Department of Psychiatry and Psychotherapy, Technische Universität München, Munich, Germany.
Medical Division, Gedeon Richter Plc, Budapest, Hungary.
Neuropsychopharmacology. 2019 Aug;44(9):1589-1596. doi: 10.1038/s41386-019-0363-2. Epub 2019 Mar 5.
Understanding how rating scale improvement corresponds to a clinical impression in patients with negative symptoms of schizophrenia may help define the clinical relevance of change in this patient population. We conducted post hoc equipercentile linking analyses of Positive and Negative Syndrome Scale (PANSS) outcomes (e.g., PANSS-Factor Score for Negative Symptoms [FSNS]) with Clinical Global Impressions-Improvement (CGI-I) and -Severity (CGI-S) ratings on data from patients treated with cariprazine (n = 227) or risperidone (n = 229) in a clinical study evaluating negative symptoms in schizophrenia. Patients were prospectively selected for persistent, predominant negative symptoms of schizophrenia (PNS), and minimal positive/depressive/extrapyramidal symptoms. Linking results demonstrated that greater improvement on PANSS-derived measures corresponded to clinical impressions of greater improvement, as measured by the CGI-I, and less severe disease states, as measured by the CGI-S. For example, CGI-S scores of 1 (normal), 2, 3, 4, 5, and 6 (severely ill) corresponded to PANSS-FSNS scores of 7, 13, 19, 24, 29, and 35, respectively. Likewise, CGI-I scores of minimally improved, much improved, and very much improved corresponded to a change from baseline in PANSS-FSNS scores of -27%, -49%, and -100%, respectively. These are important findings for the interpretation of the results of trials in patients with persistent negative symptoms.
了解在伴有阴性症状的精神分裂症患者中,评分量表的改善与临床印象如何对应,可能有助于确定该患者人群中变化的临床相关性。我们对一项评估精神分裂症阴性症状的临床研究中接受卡利培嗪(n=227)或利培酮(n=229)治疗的患者的数据进行了阳性和阴性症状量表(PANSS)结局(例如,阴性症状因子评分[FSNS])与临床总体印象改善(CGI-I)和严重程度(CGI-S)评分的事后等百分位链接分析。患者前瞻性选择存在持续性、主要阴性症状的精神分裂症(PNS),且阳性/抑郁/锥体外系症状最小。链接结果表明,PANSS 衍生测量指标的改善越大,与 CGI-I 测量的更大改善以及 CGI-S 测量的疾病状态较轻的临床印象越对应。例如,CGI-S 评分为 1(正常)、2、3、4、5 和 6(严重)分别对应 PANSS-FSNS 评分为 7、13、19、24、29 和 35。同样,CGI-I 评分为轻度改善、明显改善和非常明显改善分别对应 PANSS-FSNS 评分从基线变化了-27%、-49%和-100%。这些对于解释伴有持续性阴性症状患者的试验结果非常重要。