氟西汀合用小剂量奥氮平对重度抑郁症患者睡眠及焦虑躯体症状的改善作用

背景重度抑郁症是抑郁症的一种亚型,单用抗抑郁剂治疗效果差,国外有关研究显示氟西汀合用非典型抗精神病药,可能是有效的治疗策略.目的观察奥氮平合用氟西汀治疗重度抑郁症的疗效及起效时间.设计对门诊初诊患者进行完全随机抽样,采用开放性临床试验的观察对比研究.单位一所军医大学医院临床心理咨询门诊.对象病例为2004-01/2004-08在本院临床心理咨询门诊就诊的140例患者.纳入标准符合中国精神障碍与诊断标准第3版(CCMD-3)抑郁症的诊断标准,首诊时17项汉密顿抑郁量表评分总分(HAMD)≥28分,年龄≥18岁.排除标准①轻-中度抑郁症HAMD(17项≤27分);②继发性抑郁症;③精神分裂症恢复期及其他精神病性情感障碍;④存在严重或不稳定状态的躯体疾病,包括肝、肾、心血管、呼吸、胃肠道、内分泌、神经系统、免疫系统或血液系统疾病等;⑤药物及酒精依赖者⑥妊娠期及哺乳期妇女.符合纳入标准110例,其中男40例,女70例;病程4个月～5年;年龄18～63岁,平均(37±12)岁;均自愿参加本试验.按入院日期单、双日将患者分为单日阿普唑仑组55例,男21例,女34例;双日奥氮平组55例,男19例,女36例.方法按单日、双日将患者分为2组.单日为阿普唑仑组,阿普唑仑每日中午及睡前0.4 mg,氟西汀每日早饭后20 mg顿服;双日为奥氮平组,奥氮平每日睡前2.5 mg,氟西汀每日早饭后20 mg顿服;疗程6周,分别于治疗前及治疗后1,2,4,6周末进行HAMD及汉密顿焦虑量表(HAMA)评定,用减分率来确定起效时间,用百分比显示脱落率,并观察HAMD量表中睡眠因子及躯体化因子在治疗前后各时段的改善情况.主要观察指标终点结局指标两组患者治疗前、后第1,2,4,6周末HAMD及HAMA量表评分的比较;两组患者HAMD评分中睡眠因子及焦虑躯体化因子各观察时段的评分.替代指标两组的脱落率;两组各观察时段的减分率.结果奥氮平组脱落率明显低于阿普唑仑组(P＜0.05),而且于治疗后1周显效(显效率67%);奥氮平组各观察时段HAMD及HAMA的评分较阿普唑仑组明显低(P＜0.01),睡眠障碍及躯体化因子各观察时段改善比阿普唑仑组更明显(P＜0.01).结论小剂量奥氮平合并氟西汀治疗重度抑郁症,能迅速改善抑郁症患者睡眠及焦虑的躯体症状,显著提高其生活质量.

Improvement of sleep and anxiety in patients of major depression with fluoxetine combined with small dose of olanzapine

BACKGROUND: Major depression is a subtype of depression. Application of thymoleptics alone has bad effect. It has shown from relevant studies abroad that application of fluoxetine combined with atypical antipsychotic drugs maybe an effective treating strategy.OBJECTIVE: To observe the curative effects of fluoxetine combined with olanzapine and the time of its taking effect.DESIGN: Comparative study of open clinical test with completely random sampling for the first visit outpatients SETTING: A psychological consulting clinic in a hospital of a Military Medical College of Chinese PLA.PARTICIPANTS: Totally 140 patients visiting psychological counseling outpatient clinic in the hospital were collected from January 2004 to August 2004. Inclusion criteria: According to the diagnostic criterion of depression of CCMD-3, patients with total scores of 17 items in Hamilton depression rating scale≥28and age ≥18 years old .EXclusion criteria;①slight to middle edgree of depression(Hamt≤27);②secondary depression;③convalesscent period of schizophrenia and other affective disorder caused by psychosis;④severe of unstable body diseases ,including diseases of liver,kidney,cardiae vessel,respiration,gastro-intestine,endocrine,nervous system,innune system or hematological system,cet.⑤drug or alcohol addict;⑥women in pregnancy and lactation. Totally 110 patients accorded with the inclusive criteria. Among them, there were 40 males and 70 females with the course of disease for 4 months to 5 years, aged 18 to 63 with the average (37 ± 12) years old. They all took part in the trial voluntarily. According to the date of admittance, they were divided into odd-numbered date alprazolam group in which there were 55 patients with 21 males and 34 females and double date olanzapine group in which there were 55 patients with 19 males and 36 females.METHODS: The patients were divided into 2 groups according to the date of admittance. Odd-numbered date group was alprazolam group. 0.4 mg alprazolam was given every noon and before sleep and 20 mg fluoxetine was given at a draught after breakfast every day. Even-numbered date group was olanzapine group. 2.5 mg olanzapine was given before sleep every day and 20mg fluoxetine was given at a draught after breakfast every day. The course of treatment was 6 weeks. HAMD and HAMA scores of taken were evaluated respectively before and at the end of 1st, 2nd, 4th and 6th week. Reducing score rate was used to decide effective time. Lost rate was presented as percentage. And improvement of sleep factor and somatization factor in HAMD were observed before therapy and at every observing time period after therapy.MAIN OUTCOME MEASURES: Terminus index: Comparison of HAMD,HAMA score in the two groups before therapy and at the 1st, 2nd, 4th and 6th weekend after therapy. Scores of sleep factor and anxiety somatization factor of HAMD at every observing time period in the two groups. Substitution index: lost rate in the two groups. Reducing score rate at every observing time period in the two groups.RESULTS: Lost rate in olanzapine group was significantly lower than that in alprazolam group ( P ＜ 0.05) and the effect was taken at 1 week after therapy(excellence rate 67% ) . But, scores of HAMD and HAMA at every observing time period in olanzapine group were significant lower than those in alprazolam group( P ＜ 0.01) and sleep factor and somatization factor at every observing time period improved more significantly than those of alprazolam group( P ＜ 0. 01).CONCLUSION: Small amount of olanzapine combined with fluoxetine used to treat major depression of the patients can improve sleep and anxiety body symptoms rapidly and then elevate their living quality significantly.