抑郁癥是全球致殘的首要原因之一，傳統(tǒng)診斷依賴《精神障礙診斷與統(tǒng)計手冊》（DSM-5）癥狀學(xué)標(biāo)準(zhǔn)，存在誤診率高（約30%～40%）和治療延遲（平均延遲8～10年）的問題。生物標(biāo)志物作為反映生物體生理、病理或環(huán)境暴露狀態(tài)的重要指標(biāo)，近年來在醫(yī)學(xué)診斷、藥物研發(fā)和個性化醫(yī)療等領(lǐng)域發(fā)揮著越來越關(guān)鍵的作用。系統(tǒng)綜述近年來國內(nèi)外抑郁癥生物標(biāo)志物研究進展，并分析中國、美國、歐洲藥監(jiān)政策對相關(guān)藥物研發(fā)的推動作用，為相關(guān)領(lǐng)域的研究者和政策制定者提供全面的參考，建立符合中國人群特征的生物標(biāo)志物評價體系。

Depression is one of the leading causes of disability worldwide. Traditional diagnosis relies on the symptom criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders（DSM-5）, which has led to high misdiagnosis rates（approximately 30%—40%） and delayed treatment（on average, 8—10 years）. Biomarkers, as important indicators reflecting the physiological, pathological, or environmental exposure status of organisms, have played an increasingly critical role in medical diagnosis, drug development, and personalized medicine in recent years. This article systematically reviews the progress of biomarker research on depression both domestically and internationally, and analyzes how regulatory policies in China, the United States, and Europe have promoted related drug development. It aims to provide comprehensive references for researchers and policymakers in these fields, establishing a biomarker evaluation system that aligns with the characteristics of the Chinese population.

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