[关键词]
[摘要]
目的 采用网状Meta系统评价补阳还五汤、地黄饮子、固脑益智汤、益智通脉方、通窍活血汤联用常规化学药治疗血管性痴呆(vascular dementia,VD)的有效性和安全性。方法 系统检索国内外主流文献数据库,涵盖中文数据库中国知网(CNKI)、万方、维普、中国生物医学文献数据库(SinoMed),以及英文数据库Cochrane Library、PubMed、Embase,检索时段设定为各库建库至2024年12月,尽可能全面收集补肾活血法联合常规化学药治疗VD的相关临床随机对照试验。采用EndNote 20软件进行文献管理,由2名研究者依据纳入和排除标准独立对相关补肾活血类成方联合化学药治疗VD的文献进行筛选,提取数据。采用Cochrane偏倚风险评估工具进行评价,然后使用Stata 18对纳入文献进行网状Meta分析。结果 检索共获得相关文献2 848篇,最终纳入53篇文献,累计病例4 562例(试验组2 292例、对照组2 270例)。对纳入文献进行网状Meta分析后结果显示,中药成方联合常规化学药治疗VD在临床综合疗效方面相比单用常规化学药都有提高。对比不同的成方:(1)在临床总有效率方面,疗效排名由高到低为通窍活血汤>固脑益智汤>益智通脉方>补阳还五汤>地黄饮子;(2)在改善简易智能精神状态量表(mini-mental state examination,MMSE)评分方面,疗效排名由高到低为通窍活血汤>固脑益智汤>补阳还五汤>益智通脉方>地黄饮子;(3)在改善长谷川痴呆量表(Hasegawa dementia scale,HDS)评分方面,疗效排名由高到低为地黄饮子>固脑益智汤>补阳还五汤>通窍活血汤;(4)在改善日常生活活动能力(activities of daily living,ADL)评分方面,疗效排名由高到低为固脑益智汤>通窍活血汤>地黄饮子>补阳还五汤>益智通脉方;(5)安全性方面,均未发生严重不良反应。结论 在使用常规化学药的基础上,联合使用补肾活血类成方对VD的治疗和改善作用都有所提升。由于存在一定的局限性,各中药成方的排名并不能完全说明孰优孰劣,应当对结果谨慎对待,未来需设计更大样本量的高质量随机对照试验,以提升证据的可靠性。
[Key word]
[Abstract]
Objective This study conducted a network meta-analysis to systematically evaluate the efficacy and safety of Buyang Huanwu Decoction (补阳还五汤), Dihuang Yinzi (地黄饮子), Gunao Yizhi Decoction (固脑益智汤), Yizhi Tongmai Formula (益智通脉方), and Tongqiao Huoxue Decoction (通窍活血汤) combined with conventional Western medicine in treating vascular dementia (VD). Methods Systematic searches were performed across major databases, including Chinese databases (CNKI, Wanfang, VIP, SinoMed) and English databases (Cochrane Library, PubMed, Embase), covering literature from database inception to December 2024. Randomized controlled trials (RCTs) investigating kidney-tonifying and blood-activating herbal formulas combined with conventional therapy for VD were included. Literature screening and data extraction were independently performed by two researchers using EndNote 20, based on predefined inclusion/exclusion criteria. The Cochrane Risk of Bias Tool was used for quality assessment, and network meta-analysis was conducted using Stata 18. Results A total of 2 848 articles were retrieved, with 53 studies (4 562 VD cases: intervention group, 2 292; control group, 2 270) meeting inclusion criteria. NMA results demonstrated that herbal formulas combined with conventional therapy improved clinical efficacy compared to conventional therapy alone. The efficacy rankings for specific formulas were as follows: (1) Clinical Efficiency: Tongqiao Huoxue Decoction > Gunao Yizhi Decoction > Yizhi Tongmai Formula > Buyang Huanwu Decoction > Dihuang Yinzi; (2) mini-mental state examination (MMSE) score improvement: Tongqiao Huoxue Decoction > Gunao Yizhi Decoction > Buyang Huanwu Decoction > Yizhi Tongmai Formula > Dihuang Yinzi; (3) Hasegawa dementia scale (HDS) score improvement: Dihuang Yinzi > Gunao Yizhi Decoction > Buyang Huanwu Decoction > Tongqiao Huoxue Decoction; (4) Activities of daily living (ADL) score improvement: Gunao Yizhi Decoction > Tongqiao Huoxue Decoction > Dihuang Yinzi > Buyang Huanwu Decoction > Yizhi Tongmai Formula; (5) Safety: No severe adverse reactions were reported. Conclusion Kidney-tonifying and blood-activating herbal formulas combined with conventional therapy demonstrate enhanced therapeutic efficacy for VD. However, due to methodological limitations inherent in this study, the relative rankings among interventions do not definitively establish therapeutic superiority. These comparative results should be interpreted with caution. Future investigations should prioritize large-scale, high-quality RCTs to validate intervention hierarchies and enhance the reliability of evidence.
[中图分类号]
R285
[基金项目]
国家自然科学基金NSFC-FDCT联合项目(82061160374);黑龙江省卫生健康委科研课题(20220303071043)