| Chimeric antigen receptor T cell(CAR-T)therapy,as a new type of anti-tumor immune therapy,has made important breakthroughs in the treatment of acute lymphoblastic leukemia(ALL),lymphoma,multiple myeloma(MM)and other diseases.However,some complications have been observed in patients after CAR-T cells infusion,among which the most common and serious complication is cytokine release syndrome(CRS)which may lead to death if not managed promptly.After long time development of the previous autologous cell immunotherapy,we have accumulated rich experience in the treatment and nursing.However,the clinical research on CAR-T cell therapy has only been carried out in recent years,and its management system is not perfect.In the nursing work,the experience of previous autologous cell immunotherapy cannot be fully applicable to care for patients treated by CAR-T cell,especially those patients with severe CRS after CAR-T cells transfusion.And,the nursing measures and experience related to CAR-T cell therapy still need to be continuously explored,improved and perfected.Therefore,there are urgent problems for nursing workers to scientifically and normatively care for CAR-T cell treatment patients,manage their CRS symptoms,and ensure the effects of CAR-T cell therapy and patients' safeties.Objective:This project aims to construct a scientific and applicable nursing program for CRS in CAR-T cell treatment patients with hematologic malignancies,providing scientific and standardized nursing measures and nursing procedures for the care of CAR-T cell treatment patients,so as to reduce the incidence of CRS,improve the quality of life and promote the rehabilitation of patients.Methods:1.PubMed,Embase,Cochrane library,Web of Science,China National Knowledge Infrastructure(CNKI),Wan Fang Data,Chinese Biomedical Literature Database(CBM),VIP Database were retrieved through evidence-based medicine research methods.The literature was screened and analyzed to collect and extract the evidence of nursing intervention on patients with hematologic tumor treated by CAR-T cells,which can be used to guide the construction of CRS nursing program.2.Through the retrospective analysis of medical records,the occurrence and clinical manifestations of CRS in CAR-T cell treatment patients were analysed,and the management measures of CRS were summarized,providing references for the formulation of CRS nursing program.3.Through qualitative interview,the current situation of the nursing practice for CAR-T cell therapy was analyzed,the existing problems were found,laying the foundation for the formulation of CRS nursing program.4.Through basic experimental research,we can be familiar with the process of CAR-T cell preparation and transfusion,explore the mechanism of CRS,discuss the key points of nursing intervention in CAR-T cell therapy,and evaluate the safety and effectiveness of CAR-T cell therapy,providing basic data support for the formulation of CRS nursing program.5.Delphi method was used to invite senior experts to evaluate the CRS nursing program,so as to increase the scientificity,practicability and feasibility of the nursing program and make it more consistent with the clinical nursing practice to facilitate the implementation and application of CRS nursing program.6.A specialized hospital of hematology was selected as an empirical research institution of the nursing program.According to the principle of randomized control,40 patients with hematologic tumors who were hospitalized for CAR-T cell therapy from May 2019 to December 2019 were randomly divided into the control group and the experimental group.The control group of 20 patients were given routine nursing,while the experimental group of 20 patients were given nursing according to the constructed nursing program.After intervention,the following outcome indicators of the two groups were compared: depression and anxiety,quality of life,nursing satisfaction and the occurrence of CRS,so as to evaluate the application effect of the CRS nursing program.Results:1.Formulation of nursing program(1)Through searching relevant databases,a total of 999 literatures were retrieved.According to the inclusion and exclusion criteria,the researchers finally screened out 25 literatures,among which there were 9 articles reported the nursing care of patients during CAR-T cell therapy,6 articles reported the nursing or management of various complications,4 articles reported the nursing or management methods for CRS and neurotoxicity,4 articles focused on the management of CRS,2 articles focused on the management of neurotoxicity.The nursing intervention measures reported in the literatures were summarized,including admission evaluation,nursing of blood collection,nursing of CAR-T cell transfusion,management of complications,psychological nursing,and discharge guidance.(2)Through analyzing the medical records of CAR-T cell treatment patients,we found that the domestic existing nursing practices had certain achievements,but no scientific and standardized nursing program has been formed.Moreover,the incidence of CRS was still high in patients after CAR-T cell infusion,and the clinical symptoms of CRS were complex and serious.Nursing staffs should continuously refine the existing nursing practice and improve the ability of early detection and recognition of CRS,so as to reduce the occurrence of CRS in patients,and promote the recovery of patients.(3)Through the interview with doctors and nurses,it was found that the clinical nursing practice was mainly based on basic nursing,with limited nursing contents and a lack of norms,which could not meet the actual needs of CAR-T cell treatment patients.In addition,there were some problems in the clinical work of nursing staffs,such as lack of knowledge about CAR-T cell therapy,inadequate health education for patients and their families,and insufficient ability to deal with CRS.Therefore,the special knowledge training should be carried out for nurses to strengthen their nursing skills and improve their abilities to manage patients' CRS.Moreover,the importance of health education should be made clear to nurses,so as to improve their self-discipline and professionalism.(4)Through basic experimental research,the CAR-T cells were prepared,animal models were constructed,and CRS-related inflammatory factors expression were detected.It was found that the CAR-T cells significantly expressed T cell immunophenotype,effectively reduced the tumor load of mice,and highly expressed CRS-related inflammatory factor.In addition,the relevant quality inspection results were consistent with the quality control requirements of cell products.(5)15 senior experts in the field of hematology treatment,nursing and biotherapy were selected,with an average age of 41.33 ± 8.08 years and an average working years of 18.80 ± 8.74 years.After two rounds of expert consultation,the effective recovery rates of the questionnaire were 100% and 100% respectively.The degrees of expert authority were 0.86 and 0.88,respectively.Kendall's W coordination coefficients were 0.326 and 0.348,respectively.According to the inclusion and exclusion criteria of the items,the nursing program of CRS for CAR-T cell treatment patients with hematologic tumor was finally formed with 5 items of level 1,21 items of level 2 and 46 items of level 3.2.Application of nursing program(1)Before the interventions,there were no statistically significant differences(P>0.05)between the two groups in terms of gender,age,education level,monthly family income,medical payment method,residence and disease type,indicating that the two groups were comparable.(2)After the interventions,the incidence of pain in the experimental group was significantly lower than that in the control group,and the difference was statistically significant(P<0.05).There was no significant difference in the incidence of CRS and other symptoms,but the incidence of the corresponding symptom in the experimental group was lower than that in the control group.In addition,there were 2 patients with grade 3 CRS,and no patients developed grade 4 CRS in the experimental group,while there were 4 patients with grade 3 CRS and 1 patient with grade 4 CRS in the control group.These results indicated that the implementation of CRS nursing program could reduce the severity of CRS and effectively relieve the symptoms of patients.(3)Before the interventions,there were no statistical significance(P>0.05)in depression score(SDS)and anxiety score(SAS)between the two groups.However,the SDS and SAS scores of patients in the experimental group were lower than those of patients in the control group after the interventions,and with statistically significant differences(P<0.05),indicating that nursing the patients according to the standardized nursing program could effectively reduce the degree of depression and anxiety in CAR-T cell treatment patients.(4)Before the intervention,there was no statistical difference in the scores of quality of life between the two groups(P>0.05).After the interventions,the scores of role function,emotional function,cognitive function,social function and overall quality of life in the experimental group were all higher than those in the control group,and the differences were statistically significant(P<0.05).And,the scores of nausea,vomiting,pain,insomnia,constipation and diarrhea in the symptom areas of the experimental group were all lower than those of the control group,and with statistically significant differences(P<0.05),indicating that the application of standardized nursing program could significantly improve the patients' qualities of life.(5)After the interventions,the scores of nursing work satisfaction of the patients in the experimental group were significantly higher than that of the patients in the control group(P<0.05),indicating that the application of standardized nursing program could effectively improve the patients' satisfaction toward the nurses' work.Conclusions:1.In this study,we formulated the nursing program of CRS in CAR-T cell treatment patients with hematologic tumor through literature study,retrospective analysis of medical records,qualitative interview and expert consultation,and conducted a clinical empirical study on the program.It was found that the application of CRS nursing program can not only reduce the degree of anxiety and depression of patients,improve the patients' qualities of life and patients' satisfaction towards nursing work,but also reduce the incidence and severity of CRS and effectively relieve the symptoms of patients,which is of great clinical significance.2.The CRS nursing program constructed in this study provides evidence-based procedures and norms for the nursing of CAR-T cell treatment patients,and also provides empirical references for the development of standardized nursing program for patients treated by CAR-T cells. |
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