机构地区:[1]南京中医药大学附属医院,江苏省南京市210029 [2]南京中医药大学第一临床医学院
出 处:《中医杂志》2024年第13期1353-1362,共10页Journal of Traditional Chinese Medicine
基 金:江苏省中医药管理局中医临床医学创新中心研究项目(ZX202101);江苏省卫生健康委员会江苏省中医药科技发展计划、人才项目(RC201901);江苏省财政厅江苏省科学技术厅2022年省科技计划专项资金(重点研发计划社会发展)项目(BE2022818);南京中医药大学自然科学基金(XZR2021007)。
摘 要:目的探讨通脑益智方治疗非痴呆型血管性认知障碍(VCIND)脾肾亏虚、痰瘀阻络证患者的作用机制。方法92例VCIND脾肾亏虚、痰瘀阻络证患者随机分为治疗组50例和对照组42例。两组均予常规基础治疗,对照组联合口服多奈哌齐片,每次5 mg,每晚1次;治疗组联合通脑益智方,每日1剂,水煎分早晚两次口服。两组均连续治疗3个月。治疗前后比较两组患者简易精神状态检查量表(MMSE)评分、血管性痴呆评估量表(VaDAS-Cog)评分、日常生活能力量表(ADL)评分、中医证候评分(主症包括思维呆滞、善忘无记、性情改变、语言错乱,次症包括腰膝酸软、头晕头痛、耳鸣时作、神疲乏力、肢体困重、失眠烦躁、纳呆脘胀、面部发麻)。比较两组患者肠道菌群多样性和菌群丰度结构的变化及粪便中短链脂肪酸(SCFAs)水平(包括乙酸、丙酸、丁酸、异丁酸、异戊酸、戊酸、己酸)。并纳入同期20例健康受试者粪便相关数据作为参照。研究过程中进行安全性观察。结果与本组治疗前比较,两组患者治疗后MMSE评分升高,VaDAS-cog评分降低(P<0.05或P<0.01),治疗组ADL评分较治疗前升高(P<0.05)。两组患者治疗后思维呆滞、善忘无记、性情改变、语言错乱、肢体困重、失眠烦躁、纳呆脘胀、面部发麻评分及中医证候总积分均较治疗前明显降低(P<0.05或P<0.01);治疗后组间比较,治疗组腰膝酸软、耳鸣时作、神疲乏力、肢体困重、失眠烦躁、纳呆脘胀评分较对照组明显下降(P<0.05或P<0.01)。肠道菌群多样性结果显示,治疗组Shannon指数较治疗前升高(P<0.05)。治疗后各样本在主坐标分析图上经Anosim分析比较差异有统计学意义(P<0.01),提示两组间物种发生改变。治疗后,治疗组拟杆菌门和梭杆菌门相对丰度上升,放线菌门、疣微菌门和蓝藻菌门等相对丰度下降(P<0.05),普拉梭菌属、双歧杆菌属、乳酸杆菌属、瘤胃球�Objective To observe the clinical efficacy and mechanism of Tongnao Yizhi Formula(通脑益智方,TYF)in treating vascular cognitive impairment no dementia(VCIND)with spleen and kidney depletion,phlegm and stasis obstructing collaterals syndrome.Methods Ninety-two VCIND patients with spleen and kidney depletion,phlegm and stasis obstructing collaterals syndrome were randomly divided into control group(42 cases)and treatment group(52 cases).Both groups received routine basic treatment.The control group was given donapezil hydrochloride capsules orally,5 mg each time,once at night,while the treatment group was given TYF orally,1 dose per day.Both groups were treated continuously for 3 months.The scores of Mini-Mental State Examination(MMSE),Vascular Dementia Assessment Scale-Cognitive Subscale(VaDAS-Cog),Activity of Daily Living Scale(ADL),and TCM syn⁃drome scores(the primary symptoms such as sluggish thinking,forgetfulness,temperament changes,and language confu⁃sion,and secondary symptoms such as weakness of waist and knees,dizziness and headache,occasional tinnitus,fatigue,heaviness of limbs,insomnia and irritability,poor appetite and abdominal distension,numbness of face)were observed before and after treatment in both groups.The changes in gut microflora diversity and flora abundance structure as well as fecal short-chain fatty acids(SCFAs)levels including acetic acid,propionic acid,butyric acid,isobutyric acid,isovaleric acid,valeric acid,and caproic acid were compared between groups.The feces of 20 healthy subjects in the same period were included as reference.Safety was evaluated during the study.Results After treatment,both groups exhibited significant increases in MMSE scores and decreases in VaDAS-cog scores(P<0.05 or P<0.01),and ADL scores in the treatment group significantly increased(P<0.05).Scores of symptoms includ⁃ing sluggish thinking,forgetfulness,temperament change,language confusion,heaviness of limbs,insomnia,irrita⁃bility,poor appetite,abdominal distension,and facial numbness as well a
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