小剂量奥氮平联合氟西汀治疗难治性抑郁症的随机对照研究

Efficacy of fluoxetine combined with low doses of olanzapine on refractory depression-a randomized controlled study

目的评价小剂量奥氮平联合氟西汀治疗难治性抑郁症的临床效果。方法 64例难治性抑郁症患者随机分为研究组和对照组,每组32例,研究组患者给予氟西汀合并小剂量奥氮平治疗,对照组患者给予氟西汀单药治疗,两组疗程均为8周。治疗前及治疗后第1、2、4、8周末应用汉密尔顿抑郁量表(HAMD)进行评分并评价疗效,应用治疗中需处理的不良反应症状量表(TESS)及实验室检查评定治疗安全性。结果治疗后第2周末起,两组患者HAMD评分均显著下降,与治疗前比较差异有统计学意义(P<0.05),研究组治疗后第1、2、4、8周末HAMD评分显著低于对照组,差异有统计学意义(P<0.05)。研究组临床有效率为46.88%,对照组有效率为21.88%,两组临床有效率比较,差异有统计学意义(P<0.01)。两组患者均无明显不良反应,不良反应发生率无统计学意义(P>0.05)。结论小剂量奥氮平联合氟西汀治疗难治性抑郁症具有较好的临床疗效。

Objective To evaluate the clinical efficacy of fluoxetine combined with low doses of olanzapine in the treatment of refractory depression. Methods 64 patients with refractory depression were randomly divided into study group （32 cases treated with fluoxetine combined with low doses of olanzapine for 8 weeks） and control group （32 cases treated with fluoxetine monotherapy for 8 weeks）. All patients were assessed with Hamilton Depression Scale （HAMD） at baseline and the 1 st, 2nd, 4th, 8th weekend to evaluate the efficacy. Treatment Emergent Symptoms Scale （TESS） and laboratory examinations was used to assess safety. Results Compared with the baseline, score of HAMD in both groups decreased significantly form the 2nd week of the treatment （ P 〈 0.05 ）. Score of HAMD in study group were significantly lower than that in control group at the end of the 1 st, 2nd, 4th, 8th week of the treatment （P 〈 0.05 ）. The response rate in study group were significantly higher than that in control group （46.88% vs. 21.88% , P 〈0.01 ）. No severe side effects was found in both groups, and there was no significant difference in incidence rate of side effects between the two groups （ P 〈 0.05 ）. Conclusion Low dose of olanzapine combined with fluoxetine has good effect on refractory depression.