摘要
目的评价利培酮(卓菲)治疗精神分裂症的疗效和安全性。方法共入组100例门诊或住院的精神分裂症或分裂样精神障碍患者,口服利培酮片治疗,初始剂量为1mg/d,推荐剂量为4～6mg/d。在入组时(基线0d)、治疗第7、14、21、28、42天,采用阳性和阴性综合征量表(PANSS)对所有患者的精神状况进行评定；采用药物治疗不良反应量表(TESS)评价利培酮治疗6周的过程中所出现的不良反应,同时观察利培酮对患者体重、糖代谢及心电图的影响。结果99例患者完成6周治疗,治愈23例,显著好转31例,好转19例,无变化26例,恶化1例。治愈率为23．2%,显效率为54．5%,有效率为73．7%；在治疗第2周末,阳性症状因子分、一般精神症状病理分和PANSS总分开始下降(P＜0．05或0．01)。自第3周起,PANSS总分和各分量表得分均较治疗前有显著下降(P＜0．01)。以TESS评定药物不良反应,共21例有不良反应记录,主要表现为失眠、静坐不能、肌张力增高、窦性心动过速、便秘、口干和轻度心电图异常。与治疗前相比,治疗后体重、血白细胞、血糖、肝功能、血脂和心电图等各项指标无显著性改变。结论国产利培酮对精神分裂症患者疗效较好,不良反应较轻,安全性较好。
Objective To investigate the clinical efficacy and safety of risperidone tablet in the treatment of the patients with schizophrenia. Methods 100 patients with schizophrenia or schizoaffective were enrolled and treated with risperidone tablet for 6-week. The starting dosage was lmg per day and the recommendated dosage was 4-6mg per day. To assess the efficacy and side effects were assessed by Positive and Negative Symptoms Scale （PANSS）, Treatment Emergent Symptoms Scale （TESS）, the changes of biochemical index and electrocardiogram and weight gain during 6 weeks. Results Ninety-nine patients completed the treatment. After 6-week treatment, 23 patients （23.2%） were cured, 50 patients （50.5%） were improved, the symptoms of 26 patients （26.3%） were unchanged, and the symptoms of one case were aggravated. The positive, negative sub-scores and total score were decreased （P〈0.05 or 0.01） after 2 week treatment. Since the third week, the PANSS total score and sub-scores were significantly lower than baseline （P〈0.01）. During the treatment, 21 patients had observable side effects listed in＇the TESS, such as insomnia, akathisia, dystonia, sinus tachycardia, constipation, dryness of mouth and slight abnormal electrocardiogram （ECG）. In this study, we did not find not found changes in body weight, number of blood white cellcount, level of serum glucose, cholesterol and glycerid and EEG. Conclusions Risperidone tablet can effectively improve the symptoms of the patients with schizophrenia, the side effects are mild and, the safety of this product is good.
出处
《北京医学》
CAS
2006年第10期618-621,共4页
Beijing Medical Journal
