P. Fei, Yishan Liu, Lingyun Zuo, Bin-fang Gu, Liqun Liang, Luhao Wang, Y. Nie, Minying Chen, X. Guan, Jianfeng Wu
{"title":"胸腺素- 1治疗可减轻败血症患者的器官功能障碍:一项回顾性队列研究","authors":"P. Fei, Yishan Liu, Lingyun Zuo, Bin-fang Gu, Liqun Liang, Luhao Wang, Y. Nie, Minying Chen, X. Guan, Jianfeng Wu","doi":"10.37349/ei.2022.00045","DOIUrl":null,"url":null,"abstract":"Aim:\n\nThymosin alpha 1 (Tα1) is a promising treatment for the improvement of sepsis patients. Until now, its function in reducing acute organ damage of sepsis patients is still unclear. The aim of this study was to determine whether Tα1 can alleviate organ dysfunction in sepsis patients.\nMethods:\n\nThis study retrospectively enrolled sepsis patients from a multicenter randomized controlled trial [efficacy of Tα1 for severe sepsis (ETASS)]. The sequential organ failure assessment (SOFA) score on day 0 (initial), day 3, and day 7 was collected. Absolute SOFAday07 was defined as initial SOFA score minus SOFA score on day 7 (initial SOFA–SOFA day7). Delta SOFA score (ΔSOFAday07) was provided by the formula: (initial SOFA–SOFA day7) × 100/initial SOFA, and it was expressed as a percentage. After propensity score matching (1:1 ratio), baseline characteristics were well-balanced between the Tα1 group and placebo group. The primary outcome was evaluated with a comparison of ΔSOFAday07 decline between patients treated with or without Tα1 therapy.\nResults:\n\nAmong 288 enrolled patients, 149 patients received both Tα1 and standard therapy (Tα1 group), and 139 patients received both placebo and standard therapy (placebo group). Compared with the placebo group, the Tα1 group had significantly lower Absolute SOFAday07 [95% confidence interval (CI) 0.8 (0–1.7), P = 0.049]. Among 111 pairs of patients matched by propensity score, the Tα1 group still had lower Absolute SOFAday07 [95% CI 1.0 (0.1–1.9), P = 0.029]. Meanwhile, Tα1 treatment could significantly improve ΔSOFAday07. When the amplitude of ΔSOFAday07 was graded, one third of patients in the Tα1 group had an increase of more than 60%, compared with 22% in the placebo group. Subgroup analysis found that the ΔSOFAday07 improved significantly after Tα1 therapy in sepsis patients with no immunoparalysis at baseline, no complications, and early intervention.\nConclusions:\n\nFor sepsis patients, Tα1 treatment can alleviate organ dysfunction, and ΔSOFAday07 can be used as an indicator of its therapeutic effect (ClinicalTrials.gov identifier: NCT00711620).","PeriodicalId":93552,"journal":{"name":"Exploration of immunology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"Thymosin alpha 1 therapy alleviates organ dysfunction of sepsis patients: a retrospective cohort study\",\"authors\":\"P. Fei, Yishan Liu, Lingyun Zuo, Bin-fang Gu, Liqun Liang, Luhao Wang, Y. Nie, Minying Chen, X. Guan, Jianfeng Wu\",\"doi\":\"10.37349/ei.2022.00045\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Aim:\\n\\nThymosin alpha 1 (Tα1) is a promising treatment for the improvement of sepsis patients. Until now, its function in reducing acute organ damage of sepsis patients is still unclear. The aim of this study was to determine whether Tα1 can alleviate organ dysfunction in sepsis patients.\\nMethods:\\n\\nThis study retrospectively enrolled sepsis patients from a multicenter randomized controlled trial [efficacy of Tα1 for severe sepsis (ETASS)]. The sequential organ failure assessment (SOFA) score on day 0 (initial), day 3, and day 7 was collected. Absolute SOFAday07 was defined as initial SOFA score minus SOFA score on day 7 (initial SOFA–SOFA day7). Delta SOFA score (ΔSOFAday07) was provided by the formula: (initial SOFA–SOFA day7) × 100/initial SOFA, and it was expressed as a percentage. After propensity score matching (1:1 ratio), baseline characteristics were well-balanced between the Tα1 group and placebo group. The primary outcome was evaluated with a comparison of ΔSOFAday07 decline between patients treated with or without Tα1 therapy.\\nResults:\\n\\nAmong 288 enrolled patients, 149 patients received both Tα1 and standard therapy (Tα1 group), and 139 patients received both placebo and standard therapy (placebo group). Compared with the placebo group, the Tα1 group had significantly lower Absolute SOFAday07 [95% confidence interval (CI) 0.8 (0–1.7), P = 0.049]. Among 111 pairs of patients matched by propensity score, the Tα1 group still had lower Absolute SOFAday07 [95% CI 1.0 (0.1–1.9), P = 0.029]. Meanwhile, Tα1 treatment could significantly improve ΔSOFAday07. When the amplitude of ΔSOFAday07 was graded, one third of patients in the Tα1 group had an increase of more than 60%, compared with 22% in the placebo group. 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引用次数: 2
摘要
目的:胸腺素α1 (Tα1)是一种很有希望改善脓毒症患者的治疗方法。迄今为止,其在减轻脓毒症患者急性器官损伤中的作用尚不清楚。本研究旨在探讨Tα1是否能减轻脓毒症患者的器官功能障碍。方法:本研究回顾性纳入了一项多中心随机对照试验[Tα1治疗严重脓毒症(ETASS)的疗效]的脓毒症患者。收集第0天(初始)、第3天和第7天的序贯器官衰竭评估(SOFA)评分。绝对SOFAday07定义为初始SOFA评分减去第7天的SOFA评分(初始SOFA - SOFA第7天)。Delta SOFA评分(ΔSOFAday07)的计算公式为:(initial SOFA - SOFA day7) × 100/initial SOFA,并以百分比表示。倾向评分匹配(1:1)后,Tα1组和安慰剂组的基线特征平衡良好。通过比较接受或不接受t - α1治疗的患者的ΔSOFAday07下降来评估主要结局。结果:288例入组患者中,同时接受Tα1和标准治疗的患者149例(Tα1组),同时接受安慰剂和标准治疗的患者139例(安慰剂组)。与安慰剂组相比,Tα1组的绝对SOFAday07明显降低[95%置信区间(CI) 0.8 (0-1.7), P = 0.049]。在倾向评分匹配的111对患者中,Tα1组的绝对SOFAday07仍较低[95% CI 1.0 (0.1 ~ 1.9), P = 0.029]。同时t - α1处理可显著改善ΔSOFAday07。当ΔSOFAday07的振幅被分级时,Tα1组中三分之一的患者增加超过60%,而安慰剂组为22%。亚组分析发现,基线时无免疫瘫痪、无并发症、早期干预的败血症患者经Tα1治疗后ΔSOFAday07明显改善。结论:对于脓毒症患者,Tα1治疗可减轻器官功能障碍,ΔSOFAday07可作为其治疗效果的指标(ClinicalTrials.gov标识符:NCT00711620)。
Thymosin alpha 1 therapy alleviates organ dysfunction of sepsis patients: a retrospective cohort study
Aim:
Thymosin alpha 1 (Tα1) is a promising treatment for the improvement of sepsis patients. Until now, its function in reducing acute organ damage of sepsis patients is still unclear. The aim of this study was to determine whether Tα1 can alleviate organ dysfunction in sepsis patients.
Methods:
This study retrospectively enrolled sepsis patients from a multicenter randomized controlled trial [efficacy of Tα1 for severe sepsis (ETASS)]. The sequential organ failure assessment (SOFA) score on day 0 (initial), day 3, and day 7 was collected. Absolute SOFAday07 was defined as initial SOFA score minus SOFA score on day 7 (initial SOFA–SOFA day7). Delta SOFA score (ΔSOFAday07) was provided by the formula: (initial SOFA–SOFA day7) × 100/initial SOFA, and it was expressed as a percentage. After propensity score matching (1:1 ratio), baseline characteristics were well-balanced between the Tα1 group and placebo group. The primary outcome was evaluated with a comparison of ΔSOFAday07 decline between patients treated with or without Tα1 therapy.
Results:
Among 288 enrolled patients, 149 patients received both Tα1 and standard therapy (Tα1 group), and 139 patients received both placebo and standard therapy (placebo group). Compared with the placebo group, the Tα1 group had significantly lower Absolute SOFAday07 [95% confidence interval (CI) 0.8 (0–1.7), P = 0.049]. Among 111 pairs of patients matched by propensity score, the Tα1 group still had lower Absolute SOFAday07 [95% CI 1.0 (0.1–1.9), P = 0.029]. Meanwhile, Tα1 treatment could significantly improve ΔSOFAday07. When the amplitude of ΔSOFAday07 was graded, one third of patients in the Tα1 group had an increase of more than 60%, compared with 22% in the placebo group. Subgroup analysis found that the ΔSOFAday07 improved significantly after Tα1 therapy in sepsis patients with no immunoparalysis at baseline, no complications, and early intervention.
Conclusions:
For sepsis patients, Tα1 treatment can alleviate organ dysfunction, and ΔSOFAday07 can be used as an indicator of its therapeutic effect (ClinicalTrials.gov identifier: NCT00711620).