齐拉西酮治疗男性与女性精神分裂症的疗效与安全性对比研究

摘要

目的：比较齐拉西酮治疗男性与女性精神分裂症患者的疗效及安全性。方法：25例男性（男性组）和64例女性（女性组）精神分裂症患者均接受齐拉西酮治疗8周。于治疗前后采用阳性与阴性症状量表（PANSS）评定疗效，并通过体检、实验室和心电图检查以及其他不良事件的描述性记录资料评价其安全性。结果：总显效率男性组和女性组分别为80.0%和78.13%（P =0.53）。两组 PANSS总分及各项评分治疗后均较治疗前显著下降（P <0.05或 P <0.01）；PANSS 总分及一般病理症状减分值女性组较男性组明显增高（t =-2.27~-2.53；P <0.05或 P <0.01）。女性组治疗后心电图 QTc 间期（t =-3.04，P =0.00）、体质量（t =-2.81，P =0.00）和三酰甘油（t =-2.82，P =0.01）明显上升；中性粒细胞（t =2.06，P =0.04）、总蛋白（t =2.10，P =0.04）、空腹血糖（t =2.34，P =0.02）明显下降。不良反应发生率男性组和女性组分别为20%和18.75%（P >0.05）。结论：齐拉西酮对男性和女性精神分裂症患者均具有良好的疗效和安全性；但对女性患者 QTc 间期、体质量、空腹血糖及血脂的影响较大。%Objective:To explore the efficacy and safety of ziprasidone in the treatment of male and fe-male schizophrenia. Method:Schizophrenia patients(male 25,female 64)were enrolled and treated by 8 week ziprasidone. The positive and negative symptom scale(PANSS)was used to assess the efficacy. And the safety was assessed by the physical and laboratory examination,electrocardiogram and other descriptive adverse events. Results:The total effective rate of the male patients was 80% and that of female patients was 78. 13%(P = 0. 53). The total,positive,negative and general pathological symptom scores of PANSS after treatment were lower than those before treatment in both groups(P < 0. 05 or P < 0. 01). Two weeks after treatment,reduced scores in female patients in total and general pathological symptom of PANSS,were higher than those of male, and maintained to fourth week. But the reduced positive soces of PANSS between fourth and eighth was lower than those of male(t = - 2. 27- - 2. 53,P < 0. 05 or P < 0. 01). In female patients,QTc interval(t = - 3. 04, P = 0. 00),weight(t = - 2. 81,P = 0. 00)and triglyceride(t = - 2. 82,P = 0. 01)after treatment were higher than those before treatment in female patients. But the neutrophil(t = 2. 06,P = 0. 04),total protein(t = 2. 10, P = 0. 04)and fasting blood glucose(t = 2. 34,P = 0. 02)were lower. The adverse reactions rate of male and fe-male patients were 20% and 18. 75% respectively(P > 0. 05). Conclusion:Ziprasidone has good efficacy and safety in the treatment of male and female schizophrenia. But it has more impact on QTc interval,weight,tri-glyceride and fasting blood glucose in female.