Shoja Shafti Saeed, Azizi Khoei Abbas
University of Social Welfare and Rehabilitation Sciences (USWR), Razi Psychiatric Hospital, Tehran, Iran.
Razi Psychiatric Hospital, Tehran, Iran.
Ther Adv Psychopharmacol. 2016 Oct;6(5):308-316. doi: 10.1177/2045125316656334. Epub 2016 Sep 14.
Several lines of evidence suggest that the cholinergic system may be disrupted in schizophrenia and so this may contribute to the cognitive impairments of schizophrenic patients. Because such deficits do not respond to neuroleptic treatment, different approaches have been done by acetylcholinesterase inhibitors (AChEIs). The objective of the present assessment was to evaluate the safety and clinical effects of rivastigmine, as an adjunctive drug, on the clinical symptoms of schizophrenia.
A total of 46 patients with a diagnosis of schizophrenia entered into a 12-week, double-blind, clinical trial for random assignment to rivastigmine or placebo, as adjuvant to their current antipsychotic medication. Positive and Negative Symptom Scale (PANSS) and Mini Mental State Examination (MMSE) had been used as the primary outcome measures. Clinical Global Impressions- Improvement (CGI-I) Scale and Extrapyramidal Symptom Rating Scale (ESRS) had been used as the secondary measures. Treatment efficacy was evaluated by a Student's test and repeated-measures analysis of variance (ANOVA). Statistical significance was defined as a two-sided value ⩽ 0.05. Cohen's standard () and correlation measures of effect size () had been calculated for comparing baseline to endpoint changes.
According to the findings, except for significant enhancement of MMSE by rivastigmine ( < 0.001), no significant improvement in PANSS (negative symptoms), PANSS (positive symptoms), and PANSS (general psychopathology) was evident in the target group. Also, except for significant improvement of CGI-I by rivastigmine in intragroup analysis, no significant effectiveness was evident in between-group analysis or repeated-measures ANOVA. ESRS, also, did not show any significant alteration in either group. Effect size (ES) analysis showed a large improvement in MMSE by rivastigmine.
According to the findings, while rivastigmine could not induce significant improvement of positive and negative symptoms of schizophrenia, it caused significant enhancement of cognitive function in this group of patients.
多项证据表明,精神分裂症患者的胆碱能系统可能受到破坏,这可能是导致其认知障碍的原因之一。由于此类缺陷对抗精神病药物治疗无反应,乙酰胆碱酯酶抑制剂(AChEIs)已采用了不同的治疗方法。本评估的目的是评价作为辅助药物的卡巴拉汀对精神分裂症临床症状的安全性和临床疗效。
共有46例精神分裂症患者进入一项为期12周的双盲临床试验,随机分配接受卡巴拉汀或安慰剂治疗,作为其当前抗精神病药物治疗的辅助用药。采用阳性与阴性症状量表(PANSS)和简易精神状态检查表(MMSE)作为主要疗效指标。采用临床总体印象改善量表(CGI-I)和锥体外系症状评定量表(ESRS)作为次要指标。通过学生t检验和重复测量方差分析(ANOVA)评估治疗效果。统计学显著性定义为双侧P值≤0.05。计算了Cohen标准效应量(d)和效应大小的相关测量值(r),以比较基线至终点的变化。
根据研究结果,除卡巴拉汀显著提高MMSE评分外(P<0.001),目标组在PANSS(阴性症状)、PANSS(阳性症状)和PANSS(一般精神病理学)方面均无显著改善。此外,除卡巴拉汀在组内分析中显著改善CGI-I外,组间分析或重复测量方差分析均未显示出显著疗效。ESRS在两组中也未显示出任何显著变化。效应量(ES)分析显示卡巴拉汀可使MMSE有显著改善。
根据研究结果,虽然卡巴拉汀不能显著改善精神分裂症的阳性和阴性症状,但可显著提高该组患者的认知功能。