摘要：The international standard for traditional Chinese medicine (TCM) released by the International Organization for Standardization (ISO) is of great significance in promoting China's international trade of TCM and exerting its role in global health governance. This article expounds on the development course of TCM international standardization centering on the construction and development of the Technical Committee of TCM within ISO (ISO/TC 249),analyzes and evaluates the achievements and the current situation oninternational standardization of TCM released by ISO,and puts forward future development ideas on this basis.

摘要：The difficulty in defining the ambiguous"natural language"within the theoretical system of traditional Chinese medicine (TCM),the dynamic evaluation and individual differences of treatment based on syndrome differentiation,as well as"hard-to-quantify"char-acteristics of subjectiveness in the evaluation of treatment efficacy during the treatment,has resulted in the questioning and limited use of various TCM therapies with extensive application in clinical practice,which also arises from the lack of recognized and scientific evaluation methods. The standards evaluating the clinical efficacy of TCM remain the key bottleneck restricting the modernization and internationalization of TCM. Although the concept of evidence-based medicine was introduced into the field of TCM and applied to the evaluation and exploration of the clinical efficacy of TCM,there is still a lack of systematic methodological tools for its applicability evaluation. The concept of"digital-intelligent TCM"provides a new direction for the exploration of TCM based on the scientific and technological background of the times. It is not antagonistic to evidence-based TCM;instead,it complements and prompts evidence-based TCM to jointly accelerate the standardization of the evaluation of the clinical efficacy of TCM.

摘要：The animal experiment is the best method for therapeutic efficacy testing of various treatment methods before clinical application and serves as an irreplaceable"live reagent"and"live precise instrument,"thus playing a vital role in biomedical science research. However,there were significant differences between the results of animal experiments and clinical efficacy in previous findings that are hard to ignore,especially in cerebrovascular accident research due to the unsatisfactory specification of animal experiments. Accordingly,more prescriptive and standard tools are required for evaluating the quality of animal experiments. This study will introduce the current commonly used quality evaluation tools for animal experiments.

摘要：Taking"Clinical practice guideline for acupuncture-moxibustion treatment of mild to moderate depression in adults,"the standard issued by the World Federation of Acupuncture-Moxibustion Societies as an example,this study aims to investigate the methods of determining clinical questions in the formulation of acupuncture-moxibustion clinical practice guideline and provide a methodological reference for developing high-quality,well-applied acupuncture-moxibustion guidelines.

摘要：The clinical practice guidelines (CPGs) are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.Currently,CPGs have been developed in the field of traditional Chinese medicine (TCM) for years;however,the method of the CPG formulation process is not standardized,which has caused problems in the quality of CPGs for TCM.To promote the development and improve the status of CPGs for TCM,we used the different processes for the development of CPGs in the world for references,combined with the characteristics of TCM research,and formulated the standardized process of CPGs for TCM to provide a reference for the developers of CPGs for TCM.

摘要：Gua Sha (also known as scraping) therapy,one of the important external treatment techniques in traditional Chinese medicine (TCM),has developed into a mature system of technical standards through long-term clinical practice.In this paper,the development process of Gua Sha technical standardization is reviewed and the characteristics of the current standards system are accordingly analyzed.It turns out that standardization plays a vital role in promoting the inheritance and innovation of the Gua Sha technique.As a typical case of TCM standardization,the construction of the standardization system of Gua Sha provides valuable inspiration for further improving the TCM standardization system.For future TCM standardization,it is suggested that the problem-oriented principle should be adhered to and the formulation of standards should be based on China's national conditions and demands;the top-level design should be strengthened and the standardized system should be perfected;the implementation of standards should be enhanced and international exchange and cooperation should be promoted.The standardization of TCM has a long way to go and needs the joint efforts of all stakeholders.

摘要：Objective:To analyze the identification and typing of bone flaccidity and the law of medication in ancient books based on the Encyclopaedia of TCM(Traditional Chinese Medicine)using the hidden structure model. Methods:The formulations for bone flaccidity were searched in the Chinese Medical Code(software),based on which an Excel sheet was created to conduct frequency analysis and construct a matrix of high-frequency medications.The high-frequency medications for bone flaccidity were then analyzed using the Latent 5.0 software and a latent structure model.With SPSS Modeler and Latent 5.0 as the main analysis methods,Chinese medications with a frequency>1.00%were investigated using the latent structure model and association rules,and the medication rules in treating bone flaccidity with TCM were dissected based on the data of frequency. Results:A total of 223 TCM prescriptions were included,with 270 extracted TCM and a total medication frequency of 2340 times.Among them are Achyranthis Bidentatae Radix,Poria,Angelicae Sinensis Radix,Eucommiae Cortex,Rehmanniae Radix Praeparata,and Ginseng Radix Et Rhizoma.They were the high-frequency medicines for treating bone flaccidity,and the efficacy of tonifying medicinal,heat-clearing medicinal,and blood activating and stasis-resolving medicinal were high-frequency medicinal categories.Through the analysis of the evidence by formula,it was concluded that spleen-kidney yang deficiency,kidney deficiency and blood stasis,kidney yang deficiency,qi deficiency/qi stagnation and blood stasis,and liver and kidney yin deficiency were the 6 main types of bone flaccidity,which was generally in line with the etiology of bone flaccidity,which was caused by kidney yang deficiency and accompanied by malfunction of the liver and kidneys.In ancient books,the regulation of the kidney is put into an important position.In this study,19 correlative principles for the treatment of bone flaccidity were derived,whose main combinations are Paeoniae Radix Alba-Angelicae Sinensis Radix,Eucommiae Cortex+Poria-Ginseng Radix Et Rhizoma,Dioscoreae Spongiosae Rhizoma+Cuscutae Semen-Eucommiae Cortex. Conclusions:The medication law of bone flaccidity in the Encyclopaedia of TCM mainly shows that it attaches importance to the regulation of tonifying the liver and kidney to strengthen the tendons and bones and emphasizes that the regulation of the 3 Zang-fu organs,namely the kidney,the liver and the spleen,can play an important role in the treatment of bone flaccidity.

摘要：Objective:To investigate the mechanism of Simiao Yong'an Decoction in alleviating the damage of rheumatoid arthritis(RA),and accordingly provide pharmacological evidence and further experimental support for the application of Simiao Yong'an Decoction,as well as provide a reference direction for the development of new drugs for RA treatments. Materials and methods:Arthritis was induced in Balb/c mice.The animals were randomly divided into 4 groups:control,model,methotrexate(MTX),and Simiao Yong'an Decoction group(n=6).The Simiao Yong'an Decoction group was orally administered 4.5 g·kg-1 of Simiao Yong'an Decoction every day,and the MTX group received a single intraperitoneal injection of 2 mg·kg-1 of MTX.The arthritis symptoms of joints were scored every day after injecting a cocktail antibody.The histopathology injuries and bone destruction of joints were measured by hematoxylin and eosin staining,Safranin-O fast green staining,tartrate-resistant acid phosphatase staining,and micro-computed tomography.The regulation of Simiao Yong'an Decoction on leukocytes was analyzed by flow cytometry.The expression of inflammatory cytokines,chemokines,and matrix metalloproteinases in joints was detected by quantitative real-time polymerase chain reaction.In the network pharmacology analysis,drug targets of Simiao Yong'an Decoction were obtained from Swiss Target Prediction.Disease targets of RA were obtained from the Therapeutic Target Database and Disgenet.The ingredients-targets network,protein-protein interaction network,and gene ontology function enrichment were performed and visualized by Cytoscape software. Results:In the collagen antibody-induced arthritis(CAIA)murine model,Simiao Yong'an Decoction effectively improved arthritis symptoms,decreased the expression of inflammatory cytokines,and reduced joint pathologic damage and bone destruction.In the network pharmacology analysis,multiple active ingredients of Simiao Yong'an Decoction were found to regulate genes related to inflammation,chemotaxis,and collagen degradation in RA,and reduce RA damage by regulating biological processes including leukocyte migration,myeloid cell homeostasis,and collagen degradation metabolism.We further verified that Simiao Yong'an Decoction effectively regulated the number of myeloid cells in CAIA mice.Moreover,Simiao Yong'an Decoction suppressed the expression of myeloid cell-associated chemokines and matrix metalloproteinases in inflamed joints of CAIA mice. Conclusion:Simiao Yong'an Decoction effectively reduces RA damage by regulating myeloid cells and reducing collagen degradation.

摘要：Depression is a refractory disease involving multiple pathologic changes,characterized by long-term disease course,low curative rate,and complex symptoms.However,the pathologic mechanism of this disease is incompletely known.Current research mainly focuses on the monoamine neurotransmitter hypothesis,neuroendocrine-related hypothesis,neuroinflammation hypothesis,and brain structure-function hypothesis.An intimate interplay exists between estrogen with the development and progression of depression.Estrogen receptors are widely distributed in the central nervous system,the expression of which can exert genetic and nongenetic effects to improve depression through regulating the level of neurotransmitters,mediating the function of the hypotha-lamus-pituitarium-adrenal axis,alleviating neuroinflammation,and protecting neurons.This study elaborated on the regulatory effect and mechanism of brain estrogen receptors on depression,hoping to provide new ideas for the clinical treatment of depression.

摘要：Objective:To analyze syndrome differentiation and medication rules for leucorrhea in ancient books of traditional Chinese medicine(TCM)based on the"Chinese Medical Code"using the latent structure model. Methods:The formulations for leucorrhea were searched in the Chinese Medical Code(software),based on which an Excel sheet was created to conduct frequency analysis and construct a matrix of high-frequency medications.The high-frequency medications for leucorrhea were then analyzed using the Latent 5.0 software and a latent structure model.With SPSS Modeler and Latent 5.0 as the main analysis methods,Chinese medications with a frequency>1.00%were investigated using the latent structure model and association rules,and the medication rules in treating leucorrhea with TCM were dissected based on the data of frequency. Results:For 373 kinds of Chinese medicines retrieved from 236 TCM prescriptions,the total medication frequency was 2522.Chinese Angelica(Angelicae Sinensis Radix),White Peony Root(Paeoniae Radix Alba),Indian Buead Tuckahoe(Poria),Common Oyster Shell(Ostreae Concha),and Largehead Atractylodes Rhizome(Atractylodis Macrocephalae Rhizoma)were high-frequency medicines for leucorrhea.Tonic,heat-clearing,and qi-regulating medicines had a high frequency of usage.According to a formula-based analysis of the evidence,the main syndromes of leucorrhea included liver qi affecting the spleen pattern,damp heat accumulation pattern,liver qi stagnation pattern,liver-stomach disharmony pattern,yin deficiency of the liver and kidney pattern,and spleen deficiency with dampness pattern,which are generally in line with the etiology and pathogenesis of leucorrhea,namely pathogenic dampness as the detrimental factor together with spleen-kidney dysfunction.However,in ancient books,emphasis was laid out on the regulation of the liver.This study determined 31 association rules for treating leucorrhea,where the primary compatible medicines contained Chinese Angelica(Angelicae Sinensis Radix)-Nutgrass Galingale Rhizome(Cyperus rotundus),Chinese Angelica(Angelicae Sinensis Radix)-Szechwan Lovage Rhizome(Ligusticum chuanxiong Hort.),White Peony Root(Paeoniae Radix Alba)-Szechwan Lovage Rhizome(Ligusticum chuanxiong Hort.),White Peony Root(Paeoniae Radix Alba)-Adhesive Rehmannia Root Tuber(Rehmanniae Radix)and Tangerine Peel(Citri Reticulatae Pericarpium)-Ternate Pinellia(Rhizoma Pinelliae). Conclusion:The medication rules targeting leucorrhea in the Chinese Medical Code were mainly represented by the regulation of qi and blood,as well as the 3 internal organs—the kidney,spleen,and liver.

摘要：Breast cancer has emerged as one of the most common malignancies among women globally,constituting a major cause of female cancer-related mortality.Among breast cancer patients,the incidence of emotional disorders is notably high,significantly impacting their quality of life and disease prognosis.Traditional Chinese medicine(TCM)offers numerous advantages in addressing emotional disorders.However,currently there are no standardized diagnostic or therapeutic guidelines for TCM management of emotional disturbances accompanying breast cancer.This guideline,authored by a panel of experts in the field of TCM,including specialists in breast oncology,breast surgery,and psychosomatic medicine,is based on the current best evidence and expert insights.It standardizes the terms and definitions,diagnostic criteria,etiology and pathogenesis,clinical staging,and treatment principles of breast cancer with emotional disorders.Meanwhile,the guideline establishes 6 main TCM syndrome types and their corresponding treatment strategies.Its purpose is to serve as a reference and foundation for the clinical syndrome differentiation and treatment of emotional disorders in breast cancer patients.

摘要：The traditional Chinese medicine evaluation indicator system can effectively identify and recognize deficiencies in the implementation of standards and provide a rationale for improving the technical content,enhancing the effectiveness of implementation and pro-moting the dissemination of traditional Chinese medicine culture and technology globally.Evidence-based principles can be an important method to guide the development of traditional Chinese medicine indicators and to promote the application of standards.This paper introduces the development status of NICE indicators and provides reference ideas for constructing evaluation indicators for traditional Chinese medicine standards application based on evidence-based principles.The specific steps for constructing an evaluation indicator system for traditional Chinese medicine standard application include identifying indicator domains,evidence synthesis,developing indicators,constructing an indicator system,cost-effectiveness and resource impact analyses,and finalizing indicators for training and promotion.To promote the further development of traditional Chinese medicine,it is necessary to strengthen the integrated construction of"guidelines-standards-indicators,"accelerate the establishment of a coordination mechanism between domestic and international organizations,and pay attention to the characteristics of traditional Chinese medicine and focus on implications for practice and policy.

摘要：Background:Non-small cell lung cancer(NSCLC)is a highly vascularized solid tumor,and tumor angiogenesis is closely associated with the metastasis and progression of NSCLC.Antiangiogenic drugs can target the tumor microenvironment to degrade existing tumor blood vessels while inhibiting tumor angiogenesis and have become one of the indispensable treatments for patients with advanced NSCLC.Although various new drugs have been tested in different settings of NSCLC,none of them have shown the desired therapeutic effects so far.Therefore,the search for new and effective therapeutic modalities has become a new goal for treating NSCLC. Objective:Eugenol is a phenolic aromatic compound derived from Eugenia caryophyllata,Cinnamomum cassia,etc.,which has historically been used for various medical purposes.Studies have shown that eugenol exhibits significant anticancer effects against several types of cancer;however,its therapeutic effect on angiogenesis remains a mystery.In this study,the in vitro and in vivo antiangiogenic effects of eugenol in NSCLC and the underlying molecular mechanism were explored,which could provide a promising strategy for the treatment of NSCLC. Methods:The effects of eugenol on the proliferative capacity of human umbilical vein endothelial cells(HUVECs)and A549 cells were examined by methyl thiazolyl tetrazolium assay.The migration and invasion of eugenol-treated HUVECs were evaluated by wounding-healing and transwell assay,and the angiogenesis was measured by tube formation assay.The expression of angiogenesis-related genes and proteins,as well as the JAK2/STAT3 pathway,was evaluated by real-time quantitative PCR and western blot.Flow cytometry was performed to detect the effect of eugenol on the apoptotic profile of A549 cells.Finally,the A549 tumor-bearing nude mice were constructed to evaluate the in vivo anti-NSCLC activity of eugenol. Results:Eugenol inhibited the migration,invasion,and tube formation of HUVECs.Meanwhile,eugenol blocked the phosphorylation of vascular endothelial growth factor reporter-2 and inhibited the expression of other angiogenesis-related proteins.In addition,eugenol suppressed the expression of p-JAK2 and p-STAT3 in HUVECs and A549 cells.Eugenol also suppressed the proliferation of A549 cells by promoting apoptosis and inhibited tumor growth and microvessel formation in A549 cell xenograft-bearing nude mice. Conclusions:Eugenol could be a potential lead compound for the treatment of NSCLC by blocking the vascular endothelial growth factor/vascular endothelial growth factor reporter-2 and JAK2/STAT3 signaling pathways.

摘要：Background:Acute lung injury(ALI)is a high-fatality respiratory disease,and the development of new therapeutic agents is ongoing.Chuanxiong Rhizoma has been prescribed for the therapy of ALI in traditional Chinese medicine. Objective:The purpose of this article is to explore the effective ingredients,targets,and mechanisms in the treatment of Chuanxiong Rhizoma on ALI. Methods:The active ingredients of Chuanxiong Rhizoma were obtained in the TCMSP,and their potential targets and ALI targets were predicted in TCMSP,Swiss target prediction,and Genecards database.A PPI network was constructed in the string online platform,and KEGG and GO enrichment analysis were conducted in the metascape online platform.Phytochemical investigation of Chuanxiong Rhizoma was performed with chemical separation methods and structural elucidation techniques,and their pharmacological effects were evaluated using LPS-induced mouse ALI model and cell-based assays. Results:Network pharmacology analyses indicated that the treatment of Chuanxiong Rhizoma on ALI was associated with its anti-inflammatory effect.The key genes mainly include TNF,STAT3,EGFR,AKT1,BCL2,CASP3,and SRC,and the active compounds are its signature component,phthalides.Phytochemical investigation led to the elucidation of 23 phthalides,which demonstrated an anti-inflammatory effect in vitro and in vivo.Of which,chuanxiongdiolide A,levistilide A,butylphthalide,and senkyunolide A were indeed effective in mitigating ALI in an LPS-induced mouse model. Conclusions:The combined network pharmacological,phytochemical,and pharmacological investigations revealed that the therapeutical effect of Chuanxiong Rhizoma against ALI was associated with inhibition of the inflammatory response by phthalides.

摘要：Objective:To analyze clinical trials of traditional medicine(including Chinese herbal medicine and nonpharmacological therapies)for the treatment of type 2 diabetes mellitus(T2DM)registered in the International Clinical Trials Registry Platform(ICTRP),and accordingly to explore their clinical trial registration characteristics,development trend and intervention status,in an attempt to provide references for future research design,diagnosis and management of traditional Chinese medicine therapy for T2DM. Methods:The clinical trials related to Chinese herbal medicine and nonpharmacological therapies for treating T2DM were retrieved on the ICTRP online from the time of database construction to August 13,2023,to analyze the time of registration,country and institution of the study,source of funding,type and design of the study,randomization and blinding methods,clinical staging,therapeutic measures,and main therapeutic effect indexes.Descriptive statistical analysis was performed using R4.3.0 and Excel software. Results:A total of 774 clinical trials for T2DM treatment were included,of which 127 were traditional herbal therapies and 647 were nonpharmacological therapies.The T2DM clinical trial registration institutions were distributed in 50 countries worldwide involving 15 clinical registration platforms,with the most registrations in Iran,China,and Australia,and the top 3 registration platforms were the Iranian Clinical Trial Registry,the Australian New Zealand Clinical Trials Registry,and the ICTRP.Universities(551,71.19%)were the main funding sources.Intervention studies(750,96.90%)were the primary study type,including randomized controlled trials(432,56.4%),and 225 studies mentioned the blinding method.A total of 530(68.48%)with a sample size≤100 were included.Study phases were predominantly phase 2 and phase 3(108,51.43%).The interventions of traditional medicine for T2DM were composed of Chinese herbal medicines(mainly ginseng and astragalus compound),nonpharmacological therapies(mainly exercise and diet therapies),and 2 or more comprehensive treatment regimes.According to the type of study design,the first 3 main therapeutic indexes were fasting blood glucose(286 times),glycated hemoglobin(282 times),and insulin resistance(120 times),and the top 3 secondary therapeutic indexes were body mass index(179 times),fasting blood glucose(175 times),and glycated hemoglobin(134 times). Conclusion:The study dissects the current status and trend of registration of clinical trials on traditional medicine for T2DM treatment.The number of trial registrations is on the rise year by year,and there are obvious geographical differences in the countries and platforms of registration.The trial design is mainly randomized controlled blind trials with a sample size of<100,and the main interventions are nonpharmacological therapies.Correct and standardized registration of clinical trials and timely reporting of study results are greatly important to facilitate the implementation of clinical trials,reduce publication bias,provide high-level diagnostic and therapeutic bases for clinical practice guidelines,and develop effective treatment strategies.This study is expected to help other scholars,health care professionals,patients,and the public to understand the latest research trends and hotspots in this field and provide certain references and inspirations for the future research design and clinical practice of traditional Chinese medicine in the treatment of T2DM.

摘要：Polyporaceae fungi are widely found in nature and have long been an important part of the field of traditional Chinese medicine field.The numerous health benefits of Polyporaceae fungi may be related to their polysaccharides,which have significant biological activities in terms of antitumor,immunomodulation,antioxidation,liver protection,and blood lipid-lowering effects.Studies have shown that different extraction methods have a significant impact on the structural characteristics and biological activity of poly-saccharides.The structural characteristics of fungal polysaccharides,such as composition,molecular weight,branching degree,and glycosidic bond type,are closely related to their biological activity.This article has systematically reviewed the relationship between the extraction and purification methods,structural characteristics,and biological activities of 5 typical fungal poly-saccharides,aiming to provide a scientific basis for the application of polypore fungal polysaccharides in the field of traditional Chinese medicine and lay the foundation for their further research and development.

摘要：Objective:Mendelian randomization(MR)has been widely utilized for causal inference between diseases,and its implementation within the domain of traditional Chinese medicine(TCM)is considered feasible.Although previous clinical and epidemiological studies have demonstrated a close relationship between insomnia and depression,the inherent genetic factors underlying these associations are unclear.The aim of this study was to evaluate the causal relationship between depression and insomnia via bidirectional 2-sample MR and increase the understanding of the TCM theory of treating different diseases with the same method,particularly in the context of comorbid depression and insomnia. Methods:Genetic data related to depression and insomnia were extracted from published genome-wide association studies(GWAS)data sets.Single-nucleotide polymorphisms(SNPs)associated with depression and insomnia were used as instrumental variables to construct an"SNP-exposure-outcome"model.Bidirectional 2-sample MR analysis was conducted via inverse-variance weighted(IVW),weighted median,MR Egger regression,simple mode,and weighted mode methods.Furthermore,heterogeneity tests,pleiotropy analyses,and sensitivity analyses were performed. Results:The MR results revealed a causal relationship between depression and an increased risk of developing insomnia(IVW,OR=1.400,95%CI:1.246-1.573,P<0.001),and a causal relationship between insomnia and an increased risk of developing depression(IVW,OR=1.204,95%CI:1.144-1.266,P<0.001). Conclusions:There is a bidirectional causal relationship between depression and insomnia.These findings provide new theoretical support for the TCM approach of treating different diseases with the same method in the prevention and treatment of depression and insomnia and provide a scientific basis for the modernization of TCM.

摘要：Ojective:To explored the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and its mechanism from the aspect of the anti-infiammatory response. Background:Bipolar disorder is a very common,often misdiagnosed mental disorder strongly associated with comorbidity,disability,and premature mortality.Bipolar depression(ie,depressive episode in bipolar disorder)is poorly responsive to available treatments.Acupuncture at back-shu points of five zang and Geshu(BL 17),a prescription from Dr.Leting Wang,is a popular therapy for depression in China.Its effectiveness and safety for bipolar depression are yet to be verified by clinical studies. Methods:The study is a single-center,prospective,randomized controlled trial involving 72 patients diagnosed with bipolar depression.Participants will be randomized either to the study group or the control group in a 1:1 ratio.All participants will receive mood stabilizer therapy.In addition,the study group will receive acupuncture therapy at back-shu points of five zang and Geshu(BL 17),three times per week.The control group will orally take the antidepressant bupropion.Observation and intervention will last for 8 consecutive weeks.Outcome measurements include Hamilton Depression Rating Scale-17,Hamilton Anxiety Rating Scale,Clinical Global Impression Scale,Young Manic Rating Scale,Treatment Emergent Symptom Scale,serum levels of anti-infiammatory cytokines[interleukin-4(IL-40),IL-10,and transforming growth factor-β,pro-infiammatory cytokines(IL-1β,IL-6,and tumor necrosis factor-α),brain-derived neurotrophic factor,and C-reactive protein.Assessments will be conducted at baseline,first,second,fourth,and eighth weeks after randomization.Safety assessments will be performed throughout the study. Discussion:The results of this study are expected to verify the effectiveness and safety of acupuncture at back-shu points of five zang and Geshu(BL 17)for bipolar depression,and explore its therapeutic mechanisms from the point of anti-infiammation.

摘要：Glycoalkaloids(GAs)are a class of special secondary metabolites found in plants.Studies have found that they have a wide range of pharmacological activities,such as antiviral,antifungal,and anticancer properties,with significant potential for development and utilization value.At present,alkaloid glucosides mainly fall into 2 categories:indole alkaloid glucosides and steroid alkaloid glucosides.In addition,there are small amounts of quinolines,isoquinolines,isoguanines,and other alkaloids.At present,only a few of the GAs have been found,which is inconsistent with the diversity of alkaloids.In addition,only a few GAs have been isolated and identified.This paper reviews the natural alkaloid glycosides from the perspectives of structural classification and pharmacological activity.It analyzes the reasons for the limited number of isolated components and pro-poses a rational separation method based on the literature.To provide references for the separation,identification,and bioactivity of glycoalkaloids.

摘要：Background:Even with long-term complete suppression of the virus through antiretroviral therapy(ART),people infected with HIV cannot attain optimal immune reconstitution.This phenomenon is called immune reconstitution deficiency,there are no effective therapeutic interventions for immune reconstitution deficiency in modern medicine. Objective:To evaluate the efficacy and safety of ART with Shenling Guben Granules Traditional Chinese medicine in boosting immunological reconstitution compared with ART alone. Methods:This was a randomized,double-blind,placebo-controlled,multicenter clinical trial evaluating the efficacy and safety of ART combined with Chinese medicine.The individuals aged 18-65 years with poor immune reconstitution following ART were included in this trial.The primary outcome was a change in the absolute value of CD4+T lymphocytes after 72 weeks of combined ART and Chinese medicine administration.Secondary outcomes included changes in CD4+T lymphocyte functional subpopulations,activated T lymphocyte subpopulations,CD4+T lymphocyte proliferation,and T lymphocyte apoptosis from baseline to after 72 weeks.We also evaluated efficacy at 24-and 48-week intervals to better understand the dynamics of the trial drug's efficacy. Results:There was a significant increase in CD4+cell counts in groups treated with the Shenling Guben Granules after 24,48,and 72 weeks of treatment(P<0.05),and the difference in CD4+cell counts at 24 weeks of treatment was statistically significant(P=0.010).After 48 and 72 weeks of therapy,the CD4+CD38+cell counts in the Shenling Guben Granules group were significantly higher than in the control group(P<0.05).In the subgroup analysis of CD4+cell counts≥200 cells/mm3,the CD4+cell counts in the treatment group were higher than the control group after treatment for 24,48,and 72 weeks(P<0.05). Discussion:CD4 cell counts in HIV/AIDS patients with immunological reconstitution insufficiency can be improved to a certain extent using Shenling Guben Granules.The greater the CD4 cell count at the start,the better the therapy response.Furthermore,Shenling Guben Granules have the efficacy and safety to prevent aberrant immunological activation.A large sample size,long-term follow-up,and multiple efficacy indicators were employed to assess the therapy's safety.Our findings will lead to new therapeutic alternatives for HIV/AIDS patients suffering from immune reconstitution deficiency. Clinical Trial Registry:Name of the registry:Sundy on promote the reconstruction of Inadequate responders in HIV/AIDS patients after combined antiretroviral therapy by Shen Ling Gu Ben Granules;Chictr.org.cn Identifier:ChiCTR1800015290,registered on March 21,2018(