As a relatively novel technique for drug delivery, the needle-free injection technique is characterized by transporting the drug liquid to the designated subcutaneous position through a high-speed micro-jet. Although this technique has been applied in many fields, the research on its drug dispersion mechanism and injection performance is insufficient. The presented study aims to identify critical parameters during the injection process and describe their influence on the injection effect. The injection completion rate and performance of a needle-free injector under various operating conditions were compared based on mouse experiments. The results show that the nozzle diameter imposes a more significant influence on jet characteristics than other injection parameters. Moreover, the injection completion rate increases with the nozzle diameter. The nozzle diameters of 0.14 mm and 0.25 mm correspond to injection completion rates of 89.7% and 95.8%, respectively. Furthermore, by analyzing the rate of blood glucose change in the tested mice, it is found that insulin administration through the needle-free injection can achieve a drug effect duration longer than 120 min, which is better than that obtained using conventional needle-syringe technique. In summary, the obtained conclusions can provide an important reference for the optimal design and extending application of the air-powered needle-free injector.
Animals ; Mice ; Insulin/administration & dosage* ; Needles ; Injections, Subcutaneous/methods* ; Injections, Jet/instrumentation* ; Drug Delivery Systems/instrumentation* ; Blood Glucose/analysis* ; Equipment Design

Humans ; Consensus ; Hypersensitivity ; Desensitization, Immunologic/adverse effects* ; Immunotherapy/adverse effects* ; Injections, Subcutaneous ; Allergens

Objective: To analyze the factors affecting the efficacy of mite subcutaneous immunotherapy (SCIT) in allergic asthma patients aged 5-18 years, and to find the best predictive model for the curative effect. Methods: The data of 688 patients aged 5-18 years with allergic asthma who completed more than 3 years of mite SCIT from December 2006 to November 2021 in the Department of Respiratory Medicine, Children's Hospital Affiliated to Nanjing Medical University were retrospectively analyzed. Male, results of skin prick test (SPT), age, daily medication score (DMS), visual analogue scale (VAS) score, and enrollment season were defined as independent variables. R language models, including Logistic regression model, random forest model and extreme gradient boosting (XGboost) model, were used to analyze the impact of these independent variables on the outcomes. The receiver operating characteristic curve was applied to compare the predictive ability of the models. Hypothesis testing of the area under curve (AUC) of the 3 models was performed using DeLong test. Results: There were 435 males and 253 females in the 688 patients. There were 349 patients aged 5-<8 years, 240 patients aged 8-<11 years, and 99 patients aged 11-18 years. SPT showed that 429 cases (62.4%) were only allergic to mite, and 259 cases (37.7%) were also allergic to other allergens. According to the efficacy after 3 years of SCIT, 351 cases (51.0%) discontinued the treatment and 337 cases (49.0%) required continued treatment. The DMS was 4 (3, 6) at initiation, 3 (2, 5) at 3 months, 3 (2, 5) at 4 months, 2 (1, 3) at 12 months, and 0 (0, 1) at 3 years of SCIT treatment. The VAS was 3.5 (2.5, 5.2) at initiation, 3.2 (2.2, 4.8) at 3 months, 2.6 (1.4, 4.1) at 4 months, 1.0 (0.6, 1.8) at 12 months, and 0.5 (0, 1.2) at 3 years of treatment. At 3, 4, and 12 months, the rate of decline in DMS was 0 (0, 20%), 16.7% (0, 33.3%), and 50.0% (31.0%, 75.0%), respectively; and the VAS decreased by 7.1% (3.2%,13.8%), 27.6% (16.7%,44.4%), and 70.2% (56.1%, 82.3%), respectively. Regarding the enrollment season, 99 cases were in spring, 230 cases in summer, 171 cases in autumn, and 188 cases in winter. The R language Logistic regression model found that DMS>3 points at 3 months (OR=-3.5, 95%CI:-4.3--2.7, P<0.01), male (OR=-1.7, 95%CI:-2.3--1.0), P<0.01), DMS decline rate>16.7% at 4 months (OR=-1.6, 95%CI:-2.3--0.8, P<0.01) and DMS decline rate>0 at 3 months (OR=-0.7, 95%CI:-1.3--0.2, P<0.05) had higher possibility of drug discontinuation; whereas, the decline rate of DMS at 12 months>50.0% (OR=0.7, 95%CI: 0.1-1.3, P<0.05), VAS at 12 months>1.0 points (OR=0.9, 95%CI: 0.3-1.6, P<0.05), and initial VAS<4.0 points (OR=1.0, 95%CI: 0.4-1.6, P<0.01) had lower possibility of drug discontinuation. Both the random forest model and the XGboost model showed that DMS>3 points at 3 months (mean decrease accuracy=30.9, importance=0.45) had the greatest impact on drug discontinuation. The AUC of the random forest model was the largest at 0.900, with an accuracy of 78.2% and a sensitivity of 84.5%. Logistic regression model had AUC of 0.891, accuracy of 80.0%, and sensitivity of 80.0%; XGboost model had AUC of 0.886, accuracy of 76.9%, and sensitivity of 84.5%. The AUC of the pairwise comparison model by DeLong test found that all three models could be used for the prediction of this data set (all P>0.05). Conclusions: The more drugs used to control the primary disease, and the more careful reduction of the control medicine after starting SCIT treatment, the more favorable it is to stop all drugs after 3 years. The random forest model is the best predictive model for the efficacy of mite SCIT in asthmatic children.
Adolescent ; Allergens ; Animals ; Asthma/therapy* ; Child ; Child, Preschool ; Desensitization, Immunologic/methods* ; Female ; Humans ; Immunotherapy/methods* ; Injections, Subcutaneous ; Male ; Mites ; Retrospective Studies

Objective: To evaluate the safety and effectiveness of a vaccine based on latent membrane protein 2 (LMP2) modified dendritic cells (DCs) that boosts specific responses of cytotoxic T lymphocytes (CTLs) to LMP2 before and after intradermal injection in patients with nasopharyngeal carcinoma (NPC). Methods: DCs were derived from peripheral blood monocytes of patients with NPC. We prepared LMP2-DCs infected by recombinant adenovirus vector expressing LMP2 (rAd-LMP2). NPC patients were immunized with 2 × 10 Results: We demonstrated that DCs derived from monocytes displayed typical DC morphologies; the expression of LMP2 in the LMP2-DCs vaccine was confirmed by immunocytochemical assay. Twenty-nine patients with NPC were enrolled in this clinical trial. The LMP2-DCs vaccine was well tolerated in all of the patients. Boosted responses to LMP2 peptide sub-pools were observed in 18 of the 29 patients with NPC. The follow-up data of 29 immunized patients from April, 2010 to April 2015 indicated a five-year survival rate of 94.4% in responders and 45.5% in non-responders. Conclusion In this pilot study, we demonstrated that the LMP2-DCs vaccine is safe and effective in patients with NPC. Specific CTLs responses to LMP2 play a certain role in controlling and preventing the recurrence and metastasis of NPC, which warrants further clinical testing.
Adult ; Aged ; Cancer Vaccines/therapeutic use* ; China ; Dendritic Cells/immunology* ; Female ; Humans ; Immunotherapy/methods* ; Injections, Intradermal ; Male ; Middle Aged ; Nasopharyngeal Carcinoma/therapy* ; Nasopharyngeal Neoplasms/therapy* ; T-Lymphocytes, Cytotoxic/immunology* ; Viral Matrix Proteins/therapeutic use* ; Young Adult

OBJECTIVE: To investigate the incidence of systemic reactions (SR) to subcutaneous immunotherapy (SCIT) for bronchial asthma and/or allergic rhinitis in children and their risk factors. METHODS: A retrospective analysis was performed on 198 children with bronchial and/or allergic rhinitis. According to the presence or absence of SR and local reactions (LR) during SCIT, the patients were divided into two groups: SR (with SR and LR, n=31) and control (without SR or LR, n=142). A multivariate logistic regression analysis was used to determine the risk factors associated with SR. RESULTS: Among the 198 patients who received 8 157 injections of SCIT, 25 (12.6%) experienced SR (31 times, 0.38%), including grade I SR (18 times, 58%), grade II SR (10 times, 32%), grade III SR (3 times, 10%), and no grade IV SR. The multivariate logistic regression analysis showed that multiple sensitization with both food and inhaled allergens, specific IgE to dust mites (grade 6), total IgE (grade 6), and a history of LR were independent risk factors for SR (P<0.05). CONCLUSIONS SCIT is a safe treatment for bronchial asthma and/or allergic rhinitis in children, with a low incidence of SR. Children with multiple sensitization with both food and inhaled allergens, a hypersensitive state (specific IgE to dust mites, grade 6; total IgE, grade 6), and a history of LR have an increased risk of SR to SCIT.
Allergens ; Animals ; Asthma/drug therapy* ; Child ; Desensitization, Immunologic ; Humans ; Injections, Subcutaneous ; Retrospective Studies ; Rhinitis, Allergic/therapy* ; Risk Factors

OBJECTIVE: An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests. METHODS: According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed. RESULTS: After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested. CONCLUSIONS Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.
Disposable Equipment/standards* ; Equipment Safety ; Injections, Intradermal/instrumentation* ; Syringes

OBJECTIVE: To compare the effects of intravenous and subcutaneous injection of bortezomib on incidence and relative risk of peripheral neuropathy in patients with multiple myeloma(MM). METHODS: The electronic database of PubMed, Embase, Cochrance library, CNKI and related meeting records were searched by computers. The data were derived all from a matched randomized controlled studies. The incidence, relative risk(RR) and 95% confidence interval of peripheral neuropathy caused by intravenous and subcustaneous injections were calculated by the statistical methods. RESULTS: Four RCT studies were selected for meta-analysis, with a total of 911 patients (479 cases and 432 cases in the subcutaneous injection and intravenous injection groups, respectively). The incidence of peripheral neuropathy in the intravenous injection group was 41.4% (95% CI=0.137-0.692, P=0.003), and the incidence of >2 grade of peripheral neuropathy was 15.6% (95% CI=0.005-0.308, P=0.043). The corresponding incidence rates of the subcutaneous injection group were 16% (95% CI=0.021-0.299, P=0.024) and 3.4% (95% CI=-0.011-0.080, P=0.141) respectively. Compared with the intravenous injection group, the RR of peripheral neuropathy and the relative risk of peripheral neuropathy above grade 2 were 0.525, 95% CI=0.297-0.928 (P=0.027) and 0.376, 95% CI=0.196-0.722 (P=0.003) respectively. CONCLUSION Subcutaneous injection of bortezomib at therapeutic doses significantly reduces the incidence of peripheral neuropathy compared with intravenous injection.
Antineoplastic Agents ; Bortezomib ; adverse effects ; Humans ; Incidence ; Injections, Subcutaneous ; Multiple Myeloma ; Peripheral Nervous System Diseases ; chemically induced

BACKGROUND AND OBJECTIVES: Beneficial effects of human adipose-derived stromal vascular fraction (SVF) cell injection on microcirculation have been recently reported in in vitro and in vivo studies. However, no clinical studies have reported its effect in diabetic patients who commonly experience compromised tissue perfusion, regardless of the status of intravascular blood flow. The present piloting study was designed to clinically examine the possibility of SVF cell injection to accelerate microcirculation, particularly in ischemic diabetic feet. METHODS: Ten diabetic feet were included to receive subcutaneous injection of SVF cells around wounds. Transcutaneous partial oxygen pressure (TcPO2) and cutaneous microvascular blood flow were measured before and every four weeks after cell injection until the 12th week visit. RESULTS: TcPO2 values increased from 31.3±7.4 before injection to 46.4±8.2 mmHg at 12 weeks after SVF injection (1.5-fold, p<0.05). Cutaneous microvascular blood flow levels increased from 34.0±21.1 before injection to 76.1±32.5 perfusion unit at 12 weeks after SVF injection (2.2-fold, p<0.05). There were no adverse events related to SVF cell injection. CONCLUSIONS: Results of this study demonstrate that adipose-derived SVF cell injection have the possibility to provide beneficial effects on microcirculation in ischemic diabetic feet.
Diabetic Foot ; Humans ; In Vitro Techniques ; Injections, Subcutaneous ; Microcirculation ; Oxygen ; Perfusion ; Pilot Projects ; Wounds and Injuries

OBJECTIVE: Osteoporosis is one of the most common causes of vertebral compression fractures (VCFs). Teriparatide, a recombinant human parathyroid hormone, is the first anabolic agent for the treatment of osteoporosis. The aim of this study was to determine whether 3 months of teriparatide could be effective for patients with osteoporotic VCF at the thoracolumbar spine. METHODS: We reviewed 25 patients with thoracolumbar osteoporotic compression fractures between July 2012 and October 2016 who could be followed up for more than 1 year. Patients were divided into 2 groups depending on the use of teriparatide: 14 patients received teriparatide through subcutaneous injection (group I) and 11 patients did not receive teriparatide (group II). Demographic data, bone mineral density, hospitalization period, changes in the visual analogue scale (VAS) score, body mass index, and medical history such as smoking, alcohol, diabetes, and steroid usage were reviewed. Radiographs were also reviewed to evaluate vertebral body compression percentages and kyphotic angles. RESULTS: Overall changes of VAS score between injury and follow-up were statistically improved in both groups at 2 to 3 weeks post-injury. However, difference in VAS improvement at a specific time between the 2 groups was not statistically significant. Overall kyphotic angle and compression percentage between injury and follow-up time were increased in group II than those in group I, although the difference between the 2 groups was not statistically significant. CONCLUSION: Three-month of teriparatide did not show protective effects on progression of fractured vertebral body collapse or kyphotic changes in patients with osteoporosis.
Body Mass Index ; Bone Density ; Follow-Up Studies ; Fractures, Compression ; Hospitalization ; Humans ; Injections, Subcutaneous ; Osteoporosis ; Osteoporotic Fractures ; Parathyroid Hormone ; Smoke ; Smoking ; Spine ; Teriparatide ; Thoracic Vertebrae ; Treatment Outcome

PURPOSE: Ultra-rush schedule of subcutaneous allergen immunotherapy (UR-SCIT) administering maximum maintenance dose of allergen extract within one day can save time and effort for allergen immunotherapy in patients with allergic disease. However, UR-SCIT is associated with an increased risk of systemic reaction (SR) and typically has been conducted in a hospital admission setting. To overcome disadvantages of UR-SCIT, we evaluated the safety of UR-SCIT conducted in an outpatient clinic in patients with atopic dermatitis (AD) and allergic rhinitis (AR). METHODS: UR-SCIT was performed in 538 patients with AD and/or AR sensitized to house dust mite (HDM). A maximum maintenance dose of tyrosine-adsorbed HDM extract (1 mL of maintenance concentration) was divided into 4 increasing doses (0.1, 0.2, 0.3, and 0.4 mL) and administered to the patients by subcutaneous injection at 2-hour intervals for 8 hours in an outpatient clinic. SRs associated with UR-SCIT were classified according to the World Allergy Organization grading system. RESULTS: SR was observed in 12 of 538 patients (2.2%) with AD and/or AR during UR-SCIT. The severity grades of the observed SRs were mild-to-moderate (grade 1 in 7 patients, grade 2 in 4 patients, and grade 3 in 1 patient). The scheduled 4 increasing doses of HDM extract could be administered in 535 of 538 patients (99.4%) except 3 patients who experienced SR before administration of the last scheduled dose. SR was observed within 2 hours in 11 patients after administration of the scheduled doses of HDM extract except one patient who experienced a grade 2 SR at 5.5 hours after administration of the last scheduled dose. CONCLUSIONS: UR-SCIT with tyrosine-adsorbed HDM extract conducted in an outpatient clinic was tolerable in patients with AD and AR. UR-SCIT can be a useful method to start a SCIT in patients with AD and AR.
Ambulatory Care Facilities ; Appointments and Schedules ; Dermatitis, Atopic ; Desensitization, Immunologic ; Dust ; Humans ; Hypersensitivity ; Injections, Subcutaneous ; Methods ; Outpatients ; Pyroglyphidae ; Rhinitis, Allergic