Brzeziński Piotr, Feszak Igor Jarosław, Śmigielski Janusz, Kawczak Piotr, Bączek Tomasz
Institute of Health Sciences, Pomeranian University in Słupsk, 76-200 Słupsk, Poland.
Department of Dermatology, Voivodeship Specialist Hospital, 76-200 Słupsk, Poland.
J Clin Med. 2025 May 16;14(10):3497. doi: 10.3390/jcm14103497.
Isotretinoin is a highly effective treatment for moderate-to-severe acne, but strict contraceptive measures are required because of its teratogenicity. The European Pregnancy Prevention Programme (PPP) aims to minimise foetal exposure through structured protocols. However, real-world data on patient compliance and treatment outcomes are limited. This retrospective study included 569 female patients aged 14-25 years treated with isotretinoin in Poland (2021-2022). Patients were assigned to three groups based on PPP compliance: full (Group I), partial (Group IIA), and minimal (Group IIB). Data on contraception, cumulative dose, treatment duration, adverse events, laboratory monitoring, and therapy discontinuation were analysed using non-parametric statistical tests ( < 0.05). No pregnancies occurred during treatment. Overall compliance with PPP requirements was high: 100% of the patients used contraception or declared abstinence. The majority (92.79%) used condoms, 1.93% used oral contraceptives, and 7.21% reported abstinence. Significant differences in cumulative isotretinoin dose were observed between the groups (Kruskal-Wallis H = 19.89, < 0.001), with Group I receiving a lower mean dose than those in Groups IIA ( < 0.001) and IIB ( < 0.01). Notably, all therapy discontinuations (4.75%) occurred in Group I (full compliance), which may reflect stricter monitoring and an earlier identification of adverse effects or patient concerns. These discontinuations were associated with lower cumulative dosing (Mann-Whitney Z = 7.81, < 0.001) than that seen in the other groups. An inverse correlation between age and cumulative dose was also found (H = 13.09, = 0.0004), with younger patients (≤17 years) more likely to reach therapeutic targets. Isotretinoin therapy under structured PPP protocols is safe and effective, with no pregnancies reported and excellent contraceptive compliance. Significant differences in dosing and adherence patterns highlight the need for flexible patient-centred approaches to optimise safety and outcomes.
异维A酸是治疗中度至重度痤疮的高效药物，但因其具有致畸性，所以需要采取严格的避孕措施。欧洲预防妊娠计划（PPP）旨在通过结构化方案将胎儿暴露风险降至最低。然而，关于患者依从性和治疗结果的真实世界数据有限。这项回顾性研究纳入了波兰（2021 - 2022年）569名年龄在14至25岁接受异维A酸治疗的女性患者。根据PPP依从性将患者分为三组：完全依从组（第一组）、部分依从组（第二A组）和最低依从组（第二B组）。使用非参数统计检验（<0.05）分析避孕、累积剂量、治疗持续时间、不良事件、实验室监测和治疗中断的数据。治疗期间未发生妊娠。总体而言，对PPP要求的依从性较高：100%的患者采取了避孕措施或声明禁欲。大多数患者（92.79%）使用避孕套，1.93%使用口服避孕药，7.21%声明禁欲。各组之间异维A酸累积剂量存在显著差异（Kruskal - Wallis H = 19.89，<0.001），第一组的平均剂量低于第二A组（<0.001）和第二B组（<0.01）。值得注意的是，所有治疗中断（4.75%）均发生在第一组（完全依从组），这可能反映了更严格的监测以及对不良反应或患者担忧的更早识别。这些治疗中断与较低的累积剂量相关（Mann - Whitney Z = 7.81，<0.001），低于其他组。还发现年龄与累积剂量呈负相关（H = 13.09，= 0.0004），年轻患者（≤17岁）更有可能达到治疗目标。在结构化的PPP方案下进行异维A酸治疗是安全有效的，未报告妊娠情况且避孕依从性良好。剂量和依从模式的显著差异凸显了需要以患者为中心的灵活方法来优化安全性和治疗结果。
