAJ
description Carrimycin is a potential immune-regulating agent for sepsis in patients with tumors. In this study, we investigated its effects on inflammation and immune function in tumor patients with sepsis. In total, 120 participants were randomized to receive either carrimycin treatment (400 mg/day) (n = 62) or placebo (n = 58) for 7 days. The primary outcomes were immune-related indicators. Subsequently, patients were stratified into two subgroups (CD4 < 38.25% and CD8 < 25.195%). Ninety-nine participants were analyzed: 47 and 52 in the carrimycin and placebo groups, respectively. HLA-DR levels were rapidly increased in the carrimycin group; however, the placebo group initially experienced a decline in HLA-DR level at 1 day after administration. In the subgroup with CD4 < 38.25%, the carrimycin group exhibited significantly higher HLA-DR levels than the placebo group (2.270, P = 0.023) 1 day after administration and the degree of increase in HLA-DR in the carrimycin group was higher than that in the placebo group (2.057, P = 0.040). In the CD8 < 25.195% subgroup, the carrimycin group demonstrated significantly higher levels of CD8+ T cells than the placebo group at 3 (2.300, P = 0.027) and 5 (2.106, P = 0.035) days after administration. Carrimycin intervention led to significant reductions in the SOFA, APACHE II, PCT, and CRP levels. No adverse events were observed. In tumor patients with sepsis, particularly in those experiencing immunological suppression, carrimycin effectively regulates immune responses by increasing HLA-DR and CD8+ T cell levels and plays an anti-infective role, reducing disease severity. (Chictr.org.cn, ID Number: ChiCTR2000032339).
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spelling doaj.art-f2252d7e316045279d46a36620a914582023-12-03T05:39:39ZengElsevierPharmacological Research1096-11862023-12-01198106991Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: A multicenter double-blind randomized controlled trialChuanchuan Nan0Xiaowu Zhang1Wei Huang2Biao Zhu3Jianghong Zhao4Song Lu5Lewu Xian6Kaizhong Liu7Gang Ma8Wei Yang9Mingguang Huang10Dongmin Zhou11Ming Zhang12Yan Duan13Guixin Wu14Zhengying Jiang15Li Zhang16Xinrong He17Yuhong Chen18Xuezhong Xing19Changsong Wang20Donghao Wang21Kaijiang Yu22Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China; Department of Critical Care Medicine, Harbin Medical University Cancer Hospital, Harbin 150001, China; Department of Critical Care Medicine, Shenzhen People’s Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen 518000, ChinaDepartment of Critical Care Medicine, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, ChinaDepartment of Critical Care Medicine, Harbin Medical University Cancer Hospital, Harbin 150001, ChinaDepartment of Critical Care Medicine, Shanghai Cancer Center of Fudan University, Shanghai 200032, ChinaDepartment of Critical Care Medicine, Hunan Cancer Hospital, Changsha 410013, ChinaDepartment of Critical Care Medicine, Sichuan Cancer Hospital &amp; Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610041, ChinaDepartment of Critical Care Medicine, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou 510000, ChinaDepartment of Critical Care Medicine, Zhejiang Cancer Hospital, Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou 310022, ChinaDepartment of Critical Care Medicine, Sun Yat-sen University Cancer Center, Guangzhou 510000, ChinaDepartment of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, ChinaDepartment of Critical Care Medicine, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan 030000, ChinaDepartment of Critical Care Medicine, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450000, ChinaDepartment of Critical Care Medicine, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, Hangzhou 310022, ChinaDepartment of Critical Care Medicine, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan 030000, ChinaDepartment of Critical Care Medicine, Chongqing University Cancer Hospital, Chongqing 404100, ChinaDepartment of Critical Care Medicine, Chongqing University Cancer Hospital, Chongqing 404100, ChinaDepartment of Critical Care Medicine, Hubei Cancer Hospital, Wuhan 430079, ChinaDepartment of Critical Care Medicine, Sun Yat-sen University Cancer Center, Guangzhou 510000, ChinaDepartment of Critical Care Medicine, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050000, ChinaDepartment of Critical Care Medicine, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100000, ChinaDepartment of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China; Department of Critical Care Medicine, Harbin Medical University Cancer Hospital, Harbin 150001, China; Corresponding author at: Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China. Department of Critical Care Medicine, Harbin Medical University Cancer Hospital, Harbin 150001, China.Department of Critical Care Medicine, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China; Corresponding authors.Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China; Corresponding authors.Carrimycin is a potential immune-regulating agent for sepsis in patients with tumors. In this study, we investigated its effects on inflammation and immune function in tumor patients with sepsis. In total, 120 participants were randomized to receive either carrimycin treatment (400 mg/day) (n = 62) or placebo (n = 58) for 7 days. The primary outcomes were immune-related indicators. Subsequently, patients were stratified into two subgroups (CD4 < 38.25% and CD8 < 25.195%). Ninety-nine participants were analyzed: 47 and 52 in the carrimycin and placebo groups, respectively. HLA-DR levels were rapidly increased in the carrimycin group; however, the placebo group initially experienced a decline in HLA-DR level at 1 day after administration. In the subgroup with CD4 < 38.25%, the carrimycin group exhibited significantly higher HLA-DR levels than the placebo group (2.270, P = 0.023) 1 day after administration and the degree of increase in HLA-DR in the carrimycin group was higher than that in the placebo group (2.057, P = 0.040). In the CD8 < 25.195% subgroup, the carrimycin group demonstrated significantly higher levels of CD8+ T cells than the placebo group at 3 (2.300, P = 0.027) and 5 (2.106, P = 0.035) days after administration. Carrimycin intervention led to significant reductions in the SOFA, APACHE II, PCT, and CRP levels. No adverse events were observed. In tumor patients with sepsis, particularly in those experiencing immunological suppression, carrimycin effectively regulates immune responses by increasing HLA-DR and CD8+ T cell levels and plays an anti-infective role, reducing disease severity. (Chictr.org.cn, ID Number: ChiCTR2000032339).http://www.sciencedirect.com/science/article/pii/S104366182300347XCarrimycinCD8+ T cellsHLA-DRImmuneSepsisTumor
spellingShingle Chuanchuan Nan
Xiaowu Zhang
Wei Huang
Biao Zhu
Jianghong Zhao
Song Lu
Lewu Xian
Kaizhong Liu
Gang Ma
Wei Yang
Mingguang Huang
Dongmin Zhou
Ming Zhang
Yan Duan
Guixin Wu
Zhengying Jiang
Li Zhang
Xinrong He
Yuhong Chen
Xuezhong Xing
Changsong Wang
Donghao Wang
Kaijiang Yu
Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: A multicenter double-blind randomized controlled trial
Pharmacological Research
Carrimycin
CD8+ T cells
HLA-DR
Immune
Sepsis
Tumor
title Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: A multicenter double-blind randomized controlled trial
title_full Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: A multicenter double-blind randomized controlled trial
title_fullStr Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: A multicenter double-blind randomized controlled trial
title_full_unstemmed Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: A multicenter double-blind randomized controlled trial
title_short Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: A multicenter double-blind randomized controlled trial
title_sort effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis a multicenter double blind randomized controlled trial
topic Carrimycin
CD8+ T cells
HLA-DR
Immune
Sepsis
Tumor
url http://www.sciencedirect.com/science/article/pii/S104366182300347X
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