中国服用酪氨酸激酶抑制剂的慢性髓性白血病慢性期患者共存疾病状况及其对患者报告结果的影响

Comorbidity profile and its impact on reported outcome in Chinese patients with chronic myeloid leukemia in chronic phase receiving tyrosine kinase-inhibitor therapy

目的评估中国服用酪氨酸激酶抑制剂（TKI）的慢性髓性白血病慢性期（CML—CP）患者共存疾病状况及其对患者报告结果（PRO）的影响。方法2015年9月至2016年3月，在全同范围内向正在服用TKI的成年CML患者发放无记名调查问卷，问卷内容包括人口学特征、常见共存疾病、TKI用药、费用、治疗反应、健康相关的生活质量（HRQoL，以sF。36量表评估）、患者对TKI治疗的满意度和TKI治疗对患者工作及生活的影响等。结果1108例CML．CP受访者提供的问卷可供分析，男性701例（63．6％），中位年龄42（18-88）岁，TKI用药以伊马替尼为主（76．4％），中位服药时间为29（3-178）个月。300例（27．1％）受访者报告具有共存疾病，常见的依次为：高血压（30．3％）、糖尿病（21．0％）、冠心病（12．3％）、胃肠道疾病（12．3％）、肝病（11．7％）、肾病（8．3％）、脑血管病（6．7％）、肺病（5．7％）、血栓（1．3％），其他良性病为15．3％，其他肿瘤为8．O％，其中74例（24．7％）报告有〉12种共存疾病。多因素分析显示，具有除代谢综合征以外的其他良性共存疾病与较低的HRQoL评分和TKl治疗影响患者工作生活显著相关，但并未显著影响患者对TKI治疗的满意度。此外，女性和未获得完全细胞遗传学反应（CCyR）与较低的HRQoL评分显著相关，大学及以上学历和服药时间≥3年与较高的HRQoL评分显著相关；一二代TKI之间换药和未获得CCyR与患者对TKI治疗不满意显著相关，而免费用药与较高的治疗满意度显著相关；年龄〈60岁和未获得CCyR与TKI治疗影响患者工作生活显著相关。结论中国成人CML—CP患者中27．1％具有共存疾病，不同的共存疾病种类对患者生活质量和TKI治疗对患者工作生活的影响不同。

Objectives To explore the comorbidity profile and its impact on reported outcome of patients with chronic myeloid leukemia in chronic phase （CML-CP） receiving tyrosine kinase-inhibitor （TKI） therapy in China. Methods From September 2015 to March 2016, anonymous questionnaires were distributed to adult CML patients who were receiving TKI treatment in China. The questionnaires included demographics, comorbidity（ies）, TKI（s） therapy, annual out-of-pocket expense for TKIs, treatment responses, health-related quality of life （HRQoL） measured by the Medical Outcomes Study 36-Item Short- Form Health Survey （SF-36）, satisfaction with therapy, impact of TKI therapy on work and daily life. Results Data from 1 108 respondents in CML-CP were analyzed, 701 （63.6%） were male, median age was 42 years （range, 18-88 years）, 76.4% were currently on imatinib, median TKI-therapy-duration was 29 months （range, 3-178 months）. Of them, 300 （27.1%） had t〉1 comorbidity（ies）, including hypertension （30.3%）, diabetes （21.0%）, coronary heart disease （12.3%）, gastro-intestinal disease （12.3%）, liver disease （11.7%）, kidney disease （8.3%）, cerebrovascular disease （6.7%） and lung diseases （5.7%）, thrombosis （1.3%）, other benign diseases （15.3%） and other cancer （8.0%）, and 74 （24.7%） had 22 comorbidities. Multivariate analyses showed the comorbidity profile of other benign diseases was significantly associated with lower HRQoL score and TKI therapy affecting work and daily life, but it did not significantly affect patients＇ satisfaction with TKI treatment. Female and no complete eytogenetic response （CCyR） were associated with lower HRQoL score, education level ≥bachelor degree and TKI-therapy duration≥3 years were associated with higher HRQoL score. Switching between first and second generation TKIs and no CCyR were associated with dis-satisfaction or extreme dis-satisfaction with TKI therapy, free out-of-pocket expense for TKI was associated with better satisfaction. Age 〈 60 years and no CCyR were associated with TKI therapy affecting work and daily life. Conclusions The survey showed that 27.1% Chinese adult patients with CML-CP receiving TKI-therapy had comorbidity（ies）. Different comorbidity profile had different impact on patients＇ HRQoL and different impact ofTKI therapy on work and daily life.