PDF(Pubmed)
Abstract：
BACKGROUND: Global antipsychotic usage, including off-label prescriptions, has increased in recent decades. However, trends in China, particularly for children and adolescents, remain unclear. This study explored these trends from 2016 to 2021 and identified factors associated with off-label prescriptions.
METHODS: In this retrospective study, we analyzed on-label and off-label prescriptions based on drug information approved by the China National Medical Products Administration. To identify factors associated with off-label prescriptions, we conducted multivariate logistic regression analysis.
RESULTS: Our study included 48,258 antipsychotic prescriptions, 52.4% (25,295) of which were prescriptions for males. Of these, 61.7% (29,813) were off-label. Over time, the number of antipsychotics and the percentage of off-label prescriptions for children and adolescents overall increased from 2016 to 2021. The use of atypical antipsychotics increased, whereas that of typical antipsychotics decreased. For off-label usage, all of the factors in our study were associated with off-label usage, including age, sex, year, region, department, reimbursement, antipsychotic type, drug expense, number of polypharmacy and diagnoses. Additionally, tiapride (15.8%) and aripiprazole (18.6%) were the most common typical and atypical antipsychotics, respectively. For pediatric diseases, common diagnoses included mood or affective disorders (31.7%) and behavioral and emotional disorders, with onset usually occurring in childhood and adolescence (29.1%). Furthermore, a depressive state was the most common diagnosis for which antipsychotic polypharmacy was used for treatment.
CONCLUSIONS: In this retrospective study, off-label antipsychotic prescriptions were common, with trends generally increasing among children and adolescents from 2016 to 2021. However, there is a lack of evidence supporting off-label usage, thus emphasizing the need for studies on the efficacy and safety of these treatments.
METHODS: In this retrospective study, we analyzed on-label and off-label prescriptions based on drug information approved by the China National Medical Products Administration. To identify factors associated with off-label prescriptions, we conducted multivariate logistic regression analysis.
RESULTS: Our study included 48,258 antipsychotic prescriptions, 52.4% (25,295) of which were prescriptions for males. Of these, 61.7% (29,813) were off-label. Over time, the number of antipsychotics and the percentage of off-label prescriptions for children and adolescents overall increased from 2016 to 2021. The use of atypical antipsychotics increased, whereas that of typical antipsychotics decreased. For off-label usage, all of the factors in our study were associated with off-label usage, including age, sex, year, region, department, reimbursement, antipsychotic type, drug expense, number of polypharmacy and diagnoses. Additionally, tiapride (15.8%) and aripiprazole (18.6%) were the most common typical and atypical antipsychotics, respectively. For pediatric diseases, common diagnoses included mood or affective disorders (31.7%) and behavioral and emotional disorders, with onset usually occurring in childhood and adolescence (29.1%). Furthermore, a depressive state was the most common diagnosis for which antipsychotic polypharmacy was used for treatment.
CONCLUSIONS: In this retrospective study, off-label antipsychotic prescriptions were common, with trends generally increasing among children and adolescents from 2016 to 2021. However, there is a lack of evidence supporting off-label usage, thus emphasizing the need for studies on the efficacy and safety of these treatments.
摘要：
背景：全球抗精神病药的使用，包括标签外处方，近几十年来有所增加。然而,中国的发展趋势,特别是对于儿童和青少年，仍然不清楚。这项研究探讨了2016年至2021年的这些趋势，并确定了与标签外处方相关的因素。
方法：在这项回顾性研究中，我们根据中国国家药品监督管理局批准的药品信息分析了标签上和非标签处方。为了确定与标签外处方相关的因素，我们进行了多因素logistic回归分析.
结果：我们的研究包括48,258种抗精神病药处方，其中男性处方占52.4%(25295份)。其中,61.7%(29,813)是标签外的。随着时间的推移,从2016年到2021年,针对儿童和青少年的抗精神病药物数量和标签外处方的百分比总体上有所增加.非典型抗精神病药物的使用增加，而典型的抗精神病药物则有所下降。对于标签外使用，我们研究中的所有因素都与标签外使用有关，包括年龄,性别,Year,区域,部门,报销,抗精神病药物类型，药费,多重用药和诊断的数量。此外,tiapride(15.8%)和阿立哌唑(18.6%)是最常见的典型和非典型抗精神病药物，分别。对于儿科疾病，常见诊断包括情绪或情感障碍（31.7％）以及行为和情绪障碍，发病通常发生在儿童期和青春期（29.1%）。此外，抑郁状态是最常见的诊断,抗精神病药物多药用于治疗.
结论：在这项回顾性研究中，标签外的抗精神病药处方很常见，从2016年到2021年，儿童和青少年的趋势普遍上升。然而,缺乏支持标签外使用的证据，因此强调需要对这些治疗的疗效和安全性进行研究。
方法：在这项回顾性研究中，我们根据中国国家药品监督管理局批准的药品信息分析了标签上和非标签处方。为了确定与标签外处方相关的因素，我们进行了多因素logistic回归分析.
结果：我们的研究包括48,258种抗精神病药处方，其中男性处方占52.4%(25295份)。其中,61.7%(29,813)是标签外的。随着时间的推移,从2016年到2021年,针对儿童和青少年的抗精神病药物数量和标签外处方的百分比总体上有所增加.非典型抗精神病药物的使用增加，而典型的抗精神病药物则有所下降。对于标签外使用，我们研究中的所有因素都与标签外使用有关，包括年龄,性别,Year,区域,部门,报销,抗精神病药物类型，药费,多重用药和诊断的数量。此外,tiapride(15.8%)和阿立哌唑(18.6%)是最常见的典型和非典型抗精神病药物，分别。对于儿科疾病，常见诊断包括情绪或情感障碍（31.7％）以及行为和情绪障碍，发病通常发生在儿童期和青春期（29.1%）。此外，抑郁状态是最常见的诊断,抗精神病药物多药用于治疗.
结论：在这项回顾性研究中，标签外的抗精神病药处方很常见，从2016年到2021年，儿童和青少年的趋势普遍上升。然而,缺乏支持标签外使用的证据，因此强调需要对这些治疗的疗效和安全性进行研究。
