目的

探讨追踪方法学联合失效模式与效应分析（FMEA）模式在膀胱灌注化疗患者中的应用效果。

方法

纳入2020年5月至2021年5月在海军军医大学第一附属医院行经尿道膀胱肿瘤电切术，且随后于门诊行膀胱灌注化疗的患者共计5 436例。干预手段为通过应用追踪方法学联合 FMEA模式对患者进行护理风险评估，并设立计划及实施改善措施。本研究采用便利抽样方法，选取了实施改善措施患者646例（实施组），未实施患者531例（对照组）。通过比较两组患者风险优先指数（RPN）、护理质量指标满意度及年度不良事件发生率，评估该护理方案是否使膀胱灌注化疗患者获益。

结果

相较无措施患者，应用追踪方法学联合FMEA模式后，患者在膀胱灌注治疗前、中、后RPN得分均有不同程度下降，实施组较对照组的差异有统计学意义（P＜0.001）；操作前宣教、患者隐私保护、护士的服务态度、操作室条件、操作手法熟练程度、操作后病情观察、处理不良反应发生能力、院外指导、患者对操作全过程满意度及治疗效果10项指标均有明显提升，与对照组相比差异有统计学意义（P＜0.001）；不良事件发生率由3.58%（未实施）降至0.77%（实施后），不良反应发生率也明显低于对照组，差异有统计学意义（P=0.001）。

结论

追踪方法学联合FMEA模式可有效改善膀胱灌注化疗过程中的薄弱环节，保障膀胱灌注化疗的安全性，降低不良事件发生比例，提高护理指标的满意度，是一项有利的护理尝试，值得学习与推广。

Objective

To explore the application effect of tracking methodology combined with Failure Mode and Effects Analysis （FMEA） in patients undergoing bladder infusion chemotherapy.

Methods

A total of 5436 patients who underwent transurethral resection of bladder tumors in the First Affiliated Hospital of Navy Military Medical University from May 2020 to May 2021 and subsequently received bladder instillation chemotherapy in the outpatient department were included. The intervention method is to conduct nursing risk assessment of patients through the application of tracking methodology combined with FMEA，and establish plans and implement improvement measures. This study used convenience sampling method to select 646 patients who implemented improvement measures （observation group） and 531 patients who did not implement measures （control group）. By comparing the risk priority index （RPN），satisfaction with nursing quality indicators，and annual incidence of adverse events between two groups of patients，evaluate whether the nursing plan benefits patients undergoing bladder infusion chemotherapy.

Results

Compared with patients without intervention，the application of tracking methodology combined with FMEA mode resulted in varying degrees of decrease in RPN scores before，during，and after bladder infusion therapy. The difference between the implementation group and the control group was statistically significant （P＜0.001）； Pre operation education，patient privacy protection，nurse service attitude，operating room conditions，proficiency in operating techniques，post operation condition observation，ability to handle adverse reactions，out of hospital guidance，patient satisfaction with the entire operation process，and treatment effectiveness all showed significant improvements compared to the control group （P＜0.001）； The incidence of adverse events decreased from 3.58% （not implemented） to 0.77% （implemented），and the incidence of adverse reactions was significantly lower than that of the control group，with statistical significance （P=0.001）.

Conclusions

The combination of tracking methodology and FMEA mode can effectively improve the weak links in the process of bladder perfusion chemotherapy，ensure the safety of bladder perfusion chemotherapy，reduce the incidence of adverse events，and improve the satisfaction of nursing indicators. It is a beneficial nursing attempt that is worth learning and promoting.