Data from: Hepatotoxicity of isotretinoin in patients with acne and Gilbert's syndrome: comparative study

Objectives: The objective of our follow-up study is to evaluate liver function tests (LFTs) and lipid profiles in patients with Gilbert's syndrome treated with isotretinoin because of severe acne. Setting: Dermatology outpatient clinics of three regional hospitals of Jaén (Spain). Participants: Over 4 years, we included all patients diagnosed with severe acne. Only 37 patients were identified, of which 11 had Gilbert's syndrome. Interventions: All patients were treated with isotretinoin and followed-up in our outpatient clinics after 10 and 20 weeks. Patients were subjected to an interview questionnaire which included data on age, gender, complete blood count, coagulation profile, fasting blood glucose, LFTs and lipid profiles. Data and results of patients with severe acne and Gilbert's syndrome were compared with those of 26 patients with only severe acne (control group). Primary: outcome Blood analyses were repeated in the follow-up visits. Results: In patients with Gilbert's syndrome, bilirubin levels showed substantial decrease over the 20-week follow-up, with more decrease after 10 weeks. None of the control group patients had significant increase in total bilirubin levels after 10 and 20 weeks of follow-up. Liver enzymes were maintained within normal levels in both groups. Both study groups did not show significant pathological increase in lipid profile levels. LDL levels were increased in the two study groups, but this increase was less substantial in patients with Gilbert's syndrome. Conclusions: Our preliminary results suggest that oral isotretinoin could be an effective, safe treatment for patients with Gilbert's syndrome, and may lower bilirubin levels in the first 10 weeks of treatment. Limitations of the study include the small numbers of participants and the fact that it is restricted to one region of Spain.研究目的：本随访研究旨在评估因重度痤疮接受异维A酸（isotretinoin）治疗的吉尔伯特综合征（Gilbert's syndrome）患者的肝功能试验（liver function tests，LFTs）及血脂谱（lipid profiles）情况。 研究地点：西班牙哈恩市三家地区医院的皮肤科门诊。 研究对象：本研究周期逾4年，共纳入所有确诊重度痤疮的患者。最终甄别出37例符合条件的患者，其中11例合并吉尔伯特综合征。 干预措施：所有患者均接受异维A酸治疗，并于治疗后10周、20周前往门诊接受随访。研究人员对患者开展访谈式问卷调查，收集其年龄、性别、全血细胞计数、凝血功能谱、空腹血糖、肝功能试验及血脂谱相关数据。将重度痤疮合并吉尔伯特综合征患者的临床数据，与仅患重度痤疮的26例患者（对照组）的数据进行对比分析。主要结局指标：随访期间需重复完成血液检测。 研究结果：合并吉尔伯特综合征的患者，其胆红素水平在20周随访期内呈显著下降趋势，且10周时的下降幅度更为明显。对照组患者在随访10周、20周后，总胆红素水平均未出现显著升高。两组患者的肝酶水平均维持在正常范围内。两组研究对象的血脂谱均未出现具有病理学意义的显著升高。两组的低密度脂蛋白（low-density lipoprotein，LDL）水平均有所升高，但吉尔伯特综合征患者的升高幅度相对更小。 研究结论：本研究的初步结果提示，口服异维A酸或许是治疗吉尔伯特综合征患者的有效且安全的方案，且可在治疗最初10周内降低患者的胆红素水平。 研究局限性：本研究存在两点局限，一是纳入样本量较小，二是研究仅局限于西班牙的一个地区。