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Abstract：
BACKGROUND: Imatinib is the gold standard for the treatment of all phases of Philadelphia positive Chronic Myeloid Leukemia (CML). During treatment, patients may develop cytopenia. We aimed to study the baseline characteristics and factors associated with cytopenia at a Nairobi Hospital.
METHODS: This was a retrospective case-control study of patients aged ≥18 years on follow-up at the Glivec International Patient Access Program (GIPAP) clinic from 2007 to 2015. The cases consisted of CML patients on imatinib who developed cytopenia. The controls were CML patients on imatinib who did not develop cytopenia. Baseline socio - demographic, clinical, hematologic, and molecular data were retrieved from patients\' files. Chi square or fishers\' exact tests were used to analyze for differences between cytopenia and no cytopenia. Binary logistic regressions were employed to identify relationships. Univariate and multivariate analyses were done to identify independent predictors of cytopenia. Odds ratios (OR) were presented including the 95% confidence intervals and respective p values.
RESULTS: A total of 201 patients were studied consisting of ninety-four (94) patients with cytopenia and 107 with no cytopenia. Among the entire population, males were 52, and 42% were aged 36-50 years. Sex, age, marital status, occupation and education level were similar between the cytopenia and no cytopenia groups. Among the 201 patients, 70% had symptoms for > 12 months before diagnosis, 78.6% had B symptoms at baseline, 80% had a moderate splenomegaly at baseline. Among patients with cytopenia, 40 and 37.4% developed cytopenia within 3 months and 3-6 months respectively after imatinib initiation. Baseline neutrophilia, neutropenia, anaemia, thrombocytosis, thrombocytopenia was found in 68, 11, 11, 23.5 and 11% respectively. Baseline hemoglobin, neutrophil and platelet level were significantly different between the cytopenia and the no cytopenia group. On univariable analysis, baseline anemia with hb < 7.9 g/dL (p = 0.002), neutropenia (p = 0.001), neutrophilia > 100,000/mm3 (p = 0.002) and thrombocytopenia (p = 0.001) increased the odds of developing cytopenia. On multivariable analysis, baseline anaemia (p value < 0.002), neutropenia (p value < 0.001), thrombocytopenia (p value, < 0.001) and thrombocytosis (p value, 0.033) increased the odds of developing cytopenia.
CONCLUSIONS: Odds of cytopenia were higher in presence of baseline cytopenia and thrombocytosis. Clinicians should have a high index of suspicion for these patients.
METHODS: This was a retrospective case-control study of patients aged ≥18 years on follow-up at the Glivec International Patient Access Program (GIPAP) clinic from 2007 to 2015. The cases consisted of CML patients on imatinib who developed cytopenia. The controls were CML patients on imatinib who did not develop cytopenia. Baseline socio - demographic, clinical, hematologic, and molecular data were retrieved from patients\' files. Chi square or fishers\' exact tests were used to analyze for differences between cytopenia and no cytopenia. Binary logistic regressions were employed to identify relationships. Univariate and multivariate analyses were done to identify independent predictors of cytopenia. Odds ratios (OR) were presented including the 95% confidence intervals and respective p values.
RESULTS: A total of 201 patients were studied consisting of ninety-four (94) patients with cytopenia and 107 with no cytopenia. Among the entire population, males were 52, and 42% were aged 36-50 years. Sex, age, marital status, occupation and education level were similar between the cytopenia and no cytopenia groups. Among the 201 patients, 70% had symptoms for > 12 months before diagnosis, 78.6% had B symptoms at baseline, 80% had a moderate splenomegaly at baseline. Among patients with cytopenia, 40 and 37.4% developed cytopenia within 3 months and 3-6 months respectively after imatinib initiation. Baseline neutrophilia, neutropenia, anaemia, thrombocytosis, thrombocytopenia was found in 68, 11, 11, 23.5 and 11% respectively. Baseline hemoglobin, neutrophil and platelet level were significantly different between the cytopenia and the no cytopenia group. On univariable analysis, baseline anemia with hb < 7.9 g/dL (p = 0.002), neutropenia (p = 0.001), neutrophilia > 100,000/mm3 (p = 0.002) and thrombocytopenia (p = 0.001) increased the odds of developing cytopenia. On multivariable analysis, baseline anaemia (p value < 0.002), neutropenia (p value < 0.001), thrombocytopenia (p value, < 0.001) and thrombocytosis (p value, 0.033) increased the odds of developing cytopenia.
CONCLUSIONS: Odds of cytopenia were higher in presence of baseline cytopenia and thrombocytosis. Clinicians should have a high index of suspicion for these patients.
摘要：
背景：伊马替尼是治疗费城阳性慢性髓性白血病（CML）所有阶段的金标准。治疗期间,患者可能出现血细胞减少。我们旨在研究内罗毕医院的基线特征和与血细胞减少相关的因素。
方法：这是2007年至2015年在Glivec国际患者访问计划（GIPAP）诊所进行随访的18岁以上患者的回顾性病例对照研究。这些病例包括伊马替尼治疗的CML患者，他们出现了血细胞减少症。对照组是接受伊马替尼治疗的CML患者，他们没有出现血细胞减少症。基线社会人口统计学，临床,血液学，和分子数据从患者档案中检索。使用卡方或fishers精确检验来分析血细胞减少和无血细胞减少之间的差异。采用二元逻辑回归来识别关系。进行单变量和多变量分析以确定血细胞减少的独立预测因子。呈现的赔率比(OR)包括95%置信区间和各自的p值。
结果：共研究了201例患者，其中包括94例血细胞减少症患者和107例无血细胞减少症患者。在整个人口中，男性为52，42％的年龄为36-50岁。性,年龄,婚姻状况,血细胞减少组和非血细胞减少组的职业和教育水平相似.在201名患者中，70%的人在诊断前出现症状超过12个月，78.6%在基线时出现B症状，基线时80%有中度脾肿大。在血细胞减少症患者中，40％和37.4％分别在伊马替尼开始后3个月和3-6个月内出现血细胞减少。基线嗜中性粒细胞增多症,中性粒细胞减少症,贫血,血小板增多症,血小板减少症分别为68、11、11、23.5和11％。基线血红蛋白,中性粒细胞和血小板水平在血细胞减少组和非血细胞减少组之间有显著差异。关于单变量分析，基线贫血hb<7.9g/dL（p=0.002），中性粒细胞减少症（p=0.001），嗜中性粒细胞>100,000/mm3(p=0.002)和血小板减少(p=0.001)增加了发生血细胞减少的几率。在多变量分析中，基线贫血（p值<0.002），中性粒细胞减少症（p值<0.001），血小板减少症（p值，<0.001)和血小板增多(p值，0.033）增加了发生血细胞减少的几率。
结论：在存在基线血细胞减少和血小板增多的情况下，血细胞减少的几率更高。临床医生应该对这些患者有很高的怀疑指数。
方法：这是2007年至2015年在Glivec国际患者访问计划（GIPAP）诊所进行随访的18岁以上患者的回顾性病例对照研究。这些病例包括伊马替尼治疗的CML患者，他们出现了血细胞减少症。对照组是接受伊马替尼治疗的CML患者，他们没有出现血细胞减少症。基线社会人口统计学，临床,血液学，和分子数据从患者档案中检索。使用卡方或fishers精确检验来分析血细胞减少和无血细胞减少之间的差异。采用二元逻辑回归来识别关系。进行单变量和多变量分析以确定血细胞减少的独立预测因子。呈现的赔率比(OR)包括95%置信区间和各自的p值。
结果：共研究了201例患者，其中包括94例血细胞减少症患者和107例无血细胞减少症患者。在整个人口中，男性为52，42％的年龄为36-50岁。性,年龄,婚姻状况,血细胞减少组和非血细胞减少组的职业和教育水平相似.在201名患者中，70%的人在诊断前出现症状超过12个月，78.6%在基线时出现B症状，基线时80%有中度脾肿大。在血细胞减少症患者中，40％和37.4％分别在伊马替尼开始后3个月和3-6个月内出现血细胞减少。基线嗜中性粒细胞增多症,中性粒细胞减少症,贫血,血小板增多症,血小板减少症分别为68、11、11、23.5和11％。基线血红蛋白,中性粒细胞和血小板水平在血细胞减少组和非血细胞减少组之间有显著差异。关于单变量分析，基线贫血hb<7.9g/dL（p=0.002），中性粒细胞减少症（p=0.001），嗜中性粒细胞>100,000/mm3(p=0.002)和血小板减少(p=0.001)增加了发生血细胞减少的几率。在多变量分析中，基线贫血（p值<0.002），中性粒细胞减少症（p值<0.001），血小板减少症（p值，<0.001)和血小板增多(p值，0.033）增加了发生血细胞减少的几率。
结论：在存在基线血细胞减少和血小板增多的情况下，血细胞减少的几率更高。临床医生应该对这些患者有很高的怀疑指数。
