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.
Conclusions: 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.
目的: 评估中国服用伊马替尼原研药格列卫的慢性髓性白血病（CML）慢性期患者药物不良反应对其日常生活的影响。
方法: 2014年5月至11月，在全国范围内向正在接受酪氨酸激酶抑制剂（TKI）治疗的成年CML患者发放无记名调查问卷。TKI不良反应对患者日常生活的影响程度采用自我报告的形式，以1（没有影响）至5分（严重影响）评估。分析对象为其中正在服用格列卫的CML慢性期患者。
结果: 共收集548例服用格列卫的CML慢性期受访者的答卷，其中，男性303例（55%），中位年龄40(18~88）岁，437例（80%）确诊至开始格列卫治疗时间<1年。中位服用格列卫3（<1~13）年，442例（81%）获得完全细胞遗传学反应，261例（48%）获得完全分子学反应。格列卫最多见的不良反应依次为：水肿（51%）、乏力（40%）、胃肠道不适（35%）、肌肉痉挛（22%）、面部颜色改变（22%）、体重增加（13%）、皮疹（11%）、肝功能异常（10%）和血细胞计数降低（7%）。患者自我报告格列卫相关的不良反应导致的日常生活受影响程度评分为（2.4±1.2）分，161例（29%）没有影响（1分），295例（54%）轻中度影响（2~3分），92例（17%）严重影响（4~5分）。多因素分析显示，格列卫服药时间<4年（OR=1.9，95% CI 1.3~2.6；P<0.001）、乏力（OR=2.9，95% CI 2.1~4.1；P<0.001)、水肿（OR=2.2, 95% CI 1.6~3.1；P< 0.001）、胃肠道不适（OR=2.6, 95% CI 1.9~3. 7；P<0.001）、皮疹（OR=2.1，95% CI 1.2~3.4；P=0.005）和肝功能异常（OR=2.3, 95% CI 1.4~3.9；P=0.001）与患者较高的日常生活受影响程度评分显著相关。
结论: 服用格列卫的中国CML慢性期患者中，少数患者因药物不良反应而严重影响其日常生活，特别是在治疗的前4年。乏力、水肿、胃肠道不适、皮疹和肝功能异常是主要的影响患者日常生活的不良反应。