1.TCM Treatment of Sarcopenia Based on PI3K/Akt Signaling Pathway: A Review
Yan CHEN ; Ting DAI ; Changsheng GUO ; Zhihai FENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):316-326
Sarcopenia is a systemic skeletal muscle disease characterized by the gradual decline of muscle mass,strength,and function,and its occurrence and development are related to multiple factors,involving several signaling pathways. Among them,the phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt) signaling pathway,as a key pathway regulating cellular growth,survival,and metabolism,plays an important role in the formation and development of sarcopenia. Its abnormal activation or deactivation may lead to an imbalance in muscle protein metabolism,resulting in muscle atrophy and reduction. Modern medicine is still in the exploratory stage of treatment for sarcopenia. Traditional Chinese medicine (TCM),with its multi-pathway and multi-target characteristics,has shown increasing advantages in the prevention and treatment of sarcopenia. In recent years,various monomers, extracts,and compound formulas of TCM have been proven to effectively prevent and treat sarcopenia by promoting muscle cell protein synthesis,reducing protein degradation,inhibiting cell apoptosis and inflammatory response,and improving mitochondrial function. This paper reviewed the improvement effects of TCM on sarcopenia based on the PI3K/Akt pathway and explored its specific action mechanisms, aiming to provide new insights for the treatment of sarcopenia with TCM.
2.A National Registry to Improve the Quality of Care for Patients With Acute Coronary Syndrome and Diabetes: Protocol for the China Diabetes Cardiovascular (CDCV) Project
Na YANG ; Jing LIU ; Changsheng MA ; Dalong ZHU ; Smith Sidney C. ; Robert ECKEL ; Louise MORGAN ; Yongchen HAO ; Jun LIU ; Yan ZHOU ; Yaling HAN ; Dong ZHAO
Cardiology Discovery 2025;05(3):208-214
Evidence-based treatment strategies for patients with cardiovascular disease and diabetes have been updated in recent years. However, substantial gaps remain between guideline recommendations and clinical practice, which justify the urgent need to improve the quality of care for patients with these conditions. The Chinese Society of Cardiology and the Chinese Society of Diabetes, in collaboration with the American Heart Association and the American Diabetes Association, designed the China Diabetes Cardiovascular project. The China Diabetes Cardiovascular project is a nationwide registry study aimed at improving the quality of care for patients with acute coronary syndrome and diabetes in China. Launched in 2021, this project has enrolled 36 hospitals across mainland China. Patients with a primary discharge diagnosis of comorbid acute coronary syndrome and diabetes will be eligible to participate. Pre-defined performance measures will be adopted to evaluate the quality of care for these patients. Multiple quality improvement strategies will be adopted, including providing monthly quality reports based on these measures, conducting a series of training courses, and distributing educational materials. A comprehensive dataset, encompassing patients' characteristics, medical history, treatment before and during the current hospitalization, and discharge medications for secondary prevention, will be collected through a web-based data collection platform. This project has the potential to improve the quality of care and reduce the care disparities in the management of patients with these diseases. Moreover, with its comprehensive data collection, this project will provide a strong foundation for exploring key clinical questions.
3.Effects of upper limb rehabilitation robot training combined with intermittent theta burst stimulation on upper limb motor and neurological function in stroke patients with hemiplegia
Ling ZHANG ; Changsheng LIN ; Min BAI ; Qiang LIN ; Teng MA ; Ran TIAN ; Yan ZHOU ; Xian LI ; Xueping LI
Chinese Journal of Cerebrovascular Diseases 2025;22(11):763-771
Objective To investigate the therapeutic effects of upper limb rehabilitation robot training combined with intermittent theta burst stimulation(iTBS)on upper limb motor and neurological function in stroke patients with hemiplegia.Methods This study retrospectively consecutive enrolled 46 stroke hemiparetic patients from the Department of Rehabilitation Medicine,Nanjing Pukou People's Hospital.The patients were randomly assigned to a control group and an experimental group(23patients in each)using a random number table.Baseline data,including sex,age,disease duration,side of hemiplegia,and stroke type,were collected from patients enrolled.All patients received conventional treatment.The control group received upper limb rehabilitation robot training combined with iTBS sham stimulation(coil placed perpendicular to the skull),while the experimental group received upper limb rehabilitation robot training combined with iTBS real stimulation(coil placed parallel to the skull).Both groups underwent treatment for 3 weeks.Upper limb motor function was assessed using the Fugl-Meyer upper extremity(FMA-UE)scale and Wolf motor function test(WMFT);while neurological function was evaluated using the motor-evoked potentials(MEP)latency,amplitude,and central motor conduction time(CMCT)of the affected thumb abductor muscle.Activities of daily living were assessed using the modified Barthel index(MBI).Results(1)No significant differences in baseline data were found between the two groups(all P>0.05).(2)Before treatment,the FMA-UE and WMFT scores in the experimental group were 27.48±7.87 and 28.22±3.87,respectively;and in the control group were 26.35±4.78 and 28.35±3.33,respectively;there were no significant differences in both FMA-UE and WMFT scores between the two groups(all P>0.05).After 3weeks of treatment,the FMA-UE and WMFT scores in the experimental group were 40.35±8.96 and 37.74±4.11,respectively;and in the control group were 32.78±4.50 and 32.57±4.11,respectively;there were significant interaction effects of time and group(Ftime×group values of 19.613 and 31.522,both P<0.01),main effects of group(Fgroup values of 5.401 and 5.897,both P<0.05),and main effects of time(Ftime values of 176.516 and 211.478,both P<0.01).(3)Before treatment,the MEP latency,amplitude,and CMCT in the experimental group were(24.39±3.56)ms,(137.77±42.67)μV,and(10.62±2.76)ms,respectively;and in the control group were(24.64±2.77)ms,(136.74±48.77)μV,and(10.73±1.84)ms,respectively,there were no significant differences between the two groups(all P>0.05).After 3weeks of treatment,the MEP latency,amplitude,and CMCT in the experimental group were(20.39±1.83)ms,(239.91±43.70)μV,and(6.58±1.23)ms,respectively,and in the control group were(22.53±3.53)ms,(198.54±50.37)μV,and(9.19±1.60)ms,respectively,there were significant interaction effects of time and group(Ftime×group values of 7.270,15.554,and 20.110,all P<0.05)and main effects of time(Ftime values of 76.540,256.706,and 100.629,all P<0.01),the main effect of group for CMCT was significant(Fgroup=7.406,P<0.01),but there were no significant difference in the main effect of group on MEP latency,amplitude between two groups(Fgroup values of 2.145,2.778,both P>0.05).(4)Before treatment,the MBI score in the experimental group was 42.83±7.36,and in the control group was 43.91±6.56,with no significant difference between two groups(P>0.05).After 3 weeks of treatments,the MBI score in the experimental group was 67.83±12.69,and in the control group was 54.13±5.57,there were significant interaction effects of time and group(Ftime×group=39.862,P<0.01),main effects of group(Fgroup=8.083,P=0.007),and main effects of time(Ftime=226.241,P<0.01).Conclusions Upper limb rehabilitation robot training combined with iTBS can improve upper limb motor function and neurological function and enhance the daily living activity ability of stroke patients.Real iTBS combined with robot training has a more significant effect than sham iTBS.
4.A National Registry to Improve the Quality of Care for Patients With Acute Coronary Syndrome and Diabetes: Protocol for the China Diabetes Cardiovascular (CDCV) Project
Na YANG ; Jing LIU ; Changsheng MA ; Dalong ZHU ; Smith Sidney C. ; Robert ECKEL ; Louise MORGAN ; Yongchen HAO ; Jun LIU ; Yan ZHOU ; Yaling HAN ; Dong ZHAO
Cardiology Discovery 2025;05(3):208-214
Evidence-based treatment strategies for patients with cardiovascular disease and diabetes have been updated in recent years. However, substantial gaps remain between guideline recommendations and clinical practice, which justify the urgent need to improve the quality of care for patients with these conditions. The Chinese Society of Cardiology and the Chinese Society of Diabetes, in collaboration with the American Heart Association and the American Diabetes Association, designed the China Diabetes Cardiovascular project. The China Diabetes Cardiovascular project is a nationwide registry study aimed at improving the quality of care for patients with acute coronary syndrome and diabetes in China. Launched in 2021, this project has enrolled 36 hospitals across mainland China. Patients with a primary discharge diagnosis of comorbid acute coronary syndrome and diabetes will be eligible to participate. Pre-defined performance measures will be adopted to evaluate the quality of care for these patients. Multiple quality improvement strategies will be adopted, including providing monthly quality reports based on these measures, conducting a series of training courses, and distributing educational materials. A comprehensive dataset, encompassing patients' characteristics, medical history, treatment before and during the current hospitalization, and discharge medications for secondary prevention, will be collected through a web-based data collection platform. This project has the potential to improve the quality of care and reduce the care disparities in the management of patients with these diseases. Moreover, with its comprehensive data collection, this project will provide a strong foundation for exploring key clinical questions.
5.Mitochondrial Quality Control Regulating Pathogenesis of Sarcopenia and Its Intervention by Traditional Chinese Medicine: A Review
Ting DAI ; Yan CHEN ; Changsheng GUO ; Jing GAO ; Xiaodong FENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):279-286
Sarcopenia is a clinical syndrome characterized by a decrease in skeletal muscle strength and quality, often accompanied by adverse outcomes such as falls, loss of function and weakness. The pathogenesis of sarcopenia is complex, and studies have shown that dysfunction due to impaired mitochondrial quality control is an important pathological factor in the occurrence and development. Traditional Chinese medicine(TCM) has been widely favoured for regulating mitochondrial homeostasis and preventing sarcopenia by virtue of its multi-target and multi-pathway advantages. They can play a role in the prevention and treatment of sarcopenia by regulating the mitochondrial quality control system to inhibit the occurrence of mitochondrial oxidative stress, regulate the balance of mitochondrial dynamics, inhibit mitochondrial autophagy, promote mitochondrial biosynthesis, resist the occurrence of mitochondrial apoptosis, and maintain the mitochondrial calcium and protein homeostasis. Based on this, the paper reviewed the relationship between mitochondrial quality control and sarcopenia, as well as the mechanism of TCM in intervening the mitochondrial quality control system to treat sarcopenia, in order to provide a new idea for the prevention and treatment of sarcopenia by TCM and to a theoretical basis for the clinical research on TCM intervention in sarcopenia.
6.Effects of upper limb rehabilitation robot training combined with intermittent theta burst stimulation on upper limb motor and neurological function in stroke patients with hemiplegia
Ling ZHANG ; Changsheng LIN ; Min BAI ; Qiang LIN ; Teng MA ; Ran TIAN ; Yan ZHOU ; Xian LI ; Xueping LI
Chinese Journal of Cerebrovascular Diseases 2025;22(11):763-771
Objective To investigate the therapeutic effects of upper limb rehabilitation robot training combined with intermittent theta burst stimulation(iTBS)on upper limb motor and neurological function in stroke patients with hemiplegia.Methods This study retrospectively consecutive enrolled 46 stroke hemiparetic patients from the Department of Rehabilitation Medicine,Nanjing Pukou People's Hospital.The patients were randomly assigned to a control group and an experimental group(23patients in each)using a random number table.Baseline data,including sex,age,disease duration,side of hemiplegia,and stroke type,were collected from patients enrolled.All patients received conventional treatment.The control group received upper limb rehabilitation robot training combined with iTBS sham stimulation(coil placed perpendicular to the skull),while the experimental group received upper limb rehabilitation robot training combined with iTBS real stimulation(coil placed parallel to the skull).Both groups underwent treatment for 3 weeks.Upper limb motor function was assessed using the Fugl-Meyer upper extremity(FMA-UE)scale and Wolf motor function test(WMFT);while neurological function was evaluated using the motor-evoked potentials(MEP)latency,amplitude,and central motor conduction time(CMCT)of the affected thumb abductor muscle.Activities of daily living were assessed using the modified Barthel index(MBI).Results(1)No significant differences in baseline data were found between the two groups(all P>0.05).(2)Before treatment,the FMA-UE and WMFT scores in the experimental group were 27.48±7.87 and 28.22±3.87,respectively;and in the control group were 26.35±4.78 and 28.35±3.33,respectively;there were no significant differences in both FMA-UE and WMFT scores between the two groups(all P>0.05).After 3weeks of treatment,the FMA-UE and WMFT scores in the experimental group were 40.35±8.96 and 37.74±4.11,respectively;and in the control group were 32.78±4.50 and 32.57±4.11,respectively;there were significant interaction effects of time and group(Ftime×group values of 19.613 and 31.522,both P<0.01),main effects of group(Fgroup values of 5.401 and 5.897,both P<0.05),and main effects of time(Ftime values of 176.516 and 211.478,both P<0.01).(3)Before treatment,the MEP latency,amplitude,and CMCT in the experimental group were(24.39±3.56)ms,(137.77±42.67)μV,and(10.62±2.76)ms,respectively;and in the control group were(24.64±2.77)ms,(136.74±48.77)μV,and(10.73±1.84)ms,respectively,there were no significant differences between the two groups(all P>0.05).After 3weeks of treatment,the MEP latency,amplitude,and CMCT in the experimental group were(20.39±1.83)ms,(239.91±43.70)μV,and(6.58±1.23)ms,respectively,and in the control group were(22.53±3.53)ms,(198.54±50.37)μV,and(9.19±1.60)ms,respectively,there were significant interaction effects of time and group(Ftime×group values of 7.270,15.554,and 20.110,all P<0.05)and main effects of time(Ftime values of 76.540,256.706,and 100.629,all P<0.01),the main effect of group for CMCT was significant(Fgroup=7.406,P<0.01),but there were no significant difference in the main effect of group on MEP latency,amplitude between two groups(Fgroup values of 2.145,2.778,both P>0.05).(4)Before treatment,the MBI score in the experimental group was 42.83±7.36,and in the control group was 43.91±6.56,with no significant difference between two groups(P>0.05).After 3 weeks of treatments,the MBI score in the experimental group was 67.83±12.69,and in the control group was 54.13±5.57,there were significant interaction effects of time and group(Ftime×group=39.862,P<0.01),main effects of group(Fgroup=8.083,P=0.007),and main effects of time(Ftime=226.241,P<0.01).Conclusions Upper limb rehabilitation robot training combined with iTBS can improve upper limb motor function and neurological function and enhance the daily living activity ability of stroke patients.Real iTBS combined with robot training has a more significant effect than sham iTBS.
7.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.
8.Hemophagocytic syndrome combined with thrombotic microangiopathy: a case report
Yan YANG ; Yuqiu LIU ; Bin WANG ; Changsheng XU ; Fengmei WANG ; Xiaoliang ZHANG ; Bicheng LIU
Chinese Journal of Nephrology 2024;40(7):558-561
The paper reports a rarely case of hemophagocytic syndrome complicated with thrombotic microangiopathy, first presented with fever of unknown origin. A 37-year-old female patient mainly presented with fever, hemolytic anemia, thrombocytopenia, and progressive decline in renal function. After infusion of fresh frozen plasma and high dose of glucocorticoid after double plasma exchange, the patient showed good prognosis, no further fever or hemolysis occurred, recovered platelet and renal function. After acute episode phase, kidney biopsy was performed and acute tubular necrosis was diagnosed. During the follow-up period, the disease did not recur, and the renal function was normal.
9.Risk of New Vertebral Fracture and Combination Therapy with Zoledronic Acid and Teriparatide in Diabetic Patients after Percutaneous Kyphoplasty
Jian ZHANG ; Bin YAN ; Zhe CHEN ; Zhaomin ZHENG ; Changsheng YANG
Asian Spine Journal 2021;15(5):611-617
Methods:
Total 106 diabetic patients who had undergone PKP and had received anti-osteoporosis treatment for osteoporotic vertebral compression fracture were enrolled and allocated into the following two groups: group I (n=52, zoledronic acid) and group II (n=54, zoledronic acid plus teriparatide). The operating time, bone cement volume, and complications related to anti-osteoporosis treatment or PKP, if any, were recorded. The Visual Analog Scale (VAS) score and Oswestry Disability Index (ODI) were assessed at admission, at discharge, and at the final follow-up. Dual-energy X-ray absorptiometry scan of the hip for the measurement of the bone mineral density (BMD) was performed preoperatively and at the final follow-up for all the patients.
Results:
There was no significant difference in the age, body mass index, bone cement volume, or follow-up time of the groups. The mean follow-up duration was 22.5±1.6 months. All the patients had improved VAS and ODI, and group II had significantly better clinical outcomes than group I. All the patients had increased BMD at the latest follow-up, while group II exhibited significantly more improvement. The prevalence of NVF was lower in group II (11.5% vs. 7.4%, p=0.523). Male patients had a higher prevalence of NVF although the difference was not statistically significant.
Conclusions
Combination therapy with zoledronic acid and teriparatide could improve the clinical outcomes, and BMD and had the potential to reduce NVF in diabetic patients following PKP.
10.HPLC Fingerprint Establishment ,Content Determination and Multivariate Statistical Analysis of Qinlian Runfei Decoction
Kaili YAN ; Chengcheng YIN ; Mengyao LIU ; Changsheng CUI ; Ying WANG ; Xiaozhou SUN ; Liping SUN ; Bin QI ; Li LIU
China Pharmacy 2021;32(16):1956-1963
OBJECTIVE:To establish the f ingerprint of Qinlian runfei decoction,determine the contents of 11 components, and conduct cluster analysis and orthogonal partial least squares discriminant analysis (OPLS-DA). METHODS :HPLC method was used. The determination was performed on ZORBAX Eclipse Plus C 18 column with mobile phase consisted of acetonitrile- 0.05% phosphoric acid solution (gradient elution )at the flow rate of 1.0 mL/min. The detection wavelength was set at 260 nm, and column temperature was 30 ℃. The sample size was 10 μL. Using wogonoside as reference,HPLC fingerprints of 10 batches of Qinlian runfei decoction were drawn and the similarity evaluation was conducted with Similarity Evaluation System of TCM Chromatographic Fingerprint (2012 edition),the common peaks were also confirmed ;the contents of 11 components in Qinlian runfei decoction were determined by the same method. SPSS 21.0 software was used for clus ter analysis ,and SIMCA 14.0 software was used for OPLS-DA to screen marker components affecting quality. RESULTS :There were 21 common peaks in 10 batches of Qinlian runfei decoction ,and the similarity with control fingerprint was greater than 0.98. A total of 11 common peaks were identified , which were rutin , forsythiaside A , forsythiaside B , iris, irigenin, baicalin, forsythiaside, wogonoside, baicalein, irisflorentin and wogonin. The line ar ranges of 11 components were 9.960 0-49.800 0,1.974 0-9.870 0,0.672 0-3.360 0,0.960 0-4.800 0,0.549 0- 2.745 0,5.040 0-25.200 0,1.374 0-6.870 0,0.615 0-3.075 0,0.759 9-3.795 0,0.162 0-0.810 0,0.042 0-0.210 0 μg(all r> 0.999); RSDs of precision , stability (48 h) and repeatability tests were less than 2% ; the average recoveries were 95.81%-100.29% with RSDs of 0.43%-1.73%(n=6);the contents were 8.924 4-12.820 8,0.352 2-0.868 7,0.435 6-0.711 2, 0.389 8-1.309 0,0.335 8-0.530 1,1.680 5-4.542 3,0.701 8-1.584 2,2.240 2-5.442 5,2.351 0-5.558 9,0.106 0-0.182 2,0.076 8- 0.128 9 mg/g,respectively. The results of cluster analysis showed that when class spacing was 10,it could be divided into two groups,S1-S3 and S 4-S10;when the class spacing was 5,the second class could be divided into two categories ,S6,S7,S9 were clustered into one category ,and S 4,S5,S8,S10 were clustered into one category. The results of OPLS-DA analysis showed that S6,S7 and S 9 were at the top of the figure ,S4,S5,S8 and S 10 were at the lower left side of the figure ,and S 1-S3 were at the lower right side of the figure ,which was consistent with the cluster analysis results ;VIP values of baicalin ,iris,forsythiaside A , baicalein and wogonoside were all greater than 1. CONCLUSIONS :Established fingerprint and content determination methods have high precision and good stability. Combined with multivariate statistical analysis ,it can be used for the quality control of Qinlian runfei decoction. Five components as baicalin are the marker components affecting the quality of Qinlian runfei decoction.

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