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 3 regional hospitals of Jaen (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 these of the 26 patients with only severe acne (control group). Primary outcome. Blood analyses were repeated in the follow-up visits. Results. In Gilbert’s syndrome patients, bilirubin levels showed substantial decrease over the 20 weeks 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 follow up. Liver enzymes were maintained within normal levels in both groups. Both studied groups did not show significant pathological increase in lipid profile levels. LDL levels were increased in the 2 studied groups, but this increase was less substantial in Gilbert’s syndrome patients. Conclusion. 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）患者的肝功能检测（liver function tests, LFTs）及血脂谱情况。
研究地点。西班牙哈恩市3家地区医院的皮肤科门诊。
研究对象。本研究历时4年，纳入所有确诊为重度痤疮的患者。最终共筛选出37例患者，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。研究人员对患者进行访谈式问卷调查，收集年龄、性别、全血细胞计数、凝血功能谱、空腹血糖、肝功能检测及血脂谱相关数据。将合并吉尔伯特综合征的重度痤疮患者的临床数据与结果，与仅患重度痤疮的26例患者（对照组）进行对比分析。
主要结局指标。随访期间需重复进行血液学检测。
研究结果。吉尔伯特综合征患者的胆红素水平在20周随访周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参考范围内。两组研究对象的血脂谱水平均未出现具有病理意义的显著升高。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。本初步研究结果提示，口服异维A酸对吉尔伯特综合征患者而言是一种安全有效的治疗手段，且可在治疗前10周内降低患者的胆红素水平。
研究局限性。本研究存在以下局限性：研究样本量较小，且研究对象仅局限于西班牙单一地区。