Objective:To investigate the long-term therapeutic effects of the Chinese medicine Jiannao Yizhi Formula(健脑益智方,JYF)in the treatment of Alzheimer’s disease(AD).Methods:Sixty mild-to-moderate AD participants were ...Objective:To investigate the long-term therapeutic effects of the Chinese medicine Jiannao Yizhi Formula(健脑益智方,JYF)in the treatment of Alzheimer’s disease(AD).Methods:Sixty mild-to-moderate AD participants were recruited and randomly allocated to the treatment(30 with JYF)and the control groups(30 with donepezil)for 6 months with the random numbers.The primary outcomes were scores of Alzheimer’s Disease Rating Scale-Cognitive(ADAS-Cog)and Chinese Medicine Symptom Scale(CM-SS).The secondary outcomes were scores of Mini Mental State Examination(MMSE),Montreal Cognitive Assessment(MoCA),and Activities of Daily Living(ADL).Safety assessments were conducted at baseline and the 6 th month of treatment.Serum levels of acetylcholine(Ach),amyloid-β protein 42(Aβ42),and the microtubule-associated protein tau(Tau)were also determined by enzyme-liked immunosorbent assay.Results:Fifty-one participants were included in the final analyses(JYF n=27;donepezil n=24).Compared with baseline,both JYF and donepezil increased the MoCA and MMSE scores and decreased the ADAS-Cog and CM-SS scores(P<0.05 or P<0.01).Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ42 and Tau(all P<0.05).There was no significant difference in these variables between the two groups,which showed that JYF was not inferior to donepezil.No obviously significant changes were observed in the ADL.No severe adverse events were observed in both groups.Conclusion:The effect and safety of JYF for the treatment of AD were not inferior to those of donepezil.展开更多
目的运用网状Meta分析评价中成药用于辅助治疗阿尔茨海默病的疗效及安全性。方法计算机检索PubMed、Web of Science、Embase、Cochrane Library、中国知网、万方、中国生物医学文献数据库(CBM)收录的口服中成药治疗阿尔茨海默病的随机...目的运用网状Meta分析评价中成药用于辅助治疗阿尔茨海默病的疗效及安全性。方法计算机检索PubMed、Web of Science、Embase、Cochrane Library、中国知网、万方、中国生物医学文献数据库(CBM)收录的口服中成药治疗阿尔茨海默病的随机对照试验,检索时限为各数据库建库至2022年4月。2名研究员独立进行文献筛选、数据提取并对纳入的研究进行质量评价,应用Stata 16对数据进行传统Meta分析以及网状Meta分析。结果最终纳入35项研究,包括复方海蛇胶囊、天智颗粒、银杏叶、六味地黄丸等8种中成药。网状Meta分析结果显示,(1)认知评估:在改善简易智力状态评分方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>红景天胶囊联合处方药>六味地黄丸联合处方药;在改善阿尔茨海默病评估量表-认知方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>复方海蛇胶囊联合处方药>复方丹参片联合处方药。(2)在治疗总有效率方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>复方海蛇胶囊联合处方药>天智颗粒联合处方药。(3)在提高日常生活活动能力方面,最优的前3种干预措施为银杏叶联合处方药>复方海蛇胶囊联合处方药>天智颗粒联合处方药。(4)在不良反应方面,不良反应发生较少的前3种方案为天智颗粒联合处方药>复方海蛇胶囊联合处方药>银杏叶联合处方药。结论中成药联合胆碱酯酶抑制剂或谷氨酸受体拮抗剂可有效改善阿尔茨海默病患者的认知功能、提高日常生活活动能力,治疗效果均优于单用处方药,且安全性较好,未观察到有明显增加不良反应发生的风险。但纳入的研究方法学质量普遍偏低,故结论仍待更多大样本、高质量的研究进一步验证。展开更多
基金Supported by Beijing Municipal Science and Technology Project(Capital Characteristic Clinic Project,No.Z171100001017106)Beijing Municipal Science and Technology Project"Ten Disease and Ten Medicine"(No.Z171100001717016)
文摘Objective:To investigate the long-term therapeutic effects of the Chinese medicine Jiannao Yizhi Formula(健脑益智方,JYF)in the treatment of Alzheimer’s disease(AD).Methods:Sixty mild-to-moderate AD participants were recruited and randomly allocated to the treatment(30 with JYF)and the control groups(30 with donepezil)for 6 months with the random numbers.The primary outcomes were scores of Alzheimer’s Disease Rating Scale-Cognitive(ADAS-Cog)and Chinese Medicine Symptom Scale(CM-SS).The secondary outcomes were scores of Mini Mental State Examination(MMSE),Montreal Cognitive Assessment(MoCA),and Activities of Daily Living(ADL).Safety assessments were conducted at baseline and the 6 th month of treatment.Serum levels of acetylcholine(Ach),amyloid-β protein 42(Aβ42),and the microtubule-associated protein tau(Tau)were also determined by enzyme-liked immunosorbent assay.Results:Fifty-one participants were included in the final analyses(JYF n=27;donepezil n=24).Compared with baseline,both JYF and donepezil increased the MoCA and MMSE scores and decreased the ADAS-Cog and CM-SS scores(P<0.05 or P<0.01).Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ42 and Tau(all P<0.05).There was no significant difference in these variables between the two groups,which showed that JYF was not inferior to donepezil.No obviously significant changes were observed in the ADL.No severe adverse events were observed in both groups.Conclusion:The effect and safety of JYF for the treatment of AD were not inferior to those of donepezil.
文摘目的运用网状Meta分析评价中成药用于辅助治疗阿尔茨海默病的疗效及安全性。方法计算机检索PubMed、Web of Science、Embase、Cochrane Library、中国知网、万方、中国生物医学文献数据库(CBM)收录的口服中成药治疗阿尔茨海默病的随机对照试验,检索时限为各数据库建库至2022年4月。2名研究员独立进行文献筛选、数据提取并对纳入的研究进行质量评价,应用Stata 16对数据进行传统Meta分析以及网状Meta分析。结果最终纳入35项研究,包括复方海蛇胶囊、天智颗粒、银杏叶、六味地黄丸等8种中成药。网状Meta分析结果显示,(1)认知评估:在改善简易智力状态评分方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>红景天胶囊联合处方药>六味地黄丸联合处方药;在改善阿尔茨海默病评估量表-认知方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>复方海蛇胶囊联合处方药>复方丹参片联合处方药。(2)在治疗总有效率方面,最优的前3种干预措施为复方苁蓉益智胶囊联合处方药>复方海蛇胶囊联合处方药>天智颗粒联合处方药。(3)在提高日常生活活动能力方面,最优的前3种干预措施为银杏叶联合处方药>复方海蛇胶囊联合处方药>天智颗粒联合处方药。(4)在不良反应方面,不良反应发生较少的前3种方案为天智颗粒联合处方药>复方海蛇胶囊联合处方药>银杏叶联合处方药。结论中成药联合胆碱酯酶抑制剂或谷氨酸受体拮抗剂可有效改善阿尔茨海默病患者的认知功能、提高日常生活活动能力,治疗效果均优于单用处方药,且安全性较好,未观察到有明显增加不良反应发生的风险。但纳入的研究方法学质量普遍偏低,故结论仍待更多大样本、高质量的研究进一步验证。
