Department of Dermatology, Ankara Numune Training and Research Hospital , Ankara , Turkey.
J Dermatolog Treat. 2019 Dec;30(8):813-817. doi: 10.1080/09546634.2019.1591578. Epub 2019 May 7.
Despite extensive usage of systemic isotretinoin in patients with acne for many years, laboratory monitoring protocols for adverse effects depend on the centers and there is no standardized practice for frequency and type of laboratory testing. We aimed to decrease unnecessary monitoring and to standardize our general clinical practice of our department as well as to provide patient comfort and cost saving. The medical charts of 704 acne patients treated with systemic isotretinoin were reviewed retrospectively. The National Cancer Institute common terminology criteria for adverse events v3.0 grading system was used in order to categorize the laboratory abnormalities of liver functions and lipid levels. All laboratory abnormalities were grade I. Abnormal liver function was seen in 7.2% of the patients ( = 51), maximum values were ALT: 87 IU/L, AST: 97 IU/L (normal values, ALT: 5-41 IU/L, AST: 5-40 IU/L) and median time of the abnormalities in liver function tests was in the second month. Lipid profile abnormalities were detected in 58% of the patients ( = 401). Maximum values during the laboratory monitoring were : 481 mg/dL CHOL: 314 mg/dL, LDL: 259 mg/dL (normal values, : 0-200 mg/dL, CHOL.: 0-200 mg/dL, LDL: 0-100 mg/dL). The median time of lipid abnormalities was in the first month (1-3 months). Abnormalities related to CBC were seen in 8.2% of the patients ( = 58). The median time of CBC abnormality was the second month of treatment. Anemia, leukopenia and thrombocytopenia were seen in 3.4%, 3.7%, and 1.6% of the patients respectively. Clinically insignificant and reversible CBC abnormalities, mild to moderate elevation of liver transaminases and serum lipids are the most common laboratory abnormalities in patients with acne treated with oral isotretinoin. Due to these abnormalities are reversible even the isotretinoin therapy continued, and generally there is no need to discontinuation of treatment due to laboratory abnormalities, frequent biochemical monitoring is not recommended.
尽管多年来异维 A 酸已广泛用于痤疮患者，但不良反应的实验室监测方案仍取决于各个中心，且缺乏标准化的检测频率和类型。我们旨在减少不必要的监测，使我们部门的常规临床实践标准化，同时为患者提供舒适感并节省成本。我们回顾性地审查了 704 例接受系统性异维 A 酸治疗的痤疮患者的病历。我们使用国家癌症研究所不良事件常用术语标准 v3.0 分级系统来对肝功能和血脂水平的实验室异常进行分类。所有实验室异常均为 1 级。7.2%（51 例）的患者出现肝功能异常，最大值为 ALT：87IU/L，AST：97IU/L（正常值：ALT：5-41IU/L，AST：5-40IU/L），肝功能异常中位时间为第 2 个月。58%（401 例）的患者检测到血脂谱异常。实验室监测期间的最大值为：CHOL：481mg/dL，CHOL：314mg/dL，LDL：259mg/dL（正常值：CHOL：0-200mg/dL，CHOL：0-200mg/dL，LDL：0-100mg/dL）。血脂异常的中位时间为第 1 个月（1-3 个月）。8.2%（58 例）的患者出现与 CBC 相关的异常。CBC 异常的中位时间为治疗的第 2 个月。贫血、白细胞减少和血小板减少分别见于 3.4%、3.7%和 1.6%的患者。口服异维 A 酸治疗痤疮患者最常见的实验室异常为临床意义不显著且可逆转的 CBC 异常、轻至中度肝转氨酶和血清脂质升高。由于这些异常是可逆的，即使继续异维 A 酸治疗，一般也不需要因实验室异常而停药，因此不建议频繁进行生化监测。
