■据报道,辛伐他汀和5HT3受体拮抗剂的辅助使用具有不同的益处,昂丹司琼,精神分裂症患者。我们调查了它们在单个试验中改善精神分裂症阴性症状的独立疗效和可能的协同作用。
■6个月,随机化,双盲,4臂安慰剂对照试验,2×2阶乘设计,在巴基斯坦的三个中心。总的来说,303名年龄在18-65岁的稳定精神分裂症患者被随机分配到添加昂丹司琼,辛伐他汀,两者或两者都没有。主要结果是3个月和6个月时的阳性和阴性综合征量表(PANSS)阴性评分。
■混合模型分析和协方差分析表明,辛伐他汀或昂丹司琼没有主要作用,但它们之间存在显着的负相互作用(p=0.03);单独使用时,与安慰剂相比,两种药物均能显著减轻阴性症状,但联合用药无效.与安慰剂相比,辛伐他汀的个体治疗效果为-1.9分(95CIs-3.23,-0.49;p=0.01),昂丹司琼的-1.6分(95CIs-3.00,-0.14;p=0.03)。联合治疗显著增加抑郁和副作用。在那些治疗时间少于5年的患者中,昂丹司琼改善了所有PANSS量表,全球功能措施和口头学习和流利,而辛伐他汀没有。
■辛伐他汀和昂丹司琼单独治疗精神分裂症阴性症状时阴性症状的改善不具有协同作用。昂丹司琼在患病后5年内对稳定抗精神病药物治疗的患者显示出广泛的疗效。研究结果表明,应在有精神病风险或早期治疗的患者中评估昂丹司琼。
UNASSIGNED: Variable benefits have been reported from the adjunctive use of simvastatin and the 5HT3 receptor antagonist, ondansetron, in patients with schizophrenia. We investigated their independent efficacy and possible synergy to improve negative symptoms of schizophrenia within a single trial.
UNASSIGNED: A 6-month, randomised, double-blind, placebo-controlled trial with a 4-arm, 2 × 2 factorial design, in three centres in Pakistan. In total, 303 people with stable treated schizophrenia aged 18-65 were randomly allocated to add-on ondansetron, simvastatin, both or neither. The primary outcome was a Positive and Negative Syndrome Scale (PANSS) negative score at 3 and 6 months.
UNASSIGNED: Mixed model analysis and analysis of covariance revealed no main effects of simvastatin or ondansetron but a significant negative interaction between them (p = 0.03); when given alone, both drugs significantly reduced negative symptoms compared to placebo but they were ineffective in combination. Individual treatment effects versus placebo were -1.9 points (95%CIs -3.23, -0.49; p = 0.01) for simvastatin and -1.6 points for ondansetron (95%CIs -3.00, -0.14; p = 0.03). Combined treatment significantly increased depression and side effects. In those with less than the median 5 years of treatment, ondansetron improved all PANSS subscales, global functioning measures and verbal learning and fluency, whereas simvastatin did not.
UNASSIGNED: Small improvement in negative symptoms on simvastatin and ondansetron individually are not synergistic in combination in treating negative symptoms of schizophrenia. Ondansetron showed broad efficacy in patients on stable antipsychotic treatment within 5 years of illness. The findings suggest that ondansetron should be evaluated in patients at risk of psychosis or early in treatment.