中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2022, Vol. 17 ›› Issue (7): 1582-1587.doi: 10.4103/1673-5374.330618

• 原著:脑损伤修复保护与再生 • 上一篇    下一篇

枸杞多糖干预青少年阈下抑郁：随机对照试验的中期结果分析

  

  • 出版日期:2022-07-15 发布日期:2022-01-18
  • 基金资助:
    国家自然科学基金项目（81671347）；广州市科学技术计划项目（202007030012）

Efficacy of Lycium barbarum polysaccharide in adolescents with subthreshold depression: interim analysis of a randomized controlled study

Xiaoyue Li1, 2, #, Xuan Mo3, #, Tao Liu1, 2, Robin Shao1, Kayla Teopiz4, 5, Roger S. McIntyre5, 6, 7, Kwok-Fai So1, 8, 9, *, Kangguang Lin1, 2, 9, *   

  1. 1Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, Guangdong Province, China; 2Laboratory of Emotion and Cognition, The Affiliated Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, Guangdong Province, China; 3Department of Psychiatry, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong Province, China; 4Canadian Rapid Treatment Center of Excellence, Mississauga, ON, Canada; 5Mood Disorders Psychopharmacology Unit, Poul Hansen Family Centre for Depression, University, Health Network, Toronto, ON, Canada; 6Department of Psychiatry, University of Toronto, Toronto, ON, Canada; 7Brain and Cognition Discovery Foundation, Toronto, ON, Canada; 8Ministry of Education Joint International Research Laboratory of CNS Regeneration, Jinan University, Guangzhou, Guangdong Province, China; 9Neuroscience and Neurorehabilitation Institute, University of Health and Rehabilitation Sciences, Qingdao, Shandong Province, China
  • Online:2022-07-15 Published:2022-01-18
  • Contact: Kangguang Lin, MD, PhD, linkangguang@163.com; Kwok-Fai So, PhD, hrmaskf@hku.hk.
  • Supported by:
    This study was financially supported by the National Natural Science Foundation of China, No. 81671347 (to KL); and The Science and Technology Program of Guangzhou, China, No. 202007030012 (to KFS and KL).

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摘要：

阈下抑郁是青少年发展成重度抑郁高风险的综合征。从中药枸杞中提取的枸杞多糖已在神经和精神疾病的临床前模型中展示出抗氧化和抗炎特性等潜在的抗抑郁作用。然而，枸杞多糖对阈下抑郁的影响尚不清楚。为检验枸杞多糖对阈下抑郁青少年的临床疗效及安全性，此次随机、双盲、安慰剂对照试验在广州医科大学第五附属医院招募了阈下抑郁青少年29名，参与者符合条件并随机分配到枸杞多糖组（n=15，3男12女，年龄15.13±2.17岁）或安慰剂组（n=14，2男12女，年龄15±1.71岁），随机接受每天300mg的枸杞多糖或安慰剂，连续治疗6周。中期分析结果显示，与安慰剂组相比，接受枸杞多糖干预的受试者在第6周时汉密尔顿抑郁量表24项总分下降幅度更大，缓解率（汉密尔顿抑郁量表24项总分≤7）更高。两组以贝克抑郁量表、匹兹堡睡眠质量指数、凯斯勒心理困扰量表和儿童焦虑性情绪障碍筛查量表评分接近，且均未报告与干预相关的不良事件。结果提示，枸杞多糖可减轻青少年阈下抑郁症状，且耐受性良好，无不良事件。研究仍在收集更多数据，继续评估枸杞多糖的抗抑郁作用，以便得出最终的分析结果。试验于2019年4月3日经广州医科大学附属第五医院医学伦理委员会批准（批准号L2019-09），并于2019年7月25日在ClinicalTrials.gov注册（注册号NCT04032795)。

https://orcid.org/0000-0003-4027-5554 (Kangguang Lin); https://orcid.org/0000-0003-4039-4246 (Kwok-Fai So)

关键词: 阈下抑郁, 枸杞, 枸杞多糖, 青少年, 疗效, 安全性, 耐受性, 随机对照临床试验

Abstract: Subthreshold depression is a highly prevalent condition in adolescents who are at high risk for developing major depressive disorder. In preclinical models of neurological and psychiatric diseases, Lycium barbarum polysaccharide (LBP) extracted from Goji berries had anti-depressant effects including but not limited to anti-oxidative and anti-inflammatory properties. However, the effect of LBP on subthreshold depression is unclear. To investigate the clinical efficacy and safety of LBP for treating subthreshold depression in adolescents, we conducted a randomized, double-blind, placebo-controlled trial (RCT) with 29 adolescents with subthreshold depression recruited at The Fifth Affiliated Hospital of Guangzhou Medical University. The participants were randomly assigned to groups where they received either 300 mg LBP (LBP group, n = 15, 3 boys and 12 girls aged 15.13 ± 2.17 years) or a placebo (placebo group, n = 14, 2 boys and 12 girls aged 15 ± 1.71 years) for 6 successive weeks. Interim analyses revealed that the LBP group exhibited a greater change in Hamilton Depression Scale (HAMD-24) scores relative to the baseline and a higher remission rate (HAMD-24 total score ≤ 7) at 6 weeks compared with the placebo group. Scores on the Beck Depression Inventory-II (BDI-II), Pittsburgh Sleep Quality Index (PSQI), Kessler Psychological Distress Scale (Kessler), and Screen for Child Anxiety-Related Emotional Disorders (SCARED) were similar between the LBP and placebo groups. No side effects related to the intervention were reported in either group. These results indicate that LBP administration reduced depressive symptoms in adolescents with subthreshold depression. Furthermore, LBP was well tolerated with no treatment-limiting adverse events. Clinical trials involving a larger sample size are needed to further confirm the anti-depressive effects of LBP in adolescents with subthreshold depression. This study was approved by the Medical Ethics Committee of the Fifth Affiliated Hospital of Guangzhou Medical University (Guangzhou, China; approval No. L2019-08) on April 4, 2019 and was registered on ClinicalTrials.gov (identifier: NCT04032795) on July 25, 2019.

Key words: adolescents, efficacy, Goji berry, Lycium barbarum polysaccharide, randomized clinical trial, safety, subthreshold depression, tolerance