Clinical Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.
PLoS One. 2024 Aug 28;19(8):e0303162. doi: 10.1371/journal.pone.0303162. eCollection 2024.
Post-stroke depression (PSD) is an emotional disease characterized by loss of interest and depression after a stroke. Acupuncture, one of the most critical non-drug therapies for the treatment of PSD, has significant clinical efficacy, but the mechanism is not fully understood. Previous study has shown that acupuncture can reduce the level of proinflammatory cytokines and increase the level of anti-inflammatory cytokines, suggesting that regulating the dynamic balance of inflammatory cytokines may be the basis for acupuncture to improve PSD symptoms.
A total of 84 patients with PSD will be recruited and randomly assigned to one of two groups at a 1:1 ratio. Based on the conventional stroke treatment, the control group will receive XingnaoKaiqiao (XNKQ) acupuncture, and the experimental group will receive antidepressant acupuncture at the same time as XNKQ acupuncture. The intervention will last four weeks, and data will be collected before and after treatment. The Hamilton depression scale (HAMD-17) is the primary outcome measure, and the secondary outcome measures include the Self-rating Depression Scale (SDS), the National Institute of Health stroke scale (NIHSS), and the Modified Barthel Index (MBI). Serum IL-1β, IL-4, 5-HT, and BDNF will be used as laboratory indicators. The scales will be assessed at baseline, two weeks, and four weeks, and serum items will be measured at baseline and four weeks after treatment. This study will observe the clinical effect of acupuncture on PSD and the changes in serum-related inflammatory cytokines and explore the possible mechanism of acupuncture against depression from the perspective of inflammatory response.
This study protocol was approved by the Medical Ethics Committee of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (item number: TYLL2023[Z]004). Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
中风后抑郁（PSD）是一种情感疾病，表现为中风后失去兴趣和抑郁。针刺作为治疗 PSD 的最重要的非药物疗法之一，具有显著的临床疗效，但机制尚不完全清楚。既往研究表明，针刺可以降低促炎细胞因子水平，增加抗炎细胞因子水平，提示调节炎症细胞因子的动态平衡可能是针刺改善 PSD 症状的基础。
将招募 84 例 PSD 患者，按照 1:1 的比例随机分为两组。在常规中风治疗的基础上，对照组给予醒脑开窍针刺，实验组同时给予醒脑开窍针刺和抗抑郁针刺。干预持续四周，在治疗前后采集数据。汉密尔顿抑郁量表（HAMD-17）是主要结局指标，次要结局指标包括自评抑郁量表（SDS）、国立卫生研究院中风量表（NIHSS）和改良巴氏指数（MBI）。血清 IL-1β、IL-4、5-HT 和 BDNF 将作为实验室指标。在基线、治疗 2 周和 4 周时进行量表评估，在治疗 4 周后测量血清项目。本研究将观察针刺治疗 PSD 的临床疗效及血清相关炎症细胞因子的变化，并从炎症反应的角度探讨针刺抗抑郁的可能机制。
本研究方案已获得天津中医药大学第一附属医院医学伦理委员会的批准（编号：TYLL2023[Z]004）。试验结果将通过同行评议的期刊和科学会议进行传播。
