Karwautz Andreas, Zeiler Michael, Schwarzenberg Julia, Mairhofer Dunja, Mitterer Michaela, Truttmann Stefanie, Philipp Julia, Koubek Doris, Glüder Maria, Wagner Gudrun, Malcher Anouk, Schöfbeck Gabriele, Laczkovics Clarissa, Rock Hans W, Zanko Annika, Imgart Hartmut, Banaschewski Tobias, Fleischhaker Christian, Correll Christoph U, Wewetzer Christoph, Walitza Susanne, Taurines Regina, Fekete Stefanie, Romanos Marcel, Egberts Karin, Gerlach Manfred
Eating Disorders Care and Research Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, Wien, Austria.
CIO Marburg GmbH, Fronhausen, Germany.
Eur Eat Disord Rev. 2024 Nov;32(6):1055-1068. doi: 10.1002/erv.3022. Epub 2023 Aug 17.
Medication is commonly used in anorexia nervosa (AN) despite largely missing high grade evidence. Olanzapine (OLZ) is the best-evidenced substance used off-label in this group, with conflicting outcome regarding BMI, clinical and safety parameters. Therefore, it is important to strictly assure quality of treatment with OLZ in AN by using 'Therapeutic Drug Monitoring' according to AGNP-guidelines, including serum levels and adverse drug reactions (ADRs) to support safety for adolescents with AN and attempt to generate an initial age- and disorder-specific therapeutic reference range.
Sixty-five adolescents with AN (aged 10-18) treated with OLZ (98% female; 97.5% AN-restricting-type) were prospectively observed, ADRs reported, and correlations between dosage and serum levels measured at trough level were calculated, a preliminary therapeutic range defined.
Mean dosage of OLZ was 8.15 (SD: 2.91) mg and 0.19 (SD: 0.07) mg/kg respectively, average concentration was 26.57 (SD: 13.46) ng/mL. Correlation between daily dosage/dosage per kg and serum level was 0.72 (**p < 0.001)/0.65 (**p < 0.001), respectively. ADRs with impairment were rare (6.3%). 75% improved clinically (CGI). BMI increased significantly by 1.5 kg/m (t = 10.6, p < 0.001). A preliminary therapeutic reference range is 11.9 and 39.9 ng/mL.
OLZ in the hands of specialists is a well-tolerated and safe treatment adjunct for adolescents with AN.
尽管在很大程度上缺乏高级别证据，但药物治疗在神经性厌食症（AN）中仍被普遍使用。奥氮平（OLZ）是该组中使用的最佳循证非标签药物，在体重指数（BMI）、临床和安全参数方面结果存在冲突。因此，根据AGNP指南，通过“治疗药物监测”严格确保AN患者使用OLZ的治疗质量非常重要，包括血清水平和药物不良反应（ADR），以支持AN青少年的安全性，并尝试生成初始的年龄和疾病特异性治疗参考范围。
前瞻性观察65例接受OLZ治疗的AN青少年（年龄10 - 18岁）（98%为女性；97.5%为限制型AN），报告ADR，并计算剂量与谷浓度时测量的血清水平之间的相关性，定义初步治疗范围。
OLZ的平均剂量分别为8.15（标准差：2.91）mg和0.19（标准差：0.07）mg/kg，平均浓度为26.57（标准差：13.46）ng/mL。每日剂量/每千克剂量与血清水平之间的相关性分别为0.72（**p < 0.001）/0.65（**p < 0.001）。有损害的ADR很少见（6.3%）。75%的患者临床改善（临床总体印象量表）。BMI显著增加1.5 kg/m²（t = 10.6，p < 0.001）。初步治疗参考范围为11.9至39.9 ng/mL。
在专家手中，OLZ是AN青少年耐受性良好且安全的治疗辅助药物。
