文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

免疫球蛋白 G 治疗坏死性软组织感染的疗效(INSTINCT):一项随机、双盲、安慰剂对照试验。

Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial.

机构信息

Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.

Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

出版信息

Intensive Care Med. 2017 Nov;43(11):1585-1593. doi: 10.1007/s00134-017-4786-0. Epub 2017 Apr 18.


DOI:10.1007/s00134-017-4786-0
PMID:28421246
Abstract

PURPOSE: The aim of the INSTINCT trial was to assess the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo on self-reported physical function in intensive care unit (ICU) patients with necrotising soft tissue infection (NSTI). METHODS: We randomised 100 patients with NSTI 1:1 to masked infusion of 25 g of IVIG (Privigen, CSL Behring) or an equal volume of 0.9% saline once daily for the first 3 days of ICU admission. The primary outcome was the physical component summary (PCS) score of the 36-item short form health survey (SF-36) 6 months after randomisation; patients who had died were given the lowest possible score (zero). RESULTS: Of the 100 patients randomised, 87 were included in the intention-to-treat analysis of the PCS score, 42 patients (84%) in the IVIG group and 45 patients (90%) in the placebo group. The two intervention groups had similar baseline characteristics with the exception of IVIG use before randomisation (1 dose was allowed) and rates of acute kidney injury. Median PCS scores were 36 (interquartile range 0-43) in the group assigned to IVIG and 31 (0-47) in the group assigned to placebo (mean adjusted difference 1 (95% confidence interval -7 to 10), p = 0.81). The result was supported by analyses adjusted for baseline prognostics, those in the per protocol populations, in the subgroups (site of NSTI) and those done post hoc adjusted for IVIG use before randomisation. CONCLUSIONS: In ICU patients with NSTI, we observed no apparent effects of adjuvant IVIG on self-reported physical functioning at 6 months. TRIAL REGISTRATION: NCT02111161.

摘要

目的:INSTINCT 试验的目的是评估静脉注射多特异性免疫球蛋白 G(IVIG)与安慰剂相比对重症监护病房(ICU)患有坏死性软组织感染(NSTI)的患者自我报告的身体功能的影响。

方法:我们将 100 名 NSTI 患者以 1:1 的比例随机分为 2 组,分别接受 25g IVIG(Privigen,CSL Behring)或相同体积的 0.9%生理盐水,每天 1 次,共 3 天。主要结局是随机分组后 6 个月的 36 项简短健康调查(SF-36)的物理成分综合评分(PCS);已死亡的患者给予最低可能评分(零)。

结果:在随机分组的 100 名患者中,87 名患者被纳入 PCS 评分的意向治疗分析,IVIG 组 42 名(84%),安慰剂组 45 名(90%)。两组干预组除随机分组前的 IVIG 使用(允许使用 1 剂)和急性肾损伤发生率外,具有相似的基线特征。分配给 IVIG 的组的中位 PCS 评分为 36(四分位距 0-43),分配给安慰剂的组为 31(0-47)(平均调整差异 1(95%置信区间-7 至 10),p=0.81)。该结果得到了调整基线预后、符合方案人群、亚组(NSTI 部位)和事后调整随机分组前 IVIG 使用的分析的支持。

结论:在 ICU 患有 NSTI 的患者中,我们未观察到辅助 IVIG 对 6 个月时自我报告的身体功能有明显影响。

试验注册:NCT02111161。

相似文献

[1]
Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial.

Intensive Care Med. 2017-4-18

[2]
Immunoglobulin for necrotising soft tissue infections (INSTINCT): protocol for a randomised trial.

Dan Med J. 2016-7

[3]
Effect of immunoglobulin G on cytokine response in necrotising soft-tissue infection: A post hoc analysis.

Acta Anaesthesiol Scand. 2021-10

[4]
Treatment of Necrotizing Soft Tissue Infections: IVIG.

Adv Exp Med Biol. 2020

[5]
Intravenous immunoglobulin in primary and secondary chronic progressive multiple sclerosis: a randomized placebo controlled multicentre study.

Mult Scler. 2007-11

[6]
Intravenous immunoglobulin treatment for secondary recurrent miscarriage: a randomised, double-blind, placebo-controlled trial.

BJOG. 2014-11-21

[7]
A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections: A Randomized Clinical Trial.

JAMA Surg. 2014-6

[8]
Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial.

Trials. 2016-7-25

[9]
Prognostic factors in necrotizing soft-tissue infections (NSTI): A cohort study.

J Am Acad Dermatol. 2015-9-26

[10]
Infliximab for intensification of primary therapy for Kawasaki disease: a phase 3 randomised, double-blind, placebo-controlled trial.

Lancet. 2014-2-24

引用本文的文献

[1]
Optimizing Antibiotic Choice, Administration, and Duration in NSTI Treatment.

Bioengineering (Basel). 2025-6-24

[2]
The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2024.

J Intensive Care. 2025-3-14

[3]
Complicated and deep bacterial skin and soft tissue infections.

J Dtsch Dermatol Ges. 2025-3

[4]
The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2024.

Acute Med Surg. 2025-2-24

[5]
The intricate pathogenicity of Group A : A comprehensive update.

Virulence. 2024-12

[6]
Treating necrotizing skin and soft-tissue infections.

Intensive Care Med. 2024-8

[7]
Adjunctive immunotherapeutic agents in patients with sepsis and septic shock: a multidisciplinary consensus of 23.

J Anesth Analg Crit Care. 2024-4-30

[8]
[Emergencies in infectious diseases].

Med Klin Intensivmed Notfmed. 2024-6

[9]
Catastrophic Disease: A Personalized Approach Based on Phenotypes and Treatable Traits.

Antibiotics (Basel). 2024-2-15

[10]
High-dose intravenous immunoglobulin versus albumin 4% in paediatric toxic shock syndrome: a randomised controlled feasibility study.

Arch Dis Child. 2024-8-16

本文引用的文献

[1]
Impact of Intravenous Immunoglobulin on Survival in Necrotizing Fasciitis With Vasopressor-Dependent Shock: A Propensity Score-Matched Analysis From 130 US Hospitals.

Clin Infect Dis. 2017-4-1

[2]
Long-term outcomes in patients with septic shock transfused at a lower versus a higher haemoglobin threshold: the TRISS randomised, multicentre clinical trial.

Intensive Care Med. 2016-9-30

[3]
IVIG-mediated protection against necrotizing pneumonia caused by MRSA.

Sci Transl Med. 2016-9-21

[4]
Immunoglobulin for necrotising soft tissue infections (INSTINCT): protocol for a randomised trial.

Dan Med J. 2016-7

[5]
Effect of a Primary Care Management Intervention on Mental Health-Related Quality of Life Among Survivors of Sepsis: A Randomized Clinical Trial.

JAMA. 2016-6-28

[6]
The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

JAMA. 2016-2-23

[7]
Pentraxin-3 as a marker of disease severity and risk of death in patients with necrotizing soft tissue infections: a nationwide, prospective, observational study.

Crit Care. 2016-2-15

[8]
The importance of source control in the management of severe skin and soft tissue infections.

Curr Opin Infect Dis. 2016-4

[9]
Management of necrotizing soft tissue infections in the intensive care unit: results of an international survey.

Intensive Care Med. 2015-8

[10]
Multiple imputation: a mature approach to dealing with missing data.

Intensive Care Med. 2015-2

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索