基于前瞻性队列的乌灵胶囊治疗阿尔茨海默病的有效性研究

    Prospective Cohort Study of the Effectiveness of Wuling Capsules in Patients with Alzheimer’s Disease

    • 摘要:
      目的  系统评估乌灵胶囊在阿尔茨海默病(Alzheimer’s disease,AD)患者中的多维度疗效,包括认知功能、精神行为症状及日常生活能力等“ABC症候群”核心指标。
      方法 本研究为前瞻性队列研究(注册号:ChiCTR2200062493)。纳入2023年1月—2023年12月在昆明医科大学第一附属医院痴呆专病门诊就诊并完成随访的临床诊断为AD或遗忘型认知障碍(amnestic mild cognitive impairment,aMCI)患者,根据是否使用乌灵胶囊分为观察组与对照组。所有患者于基线及6个月随访时接受多项神经心理学量表评估,包括临床痴呆评定量表(clinical dementia rating,CDR)的总分(CDR sum of boxes,CDR-SB)与综合评分(CDR global score,CDR-GS)以及各分项评分、蒙特利尔认知评估(Montreal cognitive assessment,MoCA)校正评分、简易精神状态量表(mini-mental state examination,MMSE)、神经精神症状量表(neuropsychiatric inventory,NPI)及阿尔茨海默病协作研究-日常生活能力量表(AD cooperative study-activities of daily living scale,ADCS-ADL),并采用多因素回归分析疗效差异。
      结果 共纳入117例患者(观察组57例,对照组60例)。与对照组相比,观察组患者在CDR-SB、CDR-GS及记忆力、判断与解决问题能力、社会事务处理能力等分项评分上改善更显著(P<0.05);NPI总分及激越/攻击行为子项下降更明显(P<0.05);ADCS-ADL评分维持稳定,而对照组显著下降(P<0.05);MoCA校正评分和MMSE评分在组间无显著差异。多因素回归显示,乌灵胶囊为CDR-SB下降的独立预测因素(P<0.05)。
      结论 在常规AD治疗基础上加用乌灵胶囊,在认知功能、精神行为症状及日常生活能力方面均带来积极改善,提示其对AD患者“ABC症候群”具有综合干预潜力,为中医药多靶点治疗AD提供新的临床证据。

       

      Abstract:
      OBJECTIVE  To evaluate the effectiveness of Wuling capsules in treating Alzheimer’s disease(AD) across multiple dimensions, including cognitive function, psychiatric and behavioral symptoms, and activities of daily living, addressing the “ABC syndrome” core components.
      METHODS  This study was a prospective cohort study(registration number: ChiCTR2200062493) that enrolled patients clinically diagnosed with AD or amnestic mild cognitive impairment(aMCI), who visited the Dementia Outpatient Department of the First Affiliated Hospital of Kunming Medical University from January 2023 to December 2023 and completed follow-up assessments. Based on whether they were treated with Wuling capsules, participants were divided into observation group and control group. All patients underwent multiple neuropsychological evaluations at baseline and after 6 months, assessment with the clinical dementia rating(CDR) scale included the total score(CDR-SB), global score(CDR-GS), and scores for all individual domains of CDR, Montreal cognitive assessment(MoCA) adjusted score, mini-mental state examination(MMSE), neuropsychiatric inventory(NPI), and AD cooperative study-activities of daily living scale(ADCS-ADL). Multivariate regression analysis was performed to evaluate the differences in efficacy between the groups.
      RESULTS  A total of 117 patients were enrolled, including 57 in the observation group and 60 in the control group. Compared with the control group, the pattients in observation group demonstrated significantly improvements in CDR-SB, CDR-GS, and subscale scores such as memory, judgment and problem-solving, and social affairs(all P<0.05); the NPI total score and the agitation/aggressive behavior subscale also showed more pronounced reductions(P<0.05), moreover, ADCS-ADL scores in the observation group remained stable, whereas the control group exhibited a significant decline(P<0.05). No significant differences were observed between groups in MoCA corrected scores or MMSE scores. Multivariate regression analysis further indicated that the use of Wuling capsules was an independent predictor of CDR-SB score decrease(P<0.05).
      CONCLUSION The addition of Wuling capsules to conventional AD treatment significantly improved cognitive function, psychiatric and behavioral symptoms, and activities of daily living, suggesting their potential for multi-dimensional intervention in AD patients’ “ABC syndrome”. It provides new clinical evidence for the use of Chinese herbal compounds in treating AD.

       

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