GuiLingJi(GLJ),a classic traditional Chinese medicine(TCM)formula,is composed of over 20 herbs,according to the Pharmacopeia of the People's Republic of China.Owing to its various activities,GLJ has been used in c...GuiLingJi(GLJ),a classic traditional Chinese medicine(TCM)formula,is composed of over 20 herbs,according to the Pharmacopeia of the People's Republic of China.Owing to its various activities,GLJ has been used in clinical settings for more than 400 years in China.However,the ambiguous chemical material basis limits the development of studies on the quality control and pharmacological mechanisms of GLJ.Therefore,comprehensive characterization of the multiple chemical components of GLJ is of great significance for the modernization of this formula.Given the great variety of herbs in GLJ,both UHPLCMS and ^(1)H NMR techniques were employed in this study.In addition,solvent extraction with different polarities was used to eliminate signal interference and the concentration of trace components.A variety of MS analytic methods were also used,including implementation of a self-built compound database,diagnostic ion filtering,mass defect filtering,and Compound Discoverer 3.0 analysis software.Based on the above strategies,a total of 150 compounds were identified,including 5 amino acids,13 phenolic acids and glycosides,11 coumarins,72 flavones,20 triterpenoid and triterpenoid saponins,23 fatty acids,and 6 other compounds.Moreover,13 compounds were identified by ^(1)H NMR spectroscopy.The UHPLC-MS and ^(1)H NMR results supported and complemented each other.This strategy provides a rapid approach to analyzing and identifying the chemical composition of Chinese herbal prescriptions.The current study provides basis for further research on the quality control and pharmacological mechanism of GLJ.展开更多
OBJECTIVE:To investigate the effectiveness and safety of Guilingji capsule(龟龄集胶囊,GLJC)in treatment of Alzheimer's disease(AD)patients with kidney-marrow deficiency pattern(KMDP)compared with gingko extract ta...OBJECTIVE:To investigate the effectiveness and safety of Guilingji capsule(龟龄集胶囊,GLJC)in treatment of Alzheimer's disease(AD)patients with kidney-marrow deficiency pattern(KMDP)compared with gingko extract tablets.METHODS:This is a secondary analysis of a large-scale multicenter randomized non-inferiority clinical trial.A total of 120 AD patients with KMDP were enrolled in this study.The participants were randomly categorized into two groups:(a)GLJC group(n=60)and(b)gingko group(n=60).The GLJC group was treated with GLJC and gingko extract mimetic tablets,whereas the gingko group received gingko extract tablets and mimetic GLJC.The data on the Mini-Mental State Examination(MMSE),Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog),Activities of Daily Living(ADL),and Chinese Medicine Symptom Scale(CM-SS)was evaluated at 0,12,and 24 weeks of treatment.The serum levels of acetylcholine(Ach),acetylcholinesterase(AchE),B-cell lymphoma-2(Bcl-2),and Bcl-2-associated X protein(Bax)in the participants were measured before and after 24 weeks of treatment.The safety was based on the incidence of adverse events.RESULTS:Both interventions significantly increased the MMSE scores of the participants and decreased their ADAS-Cog,ADL,and CM-SS scores(P<0.01).Compared with the gingko group,the GLJC group had a higher effective rate of improvement in the symptoms of“amnesia”and“dull expression and slow thinking”at the 12th week and 24th week(P<0.05,P<0.01).In the GLJC group,serum Bcl-2 levels were significantly increased at the 24th week(P<0.05).Serum Bax and AchE levels of the two groups were significantly decreased at the 24th week(P<0.01).No treatmentrelated adverse events were reported in the two groups.CONCLUSIONS:GLJC is equivalent to the gingko extract tablets in terms of improving cognitive function and the quality of life in AD patients with KMDP and has good clinical efficacy and safety.When it comes to improving TCM symptoms and anti-aging,GLJC is even more advantageous.展开更多
Background:The incidence of cognitive impairment(CI)is gradually increasing,which has attracted more attention from medical researchers worldwide.Definitive mechanisms of pathogenesis remain elusive,and there are few ...Background:The incidence of cognitive impairment(CI)is gradually increasing,which has attracted more attention from medical researchers worldwide.Definitive mechanisms of pathogenesis remain elusive,and there are few medications that have been proven effective for CI.The utilization of Chinese herbal medicine has shown positive therapeutic effects for a broad spectrum of diseases,including CI.Objective:The purpose of this study is to evaluate the safety and efficacy of Guilingji Capsules(GLJC,龟龄集胶囊)in treating mild-to-moderate CI with Shen(Kidney)and marrow deficiency syndrome.Methods:This is a randomized,double-blind,positive-controlled,multicenter clinical trial with a noninferiority design that included 348 participants randomly divided into an experimental arm and an active comparator arm.Individuals in the experimental arm(174 cases)took 0.6 g of GLJC once a day and 19.2 mg of Gingko biloba extract mimetic 3 times a day.Individuals in the active comparator arm(174 cases)took 0.6 g of GLJC mimetic once a day and 19.2 mg of Gingko biloba extract in tablet form 3 times a day.The intervention period included two sessions over 24 weeks.The primary outcome be the effectiveness of GLJC on cognitive improvement after 24 weeks of treatment,which was defined as an increase in the Mini Mental State Examination(MMSE)and Montreal Cognitive Assessment(MoCA)Scale.The secondary outcomes were improvement in independence,daily living ability,and Chinese medicine(CM)syndrome,which were measured with the Alzheimer’s disease Rating Scale-Cognitive Project(ADAS-Cog),Clinical Dementia Rating(CDR)Total Score,Activities of Daily Living(ADL)Total Score and the Chinese Medicine Symptom Scale(CM-SS),respectively.Serum acetylcholine,acetylcholinesterase,bax and bcl-2 were monitored to explore the mechanism of GLJC on CI.In addition,safety measures,including vital signs,electrocardiography,laboratory indicators(full blood count,kidney and liver function tests,routine urine test and routine stool test)and adverse events,were also recorded.Discussion:The purpose of this trial is to evaluate the efficacy and safety of GLJC in patients with mild-to-moderate CI with kidney and marrow deficiency syndrome.If successful,the results would provide a viable treatment for patients with mild-to-moderate CI.展开更多
基金support from the Shanxi Provincial Science and Technology Key Research and Development Plan(Grant Nos.:201603D3113006 and 201903D311012)。
文摘GuiLingJi(GLJ),a classic traditional Chinese medicine(TCM)formula,is composed of over 20 herbs,according to the Pharmacopeia of the People's Republic of China.Owing to its various activities,GLJ has been used in clinical settings for more than 400 years in China.However,the ambiguous chemical material basis limits the development of studies on the quality control and pharmacological mechanisms of GLJ.Therefore,comprehensive characterization of the multiple chemical components of GLJ is of great significance for the modernization of this formula.Given the great variety of herbs in GLJ,both UHPLCMS and ^(1)H NMR techniques were employed in this study.In addition,solvent extraction with different polarities was used to eliminate signal interference and the concentration of trace components.A variety of MS analytic methods were also used,including implementation of a self-built compound database,diagnostic ion filtering,mass defect filtering,and Compound Discoverer 3.0 analysis software.Based on the above strategies,a total of 150 compounds were identified,including 5 amino acids,13 phenolic acids and glycosides,11 coumarins,72 flavones,20 triterpenoid and triterpenoid saponins,23 fatty acids,and 6 other compounds.Moreover,13 compounds were identified by ^(1)H NMR spectroscopy.The UHPLC-MS and ^(1)H NMR results supported and complemented each other.This strategy provides a rapid approach to analyzing and identifying the chemical composition of Chinese herbal prescriptions.The current study provides basis for further research on the quality control and pharmacological mechanism of GLJ.
基金the“Hundreds and Tens of Thousands”Talent Project(Qihuang Project)Qihuang Scholars Project of Traditional Chinese Medicine Inheritance and Innovation(No.020450003)。
文摘OBJECTIVE:To investigate the effectiveness and safety of Guilingji capsule(龟龄集胶囊,GLJC)in treatment of Alzheimer's disease(AD)patients with kidney-marrow deficiency pattern(KMDP)compared with gingko extract tablets.METHODS:This is a secondary analysis of a large-scale multicenter randomized non-inferiority clinical trial.A total of 120 AD patients with KMDP were enrolled in this study.The participants were randomly categorized into two groups:(a)GLJC group(n=60)and(b)gingko group(n=60).The GLJC group was treated with GLJC and gingko extract mimetic tablets,whereas the gingko group received gingko extract tablets and mimetic GLJC.The data on the Mini-Mental State Examination(MMSE),Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog),Activities of Daily Living(ADL),and Chinese Medicine Symptom Scale(CM-SS)was evaluated at 0,12,and 24 weeks of treatment.The serum levels of acetylcholine(Ach),acetylcholinesterase(AchE),B-cell lymphoma-2(Bcl-2),and Bcl-2-associated X protein(Bax)in the participants were measured before and after 24 weeks of treatment.The safety was based on the incidence of adverse events.RESULTS:Both interventions significantly increased the MMSE scores of the participants and decreased their ADAS-Cog,ADL,and CM-SS scores(P<0.01).Compared with the gingko group,the GLJC group had a higher effective rate of improvement in the symptoms of“amnesia”and“dull expression and slow thinking”at the 12th week and 24th week(P<0.05,P<0.01).In the GLJC group,serum Bcl-2 levels were significantly increased at the 24th week(P<0.05).Serum Bax and AchE levels of the two groups were significantly decreased at the 24th week(P<0.01).No treatmentrelated adverse events were reported in the two groups.CONCLUSIONS:GLJC is equivalent to the gingko extract tablets in terms of improving cognitive function and the quality of life in AD patients with KMDP and has good clinical efficacy and safety.When it comes to improving TCM symptoms and anti-aging,GLJC is even more advantageous.
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Background:The incidence of cognitive impairment(CI)is gradually increasing,which has attracted more attention from medical researchers worldwide.Definitive mechanisms of pathogenesis remain elusive,and there are few medications that have been proven effective for CI.The utilization of Chinese herbal medicine has shown positive therapeutic effects for a broad spectrum of diseases,including CI.Objective:The purpose of this study is to evaluate the safety and efficacy of Guilingji Capsules(GLJC,龟龄集胶囊)in treating mild-to-moderate CI with Shen(Kidney)and marrow deficiency syndrome.Methods:This is a randomized,double-blind,positive-controlled,multicenter clinical trial with a noninferiority design that included 348 participants randomly divided into an experimental arm and an active comparator arm.Individuals in the experimental arm(174 cases)took 0.6 g of GLJC once a day and 19.2 mg of Gingko biloba extract mimetic 3 times a day.Individuals in the active comparator arm(174 cases)took 0.6 g of GLJC mimetic once a day and 19.2 mg of Gingko biloba extract in tablet form 3 times a day.The intervention period included two sessions over 24 weeks.The primary outcome be the effectiveness of GLJC on cognitive improvement after 24 weeks of treatment,which was defined as an increase in the Mini Mental State Examination(MMSE)and Montreal Cognitive Assessment(MoCA)Scale.The secondary outcomes were improvement in independence,daily living ability,and Chinese medicine(CM)syndrome,which were measured with the Alzheimer’s disease Rating Scale-Cognitive Project(ADAS-Cog),Clinical Dementia Rating(CDR)Total Score,Activities of Daily Living(ADL)Total Score and the Chinese Medicine Symptom Scale(CM-SS),respectively.Serum acetylcholine,acetylcholinesterase,bax and bcl-2 were monitored to explore the mechanism of GLJC on CI.In addition,safety measures,including vital signs,electrocardiography,laboratory indicators(full blood count,kidney and liver function tests,routine urine test and routine stool test)and adverse events,were also recorded.Discussion:The purpose of this trial is to evaluate the efficacy and safety of GLJC in patients with mild-to-moderate CI with kidney and marrow deficiency syndrome.If successful,the results would provide a viable treatment for patients with mild-to-moderate CI.
