秋水仙碱在脓毒症中的作用（COLINS）：一项随机、双盲、安慰剂对照试验的研究方案
The effect of Colchicine IN Sepsis (COLINS): a study protocol for a randomized, double-blind, placebo-controlled trial.
作者信息
Pourkarim Fariba, Mahmoodpoor Ata, Soleimanpour Hassan, Ghamari Aliakbar, Asghari-Ardabili Roghayeh, Sarbakhsh Parvin, Hamishehkar Hadi
机构信息
Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Anesthesiology and Intensive Care, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
出版信息
Trials. 2025 Jun 21;26(1):216. doi: 10.1186/s13063-025-08901-y.
BACKGROUND
Sepsis is a life-threatening condition with high mortality rates of up to 40% due to multiple organ dysfunction. Systemic inflammatory response plays a key role in the pathophysiology and progression of this disease. Therefore, anti-inflammatory drugs can be considered as augmentation therapy for the management of the early phase of inflammation in septic patients, along with appropriate antimicrobial therapy and source control. Experimental studies suggest the beneficial effects of colchicine in animal septic models. However, the clinical effects of colchicine in the setting of sepsis have not been investigated yet.
METHODS
This prospective, double-blinded, placebo-controlled, randomized trial will be conducted at Imam Reza Hospital, the largest northwest referral hospital, in Tabriz, Iran. A total of 44 patients aged 18 to 80 years with sepsis diagnosis will be randomized 1:1 to receive colchicine 1 mg daily or placebo for 10 days. The primary outcome is interleukin-6 (IL-6) changes from the baseline through day 4. Sequential organ failure assessment (SOFA) and qSOFA scores will be evaluated at baseline, day 4, and day 10. Patients will be assessed regarding the need for supplemental oxygen, mechanical ventilation, and vasopressor from the randomization through day 4 and day 10.
DISCUSSION
The Colchicine IN Sepsis (COLINS) trial will be the first to investigate colchicine's efficacy versus placebo in sepsis patients. The results of this trial will be a step forward in treating patients with sepsis.
TRIAL REGISTRATION
Clinical trial ID: IRCTID: IRCT20231017059748N1. Registration date: 21 October 2023. https://irct.behdasht.gov.ir/trial/73232 .
背景
脓毒症是一种危及生命的疾病，由于多器官功能障碍，死亡率高达40%。全身炎症反应在该疾病的病理生理学和进展中起关键作用。因此，除了适当的抗菌治疗和源头控制外，抗炎药物可被视为脓毒症患者炎症早期管理的强化治疗方法。实验研究表明秋水仙碱在动物脓毒症模型中有有益作用。然而，秋水仙碱在脓毒症环境中的临床效果尚未得到研究。
方法
这项前瞻性、双盲、安慰剂对照、随机试验将在伊朗大不里士最大的西北转诊医院伊玛目礼萨医院进行。共有44名年龄在18至80岁之间诊断为脓毒症的患者将按1:1随机分组，接受每日1毫克秋水仙碱或安慰剂治疗10天。主要结局是从基线到第4天白细胞介素-6（IL-6）的变化。将在基线、第4天和第10天评估序贯器官衰竭评估（SOFA）和qSOFA评分。从随机分组到第4天和第10天，将评估患者对补充氧气、机械通气和血管活性药物的需求。
讨论
脓毒症秋水仙碱（COLINS）试验将是首个研究秋水仙碱与安慰剂在脓毒症患者中疗效对比的试验。该试验结果将是脓毒症患者治疗方面的一大进步。
试验注册
临床试验识别号：IRCTID：IRCT20231017059748N1。注册日期：2023年10月21日。https://irct.behdasht.gov.ir/trial/73232 。
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