逍遥散出自《太平惠民和剂局方》,具疏肝健脾养血、理气调情怡性之效,原为妇人之疾所设,后世在其核心组方基础上衍生黑逍遥散、丹栀逍遥散等系列加减方,应用范围从妇科拓展至多学科,近年在肿瘤领域研究颇丰。通过方证、机制及临床应用3方面梳理其在恶性肿瘤中的价值。发现本核心组方以“和”“疏”为要,兼具扶正祛邪之功;机制上通过调控肿瘤细胞增殖、自噬、凋亡及肿瘤微环境、外泌体、代谢重编程等发挥作用,分子机制明确且经体内外实验验证;临床可阻断癌前病变,联合常规西医疗法减毒增效,改善终末期患者生活质量,对肿瘤相关抑郁、失眠等并发症疗效确切,且安全性高、适合长期服用。为其临床推广、中西医协作及抗肿瘤药物研发提供参考。

Xiaoyao San (逍遥散), derived from Formulary of the Bureau of Taiping People’s Welfare Pharmacy, possesses the effects of soothing the liver, strengthening the spleen, nourishing blood, regulating qi, and calming the mind. Initially formulated for gynecological diseases, it has since derived a series of modified prescriptions such as Hei Xiaoyao San (黑逍遥散) and Danzhi XiaoYao San (丹栀逍遥散) based on its core composition, with applications extended from gynecology to multiple disciplines. In recent years, increasing research has focused on its use in treating tumors and related conditions. This article systematically reviews the value of Xiaoyao San in malignant tumors from three aspects: formula-syndrome analysis, mechanism research, and clinical application. It is found that the core prescription focuses on “harmonizing” and “soothing”, with both the functions of strengthening healthy qi and eliminating pathogenic factors. Mechanistically, it exerts anti-tumor effects by regulating tumor cell proliferation, autophagy, apoptosis, tumor microenvironment, exosomes, and metabolic reprogramming, with clear molecular mechanisms verified by in vivo and in vitro experiments. Clinically, it can block precancerous lesions, enhance efficacy and reduce toxicity when combined with conventional Western therapies, improve the quality of life of end-stage patients, and has definite curative effects on tumor-related complications such as depression and insomnia. It is highly safe and suitable for long-term use by tumor patients. This review provides references for the clinical promotion of Xiaoyao San and its core modified prescriptions, the collaboration between traditional Chinese and Western medicine, and the development of antitumor drugs.

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全国名老中医药专家传承工作室建设项目（国中医药人教函[2022]75号）；全国名中医传承工作室建设项目（国中医药人教函[2022]245号）；中西医防治重大疾病河南省协同创新中心（教科技[2023]413号）；河南中医药大学2024年度研究生科研创新能力提升计划（2024KYCX009，2024KYCX013）