Fleischhacker W Wolfgang, Eerdekens Mariëlle, Karcher Keith, Remington Gary, Llorca Pierre-Michel, Chrzanowski Wlodzimierz, Martin Stephen, Gefvert Ola
Department of Biological Psychiatry, Innsbruck University Clinics, Anichstrasse 35, 6020 Innsbruck, Austria.
J Clin Psychiatry. 2003 Oct;64(10):1250-7. doi: 10.4088/jcp.v64n1017.
The long-term safety and efficacy of long-acting injectable risperidone, the first long-acting second-generation antipsychotic, were evaluated in stable patients with schizophrenia.
After a 2-week run-in period during which patients with DSM-IV schizophrenia received flexible doses of 1 to 6 mg of oral risperidone, patients received injections of 25 mg, 50 mg, or 75 mg of long-acting risperidone every 2 weeks for 12 months. Severity of extrapyramidal symptoms was assessed with the Extrapyramidal Symptom Rating Scale (ESRS), and efficacy was assessed with the Positive and Negative Syndrome Scale (PANSS). This study was conducted from March 29, 1999 to July 19, 2000.
The subjects were 615 patients with schizophrenia who received at least 1 injection of long-acting risperidone. The 12-month trial was completed by 65% of patients. Treatment was discontinued because of adverse events in 5% of patients. Extrapyramidal symptoms as adverse events were reported by 25% of the patients. Severity of extrapyramidal symptoms (according to ESRS scores) was low at baseline and decreased in each of the groups during the 12 months. The other most common adverse events were anxiety in 24%, insomnia in 21%, psychosis in 17%, and depression in 14% of the patients. Little pain was associated with the injections. Severity of symptoms of schizophrenia was improved in each group, with significant reductions in PANSS total scores (p <.01) and positive (p <.01) and negative (p <.001) factor scores.
In terms of both safety and efficacy, symptomatically stable patients with schizophrenia benefit from being switched to long-acting injectable risperidone.
首个长效第二代抗精神病药物长效注射用利培酮在精神分裂症稳定期患者中的长期安全性及疗效得到评估。
在为期2周的导入期,DSM-IV精神分裂症患者接受1至6毫克口服利培酮的灵活剂量治疗,之后患者每2周接受一次25毫克、50毫克或75毫克长效利培酮注射,持续12个月。采用锥体外系症状评定量表(ESRS)评估锥体外系症状的严重程度,采用阳性和阴性症状量表(PANSS)评估疗效。本研究于1999年3月29日至2000年7月19日进行。
受试者为615例接受至少1次长效利培酮注射的精神分裂症患者。65%的患者完成了为期12个月的试验。5%的患者因不良事件停药。25%的患者报告锥体外系症状为不良事件。锥体外系症状的严重程度(根据ESRS评分)在基线时较低,且在12个月期间各治疗组均有所下降。其他最常见的不良事件为24%的患者出现焦虑、21%的患者出现失眠、17%的患者出现精神病、14%的患者出现抑郁。注射相关的疼痛轻微。各治疗组精神分裂症症状的严重程度均得到改善,PANSS总分(p <.01)以及阳性(p <.01)和阴性(p <.001)因子得分均显著降低。
就安全性和疗效而言,症状稳定的精神分裂症患者改用长效注射用利培酮有益。