背景:Endoxifen,蛋白激酶C抑制剂和选择性雌激素受体调节剂,主要用于乳腺癌治疗,最近已成为治疗与双相情感障碍(BD)相关的躁狂发作的潜在治疗选择。这篇综述旨在评估内西芬在BD治疗中的现有证据基础,并评估当前研究结果的优势和局限性。
方法:在Medline上进行了系统搜索,Embase,和WebofScience数据库。我们包括了在BD中使用内西芬的英文发表的研究,以及通过手动搜索和具有全文可用性的会议论文确定的任何相关研究。有关剂量的信息,持续时间,临床效果,并从纳入的研究中提取安全性资料.Cochrane偏差风险2工具用于评估临床试验中的偏差风险。
结果:最终审查包括7份病例报告(包括2份会议报告),两项临床试验,和一项前瞻性研究。大多数研究服用了8mg的内昔芬,并报告了躁狂症状的改善。几例病例报告包括使用合并症药物的患者,大多数患者同时接受情绪稳定剂。很少有报告缺乏任何结构化的成果衡量标准。临床试验使用双丙戊酸钠1000mg作为活性比较剂,这被认为是亚治疗性的。尽管是多中心的,第一次审判缺乏集中招募的数据,在纳入的试验中观察到某些方法学问题.没有注意到严重的不良反应,除了3周内脂质分布显着升高。关于多西芬在混合发作中的疗效和安全性的数据有限,抑郁发作,和维持治疗。
结论:关于多西芬在BD中的疗效和安全性的研究很少。虽然现有证据表明躁狂发作的短期疗效,在大多数纳入的研究中发现了显著的局限性.在考虑将其推荐为可行的治疗方案之前,必须进一步研究以确定内西芬在BD中的疗效和安全性。
BACKGROUND: Endoxifen, a protein kinase C inhibitor and selective estrogen receptor modulator, primarily used in breast cancer treatment, has recently emerged as a potential therapeutic option for managing manic episodes associated with bipolar disorder (BD). This review aims to assess the existing evidence base for
endoxifen in BD treatment and evaluate the strengths and limitations of current research findings.
METHODS: A systematic search was conducted on Medline, Embase, and Web of Science databases. We included studies published in English that used
endoxifen in BD, alongside any relevant studies identified through manual searching and conference papers with full-text availability. Information pertaining to dose, duration, clinical effects, and safety profiles was extracted from the included studies. The Cochrane Risk of Bias 2 tool was used to assess the risk of bias in clinical trials.
RESULTS: The final review included seven case reports (including two conference presentations), two clinical trials, and one prospective study. Most studies administered
endoxifen 8 mg and reported an improvement in manic symptoms. Several case reports included patients with comorbid substance use, and most patients received mood stabilizers concurrently. Few reports lacked any structured outcome measures. The clinical trials used divalproex 1000 mg as an active comparator, which was deemed sub-therapeutic. Despite being multicentric, the first trial lacked data on center-wise recruitment, and certain methodological concerns were observed across the included trials. There were no serious adverse effects noted, except for a significant elevation in lipid profile within a 3-week period. Limited data were available regarding endoxifen efficacy and safety in mixed episodes, depressive episodes, and maintenance treatment.
CONCLUSIONS: There is a paucity of research on the efficacy and safety of
endoxifen in BD. While existing evidence suggests short-term efficacy in manic episodes, significant limitations were identified in most of the included studies. Further research is imperative to establish the efficacy and safety of endoxifen in BD before considering its recommendation as a viable treatment option.