1.An Analysis of Clinical Trial Registration Characteristics for Traditional Chinese Medicine in the Treatment of Overweight/Obesity
Rumeng MEI ; Ningzi ZANG ; Chengjun GONG ; Tianshu GAO ; Xiao YANG ; Libin ZHAN ; Pin LI
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(10):2999-3009
Objective To systematically review and analyze the characteristics and current status of registered clinical trials on Traditional Chinese Medicine(TCM)for the prevention and treatment of overweight/obesity.Methods We conducted a comprehensive search of two primary clinical trial registration platforms,the Chinese Clinical Trial Registry and ClinicalTrials.gov,to extract registered information on TCM interventions for overweight/obesity.The search period spanned from the establishment of each registry to December 31,2024.Statistical analysis was performed on the extracted registration data.Results A total of 226 clinical studies were included,with a cumulative sample size of 25165 participants.The annual registration volume exhibited a significant upward trend.The majority of studies were interventional in design,with primary outcome measures focusing on anthropometric and metabolic indicators.Notably,only two trials fully met the international standards for clinical trial registration as outlined by the World Health Organization(WHO).Conclusion A quality assessment of the overall registration data revealed that the quality of trial registrations remains suboptimal.Issues such as inadequate standardization,transparency,and comprehensiveness were identified.Additionally,the geographical distribution of registered trials was uneven,and there is an urgent need to refine outcome measures related to TCM syndrome differentiation.
2.An Analysis of Clinical Trial Registration Characteristics for Traditional Chinese Medicine in the Treatment of Overweight/Obesity
Rumeng MEI ; Ningzi ZANG ; Chengjun GONG ; Tianshu GAO ; Xiao YANG ; Libin ZHAN ; Pin LI
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(10):2999-3009
Objective To systematically review and analyze the characteristics and current status of registered clinical trials on Traditional Chinese Medicine(TCM)for the prevention and treatment of overweight/obesity.Methods We conducted a comprehensive search of two primary clinical trial registration platforms,the Chinese Clinical Trial Registry and ClinicalTrials.gov,to extract registered information on TCM interventions for overweight/obesity.The search period spanned from the establishment of each registry to December 31,2024.Statistical analysis was performed on the extracted registration data.Results A total of 226 clinical studies were included,with a cumulative sample size of 25165 participants.The annual registration volume exhibited a significant upward trend.The majority of studies were interventional in design,with primary outcome measures focusing on anthropometric and metabolic indicators.Notably,only two trials fully met the international standards for clinical trial registration as outlined by the World Health Organization(WHO).Conclusion A quality assessment of the overall registration data revealed that the quality of trial registrations remains suboptimal.Issues such as inadequate standardization,transparency,and comprehensiveness were identified.Additionally,the geographical distribution of registered trials was uneven,and there is an urgent need to refine outcome measures related to TCM syndrome differentiation.
3.The impact of medical insurance payment reform on medical services and costs:A case study of Jinhua
Miao YU ; Ze-yao LI ; Hong-wu TUO ; Yan-sui YANG ; Guan-pin WU ; Hua-qiang JIN ; Xiao-zhou JIANG
Chinese Journal of Health Policy 2025;18(1):43-50
Objective:This study empirically analyzes the relationship between outpatient and inpatient services under the impact of healthcare payment reform,and evaluates the effects of the reform.Methods:Data from healthcare services and basic medical insurance payments in eight districts of Jinhua City from 2020 to 2022 were used.A fixed-effects model for outpatient and inpatient services was constructed to analyze the impact of healthcare payment reforms and outpatient services on inpatient services.Results:The DRG-based payment had a significant positive effect on inpatient visits and a significant negative effect on employee basic medical insurance inpatient costs.The"capitation+APG"outpatient payment policy had a significant negative effect on inpatient visits and a significant negative effect on residents'basic medical insurance inpatient costs.The interaction between outpatient payment and outpatient visits had a significant negative effect on employee basic medical insurance inpatient visits,while the interaction between outpatient payment and outpatient costs had a significant negative effect on both overall and employee inpatient costs.Conclusions:The DRG payment reform led to an increase in inpatient visits and a reduction in employee basic medical insurance inpatient costs.The outpatient"capitation+APG"payment reform reduced inpatient visits and lowered residents'basic medical insurance inpatient costs,thereby slowing down the complementary effect between outpatient and inpatient services.
4.CNV Encompassing SNP Detection by Cross-reactivity Probe
Xiao-Mei HU ; Chen ZHOU ; Pin-Zheng ZHANG ; Yang CHEN ; Jia-Wen LI ; Yu-Kai MA ; Jia-Qi WANG ; Zhi-Yi GUO
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):895-902
Copy number variation encompassing SNP plays an important role in IVD and precision medi-cine.As the most commonly used method,FISH could not overcome the probe cross-reactivity which is common when to detect SNP.Here we developed a quantitative and qualitative method on copy number variation encompassing SNP.In this study,the rs76711854 was used as an example to establish a quanti-tative method by advantage of probe cross-reactivity.The fragment encompassing rs76711854 and its downstream to 9 514 bp were amplified by PCR.The allelic genotypes were verified by Sanger sequen-cing.Different probes with or without cross-reactivity to be used via quantitative real-time PCR and digit-al PCR.The different clusters(2D)and fluorescence intensity layers(1D)exist by adding probe with cross-reactivity.The A/G ratio measured by digital PCR is 2︰1,which is verified by probe targeting to the SNP.The copy-number variant exists in the 9kb-long fragment upstream to the SNP of prostate cancer cell line but not in human endometrial adenocarcinoma cell line Ishikawa.The data suggest that there is a multi-copy variation at this locus in DU145 cells.The method applied here is based on one single cross-reactivity probe via digital PCR.
5.CNV Encompassing SNP Detection by Cross-reactivity Probe
Xiao-Mei HU ; Chen ZHOU ; Pin-Zheng ZHANG ; Yang CHEN ; Jia-Wen LI ; Yu-Kai MA ; Jia-Qi WANG ; Zhi-Yi GUO
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):895-902
Copy number variation encompassing SNP plays an important role in IVD and precision medi-cine.As the most commonly used method,FISH could not overcome the probe cross-reactivity which is common when to detect SNP.Here we developed a quantitative and qualitative method on copy number variation encompassing SNP.In this study,the rs76711854 was used as an example to establish a quanti-tative method by advantage of probe cross-reactivity.The fragment encompassing rs76711854 and its downstream to 9 514 bp were amplified by PCR.The allelic genotypes were verified by Sanger sequen-cing.Different probes with or without cross-reactivity to be used via quantitative real-time PCR and digit-al PCR.The different clusters(2D)and fluorescence intensity layers(1D)exist by adding probe with cross-reactivity.The A/G ratio measured by digital PCR is 2︰1,which is verified by probe targeting to the SNP.The copy-number variant exists in the 9kb-long fragment upstream to the SNP of prostate cancer cell line but not in human endometrial adenocarcinoma cell line Ishikawa.The data suggest that there is a multi-copy variation at this locus in DU145 cells.The method applied here is based on one single cross-reactivity probe via digital PCR.
6.The impact of medical insurance payment reform on medical services and costs:A case study of Jinhua
Miao YU ; Ze-yao LI ; Hong-wu TUO ; Yan-sui YANG ; Guan-pin WU ; Hua-qiang JIN ; Xiao-zhou JIANG
Chinese Journal of Health Policy 2025;18(1):43-50
Objective:This study empirically analyzes the relationship between outpatient and inpatient services under the impact of healthcare payment reform,and evaluates the effects of the reform.Methods:Data from healthcare services and basic medical insurance payments in eight districts of Jinhua City from 2020 to 2022 were used.A fixed-effects model for outpatient and inpatient services was constructed to analyze the impact of healthcare payment reforms and outpatient services on inpatient services.Results:The DRG-based payment had a significant positive effect on inpatient visits and a significant negative effect on employee basic medical insurance inpatient costs.The"capitation+APG"outpatient payment policy had a significant negative effect on inpatient visits and a significant negative effect on residents'basic medical insurance inpatient costs.The interaction between outpatient payment and outpatient visits had a significant negative effect on employee basic medical insurance inpatient visits,while the interaction between outpatient payment and outpatient costs had a significant negative effect on both overall and employee inpatient costs.Conclusions:The DRG payment reform led to an increase in inpatient visits and a reduction in employee basic medical insurance inpatient costs.The outpatient"capitation+APG"payment reform reduced inpatient visits and lowered residents'basic medical insurance inpatient costs,thereby slowing down the complementary effect between outpatient and inpatient services.
7.Effect of Buzhong Yiqitang on Th17/Treg Immune Imbalance and Notch1 Signaling Pathway in AIT Mice
Zhuo ZHAO ; Nan SONG ; Ziyu LIU ; Pin LI ; Yue LUO ; Pengkun ZHANG ; Zhimin WANG ; Yuanping YIN ; Tianshu GAO ; Zhe JIN ; Xiao YANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):19-27
ObjectiveTo explore the effect of Buzhong Yiqitang on the immune imbalance of helper T cell 17 (Th17)/regulatory T cell (Treg) and Notch1 signaling pathway in mice with autoimmune thyroiditis (AIT). MethodA total of 60 8-week-old NOD.H-2h4 mice were randomly divided into the normal group, model group, western medicine group (selenium yeast tablet, 32.5 mg·kg-1), and low-dose (4.78 g·kg-1·d-1), middle-dose (9.56 g·kg-1·d-1), and high-dose (19 g·kg-1·d-1) Buzhong Yiqitang groups, with 10 mice in each group. The normal group was fed with distilled water, and the other groups were fed with water containing 0.05% sodium iodide for eight weeks. After the animal model of AIT was formed spontaneously, the mice were killed under anesthesia after intragastric administration for eight weeks. Serum anti-thyroglobulin antibodies (TGAb), thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroid hormone (FT4) were detected by enzyme-linked immunosorbent assay (ELISA), and thyroid tissue changes were observed by hematoxylin-eosin (HE) staining. The mRNA and protein expressions of retinoid-related orphan receptor-γt (RORγt), interleukin (IL)-17, forkhead box P3 (FoxP3), IL-10, Notch1, and hair division-related enhancer 1 (Hes1) in thyroid tissue were detected by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot, respectively. ResultCompared with the normal group, the thyroid structure of the model group was severely damaged, and lymphocytes were infiltrated obviously. The levels of serum TGAb, FT3, and FT4 contents were significantly increased, and TSH content was significantly decreased (P<0.01). The mRNA and protein expression levels of RORγt, IL-17, Notch1, and Hes1 were significantly increased, while those of FoxP3 and IL10 were significantly decreased in the model group (P<0.01). Compared with the model group, thyroid structural damage and lymphocyte infiltration were improved in the treatment groups, and serum TGAb, FT3, and FT4 contents were significantly decreased. TSH content was increased, and mRNA and protein expression levels of RORγt, IL-17, Notch1, and Hes1 were decreased. mRNA and protein expression levels of FoxP3 and IL-10 were increased to different degrees (P<0.05, P<0.01), and the middle-dose Buzhong Yiqitang group had the most significant intervention effect. ConclusionBuzhong Yiqitang can alleviate the thyroid structural damage in AIT mice, and its mechanism may be related to improving the abnormal differentiation of Th17/Treg immune cells and inhibiting the activation of the Notch1 signaling pathway.
8.Mechanism of Buzhong Yiqitang in Ameliorating Thyroiditis Damage in AIT Mice by Modulating TLR4/NF-κB/AIM2 Signaling Pathway
Zhuo ZHAO ; Zhe JIN ; Zhengzheng LI ; Xuanlin GUO ; Jiayun LI ; Tongran GAO ; Pin LI ; Zhimin WANG ; Yuanping YIN ; Ziyu LIU ; Xiao YANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):1-9
ObjectiveTo explore the mechanism of Buzhong Yiqitang in ameliorating inflammatory injury in autoimmune thyroiditis (AIT) mice based on the Toll-like receptor 4(TLR4)/nuclear transcription factor-kappa B(NF-κB)/absent in melanoma 2(AIM2)inflammasome signaling pathway. MethodThe 120 genetically susceptible 8-week-old NOD.H-2h4 mice were selected and randomly divided into control group, model group, low, medium and high dose groups of Buzhong Yiqitang (4.78, 9.56, 19.12 g·kg-1), and western medicine group (selenium yeast tablets, 3.033×10-5 g·kg-1). The AIT model mice in each group drank ad libitum 0.05% sodium iodide aqueous solution for 8 weeks to establish the AIT model, and the control group drank ad libitum distilled water. Eight weeks later, the mice in each dosing group were divided into groups and gavage. The swelling of thyroid tissue was observed with the naked eye, and the weight of spleen was weighed. The content of serum inflammatory factors interleukin-1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) was measured by enzyme-linked immunosorbent assay (ELISA), and Real-time PCR was used to detect the expression of HMGB1, TLR4, AIM2, NF-κB p65,apoptosis-associated speck-like protein(ASC),cysteinyl aspartate-specific protease-1(Caspase-1), IL-1β mRNA. Western blot was used to detect the expression of high motility group protein 1 (HMGB1), TLR4, AIM2, NF-κB p65, phosphorylation(p)-NF-κB p65, ASC, Caspase-1, and IL-1β proteins in thyroid tissue, and immunofluorescence staining was used to observe the protein expression of HMGB1, AIM2, and NF-κB p65 in thyroid tissue of mice. ResultCompared with the control group, the thyroid tissue of mice in the model group was significantly swollen, the spleen quality was significantly increased, and the expression of HMGB1, TLR4, NF-κB p65, AIM2, ASC, Caspase-1, IL-1β in thyroid tissue was significantly increased (P<0.01). Compared with the model group, the swelling of thyroid tissue in mice in each dose group of Buzhong Yiqitang was improved, the quality of spleen was significantly reduced, and the expression of HMGB1, TLR4, AIM2, NF-κB p65, p-NF-κB p65, ASC, Caspase-1, IL-1β in thyroid tissue was significantly reduced (P<0.05, P<0.01). ConclusionBuzhong Yiqitang can effectively improve the inflammatory injury of AIT, and regulating the abnormal activation of the TLR4/NF-κB/AIM2 inflammasome signal pathway may be one of its intervention mechanisms.
9.Effects of remifentanil-based fast-track anesthesia on the quality of anesthesia recovery in children with congenital heart disease undergoing transcatheter closure
Hai-Juan JING ; Hong-Qi LIN ; Hai-Li WANG ; Peng-Yu QIN ; Xiao-Fei SHEN ; Pin LÜ
The Chinese Journal of Clinical Pharmacology 2024;40(3):340-344
Objective To observe the effect of remifentanil-based fast-track anesthesia on the quality of anesthesia recovery in children with congenital heart disease underwent transcatheter closure.Methods Children with congenital heart disease who underwent transcatheter closure were divided into treatment group and control group according to the anesthesia plan.The anesthesia plan of the control group was as follows:anesthesia induction(intramuscular injection of ketamine at 4 mg·kg-1,intravenous injection of propofol at 2.5 mg·kg-1,fentanyl at 10 μg·kg-1and cisatracurium at 0.1 mg·kg-1)and anesthesia maintenance(fentanyl at0.4μg·kg-1·min-1 and propofol at 8 μg·kg-1·min-1).The anesthesia plan of the treatment group was as follows:anesthesia induction(intramuscular injection of ketamine at 5 mg·kg-,intravenous injection of midazolam at 0.1 mg·kg-1,sufentanil at 1.0 μg·kg-1 and cisatracurium at 0.1 mg·kg-1)and anesthesia maintenance(remifentanil at 0.5 μg·kg-1·min-1 and propofol at 8 μg·kg-1·min-1).Anesthesia recovery,facial expression,leg posture,activity,crying and comfortability(FLACC)of 5 pain scores,Ramsay score,hemodynamics,myocardial injury indexes,and adverse drug reactions were compared between the two groups.Results There were 64 cases in treatment group and 56 cases in control group.The spontaneous respiration recovery time,call time and extubation time of the treatment group were(4.87±1.22),(10.16±2.58)and(12.55±3.19)min,shorter than those in control group,which were(5.49±1.35),(13.34±3.27)and(15.67±3.62)min(all P<0.05).At 1 h and 2 h after operation,Ramsay scores of treatment group were 2.58±0.35 and 3.69±0.42,were lower than 3.02±0.47 and 4.24±0.39 in control group(all P<0.05).At 1 h and 2 h after operation,the FLACC scores of the treatment group were 3.03±0.81 and 3.75±0.84,lower than 3.78±0.62 and 4.36±0.51 in control group(all P<0.05).Mean arterial pressure(MAP)of treatment group at the insertion of laryngeal mask,the insertion of occluder and the end of the operation were(102.45±10.26),(94.18±8.37)and(91.46±10.15)mmHg,lower than those in control group,which were(107.84±10.11),(100.57±9.84)and(97.33±8.53)mmHg(all P<0.05).On day 1 and day 3 after operation,serum creatine kinase isoenzyme(CK-MB)levels in the treatment group were(10.03±2.58)and(8.65±2.16)U·L-1,lower than those in control group,which were(12.44±3.07)and(10.16±2.35)U·L-1(all P<0.05).On day 1 and day 3 after operation,serum cardiac troponin Ⅰ(cTn Ⅰ)levels in treatment group[(0.07±0.02)and(0.04±0.01)μg·L-1]were lower than those in control group[(0.09±0.03)and(0.06±0.02)μg·L-1](all P<0.05).The incidence of adverse anesthesia reactions in treatment group was 6.25%(4 cases/64 cases),lower than 17.86%(10 cases/56 cases)in control group(P<0.05).Conclusion Remifentanil-based fast-track anesthesia can improve the quality of anesthesia recovery in children with congenital heart disease undergoing transcatheter closure,with good sedative and analgesic effects,stable hemodynamics during operation,and low incidence of adverse drug reactions.
10.Analysis of CSF3R Gene Mutations and Clinical Characteristics in Patients with t(8;21) Acute Myeloid Leukemia.
Miao CUI ; Qing-Yun LI ; Xu-Zhang LU ; Hong-Ying CHAO ; Xiao-Hui CAI ; Jie LIU ; Hai-Ying HUA ; Pin WU
Journal of Experimental Hematology 2023;31(4):1019-1025
OBJECTIVE:
To investigate the occurrence of CSF3R mutation in patients with t(8;21) acute myeloid leukemia (AML) and its correlation with some clinical parameters.
METHODS:
The clinical and laboratory data of 167 newly diagnosed AML patients with t(8;21) translocation were analyzed retrospectively. High-throughput DNA sequencing technology combined with Sanger sequencing method was used to detect 112 gene mutations. The occurrence of CSF3R gene mutation and its influence on the remission rate after chemotherapy were analyzed.
RESULTS:
Among 167 patients with t(8;21) AML, 15 patients (9.0%) carried CSF3R mutations, including 6 cases of membrane proximal region mutations and 9 cases of truncation mutations in the cytoplasmic tail. The most common coexisting mutations of CSF3R were KIT (40.0%), TET2 (33.3%), DNMT3A (26.7%), FLT3 (20.0%), CBL (20.0%), IDH1 (13.3%), etc. Compared with the wild type, the CSF3R mutant group had a higher mutation rate of DNA methylation-related genes(P <0.001). The median peripheral white blood cell (WBC) count of patients with CSF3R gene mutation was 5.80 (3.20-8.56)×109/L at initial diagnosis, which was significantly lower than 8.80 (5.26-19.92)×109/L of the CSF3R wild-type patients (P =0.017). There was no significant difference between the two groups in sex, median age, FAB classification, hemoglobin level, platelet count, etc. (P >0.05). The CR rate of the CSF3R gene mutation group (100%) was significantly higher than that of the wild-type group (86.8%), but the difference was not statistically significant (P >0.05). The CSF3R gene mutation group had a significantly higher CD19 positive rate and a higher -X rate than the wild group (86.7% vs 47.4%, P =0.004; 33.3% vs 13.2%, P =0.037).
CONCLUSION
There is a high incidence of CSF3R mutation in t (8;21) AML patients. The clinical characteristics and coexisting mutation genes of CSF3R mutation-positive patients are different from those of wild-type patients.
Humans
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Retrospective Studies
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Prognosis
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Leukemia, Myeloid, Acute/genetics*
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Mutation
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Signal Transduction
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Receptors, Colony-Stimulating Factor/genetics*

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