1.Clinical Observation of Modified Zhigancao Tang in Treating Patients with Liver and Kidney Deficiency of Parkinson's Disease and Its Effect on Neuronal Signal-related Proteins
Yifo WEI ; Furong LYU ; Jia YAO ; Guonian LI ; Xianyi LUO ; Meng LUO ; Zhengzheng WEN ; Qiuqi LI ; Yihan LIU ; Linlin YANG ; Rui ZUO ; Wenxin DANG ; Fang MI ; Xiaoyan WANG ; Zhigang CHEN ; Fan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):166-173
ObjectiveMicrotube associated protein-2 (MAP-2), alpha-tubulin (α-tubulin), and synaptophysin (SYP) are important proteins in neuronal signal communication. This paper observed the effects of modified Zhigancao Tang on the expression of serum α-Synuclein (α-Syn) and its oligomers, MAP-2, α-tubulin, and SYP of patients with liver and kidney deficiency of Parkinson's disease (PD), analyzed their correlation, and evaluated the therapeutic effect of modified Zhigancao Tang in patients with liver and kidney deficiency of PD based on α-Syn transmission pathway mediated by neuronal communication in vivo. MethodsA total of 60 patients with PD who met the inclusion criteria were randomly divided into a treatment group (30 cases) and a control group (30 cases). Both groups were treated on the basis of PD medicine, and the treatment group was treated with modified Zhigancao Tang. Both groups were treated for 12 weeks. The changes in UPDRS score, TCM syndrome score, and expression of serum α-Syn and its oligomers, MAP-2, α-tubulin, and SYP were observed before and after 12 weeks of treatment in each group. The correlation between the above-mentioned serum biological indexes and the levels of serum α-Syn and its oligomers was analyzed. ResultsAfter treatment, the TCM syndrome score, UPDRS score, UPDRS-Ⅱ score, and UPDRS-Ⅲ score of the treatment group were significantly decreased (P<0.05, P<0.01). The UPDRS score, UPDRS-Ⅱ score, and UPDRS-Ⅲ scores in the treatment group were significantly decreased compared with those in the control group after treatment (P<0.05). After treatment, the total effective rate of the control group was 63.3% (19/30), and that of the treatment group was 86.7% (26/30). The clinical effect of the observation group was better than the control group (Z=-2.03, P<0.05). The total effective rate of the observation group was better than that of the control group, and the difference was statistically significant (χ2=5.136, P<0.05). After treatment, the oligomer level of serum α-Syn and MAP-2 level in the treatment group were significantly decreased (P<0.05, P<0.01). The levels of serum α-Syn and its oligomers, as well as α-tubulin in the treatment group, were significantly decreased compared with those in the control group after treatment (P<0.05, P<0.01). Serum α-Syn was correlated with serum MAP-2 and α-Syn oligomer in patients with PD (P<0.05, P<0.01) but not correlated with serum SYP . Serum α-Syn oligomers of patients with PD were correlated with serum MAP-2 and α-tubulin (P<0.05, P<0.01) but not correlated with serum SYP level. Serum SYP of patients with PD was correlated with serum MAP-2 (P<0.05). ConclusionModified Zhigancao Tang has a therapeutic effect on patients with liver and kidney deficiency of PD by inhibiting the production of α-Syn oligomers and intervening α-Syn microtubule transport pathway in vivo.
2.Analysis of Mechanism of Xingpi Capsules in Treatment of Functional Dyspepsia Based on Transcriptomics
Rongxin ZHU ; Mingyue HUANG ; Keyan WANG ; Xiangning LIU ; Yinglan LYU ; Gang WANG ; Fangfang RUI ; Qiong DENG ; Jianteng DONG ; Yong WANG ; Chun LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):164-172
ObjectiveTo investigate the ameliorative effect of Xingpi capsules on functional dyspepsia(FD) and the potential mechanism. MethodsSixty SPF-grade male SD neonatal rats(7 days old) were randomly divided into the normal group(n=12) and the modeling group(n=48), and the FD model was prepared by iodoacetamide gavage in the modeling group. After the model was successfully prepared, the rats in the modeling group were randomly divided into the model group, the low-dose and high-dose groups of Xingpi capsules(0.135, 0.54 g·kg-1) and the domperidone group(3 mg·kg-1), with 12 rats in each group. Rats in the normal and model groups were gavaged with distilled water, and rats in the rest of the groups were gavaged with the corresponding medicinal solution, once a day for 7 d. The general survival condition of the rats was observed, and the water intake and food intake of the rats were measured, the gastric emptying rate and the small intestinal propulsion rate were measured at the end of the treatment, the pathological damage of the rat duodenum was examined by hematoxylin-eosin(HE) staining, and the expressions of colonic tight junction protein(Occludin) and zonula occludens protein-1(ZO-1) were detected by immunofluorescence. The differentially expressed genes in the duodenal tissues of the model group and the normal group, and the high-dose group of Xingpi capsules and the model group were detected by transcriptome sequencing after the final administration, and Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) enrichment analyses were carried out. The transcriptomic results were validated by Western blot, immunofluorescence, and real-time fluorescence quantitative polymerase chain reaction(Real-time PCR), and the active ingredients of Xingpi capsules were screened for molecular docking with the key targets. ResultsCompared with the normal group, the general survival condition of rats in the model group was poorer, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly reduced(P<0.05), inflammatory infiltration was seen in duodenal pathology, and the fluorescence intensities of Occludin and ZO-1 in the colon were significantly reduced(P<0.01). Compared with the model group, the general survival condition of rats in the high-dose group of Xingpi capsules improved significantly, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly increased(P<0.05), the duodenal pathology showed a decrease in inflammatory infiltration, and the fluorescence intensities of colonic Occludin and ZO-1 were significantly increased(P<0.01). Transcriptomic results showed that Xingpi capsules might exert therapeutic effects by regulating the phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt) through the key genes such as Slc5a1, Abhd6. The validation results showed that compared with the normal group, the phosphorylation levels of PI3K and Akt proteins, the protein expression level of interleukin(IL)-1β, and the fluorescence intensities of IL-6 and IL-1β were significantly increased in the model group(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3, Slc5a9 and other key genes were significantly increased(P<0.01). Compared with the model group, the phosphorylation levels of PI3K and Akt, the protein expression level of IL-1β and the fluorescence intensities of IL-6 and IL-1β in the high-dose group of Xingpi capsules were significantly reduced(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3 and Slc5a9 were significantly reduced(P<0.05). Weighted gene co-expression network analysis and molecular docking results showed that E-nerolidol and Z-nerolidol in Xingpi capsules were well bound to ABDH6 protein, and linarionoside A, valerosidatum and senkirkine were well bound to Slc5a1 protein. ConclusionXingpi capsules can effectively improve the general survival and gastrointestinal motility of FD rats, its specific mechanism may be related to the inhibition of PI3K/Akt signaling pathway to alleviate the low-grade inflammation of duodenum, and E-nerolidol, Z-nerolidol, linarionoside A, valerosidatum and senkirkine may be its key active ingredients.
3.Analysis of Mechanism of Xingpi Capsules in Treatment of Functional Dyspepsia Based on Transcriptomics
Rongxin ZHU ; Mingyue HUANG ; Keyan WANG ; Xiangning LIU ; Yinglan LYU ; Gang WANG ; Fangfang RUI ; Qiong DENG ; Jianteng DONG ; Yong WANG ; Chun LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):164-172
ObjectiveTo investigate the ameliorative effect of Xingpi capsules on functional dyspepsia(FD) and the potential mechanism. MethodsSixty SPF-grade male SD neonatal rats(7 days old) were randomly divided into the normal group(n=12) and the modeling group(n=48), and the FD model was prepared by iodoacetamide gavage in the modeling group. After the model was successfully prepared, the rats in the modeling group were randomly divided into the model group, the low-dose and high-dose groups of Xingpi capsules(0.135, 0.54 g·kg-1) and the domperidone group(3 mg·kg-1), with 12 rats in each group. Rats in the normal and model groups were gavaged with distilled water, and rats in the rest of the groups were gavaged with the corresponding medicinal solution, once a day for 7 d. The general survival condition of the rats was observed, and the water intake and food intake of the rats were measured, the gastric emptying rate and the small intestinal propulsion rate were measured at the end of the treatment, the pathological damage of the rat duodenum was examined by hematoxylin-eosin(HE) staining, and the expressions of colonic tight junction protein(Occludin) and zonula occludens protein-1(ZO-1) were detected by immunofluorescence. The differentially expressed genes in the duodenal tissues of the model group and the normal group, and the high-dose group of Xingpi capsules and the model group were detected by transcriptome sequencing after the final administration, and Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) enrichment analyses were carried out. The transcriptomic results were validated by Western blot, immunofluorescence, and real-time fluorescence quantitative polymerase chain reaction(Real-time PCR), and the active ingredients of Xingpi capsules were screened for molecular docking with the key targets. ResultsCompared with the normal group, the general survival condition of rats in the model group was poorer, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly reduced(P<0.05), inflammatory infiltration was seen in duodenal pathology, and the fluorescence intensities of Occludin and ZO-1 in the colon were significantly reduced(P<0.01). Compared with the model group, the general survival condition of rats in the high-dose group of Xingpi capsules improved significantly, and the water intake, food intake, gastric emptying rate and small intestinal propulsion rate were all significantly increased(P<0.05), the duodenal pathology showed a decrease in inflammatory infiltration, and the fluorescence intensities of colonic Occludin and ZO-1 were significantly increased(P<0.01). Transcriptomic results showed that Xingpi capsules might exert therapeutic effects by regulating the phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt) through the key genes such as Slc5a1, Abhd6. The validation results showed that compared with the normal group, the phosphorylation levels of PI3K and Akt proteins, the protein expression level of interleukin(IL)-1β, and the fluorescence intensities of IL-6 and IL-1β were significantly increased in the model group(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3, Slc5a9 and other key genes were significantly increased(P<0.01). Compared with the model group, the phosphorylation levels of PI3K and Akt, the protein expression level of IL-1β and the fluorescence intensities of IL-6 and IL-1β in the high-dose group of Xingpi capsules were significantly reduced(P<0.05, P<0.01), and the mRNA levels of Slc5a1, Abhd6, Mgam, Atp1a1, Slc7a8, Cdr2, Chrm3 and Slc5a9 were significantly reduced(P<0.05). Weighted gene co-expression network analysis and molecular docking results showed that E-nerolidol and Z-nerolidol in Xingpi capsules were well bound to ABDH6 protein, and linarionoside A, valerosidatum and senkirkine were well bound to Slc5a1 protein. ConclusionXingpi capsules can effectively improve the general survival and gastrointestinal motility of FD rats, its specific mechanism may be related to the inhibition of PI3K/Akt signaling pathway to alleviate the low-grade inflammation of duodenum, and E-nerolidol, Z-nerolidol, linarionoside A, valerosidatum and senkirkine may be its key active ingredients.
4.Compatibility Principle and Efficacy Characteristics of Fuzi Shanzhuyutang from Perspective of Tangye Jingfa Tu
Xuxiao LYU ; Mingyue QI ; Hui ZHANG ; Rui JIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):210-216
Tangye Jingfa Tu is an important content in the ancient book Fuxingjue from Dunhuang, implying the fundamental principles of formula compatibility in traditional Chinese medicine (TCM). Our research group has delved into nearly 200 formulas (both classical and contemporary formulas) recorded in the Fangjixue under the theoretical framework of the deficiency or excess syndrome of five Zang-organs together with the reinforcing and reducing effects of Chinese medicinal materials of five flavors. We have initially elucidated the essential principles of the correspondence between formulas and syndromes, revealing the deep-level logic of medicinal material selection and compatibility, thus enriching the understanding about the core characteristics and essence of the diseases and syndromes targeted by formulas. The lunar year of 2024 is Jia Chen year. The formula recorded in Sanyin Jiyi Bingzheng Fanglun for treating the epidemic diseases characterized by excessive earth, prevalent dampness and wetness, and invasion of pathogenic factors into the kidney water in Jia Chen year is Fuzi Shanzhuyutang. Therefore, elucidating the compatibility principle of Fuzi Shanzhuyutang is of great significance for clinical prescription and medication modification in Jia Chen year. According to the Tangye Jingfa Tu theory on the deficiency or excess of syndrome of five Zang-organs and the reinforcing and reducing effects of Chinese medicinal materials of five flavors, this article dissects Fuzi Shanzhuyutang regarding the etiology and pathogenesis of the main indications, as well as the five-element properties and efficacy characteristics of Chinese medicinal materials constituting this formula. It explains the compatibility principles of Fuzi Shanzhuyutang and puts forward suggestions for modifying the formula to address different indications, providing a reference for guiding clinical syndrome differentiation and treatment.
5.Compatibility Principle and Efficacy Characteristics of Fuzi Shanzhuyutang from Perspective of Tangye Jingfa Tu
Xuxiao LYU ; Mingyue QI ; Hui ZHANG ; Rui JIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):210-216
Tangye Jingfa Tu is an important content in the ancient book Fuxingjue from Dunhuang, implying the fundamental principles of formula compatibility in traditional Chinese medicine (TCM). Our research group has delved into nearly 200 formulas (both classical and contemporary formulas) recorded in the Fangjixue under the theoretical framework of the deficiency or excess syndrome of five Zang-organs together with the reinforcing and reducing effects of Chinese medicinal materials of five flavors. We have initially elucidated the essential principles of the correspondence between formulas and syndromes, revealing the deep-level logic of medicinal material selection and compatibility, thus enriching the understanding about the core characteristics and essence of the diseases and syndromes targeted by formulas. The lunar year of 2024 is Jia Chen year. The formula recorded in Sanyin Jiyi Bingzheng Fanglun for treating the epidemic diseases characterized by excessive earth, prevalent dampness and wetness, and invasion of pathogenic factors into the kidney water in Jia Chen year is Fuzi Shanzhuyutang. Therefore, elucidating the compatibility principle of Fuzi Shanzhuyutang is of great significance for clinical prescription and medication modification in Jia Chen year. According to the Tangye Jingfa Tu theory on the deficiency or excess of syndrome of five Zang-organs and the reinforcing and reducing effects of Chinese medicinal materials of five flavors, this article dissects Fuzi Shanzhuyutang regarding the etiology and pathogenesis of the main indications, as well as the five-element properties and efficacy characteristics of Chinese medicinal materials constituting this formula. It explains the compatibility principles of Fuzi Shanzhuyutang and puts forward suggestions for modifying the formula to address different indications, providing a reference for guiding clinical syndrome differentiation and treatment.
6.Network Meta-analysis of Oral Chinese Patent Medicine in Adjuvant Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Binyang YU ; Jing YANG ; Xinyue DAI ; Jiaxin XU ; Xing LYU ; Yiming WANG ; Rui GAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(9):174-185
ObjectiveTo evaluate the efficacy and safety of various oral Chinese patent medicines in the adjuvant treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) based on network Meta-analysis. MethodRandomized controlled trials (RCTs) of oral Chinese patent medicine in the adjuvant treatment of CP/CPPS were retrieved from the databases of China National Knowledge Infrastructure (CNKI), Wanfang, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science from database inception to November, 2022. The quality of the included literature was evaluated according to the Cochrane risk-of-bias tool, and the data were analyzed by RevMan 5.4 and Stata 16 software. ResultA total of 63 RCTs were included, with 13 kinds of oral Chinese patent medicines involved, including Qianlie Shutong capsules, Ningmitai capsules, Qianlie Beixi capsules, Sanjin tablets, etc. The results of the network Meta-analysis showed that in terms of clinical effective rate, the intervention measure ranked first was Qianlie Beixi capsules combined with conventional western medicine. In terms of reducing pain, the intervention measure ranked first was Sanjin tablets combined with conventional western medicine. In terms of reducing urination disorder, the intervention measure ranked first was Relinqing granules combined with conventional western medicine. In terms of improving quality of life, the intervention measure ranked first was Qianlie Beixi capsules combined with conventional western medicine. In terms of reducing the total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, the intervention measure ranked first was Yinhua Miyanling tablets combined with conventional western medicine. In terms of reducing leukocyte count in prostatic secretions, the intervention measure ranked first was Qianlie Jiedu capsules combined with conventional western medicine. In terms of safety, the intervention measure with the least adverse reactions was Qianlie Shutong capsules combined with conventional western medicine. The cluster analysis results showed that Qianlie Shutong capsules combined with conventional western medicine had outstanding efficacy and high safety. ConclusionOral Chinese patent medicine in the adjuvant treatment of CP/CPPS can improve the comprehensive efficacy, reduce the NIH-CPSI score and leukocyte count in prostatic secretions, and improve the quality of life of patients. For clinical treatment, the preferred choice is Qianlie Beixi capsules or Qianlie Shutong capsules combined with conventional western medicine. Limited by the quantity and quality of literature included in this study, the results need to be verified by high-quality studies with a larger sample size.
7.Rapid Determination of 32 Kinds of Veterinary Drug Residues in Eggs Using Modified QuEChERS Based on Reduced Graphene Oxide-coated Melamine Sponge by Ultra-High Liquid Chromatography-Tandem Mass Spectrometry
Xu XU ; Jia LYU ; Lan-Rui YANG ; Zhu-Chen HOU ; Bao-Cheng JI ; Yan-Hong BAI
Chinese Journal of Analytical Chemistry 2024;52(1):121-129,中插38-中插43
A rapid analytical method for simultaneous determination of 32 kinds of multi-residue veterinary drugs in eggs was developed using a modified QuEChERS technique based on a reduced graphene oxide-coated melamine sponge(r-GO@MeS)by ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS).The influences of graphene oxide(GO)concentrations,sponge dosages,and purification modes on drug recoveries were investigated during the purification process.The optimal purification conditions involved using a GO concentration of 0.5 mg/mL,a sponge dosage of 6.0 cm3/mL,and a dynamic purification mode of 5 extrusion cycles.Separation was achieved using an Agilent Eclipse Plus C18 RRHD column(100 mm×2.1 mm,1.8 μm),and quantitative analysis was performed by the external standard method using an electrospray ionization source(ESI)in multiple reaction monitoring(MRM)mode.The results showed that all 32 kinds of veterinary drugs exhibited good linear correlation with coefficients greater than 0.999,and matrix effects(MEs)ranging from?7.8%to 18.9%.The limits of detection(LODs)and quantification(LOQs)ranged from 0.2 to 10.2 μg/kg and from 0.6 to 28.0 μg/kg,respectively.The recoveries for the three spiked levels were in the range of 66.5%?117.5%,with intra-day and inter-day precision(Relative standard deviation)below 13.3%and 16.3%,respectively.The synthetic r-GO@MeS exhibited efficient matrix purification without the need of high-speed centrifugation or strong magnetic field assistance.This significantly shorted the sample pretreatment time and improved the convenience of the matrix purification process.Combined with UPLC-MS/MS,the method was suitable for the rapid determination of multi-residue veterinary drugs in eggs.
8.The penile vibrating perception threshold assay can help diagnose the severity of erectile dysfunction
Kunlong LYU ; Tao ZHENG ; Tianbiao ZHANG ; Yonghao NAN ; Rui WANG
Journal of Modern Urology 2024;29(2):119-121
【Objective】 To analyze the application value of penile vibrating perception threshold measurement in the diagnosis of erectile dysfunction (ED) and provide reference for the seversity of ED patients. 【Methods】 The clinical data, Erectile Hardness Scale (EHS) score, International Index of Erectile Function Questionnaire-5 (IIEF-5) score, and the vibrating perception threshold (VPT) of the penis of 257 patients with decreased erectile function as the main complaint or accompanying symptoms treated during Jan. and Dec.2021 were retrospectively collected and analyzed.Patients with EHS=4 and IIEF-5≥22 were classified into the normal group, and the rest into the ED group.The differences in VPT in patients with different EHS scores were compared, and the correlation between IIEF-5 and VPT was analyzed.The diagnostic value of VPT for ED was evaluated with receiver operating characteristic (ROC) curve. 【Results】 The difference in penile VPT among patients with different EHS scores was statistically significant (P<0.05).With the decrease of EHS score, VPT showed an increasing trend.Glans VPT was negatively correlated with IIEF-5 score (ρ=-0.22, P<0.001), and penile shaft VPT was also negatively correlated with IIEF-5 score (ρ=-0.26, P<0.001).The VPT of glans penis [(4.17±1.37) V vs.(3.47±1.24) V, P=0.009] and the VPT of penis body [(3.73±1.41) V vs.(2.99±1.14)V, P=0.003] in the ED group were both higher than those in the normal group.The area under the ROC curve (AUC) of the glans VPT was 0.642.When the cut-off value was 3.537 V, the sensitivity was 63.4%, and the specificity was 63.6%.The AUC of the penile shaft VPT was 0.659.When the cut-off value was 2.775 V, the sensitivity was 72.3%, with a specificity of 54.5%. 【Conclusion】 The penile VPT of ED patients is higher than that of normal ones, and there is a correlation between VPT and the severity of ED.Severe ED is associated with higher VPT.The measurement of penile VPT is helpful for the clinical diagnosis of ED patients.
9.Discussion on the Scientific Connotation of Disease Mechanism of Stasis and Toxin Interaction of Liver Cancer based on Neutrophil Extracellular Traps
Rui QIANG ; Shuang LI ; Wenliang LYU ; Guowang YANG
Journal of Traditional Chinese Medicine 2024;65(23):2394-2398
This article is to illustrate the connection between neutrophil extracellular traps (NETs) and stasis-toxin interactions during the development of liver cancer, and to provide ideas for the prevention and treatment of liver cancer. It is believed that the mechanism of tumor-related thrombosis formation caused by NETs is closely related to "stasis" in traditional Chinese medicine (TCM), and the continuous maintenance or enhancement of tumor microenvironment by NETs is closely related to "toxin" in TCM; the strong coagulation-promoting effect of NETs makes the local microenvironment, which can be regarded as the toxin caused by blood stasis; the changes of tumor microenvironment induced by NETs further induced platelet aggregation, which may present a state of stasis caused by toxin; the pathological changes of liver cancer caused by NETs can be regarded as the microscopic manifestation of the mechanism of stasis-toxin interaction of liver cancer.
10.Diagnostic and intervention value of implantable cardiac monitor in patients over 60 years of age with unexplained syncope
Rui WANG ; Yanfei ZHANG ; Hongchao ZHANG ; Jia WANG ; Shuhui SHEN ; Jiabin TONG ; Junpeng LIU ; You LYU ; Jia CHONG ; Zhilei WANG ; Xin JIN ; Lin SUN ; Xu GAO ; Yan DAI ; Jing LIANG ; Haitao LI ; Tong ZOU ; Jiefu YANG
Chinese Journal of Cardiology 2024;52(7):784-790
Objective:To investigate the value of implantable cardiac monitor (ICM) in the diagnosis and treatment of patients over 60 years old with unexplained syncope.Methods:This was a multi-center, prospective cohort study. Between June 2018 and April 2021, patients over the age of 60 with unexplained syncope at Beijing Hospital, Fuwai Hospital, Beijing Anzhen Hospital and Puren Hospital were enrolled. Patients were divided into 2 groups based on their decision to receive ICM implantation (implantation group and conventional follow-up group). The endpoint was the recurrence of syncope and cardiogenic syncope as determined by positive cardiac arrhythmia events recorded at the ICM or diagnosed during routine follow-up. Kaplan‐Meier survival analysis was used to compare the differences of cumulative diagnostic rate between the 2 groups. A multivariate Cox regression analysis was performed to determine independent predictors of diagnosis of cardiogenic syncope in patients with unexplained syncope.Results:A total of 198 patients with unexplained syncope, aged (72.9±8.25) years, were followed for 558.0 (296.0,877.0) d, including 98 males (49.5%). There were 100 (50.5%) patients in the implantation group and 98 (49.5%) in the conventional follow-up group. Compared with conventional follow-up group, patients in the implantation group were older, more likely to have comorbidities, had a higher proportion of first degree atrioventricular block indicated by baseline electrocardiogram, and had a lower body mass index (all P<0.05). During the follow-up period, positive cardiac arrhythmia events were recorded in 58 (58.0%) patients in the ICM group. The diagnosis rate (42.0% (42/100) vs. 4.1% (4/98), P<0.001) and the intervention rate (37.0% (37/100) vs. 2.0% (2/98), P<0.001) of cardiogenic syncope in the implantation group were higher than those in the conventional follow-up group (all P<0.001). Kaplan-Meier survival analysis showed that the cumulative diagnostic rate of cardiogenic syncope was significantly higher in the implantation group than in the traditional follow-up group ( HR=11.66, 95% CI 6.49-20.98, log-rank P<0.001). Multivariate analysis indicated that ICM implantation, previous atrial fibrillation, diabetes mellitus or first degree atrioventricular block in baseline electrocardiogram were independent predictors for cardiogenic syncope (all P<0.05). Conclusions:ICM implantation improves the diagnosis and intervention rates in patients with unexplained syncope, and increases diagnostic efficiency in patients with unexplained syncope.

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