临床试验框架下噬菌体治疗多重耐药菌感染患者护理专家共识

Expert Consensus on Nursing Practices of Phage Therapy for Multi-Drug Resistant Organisms Infection Within the Framework of Clinical Trials

目的 制订《临床试验框架下噬菌体治疗多重耐药菌感染患者护理专家共识》(以下简称《共识》),规范临床试验框架下噬菌体治疗多重耐药菌感染患者的护理实践流程。方法 成立《共识》构建小组,通过查阅文献和开展利益相关者访谈,形成《共识》初稿;通过2轮德尔菲专家咨询和4轮小组会议形成《共识》终稿。结果 《共识》围绕多重耐药菌感染患者治疗开始前、治疗期间、治疗结束后3个阶段展开,包括临床研究护士职责与资质、患者评估与入组、治疗环境准备、噬菌体制剂准备、依据治疗方案执行给药、感控措施执行与督查、观察监测、追踪随访、数据记录与管理等。结论 《共识》综合了文献报道、临床经验和专家建议,具有一定的科学性和实用性,可为在临床试验框架下护理噬菌体治疗多重耐药菌感染患者方面提供指导。

Objective To establish the Expert Consensus on Nursing Practices of Phage Therapy for Multi-drug Resistant Organisms Infection within the Framework of Clinical Trials(hereinafter referred to as the Consensus),aiming to standardize the nursing practice of phage therapy for multi-drug resistant organisms infection within the framework of clinical trials.Methods A consensus construction group was established to develop the initial version of the consensus through literature review and clinical stakeholder interviews.The final version of the consensus was formed through two rounds of Delphi expert consultations and four rounds of group meetings.Results This consensus focuses on three stages:pre-treatment,during treatment,and post-treatment.It includes clinical research nurse responsibilities and qualifications,patient assessment and enrollment,treatment environment preparation,phage preparation,administration according to treatment protocols,implementation and supervision of infection control measures,observation and monitoring,follow-up and tracking,data recording and management.Conclusions The Consensus integrates literature reports,clinical experience,and expert recommendations.It is scientifically grounded and practical,providing guidance for clinical nurses in the treatment of multi-drug resistant organisms infection using phage therapy within the framework of clinical trials.