The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

The pharmaceutical industry faces challenges in quality digitization for complex multi-stage processes, especially in small-sample systems. Here, an intelligent quality prediction and diagnostic (IQPD) framework was developed and applied to Tong Ren Tang's Niuhuang Qingxin Pills, utilizing four years of data collected from four production units, covering the entire process from raw materials to finished products. In this framework, a novel path-enhanced double ensemble quality prediction model (PeDGAT) is proposed, which combines a graph attention network and path information to encode inter-unit long-range and sequential dependencies. Additionally, the double ensemble strategy enhances model stability in small samples. Compared to global traditional models, PeDGAT achieves state-of-the-art results, with an average improvement of 13.18% and 87.67% in prediction accuracy and stability on three indicators. Additionally, a more in-depth diagnostic model leveraging grey correlation analysis and expert knowledge reduces reliance on large samples, offering a panoramic view of attribute relationships across units and improving process transparency. Finally, the IQPD framework integrates into a Human-Cyber-Physical system, enabling faster decision-making and real-time quality adjustments for Tong Ren Tang's Niuhuang Qingxin Pills, a product with annual sales exceeding 100 million CNY. This facilitates the transition from experience-driven to data-driven manufacturing.

Tic disorders in children refer to the neurodevelopmental disorders usually occurring in childhood and adolescence.Guided by the theory of five-zang-organ correlation,Professor Li Yirui approaches the treatment of tic disorders in children and comorbidities primarily from the perspective of liver-spleen disharmony,and points out that the pathogenesis is due to liver-spleen disharmony,wind-phlegm disturbance,and mutual involvement of the five zang organs.In clinical practice,Professor Li established the therapeutic principle of regulating the liver and spleen,extinguishing wind,and resolving phlegm,and adopted the four liver-regulating methods(calming liver,soothing liver,clearing liver,and softening liver)to extinguish wind and stop tics,as well as the four spleen-regulating methods(replenishing spleen,activating spleen,awakening spleen,and dredging spleen)to strengthen body resistance and support healthy qi.The self-formulated Fupi Xifeng Decoction(composed of Pseudostellariae Radix,Atractylodis Macrocephalae Rhizoma,Poria,Glycyrrhizae Radix et Rhizoma,Bupleuri Radix,Paeoniae Radix Alba,Uncariae Ramulus cum Uncis,Gastrodiae Rhizoma,Pinelliae Rhizoma Praeparatum,Citri Reticulatae Pericarpium,Os Draconis,etc.)serves as the basic formula,herbs directing to the affected regions were flexibly used,and insect drugs were occasionally adopted for refractory cases.The treatment for tic disorders in children focus on simultaneous regulation of the five zang-organs by modified use of herbs for dispersing wind and benefiting lung,tranquilizing heart and calming spirit,and supplementing liver and kidney to address comorbidities and secondary symptoms.Additionally,integrated internal-external treatment,relieving the discomforts physically and mentally,and family-centered comprehensive care are also taken into account to achieve optimal outcomes.

Objective:To evaluate the effects of ketogenic diet(KD) on pancreatic β-cell dedifferentiation in db/db mice.Methods:In animal study, 8-week-old db/db male mice with type 2 diabetes mellitus(T2DM) were randomly divided into 3 groups: T2DM model group(ND), KD group, 75% caloric restriction(CR) group, and male C57BL/6 mice of the same age as normal control group(C) fed with standard diet. Both C and ND groups were on ad lititum feeding of chow, the KD group was free to eat the ketogenic diet, and the CR group was the positive control group, consuming 75% of the calories of the ND group every day. Four weeks after different diet intervention, body weight, fasting blood glucose, fasting insulin, glucose tolerance and blood β-hydroxybutyric acid(BHB) were measured. Morphology and structure of pancreatic islet was observed by hematoxylin-eosin staining(HE). Immunofluorescence co-staining was used to observe the expression of mouse pancreatic β-cell specific transcription factors.Results:After 4 weeks diet intervention, the fasting blood glucose, insulin and the area under the curve of blood glucose in KD group was significantly decreased( P<0.05); When compared with ND group, the morphology and structure of the islets in the KD group were more regular, and the number of islet cells increased as revealed with HE staining. Pancreatic immunofluorescence co-assay showed that KD not only restored the number and arrangement of β-cells and the ratio of β/α-cell in the pancreatic islets, but also reversed the expression of specific β-cell transcription factors such as pancreatic duodenal homeobox factor-1(PDX1). Conclusion:KD can reduce fasting blood glucose, fasting insulin and improve glucose tolerance in db/db mice, which may be related to its ability to restore the expression of specific β-cell transcription factors and reverse the dedifferentiation of pancreatic β-cells.

Background::Urticaria is a common skin disease characterized by episodes of wheals, and it has a negative effect on patients’ quality of life. Large-scale population-based epidemiological studies of urticaria are scarce in China. The aim of this survey was to determine the prevalence, clinical forms, and risk factors of urticaria in the Chinese population.Methods::This survey was conducted in 35 cities from 31 provinces, autonomous regions, and municipalities of China. Two to three communities in each city were selected in this investigation. Participants completed questionnaires and received dermatological examinations. We analyzed the prevalence, clinical forms, and risk factors of urticaria.Results::In total, 44,875 questionnaires were distributed and 41,041 valid questionnaires were collected (17,563 male and 23,478 female participants). The lifetime prevalence of urticaria was 7.30%, with 8.26% in female and 6.34% in male individuals ( P < 0.05). The point prevalence of urticaria was 0.75%, with 0.79% in female and 0.71% in male individuals ( P < 0.05). Concomitant angioedema was found in 6.16% of patients. Adults had a higher prevalence of urticaria than adolescents and children. Living in urban areas, exposure to pollutants, an anxious or depressed psychological status, a personal and family history of allergy, thyroid diseases, and Helicobacter pylori infection were associated with a higher prevalence of urticaria. Smoking was correlated with a reduced risk of urticaria. Conclusion::This study demonstrated that the lifetime prevalence of urticaria was 7.30% and the point prevalence was 0.75% in the Chinese population; women had a higher prevalence of urticaria than men. Various factors were correlated with urticaria.

Objective: To find the differential expression profiles of circRNA in whole blood and predict its target genes in blood of patients with tuberculosis in Xinjiang, and explore the relationship between circRNA and the development of tuberculosis. Methods: The circRNAs expression in peripheral blood from 3 pulmonary tuberculosis patients and 3 healthy individuals were tested by using circRNA microarray assay. The whole blood from 43 patients with tuberculosis, 40 healthy individuals and 43 patients with pneumonia were collected to verify the results by real-time quantitative PCR system. The possibility of differentially expressed circRNA target genes were predicted by circRNA target gene prediction database. Results: In the results of microarray assay 835 circRNAs were found to be expressed differentially in whole blood between the tuberculosis patients and healthy controls of Xinjiang area, of which 249 circRNAs were up-regulated and 586 circRNAs were down-regulated in the patients. The expressions of four significantly different circRNA were verified by real time quantitative PCR and the results showed that hsa_circ_0008276, hsa_circ_0003452, hsa_circ_0001846 and hsa_circ_0090508 were down-regulated (P＜0.05), and hsa_circ_0090508 was the more specific than the other three circRNAs. The results of circRNA target genes prediction suggested that has-miR-1294, has-miR-604, has-miR-616, has-miR-663b and has-miR-486-3p may be the potential target genes of hsa_circ_0090508. Conclusion The differentially expressed circRNA hsa_circ_0090508 was significantly downregulated in the patients with tuberculosis and may affect the regulation mechanism of tuberculosis through target genes.

Objective To analyze and compare the outcomes of esophageal carcinoma treated with simultaneous integrated boost intensity-modulated radiation therapy (SIB-IMRT) and late course boost intensity-modulated radiation therapy (LCB-IMRT).Methods We retrospectively analyzed 128 patients with esophageal squamous cell carcinoma who were treated with SIB-IMRT or LCB-IMRT at the fifth department of radiation oncology in our hospital,from January 2009 to August 2015.Propensity score matching analysis was used to balance the variables differences in the two groups.Survival,failure patterns and toxicities were observed and compared between the two groups.Results one hundred and eleven patients were finally included after propensity scores matching.The 1-,3-and 5-year local control rates and survival rates were 83.6％ vs.81.7％,70.8％ vs.46.3％ and 66.0％ vs.38.2％ in the whole group,respectively.The 1-,3-and 5-year local control rates of SIB-IMRT and LCB-IMRT group were 81.6％ vs.88.0％,72.3％ vs.67.6％ and68.5％ vs.60.8％,respectively (P＞0.05).The 1-,3-and 5-year survival rates of SIB-IMRT and LCB-IMRT group were 81.3％ vs.82.4％,51.7％ vs.36.7％ and 45.8％ vs.26.7％,respectively (P ＞ 0.05).There was no statistical difference between the two group in ≥ grade 3 toxicities (P ＞ 0.05).There were 40 (36.0％) patients result in treatment failure in all.The treatment failure rates in SIB-IMRT and LCB-IMRT group were 33.8％ (26/77) vs.41.2％ (14/34),respectively (P ＞ 0.05).The local failure accounted for 65.0％ (26/40) of all treatment-related failures.Conclusions The toxicities of esophageal squamous cell carcinoma treated with SIB-IMRT and LCB-IMRT have no significant differences and were well tolerated.There were no significant differences in local control rates and survival rates between the two groups.However,SIB-IMRT had better trend than LCB-IMRT.Given SIB-IMRT's convenient manipulation,it could be a better choice in the treatment of advanced esophageal carcinoma.

OBJECTIVETo evaluate the clinical efficacy of YANG's pricking-cupping therapy for knee osteoar thritis (KOA). Methods This was a multi-center randomized parallel controlled trial. One hundred and seventy one patients with KOA were randomly allocated to a pricking-cupping group (89 cases) and a conventional acu puncture group (82 cases). Neixiyan (EX-LE 4), Dubi (ST 35) and ashi points were selected in the two groups. Patients in the pricking-cupping group were treated with YANG's pricking-cupping therapy; the seven-star needles were used to perform pricking at acupoints, then cupping was used until slight bleeding was observed. Patients in the conventional acupuncture group were treated with semi-standardized filiform needle therapy. The treatment was given for 4 weeks (from a minimum of 5 times to a maximum of 10 times). The follow-up visit was 4 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the visual analogue scale (VAS) were adopted for the efficacy assessments.

RESULTSThe pain score, stiffness score, physical function score and total score of WOMAC were all reduced after 4-week treatment and during follow-up visit in the two groups (all P<0. 0001). Except that the difference of stiffness score between the two groups was not significant after 4-week treatment (P>0. 05), each score and total score of WOMAC in the pricking-cupping group were lower than those in the conventional acupuncture group after 4-week treatment and during follow-up visit (P<0. 0001, P<0. 01). After 2-week treatment, 4-week treatment and during follow-up visit, the VAS was all reduced compared with that before treatment (all P<0. 0001) ; with the increase of the treatment, the reducing trend of VAS was more significant (P<0. 0001). The scores of VAS in the pricking-cupping group were lower than those in the conventional acupuncture group after 4-week treatment and during follow-up visit (P < 0. 01, P <0. 0001). CONCLUSION The YANG's pricking-cupping and conventional acupuncture therapy can both significantly improve knee joint pain and function in patients with KOA, which are relatively safe. The pricking cupping therapy is superior to conventional acupuncture with the identical selection of acupoints.

Acupuncture Therapy ; Adult ; Aged ; Arthralgia ; physiopathology ; therapy ; Combined Modality Therapy ; Female ; Humans ; Knee Joint ; physiopathology ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Osteoarthritis, Knee ; physiopathology ; therapy ; Treatment Outcome

Objective To evaluate the efficacy of salvage radiotherapy for supraclavicular lymph node metastasis ( SLNM) after initial treatment in patients with esophageal cancer. Methods A total of 117 patients with SLNM after radical resection for esophageal cancer were enrolled as subjects from 2006 to 2012. All patients received three?dimensional radiotherapy with 1. 8?2. 0 Gy per cycle, 5 cycles a week. The survival rates were calculated using the Kaplan?Meier method and analyzed using the log?rank test. The Cox model was used for multivariate analysis. Results The follow?up rate was 100%. In all the patients, the 1?and 3?year overall survival (OS) rates were 38. 5% and 14. 1%, respectively. The 1?and 3?year OS rates were significantly higher in patients treated with salvage radiotherapy or radiochemotherapy ( n=100) than in patients without any salvage treatment (n=17)(42% vs. 18%,P=0. 008;17% vs. 0%, P=0. 008). The patients treated with radiochemotherapy ( n=32) had significantly higher 1?and 3?year OS rates than those treated with radiotherapy alone (n=68)(59% vs. 34%, 36% vs. 11%, P=0. 002) or without any salvage treatment (n=17)(59% vs. 18%, 36% vs. 0%, P=0. 002). Patients without visceral metastasis (n=80) had significantly higher 1?and 3?year OS rates than those with visceral metastasis ( n=37) ( 44% vs. 27%, P=0. 002;22% vs. 0%,P=0. 002) . Patients with supraclavicular doses of ≥60 Gy in salvage radiotherapy ( n=75) had significantly higher 1?and 3?year OS rates than those with supraclavicular doses of<60 Gy in salvage radiotherapy ( n=25) ( 75% vs. 25%,P=0. 000;24% vs. 8%,P=0. 000) . The multivariate analysis using the Cox model showed that supraclavicular doses of ≥60 Gy, mediastinal metastasis, visceral metastasis, and salvage treatment method were independent factors for survival ( P=0. 001,0. 015,0. 009, 0. 025) . Conclusions Salvage radiotherapy can improve the survival of patients with SLNM in esophageal cancer. Salvage radiotherapy or radiochemotherapy is highly recommended for patients with SLNM alone. A radiation dose of ≥60 Gy in salvage radiotherapy improves survival in patients.