Department of Psychiatry, School of Medicine, Vanderbilt University, 1601 23rd Avenue South, Suite 3035, Nashville, TN 37212, USA.
Am J Health Syst Pharm. 2010 Jan 1;67(1):27-37. doi: 10.2146/ajhp080595.
The effectiveness and tolerability of switching patients' therapy from brand-name to generic clozapine are reviewed.
Clozapine is the most effective treatment for patients with refractory psychotic disorders and is also effective for reducing suicidal and violent behavior in this same population. Generic versions of clozapine are widely used. However, possible differences in pharmacokinetic profiles between branded and generic clozapine, and the potential risks of medication changes in severely ill but stable patients, may result in apprehension about converting from branded to generic clozapine. Articles, abstracts, and clinical presentations that compared clinical outcomes between Clozaril (Novartis Pharmaceuticals, East Hanover, NJ) and generic forms of clozapine in patients with primary psychotic disorders, bipolar disorder, or related conditions were identified via a computerized search of the medical literature. Thirteen relevant reports, mostly uncontrolled observational studies or chart reviews, described the effects of switching from brand-name to generic clozapine in 966 patients. The majority of patients tolerated conversion without worsening of symptoms or adverse effects, increased intensive service utilization, or medication adjustment. Clinical deterioration was described in a case review and in one randomized, controlled study.
Available literature supports the effectiveness and safety of generic clozapine formulations in patients who previously were stable during treatment with brand-name clozapine. The risk of poor outcome after conversion to a generic clozapine formulation appears to be low but difficult to predict. Patients should be closely monitored during the first one to three months after conversion from one formulation to another.
审查将患者的治疗方案从品牌名氯氮平转换为仿制药的疗效和耐受性。
氯氮平是治疗难治性精神病患者最有效的药物，对于降低同一人群的自杀和暴力行为也同样有效。氯氮平的仿制药被广泛使用。然而，品牌名氯氮平和仿制药之间可能存在药代动力学特征的差异，以及病情严重但稳定的患者在药物转换时可能存在的潜在风险，这可能导致对从品牌名氯氮平转换为仿制药氯氮平的担忧。通过计算机检索医学文献，确定了比较原发性精神病、双相情感障碍或相关疾病患者在使用氯氮平（诺华制药，新泽西州东 Hanover）和仿制药时临床结局的文章、摘要和临床报告。13 份相关报告主要是未对照观察性研究或病历回顾，描述了 966 例从品牌名氯氮平转换为仿制药氯氮平的效果。大多数患者在转换过程中耐受良好，没有出现症状恶化或不良反应、增加密集服务利用或药物调整。在病例回顾和一项随机对照研究中描述了临床恶化的情况。
现有文献支持在曾使用品牌名氯氮平治疗且病情稳定的患者中使用仿制药氯氮平的疗效和安全性。转换为仿制药氯氮平后出现不良结局的风险似乎较低，但难以预测。在从一种制剂转换为另一种制剂后的头 1 至 3 个月期间，应密切监测患者。
