Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

Traditional Chinese medicine(TCM) decoction pieces are a core carrier for the inheritance and innovation of TCM, and their quality and safety are critical to public health and the sustainable development of the industry. Conventional quality control models, while having established a well-developed system through long-term practice, still face challenges such as relatively long inspection cycles, insufficient objectivity in characterizing complex traits, and urgent needs for improving the efficiency of integrating multidimensional quality information when confronted with the dual demands of large-scale production and precision quality control. With the rapid development of artificial intelligence, machine learning can deeply analyze multidimensional data of the morphology, spectroscopy, and chemical fingerprints of decoction pieces by constructing high-dimensional feature space analysis models, significantly improving the standardization level and decision-making efficiency of quality evaluation. This article reviews the research progress in the application of machine learning in the processing, production, and rapid quality evaluation of TCM decoction pieces. It further analyzes current challenges in technological implementation and proposes potential solutions, offering theoretical and technical references to advance the digital and intelligent transformation of the industry.
Machine Learning ; Drugs, Chinese Herbal/standards* ; Quality Control ; Medicine, Chinese Traditional/standards* ; Humans

OBJECTIVE: To evaluate the efficacy and safety of Chinese medicine (CM) Zihua Wenfei Zhisou Granule (ZWZG) in postinfectious cough (PIC) patients with CM syndrome of wind-cold invading Fei (Lung, WCIF). METHODS: This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase II clinical trial. PIC patients with WCIF syndrome were recruited from the Respiratory Departments in 6 hospitals across China between March 2019 and December 2020. Eligible patients were randomly assigned to group A (ZWZG-matched placebo 15 g), group B (active ZWZG 15 g), and group C (active ZWZG 10 g plus ZWZG-matched placebo 5 g) in a 1:1:1 ratio. All medications were taken orally 3 times daily for 14 consecutive days. The primary outcomes were cough relief rate and cough disappearance rate. The secondary outcomes included time to cough relief, time to cough disappearance, and changes in cough symptom score (CSS), cough Visual Analog Scale (VAS) value, Cough-Specific Quality of Life Questionnaire (CQLQ) score, and CM syndrome score from baseline (day 0) to post-treatment (day 14). Adverse events (AEs) in each group were recorded. RESULTS: A total of 198 patients were included in the full analysis set (FAS) and safety analysis set (SS), while 183 were enrolled in the per-protocol analysis set (PPS). In the FAS population, the cough relief rate was 47.76%, 90.77% and 84.85% in groups A, B, and C, respectively; while the cough disappearance rate was 31.34%, 72.31% and 68.18%, respectively. The cough relief rates and cough disappearance rates in groups B and C were significantly higher than group A (P<0.0001). Both the median time to cough relief and cough disappearance in groups B and C were shorter than group A (P<0.0001). Compared with group A, groups B and C showed significantly greater improvements from baseline to post-treatment in CSS during daytime and nighttime as well as VAS (P<0.05). There were no significant differences in changes from baseline to post-treatment in CQLQ and CM syndrome scores among 3 groups (P>0.05). Results in the PPS population were consistent with those in the FAS population. Groups B and C showed lower incidence in AEs than group A (P<0.05), while there was no significant difference between groups B and C (P>0.05). No drug-related severe AEs were reported. CONCLUSIONS ZWZG can increase cough disappearance rate and cough relief rate; and it is beneficial in shortening cough duration and reducing cough severity and frequency in patients suffering from PIC. It is safe and generally well tolerated. (Registration No. ChiCTR1900022078).
Humans ; Cough/drug therapy* ; Double-Blind Method ; Male ; Female ; Drugs, Chinese Herbal/adverse effects* ; Middle Aged ; Treatment Outcome ; Adult ; Aged ; Quality of Life

OBJECTIVE: To investigate the relationship between physical activity and genetic risk and their combined effects on the risk of developing chronic obstructive pulmonary disease. METHODS: This prospective cohort study included 318,085 biobank participants from the UK. Physical activity was assessed using the short form of the International Physical Activity Questionnaire. The participants were stratified into low-, intermediate-, and high-genetic-risk groups based on their polygenic risk scores. Multivariate Cox regression models and multiplicative interaction analyses were used. RESULTS: During a median follow-up period of 13 years, 9,209 participants were diagnosed with chronic obstructive pulmonary disease. For low genetic risk, compared to low physical activity, the hazard ratios ( HRs) for moderate and high physical activity were 0.853 (95% confidence interval [ CI]: 0.748-0.972) and 0.831 (95% CI: 0.727-0.950), respectively. For intermediate genetic risk, the HRs were 0.829 (95% CI: 0.758-0.905) and 0.835 (95% CI: 0.764-0.914), respectively. For participants with high genetic risk, the HRs were 0.809 (95% CI: 0.746-0.877) and 0.818 (95% CI: 0.754-0.888), respectively. A significant interaction was observed between genetic risk and physical activity. CONCLUSION Moderate or high levels of physical activity were associated with a lower risk of developing chronic obstructive pulmonary disease across all genetic risk groups, highlighting the need to tailor activity interventions for genetically susceptible individuals.
Humans ; Pulmonary Disease, Chronic Obstructive/epidemiology* ; Exercise ; Male ; Female ; Middle Aged ; Prospective Studies ; Aged ; Genetic Predisposition to Disease ; Risk Factors ; United Kingdom/epidemiology* ; Incidence ; Adult

Further evidence is needed to explore the impact of high-altitude environments on the neurologic function of neonates.Non-invasive techniques such as cerebral near-infrared spectroscopy and amplitude-integrated electroencephalography can provide data on cerebral oxygenation and brain electrical activity.This study will conduct multiple cerebral near-infrared spectroscopy and amplitude-integrated electroencephalography monitoring sessions at various time points within the first 3 days postpartum for healthy full-term neonates at different altitudes.The obtained data on cerebral oxygenation and brain electrical activity will be compared between different altitudes,and corresponding reference ranges will be established.The study involves 6 participating centers in the Chinese High Altitude Neonatal Medicine Alliance,with altitude gradients divided into 4 categories:800 m,1 900 m,2 400 m,and 3 500 m,with an anticipated sample size of 170 neonates per altitude gradient.This multicenter prospective cohort study aims to provide evidence supporting the impact of high-altitude environments on early brain function and metabolism in neonates.[Chinese Journal of Contemporary Pediatrics,2024,26(4):403-409]

Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75％(27/36);boys accounted for 64％(23/36).Among the 36 neonates,31(86％)had disease onset within 3 days after birth,and 19(53％)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61％)had left cerebral infarction and 13(36％)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75％)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72％)and seizures in 10 neonates(34％).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33％,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44％(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.

The mutual recognition of medical examination results is significant for improving the utilization efficiency of limited resources in large public hospitals,promoting the sharing of quality medical resources,alleviating the high costs and diffi-culties of healthcare for the public,reducing pressure on medical insurance funds,and enhancing the efficiency of fund utiliza-tion.This study reviews the research on mutual recognition of medical examination results in China,analyzing it from four as-pects:regulatory norms,platform construction,policy awareness,and performance distribution.It identifies research hotspots and directions related to mutual recognition,clarifies the challenges and key points in the implementation of relevant policies,and suggests future research directions,including strengthening theoretical research,improving empirical studies,and innovating re-search methods.

ObjectiveTo retrospectively analyze the clinical efficacy of Xibining Ⅱ prescription in the treatment of knee osteoarthritis with cold-dampness blockage syndrome by oral medication and to explore the influencing factors of endpoint events. MethodA real-world retrospective cohort design was adopted， and medical records of knee osteoarthritis patients with cold-dampness blockage syndrome treated with oral medication from the orthopedics outpatient department of Jiangsu Province Hospital of Chinese Medicine were collected. All patients received conventional Western medicine treatment and were divided into non-exposure group （573 cases） and exposure group （427 cases） according to whether or not they received treatment with Xibining Ⅱ prescription. Descriptive analysis of the baseline data of the 1 000 screened cases was performed using IBM SPSS 27.0. According to the baseline data， 334 pairs were matched using the propensity score matching method， resulting in a total of 668 cases in both groups. The changes in visual analogous scale （VAS）， Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC） total score， Japanese Knee Osteoarthritis Measure （JKOM） score， and traditional Chinese medicine （TCM） syndrome score before treatment and at 2， 6， 12 weeks after treatment， as well as the incidence of adverse reactions， were compared between the two groups. A multivariate logistic regression analysis was conducted to analyze the influencing factors of endpoint events， with clinical cure judged based on the improvement rate of WOMAC total score before and after treatment. ResultAfter 12 weeks of treatment， compared to the results before treatment， the VAS， WOMAC total score， JKOM score， and TCM syndrome score of patients in both groups significantly decreased （P<0.01）. Compared to the non-exposure group， the exposure group showed a more significant reduction in VAS， WOMAC total score， JKOM score， and TCM syndrome score （P<0.01）. After 12 weeks of treatment， the clinical cure rate and significant efficiency were higher in the exposure group than in the non-exposure group （P<0.05）. Compared to the results before treatment within each group， VAS， WOMAC pain， stiffness， function scores， JKOM score， and TCM syndrome score significantly decreased at 2， 6， 12 weeks after treatment in both groups （P<0.01）. Compared to the non-exposure group at the same time points， the exposure group showed a reduction in VAS at 2， 12 weeks， WOMAC pain at 6， 12 weeks， and function scores at 12 weeks （P<0.05， P<0.01）. The JKOM score decreased at 6， 12 weeks， and the TCM syndrome score significantly decreased at 2， 6， 12 weeks in the exposure group （P<0.05， P<0.01）. Multivariate logistic regression analysis at 12 weeks showed that factors affecting clinical cure included the course of disease， history of alcohol consumption， hypertension， coronary heart disease， and the use of Xibining Ⅱ prescription （P<0.05， P<0.01）. Compared to the non-exposure group at the same time points， the incidence of epigastric discomfort in the exposure group was lower at 2， 12 weeks （P<0.01）， the incidence of diarrhea and vomiting was slightly higher than that in the non-exposure group， but the difference was not statistically significant. ConclusionThe clinical application of Xibining Ⅱ prescription combined with conventional Western medicine treatment in the treatment of knee osteoarthritis with cold-dampness blockage syndrome is more effective than conventional Western medicine treatment alone. It can significantly reduce VAS， WOMAC total score， JKOM score， and TCM syndrome score， with more pronounced long-term effects and a low incidence of adverse reactions.

Objective To observe the clinical efficacy and safety of ticagrelor tablets combined with atorvastatin calcium tablets in the treatment of cerebral thrombosis.Methods The patients with cerebral thrombosis were divided into control group and treatment group according to cohort methods.Two groups were given basic therapy.On the basic therapy,control group was given atorvastatin calcium 20 mg per time,once a day,orally;on the basic of control group,the treatment group received ticagrelor 90 mg per time,twice a day,orally.Two groups were treated for 4 months.The clinical efficacy,nerve function,blood viscosity,platelet parameters,brain injury markers and adverse drug reactions were compared between two groups.Results Treatment and control groups enrolled 119 and 117 cases,respectively.After treatment,the total effective rates of treatment and control groups were 91.60％(109 cases/119 cases)and 82.05％(96 cases/117 cases)with significant difference(P＜0.05).After treatment,the scale scores of treatment and control groups were(5.47±0.82)and(6.51±0.96)points;the plasma viscosity levels were(1.35±0.21)and(1.62±0.24)mPa·s,whole blood high shear viscosity levels were(3.67±0.51)and(4.01±0.59)mPa·s;the whole blood low shear viscosity levels were(6.12±0.93)and(7.05±1.07)mPa·s;the platelet adhesion rates were(30.52±3.81)％and(36.21±4.02)％;the mean platelet volumes were(12.75±1.86)and(15.42±2.06)fL;the carboxy-terminal hydrolase of ubiquitin levels were(0.39±0.06)and(0.51±0.07)μg·L-1;the key protein antigen-5 of aging levels were(90.76±12.23)and(81.64±11.95)μg·L-1;and the differences were statistically significant between two groups(all P＜0.05).The adverse drug reactions of two groups were nausea,vomiting,bleeding,abdominal pain and diarrhea.The total incidences of adverse drug reactions in treatment and control groups were 5.04％and 4.27％,without significant difference(P＞0.05).Conclusion Ticagrelor tablets combined with atorvastat in calcium tablets have a significant clinical efficacy in the treatment of patients with cerebral thrombus,which can significantly improve the neurological function,blood viscosity,brain injury markers,and platelet parameters of patients,without increasing the incidence of adverse drug reactions.

Objective To explore the protective mechanism of baicalin regulating NOD like receptor thermal protein domain associated protein 3(NLRP3)inflammasomes against acne.Methods Compound acne models were prepared by intradermal injection of Propionibacterium acnes into the auricle.Rats were randomly divided into control group(normal rats were given physiological saline by gavage),model group(acne model rats were given physiological saline by gavage),experimental-L,-M,-H groups(acne model rats were given 25,50,and 100 mg·kg-1 of baicalin by gavage),and positive control group(acne model rats were given 3.125 mg·kg-1 of isotretinoin by gavage),with 10 rats in each group.Observe the morphology of rat auricles;enzyme linked immunosorbent assay(ELISA)was used to detect the level of inflammation in serum;hematoxylin-eosin staining was used to detect pathological changes in rat auricle tissue;Western blotting was used to detect the protein expression level in the auricle tissue.Results After drug treatment,the auricular thickness of rats in the control,model,experimental-H and positive control groups were(0.42±0.05),(0.75±0.10),(0.49±0.05)and(0.50±0.05)mm;the serum levels of tumor necrosis factor-α were(20.46±2.13),(62.32±5.47),(23.27±2.26)and(25.41±2.28)pg·mL-1;interleukin-1 β levels were(11.38±1.26),(31.62±2.58),(15.61±1.35)and(16.72±1.38)pg·mL-1;interleukin-6 levels were(10.62±1.02),(25.43±2.51),(13.27±1.15)and(14.01±1.17)pg·mL-1;NLRP3 protein expression levels in auricular tissues were 0.23±0.03,0.81±0.08,0.30±0.04 and 0.32±0.04;and Caspase-1 protein expression levels were 0.31±0.04,0.76±0.08,0.39±0.04 and 0.41±0.04;matrix metalloproteinase-2 protein expression levels were 0.35±0.04,0.86±0.10,0.40±0.05 and 0.42±0.05.Compared with the model group,the above indexes in the experimental-H group were statistically significant(all P＜0.05).Conclusion Baicalin can inhibit the inflammatory response in acne rats,and its mechanism of action may be related to the inhibition of the NLRP3 inflammasome signaling pathway.