OBJECTIVE: To explore the effectiveness of additional anti-rotation steel plate assisted intramedullary nail technology in treatment of aseptic femoral non-union patients. METHODS: A retrospective analysis was conducted on 21 patients with aseptic femoral non-union who admitted between September 2020 and October 2024 and treated with additional anti-rotation steel plate assisted intramedullary nail technology. There were 17 males and 4 females, aged 25-67 years (mean, 44 years). There were 19 cases of femoral anterograde intramedullary nail fixation, 1 case of femoral retrograde intramedullary nail fixation, and 1 case of steel plate fixation with fatigue fracture. There were 9 cases of hypertrophic non-union and 12 cases of atrophic non-union. All patients had varying degrees of fracture end atrophy/sclerosis. Among them, 20 patients who were fixed with intramedullary nails underwent removal of soft tissue and hardened bone at the fracture end, and cortical treatment resulted in the appearance of "chili sign" at the fracture end. Iliac bone grafting and anti-rotation steel plate fixation were performed. One patient with steel plate fixation was removed the steel palte and fixed with a retrograde intramedullary nail, while the hardened bone at the fracture end was removed, iliac bone grafting and anti-rotation steel plate fixation were performed. Postoperative follow-up observation included the incision healing, maximum knee flexion range of motion, bone healing, length of lower limbs, and subjective satisfaction. The lower extremity functional scale (LEFS) score was used to evaluate the lower limb function. RESULTS: All incisions healed by first intention. All patients were followed up 7-26 months (mean, 15.5 months). At last follow-up, the femoral fracture healed with the obvious callus formation at the fracture end; the maximum knee flexion range of motion was 95°-127° (mean, 112.67°). The LEFS score increased from 29.9±6.7 before operation to 75.9±3.0 at last follow-up, and the difference was significant (t=-29.622, P<0.001). Except for 1 patient who underwent intramedullary nail dynamic treatment before operation and had a lower limb shortening of about 0.9 cm, the other patients had bilateral lower limbs of equal length. All patients had no postoperative infections, mal-union of fractures, deep vein thrombosis, joint stiffness, or other complications. CONCLUSION The use of additional anti-rotation steel plate assisted intramedullary nail technology in the treatment of aseptic femoral non-union not only overcomes the drawbacks of insufficient stability at the fracture end of intramedullary nails, but also overcomes the shortcomings of biased fixation with steel plates. It has the advantages of minimal trauma, effective maintenance of fracture stability, and ideal postoperative functional recovery, making it an effective treatment for aseptic femoral non-union.
Humans ; Male ; Fracture Fixation, Intramedullary/instrumentation* ; Female ; Bone Plates ; Middle Aged ; Adult ; Femoral Fractures/surgery* ; Retrospective Studies ; Bone Nails ; Aged ; Fractures, Ununited/surgery* ; Treatment Outcome ; Bone Transplantation/methods* ; Steel ; Fracture Healing

BACKGROUND:The plateau environment affects the immune function and metabolic status of patients with osteomyelitis,leading to acceleration or complication of the disease process.The construction of effective and stable animal models of chronic osteomyelitis is essential for experimental studies of chronic osteomyelitis.OBJECTIVE:To establish a sheep model of chronic osteomyelitis in plateau regions for toxicity assessment and therapeutic research.METHODS:Fifteen healthy sheep were selected in this study.Sodium morrhuate and Staphylococcus aureus suspension were injected into the medullary cavity of the middle segment of the tibia to establish the chronic osteomyelitis model.General observation,body mass and temperature monitoring,blood infection index detection,radiological scoring,and microbial culture were performed for evaluation and analysis.RESULTS AND CONCLUSION:(1)Local tissue swelling and lameness of the affected leg were observed in all sheep in the early stage after modeling,accompanied by varying degrees of anorexia.A slight decrease in body mass was observed in sheep 1 week after modeling,while no significant changes in body temperature were observed.(2)The erythrocyte sedimentation rate significantly accelerated 4 days after modeling(P<0.05)and gradually returned to normal levels after 1 month.The white blood cell count showed a significant increase within 4 days after modeling and returned to normal after 1 week.The level of C-reactive protein increased significantly after modeling(P<0.05)and remained significantly higher than normal until the end of the experiment(P<0.05).(3)Fifteen sheep exhibited typical radiological manifestations of osteomyelitis,including unclear boundaries,irregular osteolytic lesions,and low-density bright absorption areas with interspersed necrotic bone fragments of increased and uneven density.Different degrees of periosteal reaction were observed in the cortex near the lesion.(4)Thirteen sheep were cultured for a single strain of Staphylococcus aureus,while two sheep were cultured for Staphylococcus aureus and Escherichia coli.These findings indicate that a reliable chronic osteomyelitis animal model of sheep tibia can be successfully established in plateau regions by injecting an appropriate amount of Staphylococcus aureus suspension into the medullary cavity of sheep,combined with local implantation of foreign cotton thread and sodium morrhuate.

To provide an in-depth interpretation of the background and rationale behind the development of the standard for plastic bottle systems and components for eye drops as outlined in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred as the Chinese Pharmacopoeia),to facilitate stakeholders thorough understanding of the standard content,and to offer a strong support for its subsequent smooth implementation.Starting from the background of standard construction,an in-depth exploration was conducted into the quality control requirements for plastic bottle systems and components used for eye drops,and a detailed analysis was provided of the logic and rationale behind the establishment of quality control items.Related parties should develop product quality standards based on the general requirements of the guidelines for plastic materials and containers used in pharmaceutical packaging,taking into account the specific characteristics and practical application scenarios of plastic bottle systems and components for eye drops.The standard for plastic bottle systems and components for eye drops in the 2025 edition of the Chinese Pharmacopoeia are more scientific and flexible,which will help improve the quality of eye drop products in our country while also promoting innovation and development in the eye drop packaging industry.

Objective To compile the"expert consensus on preventive and management of exposure keratopathy"(hereinafter referred to as"consensus"),aiming to standardize and promote the prevention of exposure keratopathy(EK)in medical institutions at different levels.Methods The evidence-based methods were used to retrieve,evaluate and summarize evidence in this field according to the level of evidence,and relevant recommendations and research conclusions were extracted,and the first draft of consensus was formed.After 2 rounds of Delphi expert letters and expert meetings,combined with evidence and expert opinions,the consensus content is written,adjusted and modified,and recommendations were made.Results 58 experts were invited to participate in the consultation.The expert positive coefficient was 100％;the expert judgment basis of the 2 rounds were 0.940 and 0.936;the degree of familiarity of the 2 rounds were 0.779 and 0.797;the coefficient of authority of the 2 rounds were 0.859 and 0.866.The Kendall W coefficients of the 2 rounds of inquiry were 0.099 and 0.117,and the difference was statistically significant(P＜0.05).The consensus includes 5 aspects of EK:risk factors,assessments,protection measures,symptom management and training and management.Conclusion The consensus was based on the existing evidence and clinical practical requirements and recommendations of experts in the field.Consensus can provide guidance for clinical nursing staff in prevention,nursing and management of EK effectively.

ObjectiveTo construct a family-centered care model for children with tuberculosis based on the double ABC-X model, and to evaluate its clinical effects. MethodsFrom December 2022 to October 2023, 64 newly admitted children with tuberculosis who met the criteria and their caregivers were recruited from the tuberculosis department of Shanghai Public Health Clinical Center were randomly divided into an experimental group (32 cases) and a control group (32 cases).The control group was given a conventional health care, while the experimental group was given a family-centered health care intervention based on the double ABC-X model, in which a multidisciplinary care team provided personalized information and emotional support for the caregivers and their children. Medication adherence of the children, caregiver’s teading burden, and disease management competence were compared between the 2 groups. ResultsA total of 29 cases in the experimental group and 27 cases in the control group completed the intervention. At 12 weeks of intervention, the medication adherence score (7.72±0.45 vs 7.41±0.50, P<0.05) and disease management competence score (36.97±7.85 vs 31.56±7.30, P<0.05) were higher in the experimental group than that in the control group while the caregiving burden score (31.79±13.40 vs 40.04±9.01, P<0.05) and difficulty of disease management score (30.41±12.41 vs 38.56±9.48, P<0.05) were lower than that in the control group. At 24 weeks of intervention, the medication adherence score (7.34±0.97 vs 6.70±1.14, P<0.05) and disease management competence score (42.07±6.93 vs 35.63±7.32, P<0.05) were higher in the experimental group than that in the control group as well, but the caregiving burden score (31.62±11.72 vs 39.63±10.17, P<0.05) and difficulty of disease management score (30.59±10.87 vs 37.81±9.32, P<0.05) were lower than that in the control group. ConclusionFamily-centered care based on the double ABC-X model can effectively promote medication adherence among children with tuberculosis, reduce caregivers’ care burden and disease management difficulties, and improve caregiver’s disease management competence.

Objective To investigate the risk factors of the infarct growth rate(IGR)in patients with acute anterior circulation large vessel occlusion.Methods This is a retrospective analysis of consecutive patients having acute anterior circulation large-vessel occlusion and being admitted to the Department of Neurointerventional Intervention,Central Hospital affiliated to Dalian University of Technology between September 2021 and July 2023.Patients were dichotomized into rapid and slow growth groups based on the median value of IGR,with 145 cases in each group.Univariate and multivariate Logistic regression models were used to analyze the risk factors of preoperative IGR.Results Multivariable Logistic regression analysis,after univariate screening,showed that hypertension(OR=2.27,95%CI:1.39-3.71),atrial fibrillation(OR=1.95,95%CI:1.22-3.12),and intracranial internal carotid artery occlusion(OR=1.98,95%CI:1.19-3.28)were risk factors of preoperative IGR(P<0.05).Hypertension,atrial fibrillation,and internal carotid artery occlusion all exhibited relatively low predictive value for IGR(P<0.05).The area under the curve for predicting IGR by combining these three factors was 0.642(95%CI:0.579-0.704),indicating a slight improvement in predictive performance,yet it remained relatively low.Conclusion Hypertension,atrial fibrillation,and proximal occlusion are risk factors of IGR in patients having acute anterior circulation large vessel occlusion.

Objective To formulate the drug packaging material method standards in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred to as the"Chinese Pharmacopoeia"),to develop the method for the determination of extractable tungsten for prefilled syringes,and to interpret the content of the method to provide guidance and help for its subsequent implementation.Methods The formulation process of"Determination of Extractable Tungsten for Prefilled Syringes"was described.Combining the current domestic and foreign relevant standards,the extraction conditions of samples were explored and verified,and the determination methods of inductively coupled plasma optical emission spectrometer(ICP-OES)and inductively coupled plasma mass spectrometer(ICP-MS)were verified.Results A method was established for extracting tungsten from glass prefilled syringes utilizing water and 0.01 mol·L-1 sodium hydroxide solution as extraction media,respectively,at 75 ℃ through ultrasound.The dissolution amount of tungsten was determined by inductively coupled plasma opticalemission spectrometry(ICP-OES)and inductively coupled plasma mass spectrometry(ICP-MS).Among them,the extraction using 0.01 mol·L-1 sodium hydroxide solution as the extraction medium is a stricter and acceptable alternative approach.Conclusion According to the quality control requirements of products,corporations can choose the appropriate extraction medium according to the method in this standard for the determination of tungsten dissolution in the prefilled syringes.

Objective To investigate the risk factors of the infarct growth rate(IGR)in patients with acute anterior circulation large vessel occlusion.Methods This is a retrospective analysis of consecutive patients having acute anterior circulation large-vessel occlusion and being admitted to the Department of Neurointerventional Intervention,Central Hospital affiliated to Dalian University of Technology between September 2021 and July 2023.Patients were dichotomized into rapid and slow growth groups based on the median value of IGR,with 145 cases in each group.Univariate and multivariate Logistic regression models were used to analyze the risk factors of preoperative IGR.Results Multivariable Logistic regression analysis,after univariate screening,showed that hypertension(OR=2.27,95%CI:1.39-3.71),atrial fibrillation(OR=1.95,95%CI:1.22-3.12),and intracranial internal carotid artery occlusion(OR=1.98,95%CI:1.19-3.28)were risk factors of preoperative IGR(P<0.05).Hypertension,atrial fibrillation,and internal carotid artery occlusion all exhibited relatively low predictive value for IGR(P<0.05).The area under the curve for predicting IGR by combining these three factors was 0.642(95%CI:0.579-0.704),indicating a slight improvement in predictive performance,yet it remained relatively low.Conclusion Hypertension,atrial fibrillation,and proximal occlusion are risk factors of IGR in patients having acute anterior circulation large vessel occlusion.

Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.

Objective This study aims to comprehensively analyze the overall framework and key quality attributes of the proposed standard system for prefilled syringes through key clause analysis.Methods Based on a thorough understanding of market product conditions and the current status of domestic and international standards;the critical quality attributes of pre-filled syringe container systems were identified.Results A new standard system for prefilled syringes was constructed to meet the regulatory and industry development needs of China.Conclusions The proposed standard system for prefilled syringes is designed with both rigidity and flexibility,meeting regulatory needs and facilitating industry development.