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目的：探讨氟西汀联合米氮平治疗难治性抑郁症的疗效和安全性。方法将73例难治性抑郁症患者随机分为两组，均口服氟西汀治疗，研究组联合米氮平治疗，观察8周。于治疗前后采用汉密顿抑郁量表、汉密顿焦虑量表评定临床疗效，副反应量表评定不良反应。结果治疗2周末起两组汉密顿抑郁量表、汉密顿焦虑量表评分均较治疗前显著下降（ P＜0．05或0．01），研究组治疗4周、8周末汉密顿抑郁量表、汉密顿焦虑量表评分较对照组下降更显著（P＜0．01），治疗8周末总有效率显著高于对照组（P＜0．05）。两组不良反应程度均为轻度到中度，发生率比较差异无显著性（P＞0．05）。结论氟西汀联合米氮平治疗难治性抑郁症疗效优于单用氟西汀，且不增加不良反应。“,”Objective To Explore the efficacy and safety of fluoxetine combined with mirtazapine in the treatment of treatment‐resistant depression (TRD) .Methods Seventy‐three TRD patients were randomly assigned to two groups ,both groups took orally fluoxetine ,and research group was plus mirtazapine for 8 weeks .Efficacies were assessed with the Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA) and adverse reactions with the Treatment Emergent Symptom scale(TESS) before and after treatment .Results Since the end of the 2nd week the HAMD and HAMA scores of both groups lowered more significantly compared with pretreatment (P<0 .05 or 0 .01) ,so did those at the end of the 4th and 8th week (P<0 .05 or 0 .01)and total effective rate at the end of the 8th week was significantly higher (P0 .05) .Conclusion Fluoxetine combined with mirtazapine is more effective and doesn’t increase adverse reactions compared with single fluoxetine in treatment‐resist‐ant depression .