Suresh Kumar P N, Anish P K, Rajmohan V
Department of Psychiatry, KMCT Medical College, Calicut, Kerala, India.
Indian J Psychiatry. 2016 Jul-Sep;58(3):311-316. doi: 10.4103/0019-5545.192016.
The safety and efficacy profile of risperidone and olanzapine were compared in a double-blind trial that used doses widely accepted in clinical practice.
Subjects ( = 71) who met Diagnostic and Statistical Manual of Mental Disorders-IV criteria for schizophrenia were randomly assigned to receive 2-8 mg/day of risperidone (mean modal dose = 5.5 mg/day) or 5-20 mg/day of olanzapine (mean modal dose = 14.4 mg/day) for 1 year.
The two study groups were similar at baseline in all aspects. Seventy-four percent of the participants completed the trial, with no between-differences in the proportion of dropouts. Olanzapine group showed significantly greater improvement in negative symptoms in assessments at 3, 6, 9, and 12 months ( = 0.05, 0.00, 0.00, and 0.00, respectively). Clinical global impression of severity (CGI-S) scores were consistently lower in the olanzapine group at 3, 6, and 9 months ( = 0.01, 0.03, and 0.05, respectively) as measured by positive and negative symptom scale (PANSS). Total scores on PANSS, positive symptoms, general psychopathology, and CGI improvement showed comparable improvement at 3, 6, 9, and 12 months of follow-up (all subjects, including dropouts). Severity of extrapyramidal symptoms was low in both groups, with no between-group differences. Mean change in body weight, fasting blood sugar, and fasting cholesterol was comparable in both groups. Risperidone group had significant hyperprolactinemia after one year ( = 0.03).
Both treatments were well-tolerated and efficacious. Greater reductions in severity of the illness and negative symptoms were seen with olanzapine consistently through 1 year. The frequency and severity of extrapyramidal symptoms were negligible and similar in the two treatment groups. Weight gain, hyperlipidemia, and hyperglycemia were comparable in both groups. Risperidone produced significant hyperprolactinemia.
在一项采用临床实践中广泛接受剂量的双盲试验中,比较利培酮和奥氮平的安全性和疗效。
符合《精神疾病诊断与统计手册》第四版精神分裂症标准的71名受试者被随机分配接受为期1年的2 - 8毫克/天的利培酮(平均标准剂量 = 5.5毫克/天)或5 - 20毫克/天的奥氮平(平均标准剂量 = 14.4毫克/天)治疗。
两个研究组在基线时各方面均相似。74%的参与者完成了试验,两组间脱落比例无差异。奥氮平组在3、6、9和12个月的评估中阴性症状改善显著更大(分别为P = 0.05、0.00、0.00和0.00)。根据阳性和阴性症状量表(PANSS)测量,奥氮平组在3、6和9个月时临床总体印象严重程度(CGI - S)评分持续较低(分别为P = 0.01、0.03和0.05)。在随访的3、6、9和12个月时,PANSS总分、阳性症状、一般精神病理学和CGI改善情况显示出相当的改善(所有受试者,包括脱落者)。两组锥体外系症状的严重程度均较低,组间无差异。两组体重、空腹血糖和空腹胆固醇的平均变化相当。利培酮组在1年后出现显著的高催乳素血症(P = 0.03)。
两种治疗耐受性良好且有效。奥氮平在1年中持续使疾病严重程度和阴性症状有更大程度的降低。两组锥体外系症状的频率和严重程度可忽略不计且相似。两组体重增加、高脂血症和高血糖情况相当。利培酮导致显著的高催乳素血症。