龟龄集治疗老年轻-中度认知功能障碍肾虚髓减证的随机双盲对照研究  

A randomized double-blind positive-controlled clinical trial of Guilingji for treating mild-to-moderate elderly cognitive impairment with kidney deficiency and marrow reduction syndrome

作　　者：谭丽 唐铭 高慧娟 王威 欧阳惠楠 冯兴中[1,2] TAN Li;TANG Ming;GAO Huijuan;WANG Wei;OUYANG Huinan;FENG Xingzhong(Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China;Yuquan Hospital of Tsinghua University,Beijing 100040,China;Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]首都医科大学附属北京世纪坛医院,北京100038 [2]清华大学玉泉医院(清华大学中西医结合医院),北京100040 [3]北京中医药大学东直门医院,北京100700

出　　处：《现代中西医结合杂志》2022年第24期3392-3397,共6页Modern Journal of Integrated Traditional Chinese and Western Medicine

基　　金：2019年重大疑难疾病中西医临床协作试点项目(国中医药办医政发[2018]3号);首都临床特色应用研究与成果推广项目(Z161100000516076)。

摘　　要：目的 评价龟龄集治疗老年轻-中度认知功能障碍肾虚髓减证患者的临床疗效及安全性。方法 选取2019年5—9月于清华大学玉泉医院门诊及住院治疗的24例老年轻-中度认知功能障碍肾虚髓减证患者作为研究对象,采用随机数字表法将受试者分为2组,试验组12例给予银杏叶片模拟剂+龟龄集治疗,对照组12例给予龟龄集模拟剂+银杏叶片治疗,治疗周期为24周。比较2组患者治疗前后简易精神状态检查量表(MMSE)评分、蒙特利尔认知评估量表(MoCA)评分、阿尔茨海默病评定量表-认知量表(ADAS-cog)评分、临床痴呆评定量表(CDR)评分、中医症状量表积分和血清Bax、Bcl-2水平和Bcl-2/Bax,观察2组治疗安全性。结果 治疗12周、24周后,2组MMSE评分、MoCA评分均较治疗前明显增高(P均<0.05),且试验组治疗12周后均明显高于对照组(P均<0.05);治疗12周、24周后,2组ADAS-cog评分均较治疗前明显降低(P均<0.05),治疗24周后均明显低于治疗12周后(P均<0.05),且试验组治疗12周、24周后均明显低于对照组(P均<0.05);试验组治疗12周后CDR评分较治疗前明显降低(P<0.05),2组治疗12周、24周后CDR评分比较差异均无统计学意义(P均>0.05);治疗12周、24周后,2组中医症状量表积分均较治疗前明显降低(P均<0.05),治疗24周后均明显低于治疗12周后(P均<0.05),且试验组治疗12周后明显低于对照组(P<0.05);治疗24周后,试验组血清Bcl-2水平、Bcl-2/Bax比值均明显高于治疗前及对照组(P均<0.05),血清Bax水平明显低于治疗前及对照组(P均<0.05)。2组患者治疗过程中血常规、肝功能、肾功能等检查均未见明显异常改变,未出现明显不良反应。结论 与银杏叶片相比,龟龄集可更有效地提高老年轻-中度认知功能障碍肾虚髓减证患者的认知功能,改善患者的健忘、倦怠等中医症状,安全性良好。龟龄集可能通过Bax/Bcl-2/Caspase信号通路抑制细胞凋亡而改善认知�Objective It is to evaluate the clinical efficacy and safety of Guilingji in the treatment of mild-to-moderate elderly cognitive impairment with kidney dificiency and marrow reduction syndrome. Methods Twenty-four elderly patients with mild-to-moderate elderly cognitive impairment with kidney dificiency and marrow reduction syndrome treated at Yuquan Hospital of Tsinghua University from May to September 2019 were selected as study subjects, and they were randomly divided into 2 groups using the random number table method, 12 cases in the experimental group were treated with Ginkgo biloba simulant+Guilingji, and the control group was treated with Guilingji simulant+Ginkgo biloba. Both groups were treated for 24 weeks. The scores of Simple Mental State Examination Scale(MMSE), Montreal Cognitive Assessment Scale(MoCA), Alzheimer’s Disease Assessment Scale-Cognitive Scale(ADAS-cog), Clinical Dementia Rating Scale(CDR), Chinese Medicine Symptom Scale, the levels of serum Bax, Bcl-2 and Bcl-2/Bax before and after treatment were compared between the two groups, and the treatment safety was observed in the two groups. Results After 12 and 24 weeks of treatment, the MMSE scores and MoCA scores in both groups were significantly higher than those before treatment(all P<0.05), and the scores were significantly higher in the experiment group than those in the control group after 12 weeks of treatment(all P<0.05). After 12 and 24 weeks of treatment, the ADAS-cog scores in both groups were significantly lower than those before treatment(all P<0.05), all were significantly lower after 24 weeks of treatment than those after 12 weeks of treatment(all P<0.05), and the experiment group was significantly lower than the control group after 12 and 24 weeks of treatment(all P<0.05). The CDR score was significantly lower in the experiment group after 12 weeks of treatment compared with that before treatment(P<0.05), and there were no statistically significant differences in the CDR scores between the 2 groups after 12 and 24 weeks of

关 键 词：龟龄集 轻-中度认知功能障碍 肾虚髓减证 Bax/Bcl-2/Caspase信号通路 

分 类 号：R592[医药卫生—老年医学]