Wang Xiaohong, Savage Robert, Borisov Andrey, Rosenberg Jill, Woolwine Bobbi, Tucker Melanie, May Roberta, Feldman Jacqueline, Nemeroff Charles B, Miller Andrew H
Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, 1639 Pierce Drive, Suite 4000, Atlanta, GA 30322, United States.
J Psychiatr Res. 2006 Oct;40(7):669-76. doi: 10.1016/j.jpsychires.2006.03.008. Epub 2006 Jun 9.
The objective of the study was to examine whether patients with schizophrenia who were judged to be stable on long-term treatment with conventional antipsychotic medications would further benefit from a switch to an atypical antipsychotic drug. Thirty-six subjects with schizophrenia spectrum disorder, on conventional antipsychotic medication therapy for at least 2 years, were randomized in double-blind fashion to risperidone versus olanzapine. Patients were titrated up to 6 mg risperidone or 15 mg olanzapine as tolerated, followed by tapering and discontinuation of conventional antipsychotic medication. Atypical antipsychotic agents were then administered alone (monotherapy) for 12 weeks. Efficacy and tolerability were assessed using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale, and Simpson Angus Scale. Body weight was measured at each visit. Both treatment groups exhibited marked and similar improvement in the total PANSS score from baseline to study endpoint (22 weeks) [risperidone: baseline=59.3 (SE 3.1), 22 weeks=44.3 (SE 2.3) (p<0.001); olanzapine: baseline=55.9 (SE 3.3), 22 weeks=46.9 (SE 3.2) (p<0.001). Both groups also exhibited significant reductions in PANSS factor scores for positive and negative symptoms and disorganized thoughts. Only risperidone-treated patients exhibited significant decreases in uncontrolled hostility/excitement and anxiety and depression. Of note, while positive factor scores exhibited the majority of change within the first 10 weeks, negative factor scores continued to decline significantly in both treatment groups throughout the study. Tolerability assessments did not differ between groups. The results indicate that both atypical antipsychotic medications provided significant additional improvement in symptom severity in patients with schizophrenia previously on conventional antipsychotic agents.
该研究的目的是检验，长期接受传统抗精神病药物治疗且病情被判定稳定的精神分裂症患者，改用非典型抗精神病药物是否会进一步获益。36名患有精神分裂症谱系障碍且接受传统抗精神病药物治疗至少2年的受试者，以双盲方式随机分为接受利培酮组和奥氮平组。患者根据耐受情况滴定至6毫克利培酮或15毫克奥氮平，随后逐渐减少并停用传统抗精神病药物。然后单独给予非典型抗精神病药物（单一疗法）治疗12周。使用阳性和阴性症状量表（PANSS）、临床总体印象量表和辛普森·安格斯量表评估疗效和耐受性。每次就诊时测量体重。两个治疗组从基线到研究终点（22周）的PANSS总分均有显著且相似的改善[利培酮组：基线=59.3（标准误3.1），22周=44.3（标准误2.3）（p<0.001）；奥氮平组：基线=55.9（标准误3.3），22周=46.9（标准误3.2）（p<0.001）]。两组的阳性、阴性症状及紊乱思维的PANSS因子得分也均显著降低。只有接受利培酮治疗的患者在未控制的敌意/兴奋以及焦虑和抑郁方面有显著下降。值得注意的是，虽然阳性因子得分在最初10周内变化最大，但在整个研究过程中，两个治疗组的阴性因子得分均持续显著下降。两组之间的耐受性评估没有差异。结果表明，两种非典型抗精神病药物均能使先前使用传统抗精神病药物的精神分裂症患者症状严重程度得到显著额外改善。
