格列卫相关不良反应对中国慢性髓性白血病患者日常生活影响的研究

OBJECTIVE: To explore the impact of Glivec related side effects on daily life in Chinese patients with chronic myeloid leukemia (CML) in the chronic phase (CP). METHODS: From May to November in 2014, anonymous questionnaires were distributed to adult CML patients who were receiving tyrosine kinase inhibitors (TKI) treatment in China. The impact of TKI related side effects on daily life were assessed by the score of 1 (no impact) to 5 (high impact) from patient self-report. RESULTS: Data from 548 respondents in the CP on Glivec were collected. 303(55%) cases were male with the median age of 40 years (range, 18 to 88 years). 437 (80%) cases started Glivec treatment within one year after diagnosis with a median treatment duration of 3 years (range, <1 to 13 years), 442 (81%) respondents achieved complete cytogenetic response (CCyR), and 261 (48%) complete molecular response (CMR). The most common Glivec related adverse effects were edema (n=278, 51%), fatigue (n=218, 40%), gastrointestinal disorders (n=190, 35%), muscle cramps (n=118, 22%), skin color changes (n=118, 22%), weight gain (n=71, 13%), rash (n=60, 11%), hepatic function abnormality (n=55, 10%), and cytopenia (n=38, 7%). Among the 548 respondents, the mean score of Glivec-related side effects on daily life was 2.4±1.2. There was no negative impact of Glivec related side effects on daily life in 161(29%) respondents. 295 (54%) and 92 (17%) respondents reported slightly or moderately (2–3 score) and significantly decreased (4–5 score) daily life, respectively. Multivariate analysis showed that Glivec treatment duration < 4 years (OR=1.9, 95% CI 1.3–2.6;P<0.001) and Glivec related side effects including fatigue (OR=2.9, 95% CI 2.1–4.1;P<0.001), edema (OR=2.2, 95% CI 1.6–3.1;P<0.001), gastrointestinal disorders (OR= 2.6, 95% CI 1.9–3.7;P<0.001), rash (OR=2.1, 95% CI 1.2–3.4; P=0.0051) and hepatic function abnormality (OR=2.3, 95% CI 1.4–3.9;P=0.0013) were factors associated with serious negative effect on daily life. CONCLUSION: Daily life was impaired seriously in a minority of Chinese CML patients who received Glivec, especially in the first 4 years of treatment. Fatigue, edema, gastrointestinal disorders, rash and hepatic function abnormality were side effects associated with negative impact on patients' daily life.