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.

OBJECTIVE: To evaluate precise assessment methods for predicting the optimal acetabular cup size in total hip arthroplasty (THA). METHODS: A clinical data of 73 patients (80 hips) who underwent primary THA between December 2022 and July 2024 and met the inclusion criteria was analyzed. There were 39 males and 34 females with an average age of 66.3 years (range, 56-78 years). Among them, 66 cases were unilateral THA and 7 were bilateral THAs. There were 29 patients (34 hips) of osteoarthritis, 35 patients (35 hips) of femoral neck fractures, and 9 patients (11 hips) of osteonecrosis of the femoral head. Based on anteroposterior pelvic X-ray films, three methods were employed to predict acetabular cup size, including preoperative template planning, radiographic femoral head diameter (FHD) measurement, and intraoperative FHD measurement. The predicted acetabular cup sizes from these methods were compared with the actual implanted sizes. RESULTS: The predicted acetabular cup sizes using the preoperative template planning, radiographic FHD measurement, and intraoperative FHD measurement were (51.25±2.81), (49.72±3.11), and (49.90±2.74) mm, respectively, compared to the actual implanted cup size of (50.57±2.74) mm, with no significant difference ( P>0.05). Regarding agreement with the actual implanted cup size, the preoperative template planning achieved exact matches in 35 hips (43.75%), one-size deviation in 41 hips (51.25%), and two-size deviations in 4 hips (5%); the radiographic FHD measurement achieved exact matches in 12 hips (15%), one-size deviation in 57 hips (71.25%), and two-size deviations in 11 hips (13.75%); and the intraoperative FHD measurement achieved exact matches in 26 hips (32.5%), one-size deviation in 52 hips (65%), and two-size deviations in 2 hips (2.5%). There were significant differences in agreement distributions between the three methods and the actual implanted cup sizes ( H=18.579, P<0.001). CONCLUSION The intraoperative FHD measurement, as a simple, cost-effective, and accurate method, effectively guides acetabular cup selection, reduces the risk of prosthesis wear, enhances postoperative joint stability.
Humans ; Arthroplasty, Replacement, Hip/instrumentation* ; Male ; Female ; Middle Aged ; Acetabulum/diagnostic imaging* ; Aged ; Hip Prosthesis ; Prosthesis Design ; Femur Head/surgery* ; Osteoarthritis, Hip/surgery* ; Radiography ; Femoral Neck Fractures/surgery* ; Femur Head Necrosis/surgery*

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 summarize the evidence of cognitive training in breast cancer patients with chemotherapy-related cognitive impairment, so as to provide evidence-based evidence for clinical decision-making and practice.Methods:The literature about the relevant cognitive training in breast cancer patients with chemotherapy-related cognitive impairment were searched for CNKI, VIP database, Wanfang, SinoMed, PubMed, Web of Science, CINAHL, Embase, Cochrane Library, JBI as well as home and abroad official website of relevant professional institutes, including clinical decisions, guidelines, evidence summaries, systematic reviews, best practice information manuals, expert consensuses, and high-quality original studies. The literature retrieval period was from the database construction to March 1, 2023. Two researchers screened and evaluated the quality of the included literature, and extracted, generalized and summarized evidence according to the topic.Results:A total of 17 articles were involved, including 3 clinical decisions, 4 guidelines, 2 evidence summaries, and 8 systematic reviews. Finally, 6 evidence topics and 25 pieces of best evidences were formed, including screening and evaluation, training principles, training time, training place, training content, training effect.Conclusions:Cognitive training can effectively improve cognitive function in breast cancer patients with chemotherapy-related cognitive impairment. Medical staff should carefully select the best evidence, early screen and dynamically evaluate the cognitive changes of patients, follow the principle of step by step and dynamic adjustment, and carry out individualized cognitive training as soon as possible according to the treatment cycle and patients wishes, so as to prevent or delay chemotherapy-related cognitive impairment and improve the quality of life of patients.

[Objective]To assess the repeatability(intra-operator variability)and reproducibility(inter-operator variability)of a new partial coherence interferometry(PCI)-based ocular biometer,Myopia Master,and its agreement with IOL Master 500 for measuring axial length(AL)and corneal curvature(K)in children aged 8-12 years.[Methods]The same operator measured school children with the Myopia Master and the IOL Master 500 in random order to assess agreement.Additionally,some of these children received measurements from another operator using the Myopia Master to assess repeatability and reproducibility.AL,flat keratometry(Kf),steep keratometry(Ks),mean keratometry(Km),J0 and J45 were analyzed.The repeatability and reproducibility were assessed by the within-subject standard deviation(Sw),test-retest repeatability(TRT),coefficient of variation(CoV)and intra-class correlation coefficient(ICC).The agree-ment between the Myopia Master and the IOL Master 500 was assessed by Bland-Altman plots and 95%limits of agree-ment(LoA).[Results]Both repeatability and reproducibility of the Myopia Master were high for AL measurements(Sw=0.02 mm,ICC=0.999;Sw=0.04 mm,ICC=0.998),but moderate for K measurements(Sw range,0.04 to 0.12 D,ICC range,0.861 to 0.991;Sw range,0.06 to 0.20 D,ICC range,0.835 to 0.992).There were significant mean differences be-tween the Myopia Master and the IOL Master 500 in measurements of AL(-0.01±0.04)mm,Kf(-0.09±0.15)D,Ks(-0.47±0.40)D,and Km(-0.28±0.23)D,J0(0.18±0.20)D and J45(-0.01±0.12)D.[Conclusions]The Myopia Master provided high repeatability and reproducibility for AL measurements in schoolchildren with myopia,but the Myopia Master and the IOL Master 500 cannot be used interchangeably in measuring AL and K.

Objective:To explore the impact of different six-character qigong training modes on respiratory muscle function early after a stroke.Methods:Sixty-six stroke survivors in the early stage of recovery were randomly divided into a control group, a modified training group, and an ancient training group, each of 22. In addition to routine rehabilitation training, the control group received conventional respiratory training. The modified training and ancient training groups were trained in modified six-character qigong or ancient six-character qigong, respectively, for two weeks. Before the treatment, after the two weeks and one month later, maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), forced expiratory volume in one second, forced vital capacity, peak expiratory flow, maximum mid-expiratory flow, and peak inspiratory flow were measured. Diaphragm mobility during quiet inspiration and maximum inspiration were also quantified.Results:After 2 weeks of treatment and at 1 and 3 months after the end of the treatment, all three groups showed significant improvement in MIP, MEP and the pulmonary ventilation indicators, but the average improvement in the modified training group was significantly greater than in the other two groups. Their average diaphragm mobility was also significantly greater.Conclusion:Modified six-character qigong respiratory training is more effective than its ancient counterpart in improving respiratory muscle function, pulmonary ventilation, and diaphragm mobility early after a stroke, with effects which persist for at least one month.

Objective:To analyze the research hotspots of self-management in patients with chronic obstructive pulmonary disease (COPD) at home and abroad.Methods:Related literature on self-management of COPD patients were searched in China National Knowledge Infrastructure and Web of Science databases, and the searched period was from January 1, 2013 to June 30, 2023. CiteSpace 5.8 software was used for keyword cluster analysis.Results:A total of 641 articles in Chinese and 1 192 in English were obtained. Domestic research hotspots about self-management of COPD patients mainly focused on health education, continuing care, rehabilitation care, etc. Foreign research hotspots about self-management of COPD patients mainly focused on mobile health, telemedicine and so on.Conclusions:This paper analyzes the research hotspots of self-management of COPD patients at home and abroad and provides reference for future research on self-management of COPD patients.

Objective:To retrieve, evaluate, and summarize the best domestic and international evidence on non-pharmacological management of sleep disorders in breast cancer patients undergoing chemotherapy, providing evidence-based guidance for healthcare professionals to conduct standardized assessment and management of sleep disorders in these patients.Methods:Clinical questions were translated into evidence-based questions using the PIPOST model. A systematic search of domestic and international databases and professional association websites was conducted for literature related to non-pharmacological management of sleep disorders in breast cancer patients undergoing chemotherapy, including clinical decisions, evidence summaries, guidelines, and systematic reviews. The search covered publications up to December 17, 2022. Two researchers trained in evidence-based nursing independently completed the quality assessment, evidence extraction, and summary of the included literature.Results:A total of 16 publications were included, comprising two clinical decisions, one evidence summary, five guidelines, six systematic reviews, and two randomized controlled studies. The best evidence was summarized from seven aspects: multidisciplinary collaboration, identification of risk factors, assessment and monitoring, referral, psychological behavioral interventions, exercise management, and complementary therapies, resulting in 25 key recommendations.Conclusions:This study summarizes the current best evidence for non-pharmacological management of sleep disorders in breast cancer patients undergoing chemotherapy. Healthcare professionals can follow these best evidence practices to standardize the assessment of patient sleep disorder symptoms and choose appropriate intervention plans based on clinical context and patient preferences, thereby improving patient sleep quality.