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目的：探讨米氮平与氟西汀治疗恶性肿瘤化疗伴发焦虑抑郁障碍患者的临床疗效、安全性以及对生活质量的影响。方法将68例恶性肿瘤化疗伴发焦虑抑郁障碍患者随机分为两组，每组34例，两组均维持原用抗肿瘤治疗方案不变，研究组口服米氮平治疗，对照组口服氟西汀治疗，观察6周。于治疗前后采用汉密顿焦虑量表评定焦虑状况，汉密顿抑郁量表评定抑郁状况，健康状况调查简表评定生活质量，副反应量表评定不良反应。结果治疗后两组汉密顿焦虑量表、汉密顿抑郁量表评分均较治疗前持续下降，研究组治疗第2周、4周末汉密顿抑郁量表评分显著低于对照组（P＜0．05或0．01）；治疗6周末研究组有效率为76．5％，对照组为73．5％，两组比较差异无显著性（χ2＝0．08，P＞0．05）。研究组治疗第6周末健康状况调查简表生理职能、活力、社会功能维度分显著高于对照组（P ＜0．05或0．01）。两组不良反应均较轻微，研究组主要表现为体质量增加、嗜睡等；对照组主要表现为恶心、头昏、肝功能受损等。结论米氮平与氟西汀均能显著改善恶性肿瘤化疗患者伴发的焦虑、抑郁情绪，总体疗效相当，但米氮平改善抑郁症状起效更快，患者主观体验好，安全性高，依从性好。“,”Objective To explore the efficacy and safety of mirtazapine and fluoxetine in the treatment of anxiety and depression in tumor patients undergoing chemotherapy and their influences on patients’ quality of life .Methods Sixty‐eight cancer patients with anxiety and depression undergoing chemotherapy were randomly assigned to two groups of 34 ones each ,both groups maintained original antineoplastic proto‐cols ,research group took orally mirtazapine and control did fluoxetine for 6 weeks .Anxious conditions were assessed with the Hamilton Anxiety Scale (HAMA) ,depressive with the Hamilton Depression Scale (HAMD) ,qualities of life with the Short Form 36 Health Survey Questionnaire (SF‐36) ,and adverse re‐actions with the Treatment Emergent Symptom Scale (TESS) .Results After treatment the HAMA and HAMD scores of both groups lowered continuously compared with pretreatment ,the HAMD scores at the end of the 2nd and 4th week were significantly lower in research than in control group(P 0 .05) .At the end of the 6th week role‐physical ,vi‐tality and social functioning score of the SF‐36 were significantly higher in research than in control group (P< 0 .05 or 0 .01) .Adverse reactions of both groups were mild ,mainly weight gain ,hypersomnia etc .in research and nausea ,dizziness ,liver function damage etc .in control group .Conclusion Both mirtazapine and fluoxetine could notably improve anxious and depressive emotions in tumor patients undergoing chemo‐therapy ,their total efficacies are equivalent ,but mirtazapine takes effect more rapidly ,patients’ subjective experiences are better ,and it has higher safety and better compliance .