银杏酮酯片干预乳腺癌化疗相关认知障碍前瞻性队列研究OA
A Prospective Cohort Study of Effect of Ginkgo Ketone Ester Tablets on Chemotherapy-Related Cognitive Impairment in Breast Cancer Patients
目的 采用前瞻性队列研究方法,对既往接受过蒽环类药物或序贯联合紫杉醇方案化疗的患者进行了为期24周的临床随访,评估银杏酮酯片对于乳腺癌患者化疗相关认知障碍(CRCI)、躯体化障碍以及生活质量评分的影响.通过血清学检测探讨银杏酮酯对化疗相关认知障碍潜在作用机制.方法 该研究纳入2022年1月至2023年9月于上海中医药大学附属龙华医院中西医结合乳腺科即将化疗或正在进行化疗的女性乳腺癌患者,共筛选出96例患者.采用前瞻性队列研究方法,将患者分为暴露组和非暴露组,分别接受银杏酮酯片+常规辅助化疗或仅接受常规辅助化疗,随访24周.主要疗效指标包括记忆与执行筛查量表(MES)、事件相关电位P300;次要疗效指标包括乳腺癌中医症状量表、血清氧化应激指标及安全性指标.结果 随访结束(第24周)暴露组认知障碍发生率显著低于非暴露组,各维度中医症状显著优于非暴露组,差异有统计学意义(P<0.05).P300不同随访节点Cz潜伏期、Cz波幅、Pz潜伏期、Pz波幅差异无统计学意义(P>0.05).血清学检测银杏酮酯片显著提高了患者血清中的谷胱甘肽(GSH)水平,降低了活性氧(ROS)水平,差异有统计学意义(P<0.05),对肿瘤坏死因子-α(TNF-α)水平的下降程度不明显(P>0.05).随访期间无不良事件发生.结论 银杏酮酯片能够改善乳腺癌CRCI患者的记忆力、注意力、执行能力以及学习能力,并缓解心理状况、躯体状况及功能状况,减少CRCI对患者生活的不良影响.其机制可能是通过提高乳腺癌CRCI患者的血清GSH水平,降低ROS水平,改善神经系统过氧化损伤.故后续拟开展动物实验研究,以明确银杏酮酯片改善乳腺癌CRCI的疗效及具体机制.
Objective This prospective cohort study conducted a 24-week clinical follow-up on patients previously treated with anthracycline-based or sequential paclitaxel-containing chemotherapy regimens to evaluate the effects of Ginkgo Ketone Ester Tablets on chemotherapy-related cognitive impairment(CRCI),somatization disorders,and quality of life scores in breast cancer patients.Serum biomarkers were analyzed to explore potential mechanisms.Methods From January 2022 to September 2023,96 female breast cancer patients scheduled for or undergoing chemotherapy at the integrated breast oncology department of Longhua hospital,Shanghai university of traditional Chinese medicine were enrolled.Using a prospective cohort design,participants were divided into an exposed group(Ginkgo Ketone Ester Tablets+adjuvant chemotherapy)and a non-exposed group(adjuvant chemotherapy alone),with 24-week follow-up.Primary outcomes included Memory and Executive Screening(MES)scale and event-related potential P300 parameters.Secondary outcomes encompassed Traditional Chinese Medicine(TCM)symptom scale,serum oxidative stress markers,and safety profiles.Results At 24-week follow-up,the exposed group demonstrated significantly lower incidence of CRCI and superior TCM symptom alleviation across all domains compared to controls(P<0.05).No significant intergroup differences were observed in P300 parameters(Cz/Pz latency and amplitude,P>0.05).Serum analysis revealed Ginkgo Ketone Ester Tablets significantly elevated GSH levels and reduced ROS(P<0.05),while TNF-α reduction was non-significant(P>0.05).No adverse events occurred during follow-up.Conclusion Ginkgo Ketone Ester Tablets improved memory,attention,executive function,and learning ability in breast cancer patients with CRCI,while alleviating psychological,somatic,and functional status,thereby reducing the adverse impact of CRCI on patients'quality of life.The therapeutic mechanism may involve elevating serum GSH levels and suppressing ROS,collectively mitigating neural oxidative damage.Further animal studies are warranted to elucidate the precise efficacy and molecular pathways underlying Ginkgo Ketone Ester Tablets in CRCI management.
陈佳静;陈力新;蒋可心;吴春宇;刘胜;秦悦农;孙霃平;宋晓耘
上海中医药大学附属龙华医院,上海 200032上海中医药大学附属龙华医院,上海 200032浙江省中医院,浙江 杭州 310006上海中医药大学附属龙华医院,上海 200032上海中医药大学附属龙华医院,上海 200032上海中医药大学附属龙华医院,上海 200032上海中医药大学附属龙华医院,上海 200032上海中医药大学附属龙华医院,上海 200032
医药卫生
银杏酮酯乳腺癌化疗相关认知障碍生活质量氧化应激
ginkgo ketone esterbreast cancerchemotherapy-related cognitive impairmentquality of lifeoxidative stress
《辽宁中医药大学学报》 2026 (2)
154-158,5
国家自然科学基金面上项目(82474508)上海市2023年度"科技创新行动计划"科技成果转化服务体系建设项目(23Y11920700)
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