复方苁蓉益智胶囊治疗轻中度阿尔茨海默病患者的临床疗效研究  

Clinical study of Compound Congrong Yizhi Capsule in treating mild to moderate Alzheimer′s disease

作　　者：李孟媛 孙锦平[2] 孙伟[3] 张占军[1] 李鹤[4] LI Mengyuan;SUN Jinping;SUN Wei;ZHANG Zhanjun;LI He(Beijing Normal University,Beijing 100091,China;Affiliated Hospital of Qingdao University,Qingdao 266003,China;Xuanwu Hospital of Capital Medical University,Beijing 100053,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]北京师范大学,北京100091 [2]青岛大学附属医院 [3]首都医科大学宣武医院 [4]中国中医科学院中医临床基础医学研究所

出　　处：《北京中医药大学学报》2024年第8期1145-1151,共7页Journal of Beijing University of Traditional Chinese Medicine

基　　金：国家自然科学基金重点项目(No.82130118);科技部科技创新2030重大项目(No.2022ZD0211600);中央级公益性科研院所基本科研业务费专项资金资助项目(No.Z0739)。

摘　　要：目的观察复方苁蓉益智胶囊对轻中度阿尔茨海默病(AD)患者的临床疗效及安全性。方法选取2023年2月—2024年2月就诊于青岛大学附属医院及首都医科大学宣武医院的轻中度AD受试者,共65例。分为复方苁蓉益智胶囊组(40例)及盐酸多奈哌齐组(25例),共治疗6个月。主要结局指标包括阿尔茨海默病评估量表(ADAS-Cog)评分及听觉词语记忆测验(AVLT)评分;次要结局指标包括简明精神状态检查量表(MMSE)、日常生活能力、Rey-Osterrich复杂图形测验、连线测验、词语流畅性测验、符号数字转化试验、数字广度测验、画钟试验(CDT)、波士顿命名测验评分,以及包括血脂、血糖、肝肾功能的临床理化指标。结果与盐酸多奈哌齐组治疗后比较,复方苁蓉益智胶囊组受试者治疗后,ADAS-Cog评分、AVLT总评分增加,MMSE、Rey-Osterrich复杂图形模仿和CDT评分降低(P<0.05);丙氨酸氨基转移酶(ALT)、尿素(BUN)、总胆红素(TBIL)含量增加,间接胆红素(IBIL)含量降低(P<0.05)。结论复方苁蓉益智胶囊在AD早期即对受试者认知功能产生调节作用,尤其在情景记忆、视空间加工能力等认知域效果明显,而且对于ALT、BUN、TBIL及IBIL等临床指标也起到一定改善作用。提示在AD早期应用复方苁蓉益智胶囊进行干预,能够有效改善患者症状、延缓疾病进程,充分体现了中医治未病的思想。Objective We aimed to observe the clinical efficacy and safety of Compound Congrong Yizhi Capsule in subjects with mild to moderate Alzheimer′s disease(AD).Methods A total of 65 subjects with mild to moderate AD who visited the Affiliated Hospital of Qingdao University and Xuanwu Hospital of Capital Medical University from February 2023 to February 2024 were selected and divided into the Compound Congrong Yizhi Capsule group(40 cases)and the Donepezil Hydrochloride group(25 cases)for a 6-month treatment.The primary outcome measures included the Alzheimer′s Disease Assessment Scale-cognitive subscale(ADAS-Cog)score and Auditory Verbal Learning Test(AVLT)score.Secondary outcome measures included the Mini-Mental State Examination(MMSE),Activities of Daily Living(ADL),Rey-Osterrieth Complex Figure Test(ROCFT),Trail Making Test(TMT),Verbal Fluency Test(VFT),Symbol Digit Modalities Test(SDMT),Digital Span Test(DST),Clock Drawing Test(CDT),and Boston Naming Test(BNT)scores,as well as clinical biochemical indicators including blood lipids,blood glucose,liver and kidney function.Results Compared with the Donepezil Hydrochloride group after treatment,subjects in the Compound Congrong Yizhi Capsule group showed an increase in ADAS-Cog and AVLT-total scores,and a decrease in MMSE,Rey-Osterrieth Complex Figure Copy Test,and CDT scores(P<0.05).Additionally,there was an increase in alanine aminotransferase(ALT),blood urea nitrogen(BUN),and total bilirubin(TBIL)levels,and a decrease in indirect bilirubin(IBIL)levels(P<0.05).Conclusion Compound Congrong Yizhi Capsule exerts a regulatory effect on cognitive function in subjects with AD,especially in the cognitive domains of episodic memory and visual-spatial processing ability.It also improves certain clinical indicators such as ALT,BUN,TBIL,and IBIL.This suggests that the early intervention with Compound Congrong Yizhi Capsule in AD can effectively improve symptoms,delay disease progression,and fully embody the concept of traditional Chinese medicine′s preventive approach t

关 键 词：复方苁蓉益智胶囊 轻中度阿尔茨海默病 认知功能 临床疗效 治未病 

分 类 号：R277.7[医药卫生—中医学]