Sahni Sukhtej, Chavan B S, Sidana Ajeet, Kalra Priyanka, Kaur Gurjit
Department of Psychiatry, Government Medical College & Hospital, Chandigarh, India.
Department of Genetic Centre, Government Medical College & Hospital, Chandigarh, India.
Indian J Med Res. 2016 Nov;144(5):697-703. doi: 10.4103/ijmr.IJMR_279_15.
BACKGROUND & OBJECTIVES: Clozapine may be more useful in treatment-naive patients with first-episode schizophrenia for better symptoms control and improving quality of life. The current study was carried out to compare the efficacy and tolerability of clozapine versus risperidone in treatment-naive, first-episode patients of schizophrenia.
This was a comparative, open-label, six months prospective study of treatment-naive, first-episode patients with schizophrenia between the age group of 18 and 40 yr diagnosed as per the International Classification of Diseases-10 (ICD-10) criteria. A total of 63 patients were recruited and randomly assigned to clozapine group or risperidone group using computer-generated random number tables. Eight patients were lost to follow up. The dosages of the respective drugs were kept in therapeutic range of 200-600 mg/day and 4-8 mg/day orally for clozapine and risperidone, respectively.
On general psychopathology score, after six months of intervention, clozapine led to 60.32 per cent mean reduction in Positive and Negative Syndrome Scale (PANSS) for Schizophrenia total score while risperidone led to 56.35 per cent mean reduction in PANSS total score, which meant more improvement with clozapine. Clozapine group was found to have significant improvement in quality of life (P = 0.04339). On Glasgow Antipsychotic Side-effect Scale, clozapine was superior to risperidone. The most common side effects observed in clozapine group were oversedation (78.96%) and dizziness (55.23%), and in risperidone group, common side effects were rigidity (62.36%), sedation (38.69%), tremors (65.69%) and menstrual irregularities in 80.25 per cent of female patients.
INTERPRETATION & CONCLUSIONS: The findings of this preliminary study showed clozapine as a better choice than risperidone in terms of efficacy, tolerability and better quality of life in treatment-naive, first-episode schizophrenia. However, further studies need to be done on a larger group of patients to confirm the findings.
氯氮平对于首发未治疗的精神分裂症患者可能在更好地控制症状和改善生活质量方面更具优势。本研究旨在比较氯氮平和利培酮对首发未治疗的精神分裂症患者的疗效和耐受性。
这是一项比较性、开放标签的前瞻性研究,研究对象为年龄在18至40岁之间、根据国际疾病分类第10版(ICD - 10)标准诊断为首发未治疗的精神分裂症患者。共招募了63例患者,使用计算机生成的随机数字表将其随机分为氯氮平组或利培酮组。8例患者失访。氯氮平和利培酮的各自药物剂量分别口服维持在200 - 600毫克/天和4 - 8毫克/天的治疗范围内。
在一般精神病理学评分方面,干预6个月后,氯氮平使精神分裂症阳性与阴性症状量表(PANSS)总分平均降低60.32%,而利培酮使PANSS总分平均降低56.35%,这意味着氯氮平的改善更明显。氯氮平组在生活质量方面有显著改善(P = 0.04339)。在格拉斯哥抗精神病药物副作用量表上,氯氮平优于利培酮。氯氮平组观察到的最常见副作用是过度镇静(78.96%)和头晕(55.23%),而在利培酮组,常见副作用是僵硬(62.36%)、镇静(38.69%)、震颤(65.69%)以及80.25%的女性患者出现月经不调。
这项初步研究的结果表明,在首发未治疗的精神分裂症患者中,就疗效、耐受性和更好的生活质量而言,氯氮平是比利培酮更好的选择。然而,需要对更大规模的患者群体进行进一步研究以证实这些发现。