Verdoux Hélène, Bittner Robert A, Hasan Alkomiet, Qubad Mishal, Wagner Elias, Lepetit Alexis, Arrojo-Romero Manuel, Bachmann Christian, Beex-Oosterhuis Marieke, Bogers Jan, Celofiga Andreja, Cohen Dan, de Berardis Domenico, de Hert Marc, de Las Cuevas Carlos, Ebdrup Bjørn H, Fountoulakis Konstantinos N, Guinart Daniel, Keating Dolores, Kopeček Miloslav, Lally John, Lazáry Judit, Luykx Jurjen J, Maronas Amigo Olalla, Molden Espen, Nielsen Jimmi, O'Donoghue Brian, Oswald Pierre, Radulescu Flavian S, Rohde Christopher, Sagud Marina, Sanz Emilio J, Šimunović Filipčić Ivona, Sommer Iris E, Taipale Heidi, Tiihonen Jari, Tuppurainen Heli, Veerman Selene, Wilkowska Alina, Spina Edoardo, Schulte Peter
French Clozapine Task Force, University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France.
Goethe University Frankfurt, University Hospital, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Frankfurt am Main, Germany.
Eur Psychiatry. 2025 Jan 10;68(1):e17. doi: 10.1192/j.eurpsy.2024.1816.
The European Clozapine Task Force is a group of psychiatrists and pharmacologists practicing in 18 countries under European Medicines Agency (EMA) regulation, who are deeply concerned about the underuse of clozapine in European countries. Although clozapine is the most effective antipsychotic for people with treatment-resistant schizophrenia, a large proportion of them do not have access to this treatment. Concerns about clozapine-induced agranulocytosis and stringent blood monitoring rules are major barriers to clozapine prescribing and use. There is a growing body of evidence that the incidence of clozapine-induced agranulocytosis is very low after the first year of treatment. Maintaining lifelong monthly blood monitoring after this period contributes to unjustified discontinuation of clozapine. We leverage recent and replicated evidence on the long-term safety of clozapine to call for the revision and updating of the EMA's blood monitoring rules, thus aiming to overcome this major barrier to clozapine prescribing and use. We believe the time has come for relaxing the rules without increasing the risks for people using clozapine in Europe.
欧洲氯氮平特别工作组由在欧洲药品管理局（EMA）监管下的18个国家执业的精神科医生和药理学家组成，他们对欧洲国家氯氮平使用不足深感担忧。尽管氯氮平是治疗难治性精神分裂症最有效的抗精神病药物，但很大一部分患者无法获得这种治疗。对氯氮平引起粒细胞缺乏症的担忧以及严格的血液监测规则是氯氮平处方和使用的主要障碍。越来越多的证据表明，治疗第一年之后氯氮平引起粒细胞缺乏症的发生率非常低。在此之后进行终身每月血液监测会导致氯氮平被不合理停药。我们利用近期关于氯氮平长期安全性的重复性证据，呼吁修订和更新EMA的血液监测规则，从而旨在克服氯氮平处方和使用的这一主要障碍。我们认为现在是放宽规则的时候了，同时又不增加欧洲使用氯氮平患者的风险。
