HACCP体系在肺癌化疗患者手臂输液港全流程管理中的应用

许燕; 吴林珂; 张琦婉; 张凯; 黄宝丽

doi:10.16766/j.cnki.issn.1674-4152.004472

HACCP体系在肺癌化疗患者手臂输液港全流程管理中的应用

doi: 10.16766/j.cnki.issn.1674-4152.004472

南京医科大学附属南京医院(南京市第一医院)呼吸与危重症医学科，江苏南京 210006

基金项目:

国家自然科学基金项目 81903089

详细信息

通讯作者:
黄宝丽，E-mail：254318828@qq.com

中图分类号: R541
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出版历程
- 收稿日期: 2025-05-15

Application of HACCP system in the whole process management of arm infusion port for patients with lung cancer chemotherapy

Department of Respiratory and Critical Care Medicine, Nanjing Hospital Affiliated with Nanjing Medical University (Nanjing First Hospital), Nanjing, Jiangsu 210006, China

摘要

摘要: 目的观察危害分析与关键控制点(HACCP)体系在肺癌化疗患者手臂输液港全流程管理中的应用效果。方法选取2022年5月—2024年5月南京医科大学附属南京医院呼吸科肺癌化疗并行手臂输液港置入术的106例患者，按照入院时间分组，HACCP组53例于2023年5月—2024年5月期间置管，实施HACCP全流程管理，对照组53例于2022年5月—2023年4月期间置管，实施常规输液港管理。比较2组输液港相关并发症发生率、流程执行与操作质量指标、医疗资料消耗指标及患者自我管理能力评分。结果 HACCP组囊袋感染、堵管、血栓形成、导管移位总发生率为7.55%(4例)，低于对照组的35.85%(19例)，差异有统计学意义(χ²=12.494，P＜0.001)；HACCP组敷料及时更换率、冲管手法合格率、敷料固定合格率分别为90.57%(48例)、92.45%(49例)、96.23%(51例)，高于对照组的60.38%(32例)、64.15%(34例)、64.15%(34例)，差异有统计学意义(χ²=13.046、12.494、17.162，P＜0.001)；HACCP组非计划返院次数少于对照组(P＜0.05)，感染预防知识、日常维护技能、并发症识别能力、医嘱依从性评分及总分达标率均高于对照组(P＜0.05)。结论 HACCP体系可降低肺癌化疗患者手臂输液港相关并发症发生率，提升流程执行质量及患者自我管理能力，且未额外增加医疗资源消耗。
- 肺癌 /
- 化疗 /
- 危害分析与关键控制点体系 /
- 手臂输液港 /
- 流程管理
Abstract: Objective To observe the application effect of hazard analysis and critical control point (HACCP) system in the whole process management of arm infusion port for patients undergoing lung cancer chemotherapy. Methods A total of 106 patients with lung cancer chemotherapy who received arm infusion port implantation were selected from Department of Respiratory Medicine of Nanjing Hospital Affiliated with Nanjing Medical University from May 2022 to May 2024, and were grouped according to admission time. In HACCP group, 53 patients were placed from May 2023 to May 2024 and implemented HACCP whole process management. In control group, 53 patients were placed from May 2022 to April 2023 and carried out routine infusion port management. The incidence rates of infusion port-related complications, process execution and operation quality indicators, medical data consumption indicators, and patient self-management ability were compared between the two groups. Results The total incidence rate of bag infection, tube plugging, thrombosis and catheter displacement in the HACCP group (7.55%, 4 patients) was lower than that in the control group (35.85%, 19 patients, χ²=12.494, P < 0.001). The compliance rate of timely replacement rate of dressing, qualified rate of flushing technique and qualified rate of dressing fixation in the HACCP group with 90.57% (48 cases), 92.45% (49 cases) and 96.23% (51 cases) were higher than 60.38% (32 cases), 64.15% (34 cases) and 64.15% (34 cases) in the control group (χ²=13.046, 12.494, 17.162, P < 0.001). The number of unplanned hospital returns was less in the HACCP group than that in the control group (P < 0.05), and the scores of infection prevention knowledge, daily maintenance skills, complication identification ability and medical order compliance and total score in the HACCP group were higher than those in the control group (P < 0.05). Conclusion HACCP system can significantly reduce the incidence rates of arm infusion port-related complications in patients with lung cancer chemotherapy, and enhance the quality of process execution and self-management ability, and it does not increase the consumption of medical resources.
- Lung cancer /
- Chemotherapy /
- Hazard analysis and critical control point system /
- Arm infusion port /
- Process management
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表 1 2组肺癌化疗患者一般资料比较

Table 1. Comparison of general characteristics between two groups of lung cancer chemotherapy patients

组别	例数	性别[例(%)]		年龄(x±s, 岁)	肿瘤分期[例(%)]		化疗方案[例(%)]		高血压[例(%)]	糖尿病[例(%)]
组别	例数	男性	女性	年龄(x±s, 岁)	Ⅲ期	Ⅳ期	紫杉醇+卡铂	培美曲塞+顺铂	高血压[例(%)]	糖尿病[例(%)]
HACCP组	53	32(60.38)	21(39.62)	58.24±10.27	18(33.96)	35(66.04)	28(52.83)	25(47.17)	15(28.30)	10(18.87)
对照组	53	29(54.72)	24(45.28)	59.63±9.82	16(30.19)	37(69.81)	26(49.06)	27(50.94)	17(32.08)	8(15.09)
统计量		0.348^a		0.712^b	0.173^a		0.151^a		0.179^a	0.370^a
P值		0.556		0.478	0.677		0.698		0.672	0.543
注：^a为χ²值, ^b为t值。

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表 2 2组肺癌化疗患者输液港相关并发症比较[例(%)]

Table 2. Comparison of port-related complications between two groups of lung cancer chemotherapy patients [cases (%)]

组别	例数	囊袋感染	堵管	血栓形成	导管移位	总发生
HACCP组	53	2(3.77)	1(1.89)	0	1(1.89)	4(7.55)
对照组	53	7(13.21)	5(9.43)	3(5.66)	4(7.55)	19(35.85)
注：2组并发症总发生率比较，χ²=12.494，P＜0.001。

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表 3 2组肺癌化疗患者流程执行与操作质量指标比较[例(%)]

Table 3. Comparison of process execution and operational quality indicators between two groups of lung cancer chemotherapy patients [cases (%)]

组别	例数	敷料及时更换	冲管手法合格	敷料固定合格
HACCP组	53	48(90.57)	49(92.45)	51(96.23)
对照组	53	32(60.38)	34(64.15)	34(64.15)
χ²值		13.046	12.494	17.162
P值		＜0.001	＜0.001	＜0.001

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表 4 2组肺癌化疗患者医疗资源消耗指标比较(x±s)

Table 4. Comparison of medical resource consumption indicators between two groups of lung cancer chemotherapy patients (x±s)

组别	例数	非计划返院次数(次)	单次维护耗材成本(元)	护理操作耗时(min)
HACCP组	53	1.08±0.29	42.36±10.52	19.82±5.27
对照组	53	1.45±0.57	38.75±9.84	18.15±5.96
t值		4.212	1.824	1.528
P值		＜0.001	0.071	0.130

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表 5 2组肺癌化疗患者自我管理能力评分比较

Table 5. Comparison of self-management ability scores between two groups of lung cancer chemotherapy patients

组别	例数	感染预防知识(x±s，分)	日常维护技能(x±s，分)	并发症识别能力(x±s，分)	医嘱依从性(x±s，分)	总分达标率例(%)
HACCP组	53	4.53±0.36	5.24±0.58	3.52±0.39	4.32±0.53	49(92.45)
对照组	53	3.22±1.07	4.05±1.12	2.15±0.68	3.28±1.04	32(60.38)
统计量		8.448^a	6.869^a	12.723^a	6.486^a	15.128^b
P值		＜0.001	＜0.001	＜0.001	＜0.001	＜0.001
注：^a为t值，^b为χ²值。

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