Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

A rapid analytical method for determination of paraquat and diquat in tea samples was established by improving the QuEChERS pre-treatment method combined with ultra-high performance liquid chromatography-tandem quadrupole mass spectrometry(UPLC-MS/MS).Four kinds of tea powder were extracted by using acetonitrile-0.1％formic acid solution(3∶7,V/V)and ultrasonic treatment,and the supernatant was purified with 400 mg C18 and 400 mg PSA and separated on hydrophilic HILIC(100 mm×2.1 mm,1.8 μm)column by using 0.1％formic acid aqueous solution(Containing 5 mmol/L ammonium formate)and acetonitrile as mobile phases.In the electrospray ion source positive ion mode(ESI+),multiple reaction monitoring scanning technology(MRM)was used for determination,and the matrix-matched standard solution external standard method was used for quantitative analysis.The results showed that paraquat obtained good linear relationship in the content range of 0.18-200 μg/kg and diquat obtained good linear relationship in the content range of 0.36-200 μg/kg,and the correlation coefficients(R2)were 0.9939-0.9976 and 0.9959-0.9987,respectively.The limits of detection(LODs)were 0.06 and 0.12 μg/kg,and the limits of quantitation(LOQs)were 0.18 and 0.36 μg/kg,respectively.The average spiked recoveries for tea samples varied from 84.4％to 128.8％,with the relative standard deviations(RSDs)from 0.6％to 13.5％.The method was simple and efficient,with accurate quantification ability and low detection limit,which could realize efficient determination of paraquat and diquat in tea samples.

Background/Aims: Non-alcoholic fatty liver disease (NAFLD) is associated with the development of cardiovascular disease. While existing studies have examined cardiac remodeling in NAFLD, there has been less emphasis on the development of carotid atherosclerosis and stroke. We sought to conduct a meta-analysis to quantify the prevalence, risk factors, and degree of risk increment of carotid atherosclerosis and stroke in NAFLD. Methods: Embase and Medline were searched for articles relating to NAFLD, carotid atherosclerosis, and stroke. Proportional data was analysed using a generalized linear mixed model. Pairwise meta-analysis was conducted to obtain odds ratio or weighted mean difference for comparison between patients with and without NAFLD. Results: From pooled analysis of 30 studies involving 7,951 patients with NAFLD, 35.02% (95% confidence interval [CI], 27.36–43.53%) had carotid atherosclerosis with an odds ratio of 3.20 (95% CI, 2.37–4.32; P<0.0001). Pooled analysis of 25,839 patients with NAFLD found the prevalence of stroke to be 5.04% (95% CI, 2.74–9.09%) with an odds ratio of 1.88 (95% CI, 1.23–2.88; P=0.02) compared to non-NAFLD. The degree of steatosis assessed by ultrasonography in NAFLD was closely associated with risk of carotid atherosclerosis and stroke. Older age significantly increased the risk of developing carotid atherosclerosis, but not stroke in NAFLD. Conclusions This meta-analysis shows that a stepwise increment of steatosis of NAFLD can significantly increase the risk of carotid atherosclerosis and stroke development in NAFLD. Patients more than a third sufferred from carotid atherosclerosis and routine assessment of carotid atherosclerosis is quintessential in NAFLD.

ObjectiveTo explore the value of plasma free metanephrines， including metanephrine（MN） and normetanephrine（NMN）， collectively referred to as MNs in the diagnosis of pheochromocytoma and paraganglioma （PPGL）. MethodsThe study included 1 631 patients suspected of PPGL from December 2014 to December 2020 in SunYat-sen Memorial Hospital. In these subjects， Plasma free MNs were measured by liquid chromatography-tandem mass spectrometry（LC-MS/MS） before surgery. Receiver operating characteristic （ROC） curves were used to determine the sensitivity and specificity of plasma NMN and MN in the diagnosis of PPGL. ResultsOf the screened patients， 108 patients had pathologically confirmed PPGL and 1 523 patients had definitive diagnoses other than PPGL as a control group. The median value of plasma MN ［0.54（0.17~4.48） nmol/L vs. 0.15（0.11~0.21） nmol/L， P<0.001］ and NMN ［7.48（2.12~15.01） nmol/L vs. 0.32（0.22~0.46） nmol/L， P<0.001］ were significant higher in the PPGL group than in the control group. Using an upper cut-off of 0.395 nmol/L for MN， the sensitivity was 60.2% and the specificity was 97.8%； when using a cut-off of 1.105 nmol/L for NMN， the diagnostic sensitivity was 87.0%， and the specificity was 98.7%. The area under the ROC curve and 95% confidence interval of plasma MN and NMN combined were 0.800（0.743， 0.858）， 0.959（0.932， 0.98） and 0.970（0.944， 0.996）， respectively. Analyzing the false-positive results， it was found that in the control group， 3% of the false-positive cases appeared. The estimated glomerular filtration rate（eGFR） were significantly lower in the false-positive group than in the true-negative group ［74.42（51.04~96.96） mL/min vs. 88.51（72.80~101.83） mL/min， P=0.001］. In 212 patients with eGFR lower than 60 mL/min， the false positive rate was increased to 8%. If the upper limit of the reference interval was increased by 25%， the specificity was increased to 96.7%； when the upper limit of the reference interval was increased by 50%， the specificity was 98.6 %. ConclusionsPlasma free MNs has a great reliability in the diagnosis of PPGL. The negative predictive value is extremely high and close to 100%. Combination analysis of plasma MN and NMN can further improve diagnostic performance. However， a few false positive cases may appear and might be influenced by impaired renal function. In patients with eGFR lower than 60 mL/min， the false positive rate is significantly increasing， which need a 25%-50% increase in the expected upper limit of a reference range to guarantee high specificity.

In recent years， the incidence rate of andrological diseases has shown a significant growth trend. Considering the unavailability of a perfect theoretical system for andrology in traditional Chinese medicine （TCM） and the complex pathogenesis despite of the limited types of andrological diseases， it is necessary to improve the clinical efficacy of andrological diseases so as to satisfy the needs of patients. Therefore， the China Association of Chinese Medicine （CACM） organized the andrologists of TCM and western medicine and the outstanding young clinicians to discuss the andrological diseases responding specifically to TCM or integrated TCM and western medicine， such as chronic prostatitis， male infertility， benign prostatic hyperplasia， erectile dysfunction， and premature ejaculation， determine their diagnostic criteria in western medicine， and standardize the specifications for TCM diagnosis and treatment based on syndrome differentiation， thus formulating recognized and integrated diagnosis and treatment protocols. Apart from proposing suggestions on the treatment of such andrological diseases with TCM and western medicine， the experts have also figured out the andrological diseases responding specifically to TCM， the optimal intervention time of TCM and western medicine， and the suitable measures including surgery. The resulting consensus helps to better guide the formulation of accurate， personalized， and optimized treatment plans in clinical practice and improve the diagnosis and treatment effects of andrological diseases by giving full play to the advantages of TCM， which will in turn contribute to further innovation and development of TCM.

Objective:To investigate the role of follicular helper T(Tfh) cells and galactose deficiency IgA 1(Gd-IgA 1) in the children that were suffering from Henoch-Sch?nlein purpura(HSP) and Henoch-Sch?nlein purpura nephritis(HSPN)and the correlation between them. Methods:According to the presence or absence of renal injury, 62 children with HSP were divided into HSP group with 32 children and HSPN group with 30 children.Twenty children who underwent physical examination at outpatients were known as the healthy control group.Flow cytometry was used to measure the proportion of Tfh(CD4 + CXCR5 + PD-1 + ) in peripheral blood.Immunoturbidimetry and ELISA were used to measure the serum levels of IgA 1 and Gd-IgA 1 respectively. Results:(1) The proportion of Tfh cells in peripheral blood and the serum levels of Gd-IgA 1 in both HSP group and HSPN group had significantly increased than those in healthy control group( P<0.01). Compared result of the HSPN group with HSP group, the proportion of Tfh cells in peripheral blood and the serum levels of Gd-IgA 1 in HSPN group were higher than that in HSP group( P<0.05). (2) In the HSPN group, the proportion of peripheral blood Tfh cells and the serum levels of Gd-IgA 1 in group of renal pathology ≥ grade Ⅲ and heavy proteinuria were significantly elevated compared with group of renal pathology < grade Ⅲ and non-heavy proteinuria(<0.01). (3) In the healthy control group, the serum levels of Gd-IgA 1 was positively correlated with the proportion of Tfh cells in peripheral blood and the serum levels of Gd-IgA 1( P<0.05). Conversely, a non-positive correlation was shown in HSP and HSPN groups( P>0.05). Conclusion:The excessive activation of Tfh cells and the serum levels of Gd-IgA 1 may be one of the pathogenesis of HSP/HSPN, the degree of increment of the two factors may be related to the activity and severity of the disease.The mechanism of Tfh cells potentially leading to an increase of Gd-IgA 1 production requires further study.

When this paper was first published the following ethical statement was omitted in error: This study was approved by the Ethics Committee of AAALAC (NO. 001488) and carried out in strict accordance with the recommendations in the Guide for the Care and Use of Laboratory Animals of Tianjin Institute of Pharmaceutical Research. The authors would like to apologise for any inconvenience caused. DOI of original article: https://doi.org/10.1016/j.chmed.2018.12.002

Betacoronavirus ; Consensus ; Coronavirus Infections ; complications ; epidemiology ; prevention & control ; Epidemics ; Humans ; Minimally Invasive Surgical Procedures ; Musculoskeletal Diseases ; complications ; therapy ; Pandemics ; prevention & control ; Pneumonia, Viral ; complications ; epidemiology ; prevention & control

To scientifically evaluate the intervention effect of Chinese medicine preventive administration(combined use of Huo-xiang Zhengqi Oral Liquid and Jinhao Jiere Granules) on community population in the case of coronavirus disease 2019(COVID-19), a large cohort, prospective, randomized, and parallel-controlled clinical study was conducted. Total 22 065 subjects were included and randomly divided into 2 groups. The non-intervention group was given health guidance only, while the traditional Chinese medicine(TCM) intervention group was given two coordinated TCM in addition to health guidance. The medical instructions were as follows. Huoxiang Zhengqi Oral Liquid: oral before meals, 10 mL/time, 2 times/day, a course of 5 days. Jinhao Jiere Granules: dissolve in boiling water and take after meals, 8 g/time, 2 times/day, a course of 5 days, followed up for 14 days, respectively. The study found that with the intake of medication, the incidence rate of TCM intervention group was basically maintained at a low and continuous stable level(0.01%-0.02%), while the non-intervention group showed an overall trend of continuous growth(0.02%-0.18%) from 3 to 14 days. No suspected or confirmed COVID-19 case occurred in either group. There were 2 cases of colds in the TCM intervention group and 26 cases in the non-intervention group. The incidence of colds in the TCM intervention group was significantly lower(P<0.05) than that in the non-intervention group. In the population of 16-60 years old, the incidence rate of non-intervention and intervention groups were 0.01% and 0.25%, respectively. The difference of colds incidence between the two groups was statistically significant(P<0.05). In the population older than 60 years old, they were 0.04% and 0.21%, respectively. The incidence of colds in the non-intervention group was higher than that in the intervention group, but not reaching statistical difference. The protection rate of TCM for the whole population was 91.8%, especially for the population of age 16-60(95.0%). It was suggested that TCM intervention(combined use of Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules) could effectively protect community residents against respiratory diseases, such as colds, which was worthy of promotion in the community. In addition, in terms of safety, the incidence of adverse events and adverse reactions in the TCM intervention group was relatively low, which was basically consistent with the drug instructions.
Adolescent ; Adult ; Betacoronavirus ; Coronavirus Infections ; drug therapy ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional ; Middle Aged ; Pandemics ; Pneumonia, Viral ; drug therapy ; Prospective Studies ; Young Adult

Anticoagulants/therapeutic use* ; Atrial Fibrillation/therapy* ; China/epidemiology* ; Humans ; Registries ; Risk Factors ; Stroke