OBJECTIVE To systematically review the key regulatory requirements for pharmacy compounding drug products in the United States， and to provide references for improving the management framework of pharmacy compounding drug products in China， thereby ensuring the safety and accessibility of medication use. METHODS A literature revi ew was conducted to summarize the regulatory requirements and practical characteristics of pharmacy compounding drug products under Section 503A of the United States Federal Food， Drug， and Cosmetic Act . Based on regulatory experience of the United States， current status and existing deficiencies in pharmacy compounding drug products in China were analyzed， and targeted recommendations were proposed. RESULTS &CONCLUSIONS The United States has established a systematic regulatory framework for pharmacy compounding drug products under Section 503A， covering prescription management， active pharmaceutical ingredient management， list management of withdrawn or removed drugs and drugs that present demonstrable difficulties for compounding， recordkeeping management， interstate distribution and so on. Through standardized regulation of the entire compounding process and collaborative governance with expert advisory committees， this framework effectively balances individualized medication needs with drug quality and safety. In contrast， pharmacy compounding drug products in China remain largely confined to traditional Chinese medicine and face several challenges， including the lack of legal and regulatory support， inadequate quality control， lagging development of industry standards， and shortages of specialized personnel. It is recommended that China should establish a tiered regulatory system， develop comprehensive technical standards， build a localized regulatory framework， promote technological innovation， and strengthen professional talent cultivation to better balance the legitimate rights and interests of public medication use with drug safety and efficacy， thereby enhancing public health.

To evaluate the therapeutic effect of baicalein topical preparation on atopic dermatitis, we first constructed two atopic dermatitis-like mouse models induced by calcipotriol and 1-fluoro-2,4-dinitrobenzene to assess their therapeutic effect with skin tissue staining and other experiments. It was found that topical preparation of baicalein could alleviate epidermal thickening of diseased skin tissues, repair damaged skin barrier proteins, and inhibit T helper 2 cells (Th2) infiltration and mast cell infiltration and activation in lesional sites. Cyberpharmacology was utilized to analyze whether baicalein could treat atopic dermatitis by interfering with multiple pathogenesis-associated pathways. Results indicated that baicalein reduced the mRNA levels of inflammatory factors and inhibited the phosphorylation of NF-κB p65 and STAT1 proteins in keratinocyte cells. Together, the topical preparation of baicalein may be effective in alleviating atopic dermatitis-like symptoms in mice by down-regulating the phosphorylation level of NF-κB in keratinocytes, thereby decreasing the expression of inflammatory factors in keratinocytes, which provides an idea and a theoretical basis for the topical preparation of baicalein for the treatment of inflammatory skin diseases such as atopic dermatitis.

Objective:To provide a scoping review of domestic and international studies on the influencing factors of frailty in stroke inpatients, and to provide guidance for interventional studies on debility in stroke inpatients in China.Methods:A systematic search of domestic and international literature databases, including China National Knowledge Infrastructure, WanFang, VIP, China Biomedical Literature Database, PubMed, Web of Science, Embase, Cochrane Library, CINAHL was conducted about the status and its influencing factors of frailty in stroke inpatients. The retrieval time limit was from database establishment to November 23, 2023. The included literature was extracted, analyzed, and summarized according to the reporting specifications of the scope review guidelines.Results:Thirty-six articles were included, all of the 36 papers reported the prevalence of frailty in patients with stroke. The top three countries with the highest prevalence were China (15.3%-86.9%), the United Kingdom (28%-78%), and Italy (31.37%). The risk factors of stroke frailty were categorized mainly into 4 themes: social demographic factors, physical health factors, disease-related factors, and psychological and social background factors.Conclusions:The confidence of frailty in stroke patients of a higher level at home and abroad, and the risk factors involved are complex and diverse. It is suggested that future studies need to conduct large-sample, multicenter longitudinal studies to clarify the causal relationship, strengthen the exploration of controversial factors of stroke debility, and carry out more targeted intervention studies, so as to reduce the incidence of frailty and improve the recovery process of patients.

Osteoporosis is a prevalent skeletal condition characterized by reduced bone mass and strength, leading to increased fragility. Buqi-Tongluo (BQTL) decoction, a traditional Chinese medicine (TCM) prescription, has yet to be fully evaluated for its potential in treating bone diseases such as osteoporosis. To investigate the mechanism by which BQTL decoction inhibits osteoclast differentiation in vitro and validate these findings through in vivo experiments. We employed MTS assays to assess the potential proliferative or toxic effects of BQTL on bone marrow macrophages (BMMs) at various concentrations. TRAcP experiments were conducted to examine BQTL's impact on osteoclast differentiation. RT-PCR and Western blot analyses were utilized to evaluate the relative expression levels of osteoclast-specific genes and proteins under BQTL stimulation. Finally, in vivo experiments were performed using an osteoporosis model to further validate the in vitro findings. This study revealed that BQTL suppressed receptor activator of NF-κB ligand (RANKL)-induced osteoclastogenesis and osteoclast resorption activity in vitro in a dose-dependent manner without observable cytotoxicity. The inhibitory effects of BQTL on osteoclast formation and function were attributed to the downregulation of NFATc1 and c-fos activity, primarily through attenuation of the MAPK, NF-κB, and Calcineurin signaling pathways. BQTL's inhibitory capacity was further examined in vivo using an ovariectomized (OVX) rat model, demonstrating a strong protective effect against bone loss. BQTL may serve as an effective therapeutic TCM for the treatment of postmenopausal osteoporosis and the alleviation of bone loss induced by estrogen deficiency and related conditions.
Animals ; NFATC Transcription Factors/genetics* ; Drugs, Chinese Herbal/pharmacology* ; Ovariectomy ; Osteoclasts/metabolism* ; Female ; Osteogenesis/drug effects* ; Rats, Sprague-Dawley ; Rats ; NF-kappa B/genetics* ; Osteoporosis/genetics* ; Signal Transduction/drug effects* ; Bone Resorption/genetics* ; Cell Differentiation/drug effects* ; Humans ; RANK Ligand/metabolism* ; Mitogen-Activated Protein Kinases/genetics* ; Transcription Factors

Objective:To investigate the clinical effect of Paris polyphylla var. yunnanensis oral care solution in the prevention of ventilator-associated pneumonia (VAP) in patients with endotracheal intubation in ICU, and to provide reference for continuing to explore the best oral care solution of traditional Chinese medicine for preventing VAP. Methods:Randomized controlled experiment was used. Fifty patients with tracheal intubation admitted to the ICU of the Affiliated Hospital of Yunnan University from May 2022 to February 2023 were selected by convenient sampling method. The patients were divided into control group and observation group with 25 cases in each group by random number table method. The control group was treated with Xipayi mouth rinse for oral care, and the observation group was treated with self-made Paris polyphylla var. yunnanensis oral care solution for oral care. The incidence of VAP, clinical efficacy of oral care, leukocyte and procalcitonin after 7 days of intervention were observed, the mechanical ventilation time and ICU hospitalization time were recorded in the two groups. Results:All patients completed the study. There were 19 males and 6 females in the control group with the age of (60.72±19.32) years old. There were 15 males and 10 females in the observation group with the age of (60.24±16.80) years old. The incidence of VAP after 7 days of intervention in the observation group was 12% (3/25), which was lower than that in the control group 36% (9/25). The difference between the two groups was statistically significant ( χ2=3.95, P<0.05). The total clinical effective rate of oral care after 7 days of intervention in the observation group was 88% (22/25), which was higher than that in the control group 68% (17/25). The difference between the two groups was statistically significant ( χ2=9.78, P<0.01). There was no significant difference in the level of the leucocyte and procalcitonin before and after 7 days of intervention between the two groups (all P>0.05). The mechanical ventilation time and ICU hospitalization time in the observation group were (6.92 ±3.89), (10.36±6.17) days respectively, which were lower than those in the control group (9.72±4.76), (12.12±4.87) days. The difference of mechanical ventilation time between the two groups was statistically significant (t=2.28, P<0.05). The ICU hospitalization time in the observation group was lower than that in the control group, but there was no significant difference between the two groups ( P>0.05). Conclusions:Paris polyphylla var. yunnanensis oral care solution can improve the oral condition of patients, reduce the incidence of VAP, shorten the time of mechanical ventilation, which has certain clinical value.

Objective:To provide a scoping review of domestic and international studies on the influencing factors of frailty in stroke inpatients, and to provide guidance for interventional studies on debility in stroke inpatients in China.Methods:A systematic search of domestic and international literature databases, including China National Knowledge Infrastructure, WanFang, VIP, China Biomedical Literature Database, PubMed, Web of Science, Embase, Cochrane Library, CINAHL was conducted about the status and its influencing factors of frailty in stroke inpatients. The retrieval time limit was from database establishment to November 23, 2023. The included literature was extracted, analyzed, and summarized according to the reporting specifications of the scope review guidelines.Results:Thirty-six articles were included, all of the 36 papers reported the prevalence of frailty in patients with stroke. The top three countries with the highest prevalence were China (15.3%-86.9%), the United Kingdom (28%-78%), and Italy (31.37%). The risk factors of stroke frailty were categorized mainly into 4 themes: social demographic factors, physical health factors, disease-related factors, and psychological and social background factors.Conclusions:The confidence of frailty in stroke patients of a higher level at home and abroad, and the risk factors involved are complex and diverse. It is suggested that future studies need to conduct large-sample, multicenter longitudinal studies to clarify the causal relationship, strengthen the exploration of controversial factors of stroke debility, and carry out more targeted intervention studies, so as to reduce the incidence of frailty and improve the recovery process of patients.

Paraplegia caused by spinal cord injury is a serious neurological complication, for which surgery is currently the main treatment method. Due to different surgical approaches, patients are usually expected to maintain a passive prone position for a long time or switch between the supine and prone positions. Affected by multiple factors such as neurogenic sensory disorders, pathological changes in muscle tone and operative duration, the risk of intraoperative acquired pressure injury (IAPI) is significantly increased. Current clinical prevention strategies for IAPI in these patients predominantly focus on localized pressure relief during positioning, lacking systematic, standardized comprehensive prevention protocols or evidence-based guidelines. To address it, Department of Nursing, Orthopedics Branch, China International Exchange and Promotive Association for Medical and Health Care, Spinal Trauma Professional Committee, Orthopedics Branch, Chinese Medical Doctor Association, Nursing Group of Spine and Spinal Cord Professional Committee of Chinese Association of Rehabilitation Medicine organized experts in relevant fields to formulate Guideline for the prevention of intraoperative acquired pressure injury in paraplegic patients with spinal cord injury ( version 2025), based on evidence-based medical evidence and latest research results and clinical practice at home and abroad. Eleven recommendations were put forward from the aspects of preoperative risk assessment, intraoperative prevention strategies, postoperative handover and monitoring, and supportive mechanisms for IAPI prevention, aiming to standardize the prevention measures and management strategies of IAPI in paraplegic patients with spinal cord injury and accelerate the recovery of patients and improve the therapeutic effect.

Objective To construct a medical consumables selection indicator system based on analytic hierarchy process(AHP)and fuzzy cluster method.Methods Firstly,a medical consumables selection indicator system was established preliminarily with the literature research results and actual situation of hospital consumables management;secondly,13 experts in related fields were selected to execute two rounds of online questionnaires,the expert weights were determined with AHP,the importance of each selection indicator was scored by the expert evaluation method and fuzzy cluster method,and consistency analysis was carried out on the two rounds of expert evaluation results;finally,the final medical consumables selection indicator system was built with the 100-point scale.Results The constructed medical consumables selection indicator system was composed of 5 primary indicators,12 secondary indicators and 38 tertiary indicators.The primary indicators included consumables quality,clinical demand,cost-effectiveness,supply capacity and after-sales service,with the percentage-based scores being 27,25,14,26 and 8,respectively.Conclusion The medical consumables selection indicator system based on AHP and fuzzy cluster method with high reliability provides effective and reliable references for medical institutions to select medical consumables.

With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.

Objective:To study the relationship between the levels of multiple elements in urine and the risk of arsenic poisoning in populations exposed to drinking water arsenic in Inner Mongolia Autonomous Region (Inner Mongolia).Methods:From April 2023 to January 2024, a case-control study method was used to select 128 individuals with a residence time of ≥10 years in drinking water arsenic exposed areas in Inner Mongolia as study subjects. Eighty-one individuals diagnosed with arsenic poisoning were selected as the case group, and 47 healthy individuals were selected as the control group for urine sample collection and questionnaire survey. Inductively coupled plasma mass spectrometry was employed to determine the levels of 10 elements (chromium, manganese, cobalt, nickel, copper, zinc, arsenic, molybdenum, cadmium and lead) in urine. The levels of each element in urine were divided into four groups ( Q1, Q2, Q3, and Q4 groups) based on quartiles. The associations between the levels of various elements in urine and the risk of arsenic poisoning were studied using binary logistic regression model and restricted cubic spline (RCS). Results:The age of the control group and the case group [ M ( Q1, Q3)] were 61 (53, 69) and 61 (56, 67) years old, respectively. There were 19 and 43 males, and 28 and 38 females, respectively. There was no statistically significant differences in age and and gender composition between the two groups ( Z = - 0.39, P = 0.700; χ 2 = 1.91, P = 0.167). The levels of urinary copper and cadmium of the case group were higher than those of the control group, and the differences were statistically significant ( Z = - 2.66, - 2.16, P < 0.05). The results of univariate logistic regression analysis showed that urinary copper was an influencing factor for arsenic poisoning ( P = 0.017). The results of multivariate logistic regression analysis revealed that after adjusting for covariates, urinary copper and arsenic were independent influencing factors of arsenic poisoning ( P < 0.05). Taking Q1 group as a reference, urinary copper in Q3 group [ OR (95% CI) = 8.23 (1.81, 37.39), P = 0.006] increased the risk of arsenic poisoning, while urinary arsenic in Q2, Q3, and Q4 groups [ OR (95% CI) = 0.24 (0.06, 0.92), 0.12 (0.03, 0.53), 0.15 (0.04, 0.63), P < 0.05] decreased the risk of arsenic poisoning. After adjusting for covariates, RCS did not show a dose-response relationship between urinary copper, urinary arsenic, and arsenic poisoning ( P > 0.05). Conclusion:Urinary arsenic and copper are associated with the risk of arsenic poisoning in the drinking water arsenic exposed areas of Inner Mongolia, copper exposure may contribute significantly to arsenic poisoning.