米安色林合并利培酮治疗精神病性抑郁症的对照研究

A STUDY ON MIANSERIN COMBINED RISPERIDONE IN THE TREATMENT OF PSYCHOTIC DEPRESSION

目的研究米安色林联合利培酮治疗精神病性抑郁症的临床疗效及安全性。方法将80例精神病性抑郁症患者随机分为两组,各40例。两组均口服利培酮治疗,研究组联合米安色林,对照组联合阿米替林,观察8周。于治疗前及治疗第1、2、4、8周末采用汉密顿抑郁量表、简明精神病量表、临床疗效总评量表、副反应量表评定临床疗效及不良反应。结果治疗第8周末抑郁症状:研究组显效率为77%,对照组为75%;精神病性症状:研究组显效率为80%,对照组为84%。两组比较均无统计学意义(P>0.05)。汉密顿抑郁量表、简明精神病量表总分及临床疗效总评量表评分:两组治疗第1周末起均较治疗前有显著下降(P<0.01);研究组治疗第2周末汉密顿抑郁量表评分及第4周末简明精神病量表、临床疗效总评量表评分均较对照组有显著下降(P均<0.05)。副反应量表评分:研究组治疗第1、2、4、8周末均显著低于对照组(P均<0.01),研究组静坐不能、嗜睡、心电图改变、震颤等不良反应发生率均显著低于对照组(P<0.01或0.05)。结论两种方法的总体临床疗效相当,但米安色林合并利培酮起效更快、安全性更高、依从性更好。

Objective To study the clinical efficacy and safety of mianserin combined with risperidone in the treatment of psychotic depression.Methods 80 patients with psychotic depression were randomly divided into two research groups（n=40）.Both groups were treated with oral risperidone,mianserin joint study group and control group combined amitriptyline for 8 weeks.Clinical efficacy was assessed with the Hamilton Depression Scale（HAMD）,the Brief Psychiatric Rating Scale（BPRS） and Clinical Global Impression（CGI） and adverse effect with the Treatment Emergent Symptom Scale（TESS） before treatment and at the end of the 1st,2nd,4th and 8th week treatment.Results At the end of the 8th week,excellence rates were respectively 78% in the research group and 75% in the control;excellence rates of psychotic symptoms were 80% in the research and 83% in the control respectively,total efficacies of the 2 groups equivalent（P〈0.05）.Since the end of the 1st week,total scores of the HAMD,BPRS and CGI lowered significantly compared with pretreatment for both groups（P〈0.01）;the HAMD score at the end of the 2nd week and the BPRS and CGI scores at the end of the 4th week lowered more notably in the research than in the control（P〈0.05）.All timepoint TESS scores（all P〈0.01） and incidences of such adverse effects as akathisia,drowsiness,ECG changes and tremor（P〈0.01～0.05） were significantly lower in the research than in the control.Conclusion The two groups have equivalent clinical efficacy,and the research groups takes effects faster and has higher safety and better compliance.