1.Innovation and application of traditional Chinese medicine dispensing promoted through integration of whole-process data elements.
Huan-Fei YANG ; Si-Yu LI ; Chen-Qian YU ; Jian-Kun WU ; Fang LIU ; Li-Bin JIANG ; Chun-Jin LI ; Xiang-Fei SU ; Wei-Guo BAI ; Hua-Qiang ZHAI ; Shi-Yuan JIN ; Yong-Yan WANG
China Journal of Chinese Materia Medica 2025;50(11):3189-3196
As a new type of production factor that can empower the development of new quality productivity, the data element is an important engine to promote the high quality development of the industry. Traditional Chinese medicine(TCM) dispensing is the most basic work of TCM clinical pharmacy, and its quality directly affects the clinical efficacy of TCM. The integration of data elements and TCM dispensing can stimulate the innovation and vitality of the TCM dispensing industry and promote the high-quality and sustainable development of the industry. A large-scale, detailed, and systematic study on TCM dispensing was conducted. The innovative practice path of data fusion construction in the whole process of TCM dispensing was investigated by integrating the digital resources "nine full activities" of TCM dispensing, creating the digital dictionary of "TCM clinical information data elements", and exploring innovative applications of TCM dispensing driven by data and technology, so as to promote the standardized, digital, and intelligent development of TCM dispensing in medical health services. The research content of this project was successfully selected as the second batch of "Data element×" typical cases of National Data Administration in 2024, which is the only selected case in the field of TCM.
Medicine, Chinese Traditional/methods*
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Drugs, Chinese Herbal
;
Humans
2.Association of hippocampal subfield volumes and cross-domain associative memory impairment in patients with schizophrenia
Zhao-lin ZHAI ; Di CHANG ; Xuan LI ; Chang LU ; Yu-ke DONG ; Yan WANG ; Chun-hong SHAO ; Qing KANG ; Deng-tang LIU
Fudan University Journal of Medical Sciences 2025;52(6):775-782
Objective To investigate the possible association between cross-domain associative memory(AM)impairment and hippocampal subfield volumes in patients with schizophrenia(SCZ).Methods We enrolled 28 SCZ patients from Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine,and 28 healthy controls(HCs)between 2019 and 2021.Based on an innovative AM paradigm and automated segmentation,3D-T1 weighted data of the objects were processed with PhiPipe and FreeSurfer.Differences in subfield volums between the two groups were analyzed using ANCOVA,while their relationship with AM scores was assessed using Pearson correlation.Results SCZ patients exhibited significantly poorer AM performance across three conditions compared with HCs.Marginally significant reductions were observed in the total volume of bilateral hippocampus,encompassing both the hippocampal head and body.Significant volume reductions were identified in the bilateral presubiculum and parasubiculum.The volumes of bilateral presubiculum head(r=0.273,P=0.042),parasubiculum(r=0.397,P=0.002),and CA1 head(r=0.382,P=0.004)exhibited positive correlations with cross-domain AM performance.Conclusion The bilateral presubiculum and parasubiculum,as hippocampal subregions significantly associated with cross-modal AM deficits in SCZ,may play a crucial role in the pathology of AM.
3.Association of hippocampal subfield volumes and cross-domain associative memory impairment in patients with schizophrenia
Zhao-lin ZHAI ; Di CHANG ; Xuan LI ; Chang LU ; Yu-ke DONG ; Yan WANG ; Chun-hong SHAO ; Qing KANG ; Deng-tang LIU
Fudan University Journal of Medical Sciences 2025;52(6):775-782
Objective To investigate the possible association between cross-domain associative memory(AM)impairment and hippocampal subfield volumes in patients with schizophrenia(SCZ).Methods We enrolled 28 SCZ patients from Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine,and 28 healthy controls(HCs)between 2019 and 2021.Based on an innovative AM paradigm and automated segmentation,3D-T1 weighted data of the objects were processed with PhiPipe and FreeSurfer.Differences in subfield volums between the two groups were analyzed using ANCOVA,while their relationship with AM scores was assessed using Pearson correlation.Results SCZ patients exhibited significantly poorer AM performance across three conditions compared with HCs.Marginally significant reductions were observed in the total volume of bilateral hippocampus,encompassing both the hippocampal head and body.Significant volume reductions were identified in the bilateral presubiculum and parasubiculum.The volumes of bilateral presubiculum head(r=0.273,P=0.042),parasubiculum(r=0.397,P=0.002),and CA1 head(r=0.382,P=0.004)exhibited positive correlations with cross-domain AM performance.Conclusion The bilateral presubiculum and parasubiculum,as hippocampal subregions significantly associated with cross-modal AM deficits in SCZ,may play a crucial role in the pathology of AM.
4.Prognostic value of serum adenosylhomocysteinase in patients with hepatitis E related acute liver failure
Hong YAN ; Ze XIANG ; Jiaqi CHEN ; Chun JIANG ; Shuxiang LI ; Guanghua ZHAI ; Jian WU
Chinese Journal of Laboratory Medicine 2024;47(8):888-894
Objective:To investigate the prognostic value of serum adenosylhomocysteinase (AHCY) in patients with hepatitis E virus acute liver failure (HEV-ALF).Methods:From 1 January 2017 to 31 December 2022, 100 patients each with HEV-ALF and acute hepatitis E (AHE) from the First Affiliated Hospital of Medical School of Zhejiang University and Affiliated Suzhou Hospital of Nanjing Medical University were included in this case-control study. The HEV-ALF group was 58.56±11.16 years old, including 71 men. The AHE group was 56.04±14.30 years old, including 61 men. All serum samples were obtained before the patient had an acute onset and were obtained without treatment. Firstly, the serum AHCY levels in patients with HEV-ALF and AHE were analyzed by ELISA. Secondly, the serum AHCY levels in HEV-ALF patients with different organ failure and disease condition were compared. According to the number of organ failure, 100 HEV-ALF patients were divided into organ failure number=2 group ( n=58), number=3 group ( n=24) and number>3 groups ( n=18). According to the disease condition, 100 patients were divided into improvement group ( n=49), disease fluctuation group ( n=37), and deterioration group ( n=14). Thirdly, the survival times between the high serum AHCY level group ( n=50) and the low serum AHCY level group ( n=50) were compared. Finally, the independent risk factors to predict mortality using the multivariate Logistic regression analysis, and evaluated the predictive and decision-making abilities of serum AHCY levels were explored using the receiver operating characteristic (ROC) curve and decision curve analysis (DCA). Results:Serum AHCY levels in HEV-ALF patients were significantly higher than those in AHE patients [326.92 (295.37-385.84) pg/ml vs. 222.88 (188.04-246.78) pg/ml, Z=-12.217, P<0.001]. Serum AHCY levels in group 2 were significantly lower than those in group 3 [303.44 (284.40-330.15) pg/ml vs. 335.36 (306.30-385.84) pg/ml, Z=-3.353, P=0.001]. Serum AHCY level in group 3 were significantly lowerthan those in group>3 [335.36 (306.30-385.84) pg/ml vs. 549.89 (423.35-660.22) pg/ml, P<0.001]. The serum AHCY levels in the fluctuation group were lower than those in the deterioration group [322.17 (283.92-423.74) pg/ml vs. 458.26 (374.66, 593.89) pg/ml, Z=-4.016, P=0.009]. The survival time of high serum AHCY level group was significantly lower than that of low serum AHCY level group [23.11 (20.25-25.96) days vs. 29.49 (28.79-30.20) days, Z=-2.596, P<0.001]. The multivariate Logistic regression analysis showed that the levels of serum AHCY and total bilirubin were independent risk factors to predict mortality in HEV-ALF patients [AHCY, OR (95% CI): 1.008 (1.002-1.015), P=0.008; total bilirubin, OR (95% CI): 1.011 (1.005-1.018), P=0.001]. Serum AHCY level predicting the area under the curve (AUC) of 30-day mortality in HEV-ALF patients was 0.912, with a sensitivity of 90.00% and a specificity of 93.75%. DCA results demonstrated that serum AHCY level had good decision-making power for predicting 30-day mortality in HEV-ALF patients. Conclusion:Serum AHCY has an important prognostic value for HEV-ALF patients. Higher serum AHCY levels indicate the worse prognosis of HEV-ALF patients.
5.Analysis of the current situation of skin test for β-lactam antibiotics in medical institutions in Beijing
Ying-qiu YING ; Yi-feng DING ; Yin-chu CHENG ; Ming LU ; Jia-jia ZHENG ; Chao LIN ; Ning SHEN ; Chun-yan LI ; Juan DU ; Yi-heng YANG ; Suo-di ZHAI
The Chinese Journal of Clinical Pharmacology 2024;40(22):3323-3327
Objective To investigate the current situation of skin tests for β-lactams in 155 hospitals in Beijing.Methods The questionnaires were sent to medical institutions in Beijing to statistically described the current situation of β-lactams skin test,and the relevant influencing factors were analyzed by Fisher exact test,and Chi-square test.Results A total of 3 097 questionnaires were received from 155 medical institutions,of which 3 057 were valid questionnaires(effective rate is 98.71%).In this study,122 hospitals conducted skin test before using intravenous penicillins,accounting for 99.19%of 123 hospitals with intravenous penicillins.Hospitals with infectious disease pharmacists conducted more skin tests before using intravenous penicillins(98.59%vs 88.46%,P<0.001),and some hospitals didn't conduct skin tests before using oral penicillins.Seventy hospitals(45.16%)had not yet cancelled skin tests for cephalosporins,more hospitals with infectious disease pharmacists cancelled routine skin test(59.74%vs 50.00%,P<0.05),and more tertiary hospitals cancelled cephalosporin skin test(80.65%vs 51.40%,29.41%,all P<0.01).After the promulgation of the"Guiding Principle for Skin Test of β-lactams(2021 edition)",more primary hospitals have developed or updated the rules or regulation for skin test of β-lactams according to the Guiding Principle,compared with secondary hospitals(72.22%vs 41.18%,P<0.05).Hospitals with infectious disease pharmacists developed or updated the rules or regulation for skin test of β-lactams in their hospitals(78.57%vs 60.00%,P<0.05).Infectious disease pharmacists had promoting effect on the publicity of the rules or regulation of skin test in the hospital(92.65%vs 80.46%,P<0.05).Conclusion Many hospitals in Beijing have not cancelled cephalosporins skin test,and the current situation of cancelling cephalosporins skin test in tertiary hospitals is better than that in primary and secondary hospitals.
6.Analysis of the current situation of skin test for β-lactam antibiotics in medical institutions in Beijing
Ying-qiu YING ; Yi-feng DING ; Yin-chu CHENG ; Ming LU ; Jia-jia ZHENG ; Chao LIN ; Ning SHEN ; Chun-yan LI ; Juan DU ; Yi-heng YANG ; Suo-di ZHAI
The Chinese Journal of Clinical Pharmacology 2024;40(22):3323-3327
Objective To investigate the current situation of skin tests for β-lactams in 155 hospitals in Beijing.Methods The questionnaires were sent to medical institutions in Beijing to statistically described the current situation of β-lactams skin test,and the relevant influencing factors were analyzed by Fisher exact test,and Chi-square test.Results A total of 3 097 questionnaires were received from 155 medical institutions,of which 3 057 were valid questionnaires(effective rate is 98.71%).In this study,122 hospitals conducted skin test before using intravenous penicillins,accounting for 99.19%of 123 hospitals with intravenous penicillins.Hospitals with infectious disease pharmacists conducted more skin tests before using intravenous penicillins(98.59%vs 88.46%,P<0.001),and some hospitals didn't conduct skin tests before using oral penicillins.Seventy hospitals(45.16%)had not yet cancelled skin tests for cephalosporins,more hospitals with infectious disease pharmacists cancelled routine skin test(59.74%vs 50.00%,P<0.05),and more tertiary hospitals cancelled cephalosporin skin test(80.65%vs 51.40%,29.41%,all P<0.01).After the promulgation of the"Guiding Principle for Skin Test of β-lactams(2021 edition)",more primary hospitals have developed or updated the rules or regulation for skin test of β-lactams according to the Guiding Principle,compared with secondary hospitals(72.22%vs 41.18%,P<0.05).Hospitals with infectious disease pharmacists developed or updated the rules or regulation for skin test of β-lactams in their hospitals(78.57%vs 60.00%,P<0.05).Infectious disease pharmacists had promoting effect on the publicity of the rules or regulation of skin test in the hospital(92.65%vs 80.46%,P<0.05).Conclusion Many hospitals in Beijing have not cancelled cephalosporins skin test,and the current situation of cancelling cephalosporins skin test in tertiary hospitals is better than that in primary and secondary hospitals.
7.Effects of herbal cake separated moxibustion on Tim-4 and ubiquitination of PD-1 in rabbits with immunosuppression.
Luo-Jie XIONG ; Yue-Feng TIAN ; Xiao-Shan XU ; Chun-Tao ZHAI ; Wei LI
Chinese Acupuncture & Moxibustion 2023;43(5):529-536
OBJECTIVE:
To observe the effects of herbal cake separated moxibustion on macrophage effector molecule T-cell immunoglobulin and mucin-domain containing-4 (Tim-4) and ubiquitination of programmed cell death protein 1 (PD-1) in rabbits with immunosuppression, and to explore the possible mechanism on herbal cake separated moxibustion in improving immunosuppression.
METHODS:
Thirty-two big-ear white rabbits were randomly divided into a normal group, a model group, a moxa stick moxibustion group and a herbal cake separated moxibustion group, 8 rabbits in each group. Except the normal group, the immunosuppression model was established by intraperitoneal injection of cyclophosphamide of60 mg/kg in the other 3 groups. "Shenque" (CV 8), "Shenshu" (BL 23), "Zusanli" (ST 36), etc. were selected in both the moxa stick moxibustion group and the herbal cake separated moxibustion group. Moxa stick moxibustion was applied in the moxa stick moxibustion group, one cone at each acupoint; herbal cake separated moxibustion was applied in the herbal cake separated moxibustion group, 5 cones at each acupoint. The intervention was given once every other day for 10 times in both groups. Leukocyte content in peripheral blood was detected by blood cell analyzer; the positive expression of PD-1 in CD+4 T lymphocytes, CD+8T lymphocytes and CD+68 macrophages in peripheral blood was measured by flow cytometry, the serum levels of interleukin 2 (IL-2), CD8, CD68 and Tim-4 were detected by ELISA, and the expression of Tim-4 and F-box only protein 38 (FBXO38) in the liver and spleen tissues was measured by immunohistochemistry.
RESULTS:
Compared with the normal group, in the model group, white blood cell count (WBC) and percentage of neutrophils (NEU%) were decreased while percentage of lymphocyte (LYM%) was increased (P<0.01) in peripheral blood; the positive expression rates of PD-1 in CD+4 T lymphocytes, CD+8T lymphocytes and CD+68 macrophages in peripheral blood were increased (P<0.01); the serum levels of IL-2, CD68 and Tim-4 were increased (P<0.01), the serum level of CD8 was decreased (P<0.01); the average optical density (AOD) of Tim-4 in the liver tissue and FBXO38 in the liver and spleen tissues was increased (P<0.01). Compared with the model group, in the moxa stick moxibustion group and the herbal cake separated moxibustion group, WBC and NEU% were increased (P<0.01); the positive expression rates of PD-1 in CD+4 T lymphocytes, CD+8T lymphocytes and CD+68 macrophages in peripheral blood were decreased (P<0.01); the serum levels of IL-2, CD68 and Tim-4 were decreased (P<0.01), the serum levels of CD8 were increased (P<0.01); the AOD of Tim-4 and FBXO38 in the liver tissue and FBXO38 in the spleen tissue was decreased (P<0.01, P<0.05). Compared with the moxa stick moxibustion group, in the herbal cake separated moxibustion group, the positive expression rate of PD-1 in CD+68 macrophages in peripheral blood was increased (P<0.05); serum level of Tim-4 was increased (P<0.01); AOD of Tim-4 in the liver tissue was decreased (P<0.05).
CONCLUSION
Herbal cake separated moxibustion can improve immunosuppression by regulating the expression of macrophage effector molecule Tim-4 and the FBXO38 mediated ubiquitination of PD-1, Tim-4 may be one of the specific indexes of immunomodulation involving with herbal cake separated moxibustion.
Animals
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Rabbits
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Interleukin-2/genetics*
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Moxibustion
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Programmed Cell Death 1 Receptor/genetics*
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Immunosuppression Therapy
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Ubiquitination
8.Effect of multi-glycosides of Tripterygium wilfordii on renal injury in diabetic kidney disease rats through NLRP3/caspase-1/GSDMD pyroptosis pathway.
Chun-Dong SONG ; Dan SONG ; Ping-Ping JIA ; Feng-Yang DUAN ; Ying DING ; Xian-Qing REN ; Wen-Sheng ZHAI ; Yao-Xian WANG ; Shu-Li HUANG
China Journal of Chinese Materia Medica 2023;48(10):2639-2645
This study investigated the effect of multi-glycosides of Tripterygium wilfordii(GTW) on renal injury in diabetic kidney disease(DKD) rats through Nod-like receptor protein 3(NLRP3)/cysteine-aspartic acid protease-1(caspase-1)/gsdermin D(GSDMD) pyroptosis pathway and the mechanism. To be specific, a total of 40 male SD rats were randomized into the normal group(n=8) and modeling group(n=34). In the modeling group, a high-sugar and high-fat diet and one-time intraperitoneal injection of streptozotocin(STZ) were used to induce DKD in rats. After successful modeling, they were randomly classified into model group, valsartan(Diovan) group, and GTW group. Normal group and model group were given normal saline, and the valsartan group and GTW group received(ig) valsartan and GTW, respectively, for 6 weeks. Blood urea nitrogen(BUN), serum creatinine(Scr), alanine ami-notransferase(ALT), albumin(ALB), and 24 hours urinary total protein(24 h-UTP) were determined by biochemical tests. The pathological changes of renal tissue were observed based on hematoxylin and eosin(HE) staining. Serum levels of interleukin-1β(IL-1β) and interleukin-18(IL-18) were detected by enzyme-linked immunosorbent assay(ELISA). Western blot was used to detect the expression of pyroptosis pathway-related proteins in renal tissue, and RT-PCR to determine the expression of pyroptosis pathway-related genes in renal tissue. Compared with the normal group, the model group showed high levels of BUN, Scr, ALT, and 24 h-UTP and serum levels of IL-1β and IL-18(P<0.01), low level of ALB(P<0.01), severe pathological damage to kidney, and high protein and mRNA levels of NLRP3, caspase-1, and GSDMD in renal tissue(P<0.01). Compared with the model group, valsartan group and GTW group had low levels of BUN, Scr, ALT, and 24 h-UTP and serum levels of IL-1β and IL-18(P<0.01), high level of ALB(P<0.01), alleviation of the pathological damage to the kidney, and low protein and mRNA levels of NLRP3, caspase-1, and GSDMD in renal tissue(P<0.01 or P<0.05). GTW may inhibit pyroptosis by decreasing the expression of NLRP3/caspase-1/GSDMD in renal tissue, thereby relieving the inflammatory response of DKD rats and the pathological injury of kidney.
Rats
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Male
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Animals
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Diabetic Nephropathies/genetics*
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Interleukin-18/metabolism*
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Glycosides/pharmacology*
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Tripterygium
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NLR Family, Pyrin Domain-Containing 3 Protein/metabolism*
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Rats, Sprague-Dawley
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Caspase 1/metabolism*
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Pyroptosis
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Uridine Triphosphate/pharmacology*
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Kidney
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Valsartan/pharmacology*
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RNA, Messenger/metabolism*
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Diabetes Mellitus
9.Evaluation methods of clinical efficacy of traditional Chinese medicine.
Ming ZHUANG ; Jia-Li AN ; Meng-Yuan ZHONG ; Chun-Yang WANG ; Xue-Chen DU ; Jia-Ni ZHAI ; Wen-Ke ZHENG
China Journal of Chinese Materia Medica 2023;48(12):3263-3268
Clinical efficacy is the basis for the development of traditional Chinese medicine(TCM), and the evaluation of clinical efficacy of TCM has always been the focus of attention. The technical and methodological difficulties in the evaluation process often restrict the generation of high-level evidence. Therefore, methodological research should be deepened and innovative practice should be carried out to study the application of scientific research methods in the evaluation of the advantages of TCM. After more than ten years of development, the clinical efficacy evaluation of TCM, on the basis of the initially classic placebo randomized controlled trials, has successively carried out a series of meaningful attempts and explorations in N-of-1 trials, cohort studies, case-control studies, cross-sectional studies, real world studies, narrative medicine studies, systematic evaluation, and other aspects, laying the foundation for the transformation of TCM from "experience" to "evidence". This paper focused on the clinical efficacy evaluation of TCM, summarized the main connotation and development status of efficacy evaluation indicators, standards, and methods, and put forward corresponding countermeasures and suggestions for the problems of indicator selection, standard formulation, and methodology optimization in the research process. It is clear that scientific and objective evaluation of the efficacy of TCM is an urgent problem to be solved at present.
Medicine, Chinese Traditional
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Cross-Sectional Studies
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Treatment Outcome
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Case-Control Studies
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Narrative Medicine
10.Problems and thoughts in clinical safety evaluation of traditional Chinese medicine.
Meng-Yuan ZHONG ; Chun-Yang WANG ; Ming ZHUANG ; Jia-Li AN ; Xue-Chen DU ; Jia-Ni ZHAI ; Wen-Ke ZHENG
China Journal of Chinese Materia Medica 2023;48(12):3404-3408
Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.
Medicine, Chinese Traditional/adverse effects*
;
Social Change

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