Fleischhaker Christian, Heiser Philip, Hennighausen Klaus, Herpertz-Dahlmann Beate, Holtkamp Kristian, Mehler-Wex Claudia, Rauh Reinhold, Remschmidt Helmut, Schulz Eberhard, Warnke Andreas
Department of Child and Adolescent Psychiatry and Psychotherapy, Albert-Ludwigs-University Freiburg, Hauptstrasse 8, 79104 Freiburg, Germany.
J Child Adolesc Psychopharmacol. 2006 Jun;16(3):308-16. doi: 10.1089/cap.2006.16.308.
The aim of this study was to improve and evaluate the practibility of a method for the assessment of drug-associated side effects, and we implemented a clinical drug monitoring for atypical neuroleptics.
Side effects of initially hospitalized patients treated with clozapine (n = 16), olanzapine (n = 16), and risperidone (n = 19) were prospectively monitored on a weekly basis for the first 3 weeks. In the case of stable medication, measurements of all variables were made every 4 weeks or upon discharge. We used the Dosage Record Treatment Emergent Symptom Scale (DOTES) in a supplemented version to measure the presence and severity of side effects.
Drowsiness and decreased motor activity were common, especially in the first 2 weeks. Orthostatic hypotension, increased salivation, constipation, and nasal congestion were seen in more than 30% to 60% of patients treated with clozapine and were less common in adolescents treated with olanzapine and risperidone. Rigidity, tremor, and dystonia were seen in 5% to 15% of patients treated with risperidone and olanzapine. The average weight gain after 6 weeks of treatment with the atypical neuroleptics was significantly higher for the olanzapine group (4.6 +/- 1.9 kg) than for the risperidone (2.8 +/- 1.3 kg) and clozapine (2.5 +/- 2.9 kg) groups.
The authors' supplemented DOTES version is generally applicable to clinical use in mental health centers. The differences among the side effects of these three agents may affect compliance with medication and medical risks of metabolic syndrome, diabetes, and cardiovascular disease. More research on the short- and long-term safety of psychotropic drugs in children and adolescents, using standardized methods, should be considered.
本研究旨在改进和评估一种药物相关副作用评估方法的实用性，并对非典型抗精神病药物实施临床药物监测。
对最初住院接受氯氮平治疗的16例患者、奥氮平治疗的16例患者和利培酮治疗的19例患者，在最初3周每周前瞻性监测其副作用。在用药稳定的情况下，每4周或出院时对所有变量进行测量。我们使用补充版的剂量记录治疗突发症状量表（DOTES）来测量副作用的存在和严重程度。
嗜睡和运动活动减少很常见，尤其是在最初2周。氯氮平治疗的患者中，超过30%至60%出现体位性低血压、流涎增加、便秘和鼻塞，而奥氮平和利培酮治疗的青少年中这些情况较少见。利培酮和奥氮平治疗的患者中有5%至15%出现僵硬、震颤和肌张力障碍。非典型抗精神病药物治疗6周后，奥氮平组的平均体重增加（4.6±1.9千克）显著高于利培酮组（2.8±1.3千克）和氯氮平组（2.5±2.9千克）。
作者补充的DOTES版本一般适用于心理健康中心的临床应用。这三种药物副作用的差异可能会影响药物依从性以及代谢综合征、糖尿病和心血管疾病的医疗风险。应考虑采用标准化方法对儿童和青少年精神药物的短期和长期安全性进行更多研究。
