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

Effectiveness of Wuling Capsules in the Treatment of Alzheimer’s Disease: Evidence from a Prospective Cohort Study

关键词:  阿尔茨海默病，乌灵胶囊，前瞻性队列研究，认知功能，临床痴呆评定量表

Key words:  Alzheimer's disease, Wuling capsule, Prospective cohort study, Cognitive function, Clinical Dementia Rating

摘要:

目的 探讨乌灵胶囊治疗阿尔茨海默病的有效性。方法 本前瞻队列研究(注册号：ChiCTR2200062493)纳入自2023年1月在昆明医科大学第一附属医院痴呆专病门诊就诊的阿尔茨海默病患者,所有入组患者均于2024年6月前完成随访。根据患者是否服用乌灵胶囊,将研究对象分为观察组(使用乌灵胶囊)和对照组(未使用乌灵胶囊),在入组及服药6个月时进行神经心理测评,分析有效性。结果 共纳入117 名阿尔茨海默病患者(观察组57 人,对照组60 人)。观察组的临床痴呆评定量表总和评分(CDR-SB)变化值(P＜0.05)、总体评分(CDR-GS)变化值(P＜0.05)、其分项中的记忆变化值(P＜0.05)、判断与解决问题能力变化值(P＜0.05)、社会事务处理能力变化值(P＜0.05)均较对照组明显下降。观察组神经精神症状量表(NPI)变化值较对照组明显下降(P＜0.05),观察组阿尔茨海默病协作研究-日常活动能力量表(ADCS-ADL)变化值较对照组明显提升(P＜0.05)。多因素分析发现观察组CDR-SB变化值较对照组具有显著差异(P＜0.05)。结论 乌灵胶囊可显著改善患者的认知功能。

Abstract:

OBJECTIVE To evaluate the effectiveness of Wuling capsules in the treatment of Alzheimer’s disease (AD). METHODS This prospective cohort study (Registration No. ChiCTR2200062493) enrolled patients diagnosed with AD who attended the Dementia Outpatient Department of the First Affiliated Hospital of Kunming Medical University from January 2023. All participants completed follow-up assessments before June 2024. Based on whether patients received Wuling capsules, they were categorized into two groups: an observation group (treated with Wuling capsules) and a control group (not treated with Wuling capsules). Neuropsychological evaluations were conducted at baseline and after six months of treatment to assess therapeutic outcomes. RESULTS A total of 117 patients were included, with 57 in the observation group and 60 in the control group. After six months, the observation group showed significantly greater improvements than the control group in the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) score (P < 0.05), the Global Score (CDR-GS), and specific domains including memory, problem-solving ability, and management of social affairs (all P < 0.05). The observation group also demonstrated significantly greater improvements in the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) scores (P < 0.05) and significantly smaller increases in the Neuropsychiatric Inventory (NPI) scores compared to the control group (P < 0.05). Multivariate analysis confirmed that the changes in CDR-SB scores were significantly greater in the observation group (P<0.05). CONCLUSION Wuling capsules may significantly improve cognitive function a in patients with Alzheimer’s disease.