Objective:To investigate the clinical efficacy of 3D printed metal augment or tibial prosthesis for reconstruction of large bone defects in total knee arthroplasty (TKA) and knee revision surgery.Methods:A total of 7 patients (7 knees) with TKA or knee revision who were admitted to the Department of Orthopaedics of the Second Affiliated Hospital of Zhejiang University School of Medicine with large bone defects from July 2018 to December 2023 were retrospectively analyzed, including 4 patients with TKA and 3 patients with knee revision. There were 3 males and 4 females, aged 58.7±7.6 years (range, 54-68 years), 3 patients with left knee and 4 patients with right knee. All the patients had bone defects in the knee joint (AORI type III), 2 cases had bone defects only in the femur, 4 cases had bone defects only in the tibia, and 1 case had bone defects in both the tibia and femur, which were treated with personalized reconstruction using 3D printing. Hip-knee-ankle angles, American Knee Society score (KSS) before and after surgery were compared, and postoperative complications were observed.Results:All patients successfully completed the operation, and the operation time was 189.3±35.5 min (range, 125-240 min). Complex TKA was performed in 4 cases with surgical times of 175, 195, 210, and 240 min, and revision surgery was performed in 3 cases with surgical times of 125, 180, and 200 min, respectively. Intraoperative blood loss was 114±24.4 ml (range, 100-150 ml). Five cases used 3D printed metal augment, and two used 3D printed one-piece tibial components. All patients were followed up for 2, 2, 5, 6, 7, 20, 57 months, respectively. The KSS of the five patients at 3 months postoperatively were 56, 61, 66, 56, and 56 points, respectively, greater than the preoperative scores of 35, 44, 36, 27, and 41 points. The KSS functional scores of the five patients at 3 months postoperatively were 45, 45, 45, 30, and 45 points, respectively, which were greater than the preoperative scores of 30, 30, 15, 20, and 20 points. The hip-knee-ankle angle was 181.8°±3.4° (range, 177.9° to 188.0°) at the final follow-up and 175.8°±12.4° (range, 153.3° to 192.1°) before surgery, with no significant difference ( t=-1.230, P=0.242). At the final follow-up, the 3D printed component was well integrated with the bone surface, the prosthesis was securely positioned, and the force lines of the lower limbs were normal. There were no postoperative complications such as poor wound healing, infection, fat liquefaction, nerve injury, deep vein thrombosis of lower limbs, knee joint stiffness, periprosthesis infection and loosening. Conclusion:Using 3D printed metal augment or tibial prosthesis to reconstruct the huge bone defect in TKA and revision has a satisfactory early clinical effect, satisfactory joint function and good surgical safety.

Objective:To investigate various clinical treatment measures for thoracolumbar fractures and provide new diagnosis and treatment methods.Methods:The case data of 5 patients(3 males, 2 females, and the age ranged from 39 to 59 years with an average of 51 years) with thoracolumbar fractures were treated with Waveflex semi-rigid internaI fixation system from May 2020 to December 2021 were retrospectively analyzed, imaging indexes and clinical effects were followed up, and analyzed and summarized in combination with relevant literatures.Results:The operations of all 5 patients were successfully completed, and the follow-up period was 6 months. At the last follow-up, the internal fixation position was good, the height of the injured vertebra was maintained satisfactorily, and the clinical effect was satisfactory.Conclusion:Waveflex semi-rigid internal fixation system combines the advantages of fusion and non-fusion, providing a new idea for the treatment of thoracolumbar fractures, but its long-term effect still needs further follow-up.

Orally inhaled drug products (OIDPs) play a great role in the pharmacological treatment of chronic obstructive pulmonary disease (COPD) and asthma. There is an unmet clinical need for OIDPs. Pharmacodynamics-Bioequivalence studies (PD-BE) are recommended by several national guidelines as important research methods for bioequivalence study of OIDPs. It can effectively bridge the gap between in vitro studies and PK-BE studies in evaluating the efficacy and safety consistency of generic drugs with the original drugs. There are two research methods for PD-BE, using a diastolic model or an excitation model. The different methods use different metrics to evaluate efficacy. The more commonly used metrics include Forced Expiratory Volume in the First Second (FEV1), Specific Airway Conductance (sGaw), Peripheral Airway Resistance (R5-20), and stimulant concentration/dose (PC20/PD20). PD-BE studies using FEV1 as an efficacy metric is also recommended by the FDA (Food and Drug Administration), EMA (European Medicines Agency) and NMPA (National Medical Products Administration) guidelines and is widely accepted by investigators. In such PD-BE studies, the trial protocols for different OIDPs drugs are relatively consistent in terms of trial design, trial data processing, and equivalence evaluation criteria, while there are detailed differences in terms of target population, single/multiple dosing, dose administration, and collection site design. This paper reviews the progress of PD-BE studies in the bioequivalence evaluation of OIDPs by combining national guidelines and PD-BE-related studies of OIDPs published in the last five years, with a view to providing important theoretical information for PD-BE studies of OIDPs.

This study aimed to obtain the first national estimate of the prevalence of autism spectrum disorder (ASD) in Chinese children. We targeted the population of 6 to 12-year-old children for this prevalence study by multistage convenient cluster sampling. The Modified Chinese Autism Spectrum Rating Scale was used for the screening process. Of the target population of 142,086 children, 88.5% (n = 125,806) participated in the study. A total of 363 children were confirmed as having ASD. The observed ASD prevalence rate was 0.29% (95% CI: 0.26%-0.32%) for the overall population. After adjustment for response rates, the estimated number of ASD cases was 867 in the target population sample, thereby achieving an estimated prevalence of 0.70% (95% CI: 0.64%-0.74%). The prevalence was significantly higher in boys than in girls (0.95%; 95% CI: 0.87%-1.02% versus 0.30%; 95% CI: 0.26%-0.34%; P < 0.001). Of the 363 confirmed ASD cases, 43.3% were newly diagnosed, and most of those (90.4%) were attending regular schools, and 68.8% of the children with ASD had at least one neuropsychiatric comorbidity. Our findings provide reliable data on the estimated ASD prevalence and comorbidities in Chinese children.

Objective To establish an animal model for evaluating immunogenicity of pneumococcal conjugate vaccine.Methods New Zealand rabbits were intramuscularly administrated with three doses of 13-valent pneumococcal conjugate vaccine (PCV13) with two weeks interval between each injection.Serum samples were collected at different time points before and after vaccination.Quantitative enzyme-linked immunosorbent assay (ELISA) and opsonophagocytosis assay (OPA) that were in conformity with the World Health Organization (WHO) standards were used to detect the concentrations of serotype-specific antibodies and their bactericidal activities.Results The concentrations (Geometric mean concentration, GMC) of serotype-specific antibodies in rabbit serum samples were well correlated with their bactericidal activities (Geometric mean titer, GMT) following vaccination.Moreover, the dynamic changes of GMC and GMT of the same serotype-specific antibody remained consistent as time went by.Conclusion Rabbit model can be used to analyze the immunogenicity of PCV13 vaccine with quantitative ELISA and OPA, which indicates that it is a suitable animal model for evaluating immunogenicity of pneumococcal conjugate vaccine.

OBJECTIVE: To investigate the cost-effectiveness of standardized specific immunotherapy (SIT) for allergic rhinitis patients accompanied with asthma (ARAS) in China. METHOD: Forty ARAS patients sensitized with house dust mite (HDM) were administered with SIT (SIT group) or merely medicine treatment (control group). Alutard dermatophagoides pteronyssinus vaccine from ALK company was used for immunotherapy. The usage of symptom control medicine was according to the ARIA and GINA guideline. Cost-effectiveness ratio (CER) and Incremental cost-effectiveness ratio(ICER) analysis was conducted. The effectiveness was measured in terms of symptom scores, quality of life, objective improvement of rhinitis and asthma. Sensitive analysis was conducted to verify the stability of the results. RESULT: The cost of SIT group for 1 year (6578 yuan) was higher than that of control group (1733.3 yuan), while the cost-effectiveness ratio and incremental cost-effectiveness ratio of SIT group were significant better than that of control group in all items. CER was 1686.7 yuan in SIT group compared with 3466.6 yuan in control group for nasal symptom scores, 4698.6 yuan in SIT group compared with 5777.8 yuan in control group for asthma symptom scores, 3462.1 yuan in SIT group compared with 8666.7 yuan in control group. The sensitive analysis of the price 10 percent higher or lower showed the same results. CONCLUSION The cost-effectiveness of specific immunotherapy (SIT) for mite sensitized ARAS patients was better than that of merely medicine treatment.
Adolescent ; Adult ; Asthma ; economics ; therapy ; Child ; Costs and Cost Analysis ; Female ; Humans ; Immunotherapy ; economics ; Male ; Rhinitis, Allergic ; Rhinitis, Allergic, Perennial ; economics ; therapy ; Young Adult

Objective:To evaluate the efficacy of specific immunotherapy (SIT) with standardized dermatophagoides pteronyssinus extract for allergic rhinitis (AR)accompanied with asthma.Method:One hundred and fifty-five patients(40 AR with asthma, AR & asthma) in accordance with the inclusion criteria of SIT, were allocated to receive standardized Dermatophagoides pteronyssinus extract (SIT group, n=89) or medical treatment(control group, n=66). AR with or without asthma was observed separately. Symptom and medicine scores, quality of life were recorded and analyzed before and after 1 year treatment. Side effects were registered. Subjective evaluation of symptoms was made by the patients.Result:Rhinitis and asthma symptom scores, medicine scores and quality of life were greatly improved in SIT group of AR & asthma after 1 year, which were not significant changed in control group except for medicine scores. The subjective evaluation of symptoms was also significantly improved in SIT group. In patients of AR without asthma, the symptom scores, medicine scores and quality of life were both improved. The SIT group improved greater than that of control group.Conclusion:The clinical efficacy of patients with AR & asthma was not good with simple medical treatment, while great clinical efficacy could be acquired with SIT.

OBJECTIVE: To explore the compliance of sublingual immunotherapy (SLIT) for allergic rhinitis (AR) in real life. METHOD: Two hundred and thirty AR patients sensitive to house dust mites were divided into general treatment group and intervention treatment group. Both groups followed a SLIT schedule once daily. The general treatment group was in accordance with the normal clinical procedure. The intervention treatment group was given a systemic patient management including patients education of AR, common problems of SLIT in real life, regular telephone interviews and feedback, termly physician-patient communication. The compliance of the two groups was recorded and analyzed. RESULT: Dropouts in the first year were 47 (45.19%) of the general treatment group and 23 (18.25%) of the intervention treatment group respectively. More than half dropouts were happened at the first two months. Three major reasons of dropouts were no improvement of symptoms, no further consultation because of too far away or too busy and side effects. The occurrence of omission during SLIT was more frequently in general treatment group than intervention treatment group. Three major reasons of omission were forgetting, cold or cough, using up of the SLIT reagent before next consultation. CONCLUSION Percentage of dropouts and omission in normal SLIT patients was comparatively high, which can be significantly improved by systemic patient managements.
Administration, Sublingual ; Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Humans ; Immunotherapy ; methods ; Male ; Middle Aged ; Patient Compliance ; Patient Dropouts ; Rhinitis, Allergic, Perennial ; psychology ; therapy ; Young Adult

OBJECTIVE: To evaluate the efficacy of specific immunotherapy (SIT) with standardized dermatophagoides pteronyssinus extract for allergic rhinitis (AR)accompanied with asthma. METHOD: One hundred and fifty-five patients (40 AR with asthma, AR & asthma) in accordance with the inclusion criteria of SIT, were allocated to receive standardized Dermatophagoides pteronyssinus extract (SIT group, n = 89) or medical treatment (control group, n = 66). AR with or without asthma was observed separately. Symptom and medicine scores, quality of life were recorded and analyzed before and after 1 year treatment. Side effects were registered. Subjective evaluation of symptoms was made by the patients. RESULT: Rhinitis and asthma symptom scores, medicine scores and quality of life were greatly improved in SIT group of AR & asthma after 1 year, which were not significant changed in control group except for medicine scores. The subjective evaluation of symptoms was also significantly improved in SIT group. In patients of AR without asthma, the symptom scores, medicine scores and quality of life were both improved. The SIT group improved greater than that of control group. CONCLUSION The clinical efficacy of patients with AR & asthma was not good with simple medical treatment, while great clinical efficacy could be acquired with SIT.
Adolescent ; Adult ; Allergens ; immunology ; Animals ; Antigens, Dermatophagoides ; pharmacology ; Asthma ; complications ; immunology ; therapy ; Child ; Child, Preschool ; Female ; Humans ; Immunotherapy ; Male ; Middle Aged ; Pyroglyphidae ; Rhinitis, Allergic, Perennial ; complications ; immunology ; therapy ; Treatment Outcome ; Young Adult

OBJECTIVE: To investigate the distribution of positive allergens in patients with allergic rhinitis and the discrepancy among different age group. METHOD: Skin prick tests were done to 2 808 allergic rhinitis patients, the major allergens of local area were tested with standard allergens. Data was analyzed with age and allergens. RESULT: Dermatophagoides pteronyssinus and dermatophagoides farinae had the highest positivity among all allergens (91.03%, 86.47%). Other important allergens were cockroach (19.55%), ragweed (15.63%) and mugwort (14.13%) subsequently. The distribution of major allergens was variable among different age group. The positivity of mold mixture I was much higher in 3-9 years old group than other age group. Positive percentage of ragweed and mugwort allergens were increased with age growing. Positive ratio of cockroach which was higher in the elder than that in the younger, was highest in 30-39 years old group. Ratio in patients with single allergen positive decreased with age growing. CONCLUSION House dust mite was the most important allergen of the local area, the distribution of positive allergens was variable in different age group.
Adolescent ; Adult ; Age Distribution ; Aged ; Allergens ; analysis ; Child ; Child, Preschool ; China ; epidemiology ; Female ; Humans ; Male ; Middle Aged ; Rhinitis, Allergic, Perennial ; epidemiology ; Rhinitis, Allergic, Seasonal ; epidemiology ; Young Adult