Pu Lidan, Liu Xuefei, Fang Chaoyi, Su Zhiwei, Sheng Shiyun, Yang Haolei
Department of Encephalopathy II, Hebei Provincial Hospital of Traditional Chinese Medicine, 050000 Shijiazhuang, Hebei, China.
Traditional Chinese Medicine Diagnosis Teaching and Research Office, Hebei Provincial Hospital of Traditional Chinese Medicine, 050000 Shijiazhuang, Hebei, China.
Actas Esp Psiquiatr. 2025 May;53(3):535-545. doi: 10.62641/aep.v53i3.1809.
Current research on An Shen Jiao Tai Yi Zhi decoction remains limited, highlighting the need for further investigation to validate its therapeutic efficacy and elucidate its underlying mechanisms of action. A study was conducted to evaluate the effects of An Shen Jiao Tai Yi Zhi decoction on sleep disorders in patients with Parkinson's disease.
The study population comprised 85 patients diagnosed with Parkinson's disease and sleep disorders at the Department of Encephalopathy of Hebei Provincial Hospital of Traditional Chinese Medicine, between January 2021 and December 2023. In accordance with different treatment methods, they were divided into the Western medicine group (n = 45, conventional Western medicine treatment plus pramipexole hydrochloride) and the traditional Chinese medicine group (n = 40, An Shen Jiao Tai Yi Zhi decoction based on the Western medicine group). To minimize selection bias, propensity score matching (PSM) was employed with a 1:1 ratio, yielding 20 cases in the traditional Chinese medicine group and 20 cases in the Western medicine group. Clinical data, total effective rates, Epworth Sleepiness Scale (ESS) scores, sleep architecture parameters, homocysteine levels, interleukin-1β concentration, and adverse reactions were collected for all participants. Baseline characteristics were balanced between the two groups through PSM. The data were analyzed using t-test, chi-square test, and analysis of variance.
PSM matching was performed in a ratio of 1:1, and a total of 40 patients were divided into two groups. No significant differences in clinical characteristics were observed between the groups. The total effective rate of the traditional Chinese medicine group was higher than that of the Western medicine group (p < 0.05). Before the intervention, no differences in ESS score, sleep architecture, and related factors were found among the two groups (p > 0.05). After 14 days of intervention, the traditional Chinese medicine group exhibited significantly greater improvements across all measured indicators compared to the Western medicine group (p < 0.05). Notably, there were no significant differences in the incidence of adverse reactions between the two groups (p > 0.05).
An Shen Jiao Tai Yi Zhi decoction demonstrates significant therapeutic efficacy, exhibiting anti-inflammatory properties and promoting changes in sleep architecture, with minimal adverse effects.
目前关于安神交泰益智汤的研究仍然有限,这凸显了进一步研究以验证其治疗效果并阐明其潜在作用机制的必要性。本研究旨在评估安神交泰益智汤对帕金森病患者睡眠障碍的影响。
研究对象为2021年1月至2023年12月期间在河北省中医院脑病科诊断为帕金森病并伴有睡眠障碍的85例患者。根据不同治疗方法,将他们分为西药组(n = 45,常规西药治疗加盐酸普拉克索)和中药组(n = 40,在西药组基础上加用安神交泰益智汤)。为尽量减少选择偏倚,采用倾向评分匹配(PSM),比例为1:1,最终中药组和西药组各20例。收集所有参与者的临床资料、总有效率、爱泼华嗜睡量表(ESS)评分、睡眠结构参数、同型半胱氨酸水平、白细胞介素-1β浓度及不良反应。通过PSM使两组的基线特征达到平衡。采用t检验、卡方检验和方差分析对数据进行分析。
按1:1比例进行PSM匹配,共40例患者分为两组。两组间临床特征无显著差异。中药组总有效率高于西药组(p < 0.05)。干预前,两组间ESS评分、睡眠结构及相关因素无差异(p > 0.05)。干预14天后,与西药组相比,中药组在所有测量指标上均有显著改善(p < 0.05)。值得注意的是,两组间不良反应发生率无显著差异(p > 0.05)。
安神交泰益智汤显示出显著的治疗效果,具有抗炎特性并促进睡眠结构改变,且不良反应极小。