Lasser Robert A, Bossie Cynthia A, Gharabawi Georges M, Kane John M
Global Medical Strategy, Johnson & Johnson Pharmaceutical Services, LLC, Raritan, NJ 08869, USA.
Schizophr Res. 2005 Sep 15;77(2-3):215-27. doi: 10.1016/j.schres.2005.03.006.
Although treatment advances have improved outcomes in schizophrenia, definitions of remission and recovery are still evolving. Recently proposed criteria for remission (mild or less on multiple core-symptom ratings for at least 6 months) have been applied to a 1-year study of long-acting risperidone injection.
In a 50-week, open-label trial, stable patients with schizophrenia or schizoaffective disorder who received long-acting risperidone injection every 2 weeks were assessed using the Positive and Negative Syndrome Scale (PANSS). Remission criteria for the PANSS were applied; global illness severity (Clinical Global Impressions) and patient-rated health status (36-Item Short-form Health Survey) were measured.
Groups were identified by initial remission status (excluding the time component). Although considered clinically "stable," 68.2% (394/578) did not meet the symptom-severity component of remission criteria at baseline. Following long-acting, injectable risperidone treatment, 20.8% (82) of nonremitted patients achieved symptom remission for at least 6 months, with significant decreases in mean PANSS total and cluster scores (P < 0.0001) and significantly improved patient-rated health status (P < 0.0001). Percentages rated as not ill, very mild, or mild increased from 39% to 88%. Among 31.8% (184/578) of patients meeting the symptom-severity component of remission criteria at baseline, 84.8% (156) maintained these criteria at endpoint.
Among previously "stable," nonremitted patients, many achieved symptom remission after long-acting, injectable risperidone treatment, with significant improvements in multiple symptom domains and patient-rated health status. These results warrant further study as these remission criteria may represent a meaningful clinical endpoint and an important step towards functional recovery.
尽管治疗进展改善了精神分裂症的预后,但缓解和康复的定义仍在不断演变。最近提出的缓解标准(多个核心症状评分轻度或更低,持续至少6个月)已应用于一项关于长效利培酮注射剂的1年研究。
在一项为期50周的开放标签试验中,对每2周接受一次长效利培酮注射剂的稳定的精神分裂症或分裂情感性障碍患者,使用阳性和阴性症状量表(PANSS)进行评估。应用PANSS的缓解标准;测量总体疾病严重程度(临床总体印象)和患者自评健康状况(36项简短健康调查)。
根据初始缓解状态(不包括时间因素)对患者进行分组。尽管临床上认为“稳定”,但68.2%(394/578)的患者在基线时未达到缓解标准的症状严重程度部分。接受长效注射用利培酮治疗后,20.8%(82例)未缓解患者实现了至少6个月的症状缓解,PANSS总分及聚类分数显著降低(P<0.0001),患者自评健康状况显著改善(P<0.0001)。评定为无病、极轻度或轻度的百分比从39%增至88%。在基线时符合缓解标准症状严重程度部分的31.8%(184/578)患者中,84.8%(156例)在终点时维持了这些标准。
在之前“稳定”的未缓解患者中,许多患者在接受长效注射用利培酮治疗后实现了症状缓解,多个症状领域及患者自评健康状况有显著改善。这些结果值得进一步研究,因为这些缓解标准可能代表一个有意义的临床终点以及迈向功能康复的重要一步。