Objective  To methodically evaluate the therapeutic effect and safety of traditional Chinese medicine (TCM) in the treatment of mild cognitive impairment (MCI).

Methods  A computerized search was conducted in Chinese and English databases for clinical randomized controlled trials  on the treatment of MCI with TCM. The search was limited to studies published from the establishment of the database up to December 31, 2025. The Cochrane risk of bias assessment tool was used to evaluate the quality of the included studies, and Stata 17.0 software was employed for Meta-analysis.

Results  A total of 77 studies involving 7,997 patients were included. The results indicated that TCM significantly improved patients' cognitive function [standardized mean difference (SMD)=0.78, 95%CI (0.67, 0.89), P<0.001] and activities of daily living (ADL) [SMD=- 0.64, 95%CI (-0.90,  -0.38), P<0.001]. Subgroup analysis revealed that the combination of TCM and Western medicine yielded better results. However, in terms of ADL, there was no statistically significant difference between TCM vs. Western medicine and TCM vs. placebo/blank (P>0.05). 29 studies reported safety data, and there was no significant difference in the incidence of adverse reactions between the TCM group and the control group [relative risk (RR)=0.72, 95%CI (0.51, 1.02), P=0.066].

Conclusion  TCM can help improve cognitive function and ADL in patients with MCI, with the combination of TCM and Western medicine showing relatively better results. However, due to the small sample size and imprecise methods in some studies, further rigorous research is needed to validate these findings.

1.Yu SJ, Tang HL, Li WH, et al. Donepezil combined with traditional Chinese medicine has promising efficacy on mild cognitive impairment: a systematic review and Meta-analysis[J]. Front Neurosci, 2023, 17: 1206491. DOI: 10.3389/fnins.2023.1206491.

2.Yang Y, Xiao M, Leng L, et al. A systematic review and Meta-analysis of the prevalence and correlation of mild cognitive impairment in sarcopenia[J]. J Cachexia Sarcopenia Muscle, 2023, 14(1): 45-56. DOI: 10.1002/jcsm.13143.

3.Deng Y, Zhao S, Cheng G, et al. The prevalence of mild cognitive impairment among Chinese people: a Meta-analysis[J]. Neuroepidemiology, 2021, 55(2): 79-91. DOI: 10.1159/000512597.

4.Liang N, Chen Y, Yang S, et al. Chinese herbal medicine for mild cognitive impairment: a systematic review of randomized controlled trials[J]. Front Neurol, 2022, 13: 903224. DOI: 10.3389/fneur.2022.903224.

5.中国痴呆与认知障碍诊治指南写作组, 中国医师协会神经内科医师分会认知障碍疾病专业委员会. 2018中国痴呆与认知障碍诊治指南（五）：轻度认知障碍的诊断与治疗[J]. 中华医学杂志, 2018, 98(17): 1294-1301. [Writing Group for Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Disorders, Professional Committee of Cognitive Impairment Diseases, Neurologist Branch of Chinese Medical Doctor Association. 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Disorders (V): Diagnosis and Treatment of Mild Cognitive Impairment[J]. National Medical Journal of China, 2018, 98(17): 1294-1301.] DOI: 10.3760/cma.j.issn.0376-2491.2018.17.003.

6.Pei H, Ma L, Cao Y, et al. Traditional Chinese medicine for Alzheimer's disease and other cognitive impairment: a review[J]. Am J Chin Med, 2020, 48(3): 487-511. DOI: 10.1142/S0192415X20500251.

7.秦发展, 牛昱光, 韩萍, 等. 基于血浊理论探析轻度认知功能障碍的辨证论治[J]. 天津中医药, 2023, 40(3): 297-300. [Qin  FZ, Niu YG, Han P, et al. Exploration of the identification and treatment of mild cognitive impairment based on blood turbidity theory[J]. Tianjin Journal of Traditional Chinese Medicine, 2023, 40(3): 297-300.] DOI: 10.11656/j.issn.1672-1519.2023.03.05.

8.Higgins JP, Altman DG, Gotzsche PC, et al. The cochrane collaboration's tool for assessing risk of bias in randomised trials[J]. BMJ, 2011, 343: d5928. DOI: 10.1136/bmj.d5928.

9.俞金鑫, 夏卫明, 陈庆宇, 等. 补肾健脾活血方治疗老年2型糖尿病合并轻度认知功能障碍脾肾两虚兼血瘀证疗效观察[J]. 河北中医, 2022, 44(8): 1282-1286. [Yu JX, Xia WM, Chen QY, et al. Bushen Jianpi Huoxue formula in effect on type 2 diabetic elderly patients with mild cognitive impairment of deficiency of spleen and kidney and blood stasis[J]. Hebei Journal of Traditional Chinese Medicine, 2022, 44(8): 1282-1286.] DOI: 10.3969/j.issn.1002-2619.2022.08.011.

10.王小菊, 朴美虹, 王智贤, 等. 三补方治疗遗忘型轻度认知功能障碍脾肾两虚证的临床观察[J]. 中医药导报, 2021, 27(10): 80-84. [Wang XJ, Piao MH, Wang ZX, et al. Clinical observation of Sanbu recipe in treating amnestic mild cognitive impairment with deficiency of spleen and kidney[J]. Guiding Journal of Traditional Chinese Medicine and Pharmacology, 2021, 27(10): 80-84.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIQaG56eXlkYjIwMjExMDAxNxoIdjI4Z2pnZG8%3D.

11.田曼, 李杨, 陈延. 基于“肠-炎症-脑轴”探讨交泰丸联合奥拉西坦治疗糖尿病认知功能障碍的作用[J]. 现代中西医结合杂志, 2021, 30(23): 2540-2544. [Tian M, Li Y, Chen Y. Discussion on the mechanism of Jiaotai pill combined with oxiracetam in the treatment of diabetic cognitive dysfunction based on intestines-inflammation-brain axis[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2021, 30(23): 2540-2544.] DOI: 10.3969/j.issn.1008-8849.2021.23.007.

12.谭文澜, 张永全, 文晓东, 等. 抗震胶囊对帕金森病患者认知功能障碍的影响及机制研究[J]. 武警后勤学院学报（医学版）, 2020, 29(9): 23-27. [Tan WL, Zhang YQ, Wen XD, et al. Effect and mechanism of Kangzhen capsule on cognitive dysfunction in patients with Parkinson's disease[J]. Journal of Logistics University of PAP (Medical Sciences), 2020, 29(9): 23-27.] https://www.cnki.com.cn/Article/CJFDTOTAL-WUXB202009006.htm.

13.郭伟, 彭聪, 李伟, 等. 西格列汀联合津力达颗粒治疗老年2型糖尿病患者轻度认知功能障碍观察[J]. 药物流行病学杂志, 2020, 29(10): 657-661. [Guo W, Peng C, Li W, et al. Clinical research on sitagliptin combined with Jinlida granules in the treatment of elderly type 2 diabetic patients with mild cognitive impairment[J]. Chinese Journal of Pharmacoepidemiology, 2020, 29(10): 657-661.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIReXdseGJ4enoyMDIwMTAwMDEaCHRwOW8zdXp0.

14.沈丽萍, 乔向阳, 王萍, 等. 滋阴祛痰开窍方治疗肝肾阴虚型帕金森病轻度认知功能障碍患者的临床观察[J]. 上海中医药大学学报, 2020, 34(4): 11-14. [Shen LP, Qiao XY, Wang P, et al. Clinical observation on Ziyin Qutan Kaiqiao decoction in the treatment of Parkinson, s disease with mild cognitive impairment (syndrome of yin deficiency of liver and kidney)[J]. Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai, 2020, 34(4): 11-14.] DOI: 10.16306/j.1008-861x.2020.04.003.

15.刘照龙, 胡小梅, 王建国, 等. 祛痰通络醒神汤联合多索茶碱片口服治疗伴有轻度认知功能障碍的阻塞性睡眠呼吸暂停低通气综合征患者临床观察[J]. 世界临床药物, 2019, 40(8): 553-559. [Liu ZL, Hu XM, Wang JG, et al. Clinical observation of Qutantongluo Xingshen decoction combined with oral doxofylline tablets in treatment of patients of obstructive sleep apnea hypopnea syndrome with mild cognitive impairment[J]. World Clinical Drugs, 2019, 40(8): 553-559.] DOI: 10.13683/j.wph.2019.08.006.

16.刘扬, 刘春岭. 银杏叶片联合盐酸多奈哌齐对老年轻度认知功能障碍患者的影响[J]. 中国实用神经疾病杂志, 2015, 18(24): 130-131. [Liu Y, Liu CL. Effect of Ginkgo leaf tablets combined with donepezil hydrochloride on elderly patients with mild cognitive impairment[J]. Chinese Journal of Practical Nervous Diseases, 2015, 18(24): 130-131.] DOI: 10.3969/j.issn.1673-5110.2015.24.095.

17.石燕芳, 任胜洪. 益肾化瘀祛痰方治疗轻度认知功能损害的临床疗效及对患者血清氧化应激指标的影响[J]. 河北中医, 2018, 40(5): 658-662. [Shi YF, Ren SH. Clinical efficacy of Yi Shen Hua Yu Qu Tan decoction on mild cognitive impairment and its effect on serum oxidative stress index[J]. Hebei Journal of Traditional Chinese Medicine, 2018, 40(5): 658-662.] DOI: 10.3969/j.issn.1002-2619.2018.05.004.

18.王丽丽, 王丽芳, 韩书进. 养血清脑颗粒联合多奈哌齐对轻度认知功能障碍患者临床疗效观察[J]. 癫痫与神经电生理学杂志, 2018, 27(3 ): 176-177. [Wang LL, Wang LF, Han SJ. Clinical observation on the efficacy of Yangxue Qingnao granules combined with donepezil in patients with mild cognitive impairment[J]. Journal of Epileptology and Electroneurophysiology (CHINA), 2018, 27(3):176-177.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxITbGNzamRzbHh6ejIwMTgwMzAxNBoIbmdtdjl6Ymk%3D.

19.陆征宇, 陆玲丹, 朱冬雨, 等. 补肾填精方治疗髓海不足型帕金森病伴轻度认知功能障碍的临床研究[J]. 中国中西医结合杂志, 2018, 38(5): 539-543. [Lu ZY, Lu LD, Zhu DY, et al. Efficacy of BuShen TianJing decoction for mild cognitive impairment in Parkinson's disease patients with Sui-Hai deficiency[J]. Chinese Journal of Integrated Traditional and Western Medicine, 2018, 38(5): 539-543.] DOI: 10.7661/j.cjim.20180408.158.

20.谢步霓, 林菊珊, 吴强, 等. 补肾祛毒丸治疗脑白质疏松症认知障碍合并慢性肾功能不全疗效观察[J]. 河北中医, 2018, 40(1): 28-32. [Xie BN, Lin JS, Wu Q, et al. Clinical observation of nourishing kidney and removing poison pill on cognitive impairment of leukoaraiosis combined with chronic renal insufficiency[J]. Hebei Journal of Traditional Chinese Medicine, 2018, 40(1): 28-32.] DOI: 10.3969/j.issn.1002-2619.2018.01.007.

21.曹旸, 徐凡叶, 问莉娜, 等. 补益肝肾汤联合美多巴治疗帕金森患者的临床效果及对认知功能的影响[J]. 现代生物医学进展, 2017, 17(32 ): 6308-6311. [Cao Y, Xu FY, Wen LN, et al. Clinical effect of tonify the liver and kidney combined with madopar on the Parkinson's patients and the improvement on cognitive function[J]. Progress in Modern Biomedicine, 2017, 17(32): 6308-6311.] DOI: 10.13241/j.cnki.pmb.2017.32.023.

22.郜风清, 籍玉红, 曹红格, 等. 滋肾祛湿化痰中药治疗老年糖尿病继发血管性轻度认知功能障碍疗效及对氧化应激指标、乙酰胆碱酯酶水平的影响[J]. 现代中西医结合杂志, 2017, 26(30): 3324-3327. [Gao FQ, Ji YH, Cao HG, et al. Effects of Chinese medicine for nourishing kidney, eliminating phlegm and damp on secondary mild vascular cognitive dysfunction in elderly patients with diabetes and the effects on oxidative stress index and acetylcholinesterase[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2017, 26(30): 3324-3327.] DOI: 10.3969/j.issn.1008-8849.2017.30.

23.富宏, 黎巍威, 王华, 等. 补肾活血方治疗2型糖尿病轻度认知功能障碍的临床研究[J]. 中国中西医结合杂志 2017, 37(6): 661-665. [Fu H, Li WW, Wang H, et al. Effect of Bushen Huoxue prescription on the treatment of mild cognition impairment of type 2 diabetes[J]. Chinese Journal of Integrated Traditional and Western Medicine, 2017, 37(6): 661-665.] DOI: 10.7661/j.cjim.20170426.077.

24.杨丽静, 田军彪, 刘学飞, 等. 复方菖蒲益智汤治疗中风后轻度认知功能障碍的临床研究[J]. 南京中医药大学学报, 2017, 33(3): 235-238. [Yang LJ, Tian JB, Liu XF, et al. Clinical research on compound Puchang Yizhi decoction in treating mild cognitive impairment after stroke[J]. Journal of Nanjing University of Traditional Chinese Medicine, 2017, 33(3): 235-238.] DOI: 10.14148/j.issn.1672-0482.2017.0235.

25.肖娟, 王彩娟, 孔祥芳, 等. 复方活脑舒胶囊治疗帕金森病轻度认知功能障碍疗效及对精神状态、认知功能的影响[J]. 现代中西医结合杂志, 2017, 26(19): 2118-2120. [Xiao J, Wang CJ, Kong XF, et al. Efficacy of Compound Huonaoshu capsules in the treatment of mild cognitive impairment in Parkinson's disease and its influence on mental state and cognitive function[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2017, 26(19): 2118-2120.] DOI: 10.3969/j.issn.1008-8849.2017.19.021.

26.狄子晖, 秦雪颖, 王培福, 等. 盐酸多奈哌齐联合银杏叶片治疗老年轻度认知功能障碍临床研究[J]. 辽宁中医药大学学报, 2017, 19(2 ): 160-162. [Di ZH, Qin XY, Wang PF, et al. Clinical study of donepezil hydrochloride combined with Ginkgo biloba extract tablets in treatment of elderly patients with mild cognitive impairment[J]. Journal of Liaoning University of Traditional Chinese Medicine, 2017, 19(2): 160-162.] DOI: 10.13194/j.issn.1673-842x.2017.02.050.

27.于恩彦, 廖峥娈, 谭云飞, 等. 复方海蛇胶囊预防遗忘型轻度认知功能障碍向阿尔茨海默病转化效果的研究[J]. 中华老年医学杂志, 2017, 36(3): 278-281. [Yu EY, Liao ZL, Tan  YF, et al. Preventive effects of Haishe capsules on the conversion of amnestic mild cognitive impairment to Alzheimer's disease[J]. Chinese Journal of Geriatrics, 2017, 36(3): 278-281.] DOI: 10.3760/cma.j.issn.0254-9026.2017.03.013.

28.姬琳, 董宁, 张明庆, 等. 清脑益智颗粒治疗小血管性轻度认知功能障碍的效果及作用机制[J]. 山东医药, 2016, 56(21): 47-49. [Ji L, Dong N, Zhang MQ, et al. Effect and mechanism of Qingnao Yizhi granules in the treatment of small vessel mild cognitive impairment[J]. Shandong Medical Journal, 2016, 56(21): 47-49.] DOI: 10.3969/j.issn.1002-266X.2016.21.018.

29.金香兰, 李涛, 贾蓓, 等. 中医综合干预方案对卒中后轻度认知功能障碍疗效评价[J]. 中华中医药杂志, 2016, 31(6): 2129-2132. [Jin XL, Li T, Jia B, et al. Evaluation of TCM comprehensive intervention on mild post-stroke cognitive impairment[J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2016, 31(6): 2129-2132.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIPemd5eXhiMjAxNjA2MDI2Ggg0eDZicWhhMg%3D%3D.

30.何迎春, 汪小波, 苏蒙. 健脾填精方对轻度认知功能障碍患者血清同型半胱氨酸的影响[J]. 中国中医药科技, 2015, 22(4): 369-370. [He YC, Wang XB, Su M. Effect of Jianpi Tianjing Fang on serum homocysteine of patients with mild cognitive impairment[J]. Chinese Journal of Traditional Medical Science and Technology, 2015, 22(4): 369-370.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIQemd6eXlrajIwMTUwNDAwNhoIOXVoZjZ3am8%3D.

31.刘洋. 银杏叶片联合盐酸多奈哌齐治疗老年轻度认知功能障碍的临床研究[J]. 陕西中医, 2015, 36(3 ): 284-286. [Liu Y. Clinical study on Ginkgo biloba leaves extract tablets combined with donepezil in the treatment of mild cognitive impairment in the elderly[J]. Shaanxi Journal of Traditional Chinese Medicine, 2015, 36(3): 284-286.] DOI: 10.3969/j.issn.1000-7369.2015.03.013.

32.郭明冬, 薛庆辉, 安玉凤. 心脑宁胶囊治疗血管性轻度认知功能障碍的疗效观察[J]. 北京医学, 2015, 37(1): 97-99. [Guo MD, Xue QH, An YF. Curative effect of Xinnaoning capsule-on the treatment of mild vascular cognitive impairment no dementia[J]. Beijing Medical Journal, 2015, 37(1): 97-99.] DOI: 10.15932/j.0253-9713.2015.1.039.

33.赵欢, 郭强, 杨东东, 等. 补肾活血开窍方对糖尿病所致血管性轻度认知功能障碍（肾虚血瘀型）的二级预防研究[J]. 中国实验方剂学杂志, 2014, 20(19): 181-184. [Zhao H, Guo Q, Yang DD, et al. Bushen Huoxue Kaiqiao Fang for diabetes-induced vascular mild cognitive impairment (kidney deficiency and blood stasis) secondary prevention[J]. Chinese Journal of Experimental Traditional Medical Formulae, 2014, 20(19): 181-184.] DOI: 10.13422/j.cnki.syfjx.2014190181.

34.徐素芝, 杨海燕, 田军彪, 等. 强力增智饮治疗卒中后轻度认知功能障碍30例疗效观察[J]. 河北中医, 2014, 36(10): 1455-1457. [Xu SZ, Yang HY, Tian JB, et al. Treatment of mild cognitive funtcion impairment after stroke with Qianglizengzhi drink[J]. Hebei Journal of Traditional Chinese Medicine, 2014, 36(10): 1455-1457.] DOI: 10.3969/j.issn.1002-2619.2014.10.007.

35.赵建军, 刘珺莹, 黎明全, 等. 补肾益髓、活血化痰解毒法治疗血管性轻度认知功能损害临床研究[J]. 长春中医药大学学报, 2012, 28(5): 783-784. [Zhao JJ, Liu JY, Li MQ, et al. Clinical study on the treatment of vascular mild cognitive impairment by the method of tonifying kidney and benefiting marrow, activating blood and resolving phlegm and detoxification[J]. Journal of Changchun University of Traditional Chinese Medicine, 2012, 28(5): 783-784.] DOI: 10.3969/j.issn.1007-4813.2012.05.014.

36.况时祥, 杨辉, 刘琛, 等. 补脑1号治疗老年人轻度认知功能障碍临床观察[J]. 新中医, 2011, 43(8): 31-32. [Kuang SX, Yang H, Liu C, et al. Clinical observation on Bunao No.1 in the treatment of mild cognitive impairment in the elderly[J]. Journal of New Chinese Medicine, 2011, 43(8): 31-32.] DOI: 10.13457/j.cnki.jncm.2011.08.010.

37.肖世源, 张春燕, 李践一, 等. 银杏叶片G（斯泰隆）治疗轻度认知障碍的临床研究[J]. 中成药, 2011, 33(5): 751-754. [Xiao SY, Zhang CY, Li JY, et al. Clinical study on Ginkgo leaf tablets G (Stelon) in the treatment of mild cognitive impairment[J]. Chinese Traditional Patent Medicine, 2011, 33(5): 751-754.] DOI: 10.3969/j.issn.1001-1528.2011.05.006.

38.阚佑骞, 谢吟灵. 九味益智汤治疗中风后轻度认知功能障碍63例[J]. 河南中医, 2010, 30(10): 1001-1002. [Kan YQ, Xie YL. Therapeutic observation on 63 cases of mild cognitive impairment after stroke treated by Jiuwei Yizhi decoction[J]. Henan Traditional Chinese Medicine, 2010, 30(10):1001-1002.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxINaG56eTIwMTAxMDA0MBoIZ2o0Y3JkbGU%3D.

39.李彤, 于月明. 社区老人轻度认知功能障碍早期干预前瞻性研究[J]. 长春中医药大学学报, 2010, 26(4): 508-509. [Li T, Yu YM. Prospective study on early intervention of mild cognitive impairment in community-dwelling elderly[J]. Journal of Changchun University of Traditional Chinese Medicine, 2010, 26(4): 508-509.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIRY2N6eXh5eGIyMDEwMDQwMTMaCHZ6Yjd5azZo.

40.李福海, 王雪红, 刘灵, 等. 自拟升清益智汤治疗气虚痰阻型脑梗死后轻度血管性认知功能损害的效果[J]. 中国医药导报, 2022, 19(33): 116-119. [Li FH, Wang XH, Liu L, et al. Efficacy of self-made Shengqing Yizhi decoction in the treatment of mild vascular cognitive impairment after cerebral infarction with qi deficiency and phlegm obstruction syndrome[J]. China Medical Herald, 2022, 19(33): 116-119.] DOI: 10.20047/j.issn1673-7210.2022.33.26.

41.周建华, 杜红. 补肾活血复方治疗帕金森病轻度认知功能障碍疗效及对血浆磷脂的影响[J]. 现代中西医结合杂志, 2021, 30(3): 297-300. [Zhou JH, Du H. Efficacy of Bushen Huoxue compound in the treatment of mild cognitive impairment in Parkinson's disease and its influence on plasma phospholipids[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2021, 30(3): 297-300.] DOI: 10.3969/j.issn.1008-8849.2021.03.016.

42.周如倩, 林水淼, 袁泉. 参银口服液治疗轻度认知功能损害的临床研究[J]. 中国中西医结合杂志 2007, 27(9): 793-795. [Zhou RQ, Lin SM, Yuan Q. Clinical study on effect of Shenyin Oral liquid in treating mild cognitive impairment[J]. Chinese Journal of Integrated Traditional and Western Medicine, 2007, 27(9): 793-795.] DOI: 10.3321/j.issn:1003-5370.2007.09.008.

43.田金洲, 朱爱华, 钟剑. 金思维治疗社区轻度认知损害老年患者记忆减退症状的1年随访[J]. 中国中药杂志 2003, 28(10): 987-991. [Tian JZ, Zhu AH, Zhong J. A follow-up study on a randomized, single-blind control of King's Brain pills in treatment of memory disorder in elderly people with MCI in a Beijing community[J]. China Journal of Chinese Materia Medica, 2003, 28(10):987-991.] DOI: 10.3321/j.issn:1001-5302.2003.10.031.

44.钟剑, 朱爱华, 杨承芝, 等. 参乌胶囊治疗老年轻度认知损害临床对照研究[J]. 中国中药杂志, 2007, 32(17): 1800-1803. [Zhong J, Zhu AH, Yang CZ, et al. Clinical study on a randomized, double-blind control of Shenwu gelatin capsule in treatment of mild cognitive impairment[J]. China Journal of Chinese Materia Medica, 2007, 32(17): 1800-1803.] DOI: 10.3321/j.issn:1001-5302.2007.17.023.

45.沈英, 黄小波. 水火既济组方治疗卒中后轻度认知功能障碍临床研究[J]. 河北中医药学报 2019, 34(2): 14-17. [Shen  Y, Huang  XB. Clinical study of Shuihuo Jiji formula in the treatment of mild cognitive impairment after stroke[J]. Journal of Hebei Traditional Chinese Medicine and Pharmacology, 2019, 34(2): 14-17.] https://www.cnki.com.cn/Article/CJFDTOTAL-HZYX201902004.htm.

46.罗玮, 刘玲. 加味涤痰汤治疗缺血性脑卒中后轻度认知障碍临床观察[J]. 陕西中医, 2016, 37(2): 149-150, 154. [Luo  W, Liu L. Clinical observation of mild cognitive impairment after ischemic stroke treatment efficacy flavored ditan decoction[J]. Shaanxi Journal of Traditional Chinese Medicine, 2016, 37(2): 149-150, 154.] DOI: 10.3969/j.issn.1000-7369.2016.02.007.

47.高磊, 张宪忠, 刘相静, 等. 复方苁蓉益智胶囊治疗中风后轻度认知障碍的临床研究[J]. 世界中西医结合杂志, 2015, 10(1): 65-68, 71. [Gao L, Zhang XZ, Liu XJ, et al. Clinical research of mild cognitive impairment after stroke treated with Fufang Congrong Yizhi capsules[J]. World Journal of Integrated Traditional and Western Medicine, 2015, 10(1): 65-68, 71.] DOI: 10.13935/j.cnki.sjzx.150101.

48.韩自力. 银杏叶片治疗轻度认知障碍的临床疗效观察[J]. 实用心脑肺血管病杂志, 2016, 24(1): 91-94. [Han ZL. Clinical effect of Ginkgo biloba tablet on mild cognitive impairment[J]. Practical Journal of Cardiac Cerebral Pneumal and Vascular Diseases, 2016, 24(1): 91-94.] DOI: 10.3969/j.issn.1008-5971.2016.01.027.  

49.沈婷, 黄宁静, 顾超. 辨证分型治疗遗忘型轻度认知损害患者临床疗效研究[J]. 时珍国医国药, 2021, 32(2): 362-365. [Shen T, Huang NJ, Gu C. Clinical efficacy study on syndrome differentiation-based treatment of patients with amnestic mild cognitive impairment[J]. Lishizhen Medicine and Materia Medica Research, 2021, 32(2): 362-365.] DOI: 10.3969/j.issn.1008-0805.2021.02.31.

50.吴正治, 钟琪, 孙苏萍, 等. 天泰1号治疗轻度认知障碍前瞻性多中心随机双盲对照临床研究[J]. 中国中西医结合杂志, 2010, 30(3): 255-258. [Wu ZZ, Zhong Q, Sun SP, et al. A prospective multicenter randomized double-blinded controlled clinical trial on effects of Tiantai No.1 in treating mild cognitive impairment[J]. Chinese Journal of Integrated Traditional and Western Medicine, 2010, 30(3): 255-258.] https://www.cnki.com.cn/Article/CJFDTOTAL-ZZXJ201003006.htm.

51.董振华, 张春燕, 蒲斌红, 等. 银杏叶片对轻度认知障碍患者认知功能的影响[J]. 中国中西医结合杂志, 2012, 32(9): 1208-1211. [Dong ZH, Zhang CY, Pu BH, et al. Effects of Ginkgo biloba tablet in treating mild cognitive impairment[J]. Chinese Journal of Integrated Traditional and Western Medicine, 2012, 32(9): 1208-1211.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIOenh5amgyMDEyMDkwMTIaCHJtdGVocWp1.

52.李乐军, 李玉梅, 杨崇河. 参乌颗粒治疗遗忘型轻度认知损害患者随机双盲对照临床研究[J]. 中国中医基础医学杂志, 2016, 22(5): 655-657. [Li LJ, Li YM, Yang CH. Treatment of patients with mild cognitive impairment by Shenwu granules—a randomized double blind controlled clinical study[J]. Chinese Journal of Basic Medicine in Traditional Chinese Medicine, 2016, 22(5): 655-657.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIRemd6eWpjeXgyMDE2MDUwMjcaCDllNnlvYWF1

53.代建峰, 戚观树, 侯群, 等. 益智健脑颗粒提高轻度认知障碍患者智能水平的研究[J]. 中国中医药科技, 2011, 18(2): 136-137. [Dai JF, Qi GS, Hou Q, et al. Clinical study on enhancing effect of Yizhi Jiannao granule on intellect level of patients with mild cognitive impairment[J]. Chinese Journal of Traditional Medical Science and Technology, 2011, 18(2): 136-137.] DOI: 10.3969/j.issn.1005-7072.2011.02.033.

54.刘芳, 杨琦, 王根发, 等. 养血清脑颗粒治疗老年高血压患者合并轻度血管性认知障碍的疗效观察[J]. 世界中医药, 2010, 5(3): 160-161. [Liu F, Yang Q, Wang GF, et al. The efficacy of Yangxue Qingnao granule for mild vascular cognitive impairment in senile patients with hypertension[J]. World Chinese Medicine, 2010, 5(3): 160-161.] DOI: 10.3969/j.issn.1673-7202.2010.03.004.

55.张春燕, 刘吟枫, 李亚明. 培元益智方治疗轻度认知障碍的临床研究[J]. 老年医学与保健, 2010, 16(3): 181-183. [Zhang CY, Liu  YF, Li YM. Clinical study on effect of Pei Yuan Yi Zhi prescription on mild cognitive impairment[J]. Geriatrics & Health Care, 2010, 16(3): 181-183.] DOI: 10.3969/j.issn.1008-8296.2010.03.17.

56.顾超, 安红梅, 袁灿兴, 等. 地黄益智颗粒干预遗忘型轻度认知损害向痴呆转化的临床研究[J]. 上海中医药大学学报, 2020, 34(4): 7-10, 20. [Gu C, An HM, Yuan CX, et al. Clinical study of Dihuang Yizhi granule on the conversion from amnestic mild cognitive impairment to dementia[J]. Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai, 2020, 34(4): 7-10, 20.] DOI: 10.16306/j.1008-861x.2020.04.002.

57.赵鑫, 王珊珊, 赵楠楠 等. 补肾益髓汤联合针刺对脑梗死后轻度认知障碍认知功能改善、脑血流动力学及脑红蛋白水平影响[J]. 辽宁中医药大学学报, 2022, 24(2): 140-144. [Zhao X, Wang SS, Zhao NN, et al. Effects of Bushen Yishui decoction combined with acupuncture on improvement of cognitive function, cerebral hemodynamics, level of encephaloglobin and microcirculation of mild cognitive impairment after cerebral infarction[J]. Journal of Liaoning University of Traditional Chinese Medicine, 2022, 24(2): 140-144.] DOI: 10.13194/j.issn.1673-842x.2022.02.031.

58.刘学飞, 万溪, 徐丽娟, 等. 血管源性轻度认知障碍社区筛查情况及中医药干预研究[J]. 中华中医药杂志, 2017, 32(7): 3313-3316. [Liu XF, Wan X, Xu LJ, et al. Study on community screening of vascular mild cognitive impairment and intervention by traditional Chinese medicine[J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2017, 32(7): 3313-3316.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIPemd5eXhiMjAxNzA3MTI3Ggh4eGVwZ3RjMQ%3D%3D.

59.李乐军, 邵凤扬, 宋斐, 等. 通脉益智丸治疗遗忘型轻度认知损害患者疗效分析[J]. 中华中医药杂志 2010, 25(4): 591-594. [Li LJ, Shao FY, Song F, et al. Clinical study on effect of Tongmai Yizhi pills on patients with mild cognitive impairment-amnestic[J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2010, 25(4): 591-594.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxIPemd5eXhiMjAxMDA0MDMyGghsNHoyNmZxbQ%3D%3D.

60.朱黎明. 眩晕宁治疗老年轻度认知障碍痰浊阻窍证的临床观察[J]. 中国医药导刊, 2010, 12(12): 2107-2109. [Zhu LM. Clinical effect of Xuanyunning tablet in treating senile patients with mild cognitive impairment of turbid-phlegm blocking orifice syndrome[J]. Chinese Journal of Medical Guide, 2010, 12(12): 2107-2109.] DOI: 10.3969/j.issn.1009-0959.2010.12.052.

61.黄海燕, 钱小雷, 任丽红. 益智健脑颗粒治疗轻度认知功能损害临床研究[J]. 山东中医杂志, 2015, 34(5): 343-345. [Huang  HY, Qian XL, Ren LH. Clinical study on Yizhi Jiannao granules in the treatment of mild cognitive impairment[J]. Shandong Journal of Traditional Chinese Medicine, 2015, 34(5): 343-345.] https://www.cnki.com.cn/Article/CJFDTOTAL-SDZY201505008.htm.

62.赵擘, 胡小梅, 王建国, 等. 自拟祛痰通络醒神汤治疗阻塞性睡眠呼吸暂停低通气综合征患者合并轻度认知功能障碍的临床效果研究[J]. 世界临床药物, 2020, 41(2): 123-127. [Zhao B, Hu XM, Wang JG, et al. Clinical effects of self-made Qutan Tongluo Xingshen decoction on patients with obstructive sleep apnea hypopnea syndrome complicated with mild cognitive impairment[J]. World Clinical Drugs, 2020, 41(2): 123-127.] DOI: 10.13683/j.wph.2020.02.009.

63.戢运建, 况娥. 活血化痰方治疗血管性轻度认知障碍临床研究 [J]. 中医学报, 2017, 32(7): 1265-1268. [Ji YJ, Kuang  E. Clinical study on treatment of mild vascular cognitive impairment with Huoxue Huatan decoction[J]. China Journal of Chinese Medicine, 2017, 32(7): 1265 - 1268.] DOI: 10.16368/j.issn.1674-8999.2017.07.333.

64.张允岭, 高芳, 陈志刚, 等. 中医综合干预对脑白质疏松轻度认知障碍患者认知功能、日常生活能力及周边症状的影响[J]. 中医杂志, 2010, 51(9): 793-796. [Zhang YL, Gao F, Chen ZG, et al. Effect of TCM comprehensive intervention on the mild cognitive impairment caused by leukoaraiosis[J]. Journal of Traditional Chinese Medicine, 2010, 51(9): 793-796.] DOI: 10.13288/j.11-2166/r.2010.09.009.

65.张艳霞, 张允岭, 金香兰, 等. 中医综合干预方案治疗脑白质疏松轻度认知障碍疗效评价研究[J]. 辽宁中医杂志, 2014, 41(11): 2286-2288. [Zhang YX, Zhang YL, Jin XL, et al. Efficacy evaluation study of comprehensive traditional Chinese medicine intervention program in the treatment of mild cognitive impairment due to leukoaraiosis[J]. Liaoning Journal of Traditional Chinese Medicine, 2014, 41(11): 2286-2288.] DOI: 10.13192/j.issn.1000-1719.2014.11.006.

66.石敏, 张淑青, 孙凡. 益智煎治疗脾肾两虚型轻度认知功能障碍35例[J]. 山东中医杂志, 2015, 34(3): 173-175. [Shi  M, Zhang SQ, Sun F. Mild cognitive impairment patients with deficiency of spleen and kidney syndrome treated by Yizhijian: 35 cases report[J]. Shandong Journal of Traditional Chinese Medicine, 2015, 34(3): 173-175.] DOI: 10.16295/j.cnki.0257-358x.2015.03.006.

67.顾超, 沈婷, 梅国江, 等. 地黄益智方治疗遗忘型轻度认知损害（肾精亏虚兼痰瘀阻络证）临床观察[J]. 四川中医, 2015, 33(9): 67-73. [Gu C, Shen T, Mei GJ, et al. Clinical observation of using Dihuang Yizhi formula to treat amnestic mild Cognitive Impairment[J]. Journal of Sichuan of Traditional Chinese Medicine, 2015, 33(9): 67-73.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxINc2N6eTIwMTUwOTAzMBoIOXhpenliZG4%3D.

68.陈炜, 黄庆嘉, 蒋凌飞, 等. 壮医五桃土参方对老年轻度认知障碍患者的影响[J]. 河南中医, 2018, 38(4): 568-570. [Chen W, Huang QJ, Jiang LF, et al. The influence of Wutao Tushen decoction of Zhuang medicine on the elderly with mild cognitive impairment[J]. Henan Traditional Chinese Medicine, 2018, 38(4): 568-570.] DOI: 10.16367/j.issn.1003-5028.2018.04.0151.

69.叶青, 张红智, 蔡定芳, 等. 益智平颤方治疗帕金森病合并轻度认知障碍疗效观察[J]. 上海中医药杂志, 2016, 50(7): 47-49, 62. [Ye Q, Zhang HZ, Cai DF, et al. Clinical observation of Yi Zhi Ping Chan granule on Parkinson's disease combined with mild cognitive impairment[J]. Shanghai Journal of Traditional Chinese Medicine, 2016, 50(7): 47-49, 62.] DOI: 10.16305/j.1007-1334.2016.07.014.

70.郑恩香, 王宣涛, 周素芹. 银丹心脑通软胶囊联合茴拉西坦治疗老年轻度认知障碍痰瘀交阻证的研究[J]. 中医药导报 2014, 20(6): 46-49. [Zheng EX, Wang XT, Zhou SQ. Clinical study of Yindanxinnaotong soft capsule combined with aniracetam on elder mild cognitive impairment with phlegm and blood stasis into resistance syndrome[J]. Guiding Journal of Traditional Chinese Medicine and Pharmacology, 2014, 20(6): 46-49.] DOI: 10.13862/j.cnki.cn43-1446/r.2014.06.016.

71.王安安, 李文娟, 黄文琦, 等. 清灵方联合盐酸多奈哌齐治疗卒中后认知功能障碍的临床研究[J]. 安徽医药, 2022, 26(12): 2524-2528. [Wang AA, Li WJ, Huang WQ, et al. Clinical research of Qingling granule combined with donepezil hydrochloride in the treatment of cognitive dysfunction after stroke[J]. Anhui Medical and Pharmaceutical Journal, 2022, 26(12): 2524-2528.] DOI: 10.3969/j.issn.1009-6469.2022.12.042.

72.崔格, 谭支文. 自拟益智通窍汤对大面积脑梗塞后认知功能障碍患者神经功能、认知功能及生活自理能力的影响观察 [J]. 四川中医, 2021, 39(10): 132-135. [Cui G, Tan ZW. Effective observation of self-made Yizhi Tongqiao decoction on neurological function, cognitive function and self-care ability for patients with cognitive impairment after large-area cerebral infarction[J]. Journal of Sichuan of Traditional Chinese Medicine, 2021, 39(10): 132-135.] https://d.wanfangdata.com.cn/periodical/CiBQZXJpb2RpY2FsQ0hJU29scjkyMDI2MDMwNjE2NTI1NxINc2N6eTIwMjExMDAzORoIMjdwYzYxM2Q%3D.

73.梁兴伦, 朱敏洁, 李琛, 等. 从胰岛素抵抗角度探讨化瘀解毒法治疗轻度认知功能障碍的临床疗效研究[J]. 中国全科医学, 2017, 20(13): 1642-1647. [Liang XL, Zhu MJ, Li C, et al. Clinical effect of dissolving blood stasis and detoxication on patients with mild cognitive impairment on the basis of insulin resistance[J]. Chinese General Practice, 2017, 20(13): 1642-1647.] DOI: 10.3969/j.issn.1007-9572.2017.13.022.

74.杨丽静, 田军彪, 刘学飞, 等. 复方菖蒲益智汤联合尼莫地平治疗中风后轻度认知功能障碍的临床研究[J]. 中国药房, 2017, 28(14): 1938-1941. [Yang LJ, Tian JB, Liu XF, et al. Clinical research of compound Changpu Yizhi decoction combined with nimodipine in the treatment of mild cognitive impairment after stroke[J]. China Pharmacy, 2017, 28(14): 1938-1941.] DOI: 10.6039/j.issn.1001-0408.2017.14.18.

75.张允岭, 李涛, 金香兰, 等. 脑卒中后轻度认知障碍中医综合干预远期临床疗效评价[J]. 北京中医药 2015, 34(7): 507-512. [Zhang YL, Li T, Jin XL, et al. Evaluation on the long-term clinical efficacy of TCM comprehensive intervention on mild post-stroke cognitive impairment[J]. Beijing Journal of Traditional Chinese Medicine, 2015, 34(7): 507-512.] DOI: 10.16025/j.1674-1307.2015.07.001.

76.石燕芳, 伉奕, 张瑞娟. 益气聪明汤对轻度认知障碍患者NSE、ET-1、SOD及脑血流动力学的影响[J]. 中国老年学杂志, 2023, 43(6): 1292-1296. [Shi YF, Kang Y, Zhang RJ. Effects of Yiqi Congming decoction on NSE, ET-1, SOD and cerebral hemodynamics in patients with mild cognitive impairment[J]. Chinese Journal of Gerontology, 2023, 43(6): 1292-1296.] DOI: 10.3969/j.issn.1005-9202.2023.06.004.

77.曹玲, 闫卫红, 丁智斌, 等. 复方活脑舒胶囊联合多奈哌齐对帕金森病轻度认知功能障碍患者认知功能和血清脑神经递质的影响[J]. 现代生物医学进展, 2024, 24(8): 1482-1485, 1529. [Cao L, Yan WH, Ding ZB, et al. Effect of compound Huonaoshu capsule combined with donepezil on cognitive function and serum brain neurotransmitters in patients with mild cognitive impairment of Parkinson's disease[J]. Progress in Modern Biomedicine, 2024, 24(8): 1482-1485, 1529.] DOI: 10.13241/j.cnki.pmb.2024.08.015.

78.龙华君, 张慧, 桑艳, 等. 柔肝醒神汤治疗卒中后轻度认知障碍肾虚痰瘀证患者的临床观察[J]. 时珍国医国药, 2025, 36(10): 1906-1910. [Long HJ, Zhang H, Sang Y, et al. Clinical observation of Rougan Xingshen decoction in the treatment of post-stroke mild cognitive impairment with kidney deficiency and phlegm-stasis syndrome[J]. Lishizhen Medicine and Materia Medica Research, 2025, 36(10): 1906-1910.] DOI: 10.70976/j.1008-0805.SZGYGY-2025-1016.

79.吴冬月, 焦睿珉, 刘路遥, 等. 补肾健脾化痰方治疗遗忘型轻度认知损害的随机双盲对照研究[J]. 临床和实验医学杂志, 2025, 24(11): 1159-1162. [Wu DY, Jiao RM, Liu LY, et al. Randomized double-blind controlled study of Bushen Jianpi Huatan prescription in the treatment of amnestic mild cognitive impairment[J]. Journal of Clinical and Experimental Medicine, 2025, 24(11): 1159-1162.] DOI: 10.3969/j.issn.1671-4695.2025.11.010.

80.周子钦, 戴隆华, 符加荣, 等. 复方通络饮治疗皮质下缺血性血管性轻度认知障碍肝肾亏虚、痰瘀阻络证的随机对照试验 [J]. 中医杂志, 2025, 66(19): 2023-2029. [Zhou ZQ, Dai LH, Fu JR, et al. Randomized controlled trial of compound Tongluo decoction in treating subcortical ischemic vascular mild cognitive impairment with liver and kidney deficiency and phlegm-stasis blocking collaterals syndrome[J]. Journal of Traditional Chinese Medicine, 2025, 66(19): 2023-2029.] DOI: 10.13288/j.11-2166/r.2025.19.010.

81.Gu C, Shen T, An H, et al. Clinical therapy of Di-Huang-Yi-Zhi in treating patients with amnestic mild cognitive impairment: a prospective, open-label and randomized study[J]. Int J Clin Exp Med, 2017, 10(2): 3554-3560. https://www.ijcem.com/files/ijcem0045590.pdf.

82.Tian J, Shi J, Wei M, et al. Chinese herbal medicine Qinggongshoutao for the treatment of amnestic mild cognitive impairment: a 52-week randomized controlled trial[J]. Alzheimers Dement (N Y), 2019, 5: 441-449. DOI: 10.1016/j.trci.2019.03.001.

83.Zhang J, Liu Z, Zhang H, et al. A two-year treatment of amnestic mild cognitive impairment using a compound Chinese medicine: a placebo controlled randomized trial[J]. Sci Rep, 2016, 6: 28982. DOI: 10.1038/srep28982.

84.Pakdaman H, Harandi AA, Abbasi M, et al. Efficacy and safety of MLC601 in the treatment of mild cognitive impairment: a pilot, randomized, double-blind, placebo-controlled study[J]. Dement Geriatr Cogn Dis Extra, 2017, 7(1): 136-142. DOI: 10.1159/000458521.

85.Tian J, Shi J, Li T, et al. Efficacy and safety of an herbal therapy in patients with amnestic mild cognitive impairment: a 24-week randomized phase III trial[J]. Evid Based Complement Alternat Med, 2017, 2017: 4251747. DOI: 10.1155/2017/4251747.

86.Liu L, Zhang CS, Zhang AL, et al. The efficacy and safety of Chinese herbal medicine for mild cognitive impairment: a systematic review and Meta-analysis of randomized placebo-controlled trials[J]. Front Pharmacol, 2024, 15: 1341074. DOI: 10.3389/fphar.2024.1341074.

87.Liu L, Zhang CS, Zhang AL, et al. Oral Chinese herbal medicine combined with donepezil for mild cognitive impairment: a systematic review and Meta-analysis[J]. J Am Geriatr Soc, 2024, 72(12): 3890-3902. DOI: 10.1111/jgs.19125.

88.Dong L, May BH, Feng M, et al. Chinese herbal medicine for mild cognitive impairment: a systematic review and Meta-analysis of cognitive outcomes[J]. Phytother Res, 2016, 30(10): 1592-1604. DOI: 10.1002/ptr.5679.

89.van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer's disease[J]. N Engl J Med, 2023, 388(1): 9-21. DOI: 10.1056/NEJMoa2212948.

90.Sims JR, Zimmer JA, Evans CD, et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial[J]. JAMA, 2023, 330(6): 512-527. DOI: 10.1001/jama.2023.13239.

91.Petersen RC, Lopez O, Armstrong MJ, et al. Practice guideline update summary: mild cognitive impairment [RETIRED]: report of the guideline development, dissemination, and implementation subcommittee of the american academy of neurology[J]. Neurology, 2018, 90(3): 126-135. DOI: 10.1212/wnl.0000000000004826.

92.Birks J, Flicker L. Donepezil for mild cognitive impairment[J]. Cochrane Database Syst Rev, 2006, 2006(3): Cd006104. DOI: 10.1002/14651858.Cd006104.

93.代景妍, 张杰, 陈瑞丹，等. 轻度认知障碍中西医干预进展 [J]. 中国中医基础医学杂志, 2021, 27(4): 678-682. [Dai  JY, Zhang J, Chen RD, et al. Progress of Chinese and western medicine intervention for mild cognitive impairment[J]. Chinese Journal of Basic Medicine in Traditional Chinese Medicine, 2021, 27(4): 678-682.] https://www.cnki.com.cn/Article/CJFDTOTAL-ZYJC202104039.htm.