摘要
目的:探讨壮阳胶囊治疗阴性精神分裂症的疗效、安全性及对患者认知功能的影响。方法:采取随机、双盲、多中心对照试验设计对120例符合CCMD-3和DSM-Ⅳ诊断标准的阴性精神分裂症患者在利培酮作为基础治疗的基础上使用壮阳胶囊(n=60)或安慰剂(n=60),进行为期8周的观察。阳性阴性症状量表(PANSS),临床总体印象评定量表(CG I),社会功能缺陷量表(SDSS)、汉米尔顿抑郁量表(HRSD)、威斯康星卡片分类测验(WCST)作为评价工具。结果:壮阳胶囊加利培酮组的有效率为56.9%,安慰剂加利培酮组为36.2%,两组有效率比较差异有统计学意义(P<0.05);壮阳胶囊组改善患者的社会功能、抑郁症状及认知功能显著优越于安慰剂组(均P<0.05或0.01);在PP人群分析,壮阳胶囊组与安慰剂组比较,PANSS总分、阳性症状、阴性症状及一般精神病理症状量表分的差异无统计学意义(均P≥0.05)。在FAS人群分析,壮阳胶囊对患者的副反应(TESS、AIMS、RSESE)及ECG的影响与安慰剂组相比差异无统计学意义(P≥0.05)。结论:壮阳胶囊能改善阴性精神分裂症患者的疗效、社会功能及认知功能,其对患者的治疗过程是安全的。
Objective： To evaluate the efficacy, safety and cognition of Zhuangyang Capsule added on risperidone in patients with negative symptoms dominated schizophrenia. Methods ： A randomized, double - blind, placebo - controlled, multi -center clinical trial was conducted. All 120 patients with negative symptoms dominated schizophrenia who met the CCMD -3 and DSM - IV diagnostic criteria for schizophrenia were randomized to receive 8 weeks treatment with either Zhuangyang Capsule （ n = 60） or placebo（ n = 60） added on risperidone. The efficacy were assessed with measurement including the Positive and Negative Symptoms Scale （PANSS） , Clinical Global Impression （ CGI）, Social Disability Screening Schedule （SDSS）, Hamilton Rating Scale for Depression （HRSD） and Wisconsin Card Sorting Test（WCST）. Results： The clinical response rates were 56.9% （patients of Zhuangyang Capsule added on risperidone） and 36.2% （placebo added on risperidone） which there were significant differences （ P 〈 0.05 ）. Patients treated with Zhuangyang Capsule showed statistically significant improvement in the depression symptoms, social function and cognition function （ P 〈 0.05 or P 〈0.01 ） at the end point of treatment compared with patients treated with placebo. In PPS population, there were no significant differences in the PANSS total score, positive symptoms,negative symptoms and general psychopathology symptoms at the end point of treatment between the two groups. In FAS population, there were no significant differences in TESS （ Treatment Emergent Symptoms Scale）, AIMS （ Abnormal Involuntary Movement Scale ）, RSESE （ Rating Scale for Extrapyramidal Side Effects ） and ECG compared patients treated with Zhuangyang Capsule added on risperidone with patients treated with placebo added on risperidone during treatment. Conclusion ：Zhuangyang Capsule added on risperidone can improve clinical response, depression symptoms, social function and cognition function of patients with neg
出处
《中华中医药学刊》
CAS
2008年第9期1889-1892,共4页
Chinese Archives of Traditional Chinese Medicine
基金
美国Stanley基金资助项目(TS200301)
关键词
中药治疗
精神分裂症
壮阳胶囊
认知功能WCST
利培酮
阴性症状
traditional Chinese medicine （ TCM ）
schizophrenia
Zhuangyang capsule
cognition function
WCST
risperidone
negative symptom
