摘要
目的:基于“三元络脑”学说探讨痴呆健脑方对轻中度血管性痴呆的临床疗效与安全性评价。方法:采用单中心、前瞻性、开放性、非劣性研究设计,依据随机数字表将84例患者随机分为观察组42例和对照组42例。在控制血压、血糖和血脂的基础上,观察组给予痴呆健脑方,每日1剂口服,连续治疗30 d。对照组给予银杏叶片口服,每次2片,每日3次口服,连续治疗30 d。治疗前后对患者进行SDSVD、MMSE、ADL、BBS等量表评估,并检测患者TNF-α、IL-1β、IL-6等炎性指标,记录不良事件发生情况。结果:治疗后,观察组临床总有效率(90.48%,38/42)优于对照组(73.81%,31/42)(P<0.05);两组治疗后各观察指标均较治疗前改善(P <0.05),且观察组中医证候积分、MMSE、ADL和BBS评分方面均较对照组改善明显(P <0.05);两组不良事件发生率比较,差异无统计学意义(P> 0.05)。结论:基于“三元络脑”学说的痴呆健脑方可通过降低炎性因子浸润,减轻血管性痴呆炎症反应对脑组织的损伤,从而改善轻中度血管性痴呆的中医临床证候、认知功能、日常行为能力和生活功能,且该方安全性好、不良事件发生率低,有较高临床应用价值和深入挖掘前景。
Objective:To explore the clinical efficacy and safety of Chidai Jiannao Formula in treatment of mild to moderate vascular dementia(VD)based on‘Sanyuan Luonao’theory.Methods:A single center,prospective,open and non-inferior study design was used.84 patients were randomly divided into the observation group(n=42)and the control group(n=42).On the basis of controlling blood pressure,blood glucose and blood lipid,the observation group was given Chidai Jiannao Formula,one dose a day for 30 days.The control group was given Ginkgo Leaves Tablet,2 tablets/time,3 times a day for 30 days.The scales of SDSVD,MMSE,ADL and BBS were assessed,and the inflammatory indexes of TNF-α,IL-1βand IL-6 were detected before and after the treatment in the two groups.The adverse reactions were also recorded in the two groups.Results:The total clinical effective rate of the observation group was 90.48%(38/42),which was significantly higher than 73.81%(31/42)of the control group(P<0.05).All observation indexes were improved after the treatment compared with those before the treatment in the two groups(P<0.05);among which,the scores of SDSVD,MMSE,ADL and BBS were significantly improved in the observation group than those in the control group after the treatment(P<0.05).The levels of TNF-α,IL-1βand IL-6 were all significantly decreased after the treatment compared with those before the treatment in the two groups(P<0.05);of which the decreases in the observation group were more significant in the observation group than those in the control group(P<0.05).There was no statistical difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:Chidai Jiannao Formula based on‘Sanyuan Luonao’theory can improve the degree of inflammatory reaction of brain tissue by reducing the invasion and damage of inflammatory mediators,thus to improve clinical symptoms,cognitive function,daily behavior ability and life function of mild to moderate VD.The therapy has a good safety and a low incidence of adverse reactions,whic
作者
董新刚
赵云
李伟峰
秦冰
DONG Xingang;ZHAO Yun;LI Weifeng;QIN Bing(The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450099,China;Henan University of Chinese Medicine,Zhengzhou 450046,China;The Third Affiliated Hospital of Chinese Medicine,Zhengzhou 450008,China;Henan Medical College,Zhengzhou 451191,China)
出处
《中医药信息》
2022年第8期50-54,共5页
Information on Traditional Chinese Medicine
基金
河南省科技攻关项目(212102311142)
河南省中医药科学研究专项课题重大专项(2022ZYZD05)
河南省中医药科学研究专项课题重点项目(20-21ZY1054)。
