目的 开展嵌合抗原受体T细胞(chimeric antigen receptor T cell,CAR-T)治疗血液肿瘤患者护理管理的循证实践,评价其在提高护士和血液肿瘤患者的CAR-T细胞治疗护理相关知识水平,完善相关流程,缓解患者焦虑抑郁情绪、提高生活质量,及降低患者细胞因子释放综合征(cytokine release syndrome,CRS)、免疫效应细胞相关神经毒性综合征(immune effector cell associated neurotoxicity syndrome,ICANS)不良反应的发生率及严重程度的临床效果。方法 通过文献筛选、评价及汇总,总结CAR-T细胞治疗血液肿瘤患者护理管理的最佳证据。通过专家会议对最佳证据进行本土化调试,并依据最佳证据制定审查指标。以“基于证据的持续质量改进模式”为理论框架在湖南某两所三级甲等医院开展循证实践,2023年5月—2023年8月对符合纳入标准的护士、患者及系统层面进行基线审查。2023年9月根据基线审查结果,分析证据引入临床过程中的促进与障碍因素,并制订行动策略,进行实践改革。2023年10月—2024年1月进行效果评价,比较循证实践前后各审查指标的执行率、护士和患者CAR-T细胞治疗护理相关知识水平、患者焦虑抑郁情绪、生活质量及并发症的发生率与严重程度。结果 循证实践期间共纳入护士25名,基线审查期间纳入患者18例,效果评价期间纳入患者17例。循证实践后,各审查指标执行率均有提升,护士相关知识水平得分由(57.20±8.43)分提高到(82.20±6.78)分,患者相关知识调查问卷正确率由应用前的16.7%~94.4%提高到74.4%~100%,平均正确率由75.0%提高至96.9%,焦虑、抑郁评分由(52.44±2.12)分、(52.56±2.62)分降低至(49.94±2.77)分、(49.29±3.26)分,FACT-G得分由(67.94±8.31)分提高至(78.06±9.46)分,差异均具有统计学意义(P<0.05)。结论 循证实践的开展可完善CAR-T细胞治疗护理相关资料与流程,提高护士及患者的CAR-T细胞治疗护理相关知识水平,规范护士对CAR-T细胞治疗患者的护理管理,缓解患者焦虑抑郁的情绪,提高生活质量,可一定程度上减轻并发症的严重程度。
Abstract
Objective To construct an evidence-based management of patients with hematologic tumors treated with CAR T cells, to evaluate its clinical effects in improving nurses' and hematologic tumor patients' CAR-T cell therapy knowledge, improving related procedures, relieving patients' anxiety and depression, improving quality of life, and reducing the incidence and severity of related adverse reactions about CRS and ICANS. Method Through literature screening, evaluation and summary, the best evidence of nursing management of patients with hematologic tumors treated with CAR T cells was summarized. Through the expert demonstration meeting, the best evidence was localized debugging, and the review index was formulated according to the best evidence. Based on the theoretical framework of “evidence-based continuous quality improvement model”, evidence-based practice was carried out in two tertiary level A hospitals in Hunan Province. A baseline review was conducted on nurses and patients who met the inclusion criteria and at the system level from May 2023 to August 2023. In September 2023, based on the results of the baseline review, analyze the factors that may be encountered in promoting and impeding the introduction of evidence into the clinical process, and develop action strategies for practice reform. Effect evaluation was conducted from October 2023 to January 2024, and the implementation rate of each review indicator before and after evidence-based practice, the knowledge level of nurses and patients related to CAR T cell therapy, the incidence and severity of anxiety and depression and related complications of patients were compared. Results A total of 25 nurses were included in the evidence-based practice period, 18 patients were included in the baseline review period, and 17 patients were included in the effect evaluation period. After the evidence-based practice, the implementation rate of each review index was improved, the score of nurses' relevant knowledge level was increased from (57.20±8.43) to (82.20±6.78), and the accuracy of patients' relevant knowledge questionnaire was increased from 16.7%-94.4% before the application to 74.4%-100%. The average accuracy increased from 75.0% to 96.9%, and the scores of SAS and SDS decreased from (52.44±2.12) and (52.56±2.62) to (49.94±2.77) and (49.29±3.26). The FACT-G score increased from (67.94±8.31) to (78.06±9.46), and the differences were statistically significant (P<0.05). Conclusion The evidence-based practice of nursing management of patients with hematologic tumor treated with CAR-T cell therapy can improve the relevant department data and procedures, improve the knowledge level of nurses and patients with CAR-T cell therapy, standardize nurses' nursing management of patients with CAR-T cell therapy, relieve patients’ anxiety and depression, and improve the quality of life of patients. It can reduce the severity of complications to some extent.
关键词
嵌合抗原受体T细胞 /
血液肿瘤 /
循证护理 /
循证实践
Key words
chimeric antigen receptor T cells /
hematologic tumor /
evidence-based nursing /
evidence-based practice
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参考文献
[1] 孙于谦, 黄晓军. 我国血液肿瘤治疗待解决的问题及对策[J]. 中华内科杂志, 2021, 60(10): 857-859.
[2] 许彤瑶, 刘腊梅, 颛孙梦瑶, 等. 血液肿瘤病人支持性照护需求研究进展[J]. 护理研究, 2023, 37(19): 3481-3486.
[3] HAN B, ZHENG R, ZENG H, et al.Cancer incidence and mortality in China, 2022[J]. J Nati Cancer Cent, 2024, 4(1): 47-53.
[4] 陆忆娟, 马爱霞. CAR-T细胞免疫疗法治疗血液恶性肿瘤系统综述[J]. 中国新药杂志, 2020, 29(05): 534-540.
[5] 常英军. 我国血液肿瘤移植治疗的发展与现状[J]. 白血病·淋巴瘤, 2019, 28(8): 5.
[6] 康云, 梅恒, 胡豫. 血液肿瘤CAR-T细胞治疗的现状与挑战[J]. 中国肿瘤临床, 2023, 50(01): 49-54.
[7] HAYDEN P J, RODDIE C, BADER P, et al.Management of adults and children receiving CAR T-cell therapy: 2021 best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE) and the European Haematology Association (EHA)[J]. Annals of Oncology, 2022, 33(3): 259-275.
[8] ELLARD R, KENYON M, HUTT D, et al.The EBMT immune effector cell nursing guidelines on CAR-T therapy: a framework for patient care and managing common toxicities[J]. Clin Hematol Int, 2022, 4(3): 75-88.
[9] BAER B, DUDLEY C V, SIMONS R M.Management principles associated with cytokine release syndrome[J]. Semi Oncol Nurs, 2019, 35(5): 150931.
[10] 仉慧娟, 童浩, 张燕晖, 等. 一例嵌合抗原受体修饰T细胞联合微移植治疗复发/难治急性淋巴细胞白血病患者的护理[J]. 中国实用护理杂志, 2018, 34(4): 306-308.
[11] 阮海涛, 万滢, 徐丽. 嵌合抗原受体T细胞治疗恶性血液肿瘤并发重度细胞因子释放综合征患者的护理[J]. 护理学杂志, 2019, 34(23): 29-31.
[12] 阮海涛, 张姿怡, 周丽, 等.2例白血病患者行嵌合抗原受体T细胞治疗合并严重神经毒性的护理[J]. 护理学报, 2022, 29(12): 67-69.
[13] 李丽娜, 万滢. 嵌合抗原受体修饰T细胞免疫疗法治疗B细胞恶性肿瘤患者的护理[J]. 中华护理杂志, 2017, 52(3): 297-299.
[14] KAHN S R, MORRISON D R, DIENDÉRÉ G, et al. Interventions for implementation of thromboprophylaxis in hospitalized patients at risk for venous thromboembolism[J]. Cochrane Database Syst Rev, 2018, 4(4): CD008201.
[15] ALPER B S, HAYNES R B.EBHC pyramid 5.0 for accessing preappraised evidence and guidance[J]. Evid Based Med, 2016, 21(4): 123-125.
[16] DAVID L PORTER, DAVID G MALONEY.Cytokine release syndrome (CRS) [EB/OL]. https://www.uptodate.com/contents/cytokine-release-syndrome-crs?topicRef=129618&source=see_link
[17] JORG DIETRICH, MATTHEW J FRIGAULT. Immune effector cell-associated neurotoxicity syndrome (ICANS), [EB/OL]. (2024-04-02). https://www.uptodate.com/contents/immune-effector-cell-associated-neurotoxicity-syndrome-icans?search=CAR-T&source=search_result&selectedTitle=5~101&usage_type=default&display_rank=4
[18] THOMPSON J A, SCHNEIDER B J, BRAHMER J, et al.Management of immunotherapy-related toxicities, version 1.2022, NCCN clinical practice guidelines in oncology[J]. J Nati Compr Canc Netw, 2022, 20(4): 387-405.
[19] MAUS M V, ALEXANDER S, BISHOP M R, et al.Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events[J]. J Immunother Cancer, 2020, 8(2): e001511.
[20] SANTOMASSO B D, NASTOUPIL L J, ADKINS S, et al.Management of immune-related adverse events in patients treated with chimeric antigen receptor T-cell therapy: ASCO guideline[J]. J Clin Oncol, 2021, 39(35): 3978-3992.
[21] LEI W, XIE M, JIANG Q, et al.Treatment-related adverse events of chimeric antigen receptor T-cell (CAR T) in clinical trials: a systematic review and meta-analysis[J]. Cancers, 2021, 13(15): 3912.
[22] LUO W, LI C, ZHANG Y, et al.Adverse effects in hematologic malignancies treated with chimeric antigen receptor (CAR) T cell therapy: a systematic review and Meta-analysis[J]. BMC Cancer, 2022, 22(1): 98.
[23] GRANT S J, GRIMSHAW A A, SILBERSTEIN J, et al.Clinical presentation, risk factors, and outcomes of immune effector cell-associated neurotoxicity syndrome following chimeric antigen receptor T cell therapy: a systematic review[J]. Transplant Cell Ther, 2022, 28(6): 294-302.
[24] CUCCHIARO B, WEEKES C E.Systematic review of nutrition support interventions in adult haematology and oncology patients receiving CAR T cell therapy[J]. Clin Nutr ESPEN, 2021, 46: 60-65.
[25] LEE D W, SANTOMASSO B D, LOCKE F L, et al.ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells[J]. Biol Blood Marrow Transplant, 2019, 25(4): 625-638.
[26] 中国研究型医院学会生物治疗学专委会. CAR T细胞治疗NHL毒副作用临床管理专家共识[J]. 转化医学杂志, 2021, 10(1): 1-11.
[27] 中华医学会血液学分会白血病淋巴瘤学组, 中国抗癌协会血液肿瘤专业委员会造血干细胞移植与细胞免疫治疗学组. 嵌合抗原受体T细胞治疗相关神经系统毒副反应管理中国专家共识 (2022年版)[J]. 中华血液学杂志, 2022, 43(2): 6.
[28] 本共识撰写专家组, 邢淑君, 李强, 等. CAR-T前体细胞采集标准化流程专家共识[J]. 癌症, 2023, 42(06): 295-303.
[29] BROUWERS M C, KHO M E, BROWMAN G P, et al.AGREE II: advancing guideline development, reporting and evaluation in health care[J]. Cmaj, 2010, 182(18): E839-E842.
[30] The Joanna Briggs Institute (JBI) Checklist for Systematic Reviews and Research Syntheses[EB/OL]. (2019-07-10) [2016-12-03]. http://joannabriggs.org/research/critical-appraisal-tools.html
[31] The Joanna Briggs Institute (JBI) Checklist for Text and Opinion[EB/OL]. (2019-07-10) [2016-12-03]. http://joannabriggs.org/research/critical-appraisal-tools.html
[32] 王春青, 胡雁. JBI证据预分级及证据推荐级别系统 (2014版)[J]. 护士进修杂志, 2015, 30(11): 964-967.
[33] 周婷, 孙晗, 魏冉, 等. 预见性护理在嵌合抗原受体T细胞治疗复发难治性淋巴瘤中的应用[J]. 中西医结合护理 (中英文), 2023, 9(03): 91-93.
[34] 周雪琴. KTH整合护理干预在造血干细胞移植联合CAR-T治疗复发难治B细胞淋巴瘤病人中的应用[J]. 循证护理, 2023, 9(11): 2068-2072.
[35] TEES M, AGRAWAL T, MARTIN C, et al.Outpatient Administration of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Non-Hodgkin Lymphoma (NHL), in a Large Multi-Center Network[J]. Transplantation and Cellular Therapy, 2024, 30(2 supplement): S215-S216.
[36] 孙菲菲, 张会娟, 解文君, 等. 供者来源嵌合抗原受体T细胞治疗造血干细胞移植后复发患者的毒性观察及护理[J]. 护士进修杂志, 2020, 35(17): 1593-1595.
基金
湖南省教育厅科学研究项目“基于CAR-T疗法血液肿瘤患者护理模式的构建及临床应用”(20C1183)