aDepartment of Psychiatry, Chonbuk National University Medical School bResearch Institute of Clinical Medicine of Chonbuk National University, Biomedical Research Institute of Chonbuk National University Hospital, Jeonju cDr Cho's Neuropsychiatry Clinic and Research Center, Busan dDepartment of Psychiatry, Soonchunhyang University of College of Medicine, Seoul eGraduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon fDepartment of Psychiatry, Gil Medical Center, Gachon University, Incheon gDepartment of Psychiatry, Chonnam National University Medical School, Gwangju hDepartment of Psychiatry, Myongji Hospital, Kwandong University College of Medicine, Koyang iDepartment of Psychiatry, Inje University College of Medicine, Ilsan Paik Hospital, Goyang jDepartment of Psychiatry, Kyungpook National University School of Medicine, Daegu kSt. John of God Hospital, Kwangju lDepartment of Psychiatry, Kangwon National University College of Medicine, Chunchon mDepartment of Psychiatry, Wonkwang University, School of Medicine, Iksan, Republic of Korea.
Int Clin Psychopharmacol. 2014 Mar;29(2):77-85. doi: 10.1097/YIC.0000000000000005.
We investigated the efficacy and safety of aripiprazole in first-episode psychosis and explored the association between early response and later response to this medication. This was a 6-week, open-label, multicenter trial. The study population consisted of 59 patients with a DSM-IV diagnosis of a schizophreniform disorder, schizoaffective disorder, schizophrenia, or psychotic disorder not otherwise specified. The primary outcome measures were the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-Severity scale. To assess the safety, we measured the drug-related adverse events, weight, and lipid-related variables. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated for the response status at weeks 2 and 3 to predict the subsequent response at week 6. Among the 59 participants, 38 were able to complete the 6-week trial. Treatment with aripiprazole resulted in significant improvement in the PANSS and Clinical Global Impression scores over time. The response rate (defined as a ≥30% decrease in the PANSS total score from baseline to the last observation) was 69.1%. The most accurate prediction of later response in terms of negative predictive value and specificity was a reduction in the PANSS total score from baseline to week 3 of at least 20%. Aripiprazole had a modest side effect burden and was characterized by a safe profile with respect to weight and metabolic side effects. These results indicate that aripiprazole is effective and safe in the treatment of first-episode psychosis. The response at week 3, rather than week 2, predicted the later response more accurately.
我们研究了阿立哌唑在首发精神分裂症中的疗效和安全性，并探讨了早期反应与后期对这种药物反应之间的关联。这是一项为期 6 周、开放标签、多中心的试验。研究人群包括 59 名符合 DSM-IV 诊断的分裂样障碍、分裂情感障碍、精神分裂症或未特定的精神病性障碍患者。主要结局指标为阳性和阴性症状量表（PANSS）和临床总体印象严重程度量表。为了评估安全性，我们测量了与药物相关的不良事件、体重和血脂相关变量。计算了第 2 周和第 3 周的反应状态的敏感性、特异性、阳性预测值和阴性预测值，以预测第 6 周的后续反应。在 59 名参与者中，有 38 名能够完成 6 周的试验。阿立哌唑治疗可显著改善 PANSS 和临床总体印象评分随时间的变化。反应率（定义为从基线到最后观察时 PANSS 总分下降≥30%）为 69.1%。预测后期反应的最准确指标是阴性预测值和特异性，即从基线到第 3 周 PANSS 总分至少下降 20%。阿立哌唑具有适度的副作用负担，且在体重和代谢副作用方面具有安全的特征。这些结果表明，阿立哌唑在首发精神分裂症的治疗中是有效且安全的。第 3 周的反应比第 2 周更能准确预测后期反应。
