目的:尽管有证据表明没有其他抗精神病药物能像氯氮平一样有效治疗耐药精神分裂症,它与各种代谢有关,神经内分泌,心血管,和胃肠道不良反应。旨在监测氯氮平(严重)不良反应的指南有助于预防和治疗这些不良反应。然而,这些指南中的许多似乎缺乏一个或多个重要的监测建议。我们旨在系统地审查现有的氯氮平不良反应监测指南/建议的内容和质量。
方法:全面系统的文献检索,使用MEDLINE,Embase,WebofScience,和Cochrane数据库,进行了关于氯氮平引起的不良事件监测的指南/建议,2004年1月至2023年4月之间发布(最后搜索2023年4月16日)。只有经过同行评审的已发布指南,报告全面监测氯氮平引起的所有主要不良反应,并包括循证建议,2004年以后开发的,包括在内。报告氯氮平不良反应监测的研究没有正式的指南,关于监测一种或有限数量的氯氮平不良反应的指南,未经同行评审或发布的指南,没有正式共识指南制定的专家意见文件,或2004年之前制定的指导方针被排除在外。研究和评估指南II(AGREE-II)工具用于评估指南/建议的质量。
结果:只有一个指南符合纳入标准。该共识声明为血液学监测提出了建议,和代谢监测,心脏,和其他三个不利影响。定性评估得分最高的领域是“范围和目的”(66.7%),“表述清晰度”(44.4%),和“编辑独立性”(66.7%)。得分最低的是“发展的严谨性”(14.6%)和“适用性”(0%)。
结论:未来的指南应针对氯氮平引起的特定不良反应制定更全面的建议。包括便秘,心肌炎,心动过速,和癫痫发作,以及包括重新挑战政策。迫切需要有良好的发展,方法严格,准则。
背景:PROSPERO注册号,CRD42023402480。
Despite the evidence that no other antipsychotic is effective as clozapine for the treatment of resistant
schizophrenia, it is associated with various metabolic, neuroendocrine, cardiovascular, and gastrointestinal adverse effects. Guidelines aiming to address the monitoring of clozapine\'s (serious) adverse effects can be helpful to prevent and treat these effects. However, many of these guidelines seem to lack one or more important monitoring recommendations. We aimed to systematically review the content and quality of existing monitoring guidelines/recommendations for clozapine-induced adverse effects.
A comprehensive and systematic literature search, using the MEDLINE, Embase, Web of Science, and Cochrane databases, was conducted for guidelines/recommendations on the monitoring of clozapine-induced adverse events, published between January 2004 and April 2023 (last search 16 April 2023). Only peer-reviewed published guidelines reporting on the comprehensive monitoring of all major clozapine-induced adverse effects and including evidence-based recommendations, developed after the year 2004, were included. Studies reporting on the monitoring of adverse effects of clozapine without being a formal
guideline, guidelines reporting on the monitoring of one or a limited number of adverse effects of clozapine, guidelines that were not peer reviewed or published, expert opinion papers without formal
consensus guideline development, or guidelines developed before the year 2004, were excluded. The Appraisal of Guidelines for Research and Evaluation II (AGREE-II) tool was used to evaluate the guidelines/recommendations\' quality.
Only one
guideline met the inclusion criteria. This
consensus statement made recommendations for hematological monitoring, and the monitoring of metabolic, cardiac, and three other adverse effects. Highest scores for the qualitative assessment were found for the domains \"scope and purpose\" (66.7%), \"clarity of presentation\" (44.4%), and \"editorial independence\" (66.7%). Lowest scores were found for \"rigor of development\" (14.6%) and \"applicability\" (0%).
Future guidelines should develop more comprehensive recommendations about specific clozapine-induced adverse effects, including constipation, myocarditis, tachycardia, and seizures, as well as include a rechallenge policy. There is an urgent need for well-developed, methodologically stringent, guidelines.
PROSPERO registration number, CRD42023402480.