Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Psychiatry, School of Medicine, and Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Psychiatry, College of Medicine, National Yang-Ming University, Taipei, Taiwan.
Schizophr Res. 2018 Mar;193:107-113. doi: 10.1016/j.schres.2017.06.020. Epub 2017 Jun 17.
The purpose of this nationwide population-based study is to compare the long-term effectiveness of brand-name antipsychotics with generic antipsychotics for treating schizophrenia. We identified patients with schizophrenia who were prescribed antipsychotics from a random sample of one million records from Taiwan's National Health Insurance database, observed between January 1, 2000 and December 31, 2012. Only those with no prior use of antipsychotics for at least 180days were included. We selected patients who were prescribed brand-name risperidone (N=404), generic risperidone (N=145), brand-name sulpiride (N=334), or generic sulpiride (N=991). The effectiveness of the treatments researched in this study consisted of average daily doses, rates of treatment discontinuation, augmentation therapy, and psychiatric hospitalization. We found that compared to patients treated with generic risperidone, those treated with brand-name risperidone required lower daily doses (2.14mg vs. 2.61mg). However, the two groups demonstrated similar rates of treatment discontinuation, augmentation, and psychiatric hospitalization. On the other hand, in comparison with patients prescribed generic sulpiride, those treated with brand-name sulpiride not only required lower daily doses (302.72mg vs. 340.71mg) but also had lower psychiatric admission rates (adjusted hazard ratio: 0.24, 95% confidence interval: 0.10-0.56). In conclusion, for both risperidone and sulpiride, higher daily doses of the respective generic drugs were prescribed than with brand-name drugs in clinical settings. Furthermore, the brand-name sulpiride is more effective at preventing patients from hospitalization than generic sulpiride. These findings can serve as an important reference for clinical practices and healthcare economics for treating schizophrenic patients.
本全国性基于人群的研究旨在比较品牌抗精神病药与仿制药治疗精神分裂症的长期疗效。我们从台湾全民健康保险数据库的 100 万份记录中随机抽取了抗精神病药物处方的精神分裂症患者，观察时间为 2000 年 1 月 1 日至 2012 年 12 月 31 日。仅纳入至少 180 天未使用过抗精神病药物的患者。我们选择了处方品牌利培酮（N=404）、仿制利培酮（N=145）、品牌舒必利（N=334）或仿制舒必利（N=991）的患者。本研究治疗效果的评估指标包括平均日剂量、停药率、增效治疗和精神病住院治疗。结果发现，与使用仿制利培酮的患者相比，使用品牌利培酮的患者所需的日剂量较低（2.14mg 比 2.61mg）。然而，两组的停药、增效和精神病住院治疗率相似。另一方面，与服用仿制舒必利的患者相比，服用品牌舒必利的患者不仅所需的日剂量较低（302.72mg 比 340.71mg），而且精神病住院率较低（调整后的危险比：0.24，95%置信区间：0.10-0.56）。总之，在临床实践中，与品牌药物相比，处方的利培酮和舒必利仿制药的日剂量更高。此外，与仿制舒必利相比，品牌舒必利在预防患者住院方面更有效。这些发现可为治疗精神分裂症患者的临床实践和医疗经济学提供重要参考。
