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1.
Int J Pharm ; 568: 118503, 2019 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-31306711

RESUMO

In this study, needle-free jet injection dynamics were studied using homogeneous gelatin as model substrates. Whilst keeping nozzle properties such as orifice diameter (do) and ampoule volume (V) constant, we demonstrate the effect of standoff (s), confinement around the gel, storage modulus (G') of model gel and liquid viscosity (µ) on the penetration depth of the jet injection. High-speed imaging was used to observe the liquid jet propagation and dispersion dynamics, whilst a load cell was implemented to measure the impact force for different standoff distance and viscosity of the liquid. The different parameters considered showed significant effects on penetration depth, with non-linear dependence on standoff being the key result, which may have implications for future injector designs. Moreover, the effect of confinement serves as a caution of using gelatin substrates as a proxy for human tissue.


Assuntos
Injeções a Jato , Gelatina , Dureza , Pós , Viscosidade
2.
Lasers Surg Med ; 51(3): 278-285, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30706951

RESUMO

BACKGROUND: Needle-free pneumatic injections have been recently introduced to the field of dermatology to inject such substances as hyaluronic acid. However, data on the influence of various pneumatic injection parameters on collagen synthesis are lacking. OBJECTIVE: Compare the effect of diameter, pressure, and volume of a pneumatic injection jet on collagen synthesis and fluid dispersion pattern using a rat model. Investigate if the total work force of the injection jet is useful in predicting the degree of collagen synthesis. MATERIALS AND METHODS: We injected fluid with 1 mg/ml of hyaluronic concentration to adult rats. Different injection pressures and volumes were tested using devices with nozzles of different diameters. Collagen synthesis areas were then measured, and statistical analyses were performed. RESULTS: The area of collagen fibers increased for up to two months. The injection pressure and volume did not correlate with the degree of collagen synthesis. The nozzle diameter showed a significant after two and four weeks of injection. The total work force correlated with collagen synthesis 2, 4, and 8 weeks post-injection. (P = 0.043, 0.027, and 0.000, respectively). CONCLUSION: Collagen formation is more prominent 2 months post-hyaluronic acid injection than after 1 month when using a needle-free pneumatic injection device. The total work force, which is affected by both the nozzle diameter and injection pressure, can be helpful in predicting the degree of collagen synthesis. Lasers Surg. Med. 51:278-285, 2019. © 2019 Wiley Periodicals, Inc.


Assuntos
Colágeno/metabolismo , Sistemas de Liberação de Medicamentos , Injeções a Jato , Pele/patologia , Animais , Ácido Hialurônico/administração & dosagem , Modelos Animais , Agulhas , Pressão , Ratos , Ratos Sprague-Dawley
3.
J Appl Oral Sci ; 27: e20180195, 2019 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-30673030

RESUMO

OBJECTIVE: Pain due to administration of local anesthetics is the primary reason for patients' fear and anxiety, and various methods are used to minimize it. This study aimed to measure the degree of pain during administration of anesthesia and determine the latency time and duration of pulpal anesthesia using two anesthetic methods in the maxilla. MATERIALS AND METHODS: A randomized, single-blind, split-mouth clinical trial was conducted with 41 volunteers who required class I restorations in the maxillary first molars. Local anesthesia was administered with a needleless jet injection system (experimental group) or with a carpule syringe (control) using a 30-gauge short needle. The method of anesthesia and laterality of the maxilla were randomized. A pulp electric tester measured the latency time and duration of anesthesia in the second molar. Visual analogue scale (VAS) was used to measure the degree of pain during the anesthetic method. Data were tabulated and then analyzed by a statistician. The t-test was used to analyze the differences between the groups for basal electrical stimulation. Duration of anesthesia and degree of pain were compared using the Mann-Whitney test. A 5% significance level was considered. RESULTS: There was no statistical difference in the basal electrical stimulation threshold (mA) and degree of pain between the two methods of anesthesia (p>0.05). Latency time was 2 minutes for all subjects. The duration of pulpal anesthesia showed no statistical difference (minutes) between the two methods (p<0.001), with a longer duration for the traditional method of anesthesia (median of 40 minutes). CONCLUSIONS: The two anesthetics methods did not differ concerning the pain experienced during anesthesia. Latency lasted 2 minutes for all subjects; the traditional infiltration anesthesia resulted in a longer anesthetic duration compared with the needleless jet injection.


Assuntos
Anestesia Dentária/métodos , Anestésicos Locais/administração & dosagem , Injeções a Jato/métodos , Medição da Dor/métodos , Dor Processual/diagnóstico , Adulto , Anestesia Dentária/efeitos adversos , Polpa Dentária/efeitos dos fármacos , Restauração Dentária Permanente/métodos , Estimulação Elétrica , Feminino , Humanos , Masculino , Agulhas , Limiar da Dor , Reprodutibilidade dos Testes , Método Simples-Cego , Estatísticas não Paramétricas , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
4.
Andrology ; 7(1): 69-75, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30407744

RESUMO

BACKGROUND: Surgical sperm retrieval, requiring local anesthetic injection, is the most frequent surgical procedure in male infertility. However, needle phobia is common and may contribute to negative experiences or refusal of procedures employing needle injection. OBJECTIVES: The aim of this study was to compare the acceptability, safety, and efficacy of needle-free jet anesthetic technique (MadaJet) with conventional needle injection for surgical sperm retrievals in patients with azoospermia. MATERIALS AND METHODS: This single-blind randomized controlled trial (RCT) was included of 59 participants who underwent surgical sperm retrievals. Patients were randomly assigned to the needle-free jet (n = 29) or needle injection (n = 30) groups prior to undergoing the surgery. The primary endpoint was the pain score. RESULTS: Baseline characteristics were comparable between the two groups. The safety and adverse outcomes were also not statistically significant difference (p > 0.05). The pain score in patients using needle-free jet was significantly lower than that in patients using needle injection (p < 0.05). Patients in MadaJet group had a significantly lower discomfort score during (p < 0.001) and after (p = 0.01) injection than those in the needle injection group. However, there was no significant difference in the fear score (before, during, and after) of MadaJet and needle injection (p = 0.98, p = 0.74, and p = 0.94, respectively). The mean time to onset of anesthesia was much shorter in the MadaJet group as compared with needle injection (10 ± 4 vs. 157.5 ± 71 s, p < 0.001). However, the duration of anesthesia in patients using MadaJet was shorter compared with those using needle injection (44 ± 13 vs. 63 ± 26 min, p < 0.001). CONCLUSION: In conclusion, for local anesthesia in patients undergoing surgical sperm retrieval, MadaJet produces less pain and discomfort with quicker time to onset and offset of anesthesia compared with conventional needle injection.


Assuntos
Anestesia Local/métodos , Recuperação Espermática , Adulto , Azoospermia/terapia , Humanos , Injeções a Jato/métodos , Masculino , Agulhas , Adulto Jovem
5.
J Cosmet Dermatol ; 18(2): 487-494, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30146720

RESUMO

BACKGROUND: Transcutaneous pneumatic injection (TPI) is a minimally invasive, needle-free modality that can be used to forcefully deliver solution into soft tissues of the face and scalp. OBJECTIVE: To evaluate the effects of TPI of 5% isotonic and 20% hypertonic glucose solutions in in vivo human skin for face lifting. METHODS AND MATERIALS: A prospective, split-face, evaluator-blinded comparison study was performed on 10 Korean participants who were treated with three sessions of TPI using 5% isotonic and 20% hypertonic glucose solutions. RESULTS: The following assessment parameters were improved after TPI therapy using 5% isotonic glucose solution in descending order of mean global aesthetic improvement scale (GAIS) score: perioral expression wrinkles, zygomatic wrinkles or mid-cheek furrows, eyebrow ptosis, jowl sagging, marionette line, horizontal forehead lines, nasolabial folds, and blepharochalasis. Meanwhile, TPI therapy using 20% hypertonic glucose solution improved the following assessment parameters: zygomatic wrinkles or mid-cheek furrows, perioral expression wrinkles, eyebrow ptosis, blepharochalasis, marionette line, jowl sagging, nasolabial folds, and horizontal forehead lines. Linear mixed models revealed a significant interaction between treatment groups and time. CONCLUSION: Our data demonstrated that TPI treatment with 20% hypertonic glucose solution elicited earlier and more pronounced therapeutic responses, compared to 5% isotonic glucose solution.


Assuntos
Solução Hipertônica de Glucose/administração & dosagem , Glucose/administração & dosagem , Rejuvenescimento , Ritidoplastia/métodos , Cadáver , Estética , Feminino , Humanos , Injeções a Jato , Soluções Isotônicas , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Pele/efeitos dos fármacos , Resultado do Tratamento
6.
Conf Proc IEEE Eng Med Biol Soc ; 2019: 1686-1689, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31946221

RESUMO

Most transdermal drug delivery systems are designed to inject drugs through the skin in a direction normal to the skin surface. However, in some applications, such as local anaesthesia, it is desirable to disperse the drug in a direction parallel to the surface of the skin. In this paper we present nozzles for needle-assisted jet injection that are designed to laterally disperse the fluid drug at a chosen depth in tissue. These nozzles were manufactured by laser machining holes in the walls of 0.57 mm (24 G) hypodermic needles, and sealing the ends of the needles. An existing controllable jet injection system was used to test the nozzles. High-speed video recordings were taken to examine the shape of the high-speed jets emitted from the orifices, and jet injections into post mortem porcine tissue were performed to evaluate the resulting dispersion pattern. These injections demonstrated the ability of these nozzles to achieve a widely spread dispersion at a depth of 3 mm to 4 mm in tissue. We observed that the widest dispersion occurred at the same depth as the orifices, and dispersion was greater in the direction of the jets. Further investigation, including an in vivo study, is now required to evaluate whether this technique can reduce the time, cost or pain associated with transdermal local anaesthetic delivery.


Assuntos
Agulhas , Administração Cutânea , Animais , Sistemas de Liberação de Medicamentos , Injeções a Jato , Preparações Farmacêuticas , Suínos
7.
J Control Release ; 291: 127-134, 2018 12 10.
Artigo em Inglês | MEDLINE | ID: mdl-30359666

RESUMO

We present a new mechanism for achieving needle free jet injection that significantly reduces the power required to perform a given injection. Our 'compound ampoule' produces two phases of jet speed under a constant force input by changing the effective piston area part-way through the injection. In this paper we define the benefits associated with a compound ampoule, relative to those of the conventional single piston design, by developing expressions for the power and energy required to perform an injection. We demonstrate that a compound ampoule can reduce the maximum input power required to perform a jet injection to less than one fifth of that previously required, enabling motors of less than half the mass to perform the same injection. We then detail the development of a prototype compound ampoule injector. Results from testing of this prototype demonstrate the function of a compound ampoule and verify the expected reduction in the required power and energy. Injections into post mortem porcine tissue confirm that our compound ampoule prototype can achieve the delivery of 1 mL of liquid into post-mortem tissue at least as effectively as a conventional ampoule. This approach will advance progress toward light-weight and power-efficient needle-free jet injectors for transdermal drug delivery.


Assuntos
Sistemas de Liberação de Medicamentos/instrumentação , Injeções a Jato/instrumentação , Administração Cutânea , Algoritmos , Animais , Sistemas de Liberação de Medicamentos/economia , Desenho de Equipamento , Injeções a Jato/economia , Suínos
8.
J Invest Dermatol ; 138(12): 2531-2539, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30031029

RESUMO

Human HSP70iQ435A carries a single amino-acid modification within the dendritic cell activating region and tolerizes dendritic cells in vitro. The underlying DNA was used to prevent and treat disease in vitiligo mouse models through reduced dendritic cell activation and diminished skin T-cell infiltration, suggesting the same may be useful for patients. Physiologic differences between mouse and human skin then called for studies in large animals with human-like skin. We established the efficiency of DNA jet injection into swine skin before subcloning HSP70iQ435A into clinically suitable vector pUMVC3. Vitiligo lesions in Sinclair swine were treated with plasmid DNA to measure changes in depigmentation, T-cell infiltration, expression of HSP70i in skin, serum HSP70i, and anti-HSP70i serum titers. Remarkable repigmentation following HSP70iQ435A-encoding DNA treatment persisted throughout the 6-month follow-up period. Repigmentation was accompanied by an initial influx of T cells accompanied by increased CD4/CD8 ratios, waning by week 15. Melanocytes spanned the border of repigmenting skin, suggesting that melanocyte repopulation precedes skin melanization. Serum titer fluctuations were not treatment-associated. Importantly, treatment did not interfere with melanoma immunosurveillance. These data encourage clinical testing of HSP70iQ435A.


Assuntos
Células Dendríticas/imunologia , Proteínas de Choque Térmico HSP70/metabolismo , Imunoterapia/métodos , Melanoma/imunologia , Pigmentação da Pele/genética , Pele/patologia , Linfócitos T/imunologia , Vitiligo/imunologia , Animais , Diferenciação Celular , Movimento Celular , Células Cultivadas , DNA/genética , Modelos Animais de Doenças , Terapia Genética , Proteínas de Choque Térmico HSP70/genética , Humanos , Tolerância Imunológica , Vigilância Imunológica , Injeções a Jato , Ativação Linfocitária , Melanoma/genética , Melanoma/terapia , Mutação/genética , Neoplasias Experimentais , Pele/metabolismo , Suínos , Vitiligo/genética , Vitiligo/terapia
9.
Rev Esp Anestesiol Reanim ; 65(10): 558-563, 2018 Dec.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30033044

RESUMO

OBJECTIVES: To evaluate the preference in the anaesthetic technique by anaesthesiologists for the management of inguinal hernia surgery in Galicia. MATERIAL AND METHODS: Using the National Catalogue of Hospitals of the Ministry of Health and Consumer Affairs in Galicia, a questionnair was sent to the Heads of Anaesthesiology Service and Coordinators of the Postanaesthesia Care Unit (PACU) with 11 questions on the anaesthetic technique chosen by anaesthesiologists in the management of patients for inguinal hernia surgery, as well as their reasons. RESULTS: The questionnaire was sent to 11 hospitals: 8 with PACU and 3 District. A total of 94 professionals responded, 56% with more than 10 years of experience, who performed between 8-10 procedures/month (58%) on an outpatient basis (61.54%). The most used anaesthetic technique was intradural in 52.8%, compared to 41.8% of general anaesthesia. Respondents with more than 10 years of experience preferred spinal anaesthesia in 38.6% of cases, compared to those with less experience (6.8%) (P=.037). One in 4 of those who chose general anaesthesia used ultrasound-guided interfascial blocks (27.5%). The local anaesthetic most used in intradural anaesthesia was hyperbaric bupivacaine (70.8%) at doses higher than 7mg. CONCLUSION: Intradural anaesthesia with hyperbaric bupivacaine was the technique most chosen by anaesthesiologists for the management of inguinal hernia surgery. The anaesthetic techniques chosen among the different hospitals did not follow a homogenous distribution. In this survey, there was a tendency to choose the technique associated with the experience of the anaesthesiologist.


Assuntos
Anestesiologistas , Hérnia Inguinal/cirurgia , Herniorrafia , Padrões de Prática Médica/estatística & dados numéricos , Procedimentos Cirúrgicos Ambulatórios , Analgesia/métodos , Anestesia Geral/estatística & dados numéricos , Raquianestesia/estatística & dados numéricos , Anestésicos Locais/administração & dosagem , Bupivacaína/administração & dosagem , Pesquisas sobre Serviços de Saúde , Humanos , Injeções a Jato , Ambulatório Hospitalar/estatística & dados numéricos , Dor Pós-Operatória/tratamento farmacológico , Utilização de Procedimentos e Técnicas/estatística & dados numéricos , Espanha
11.
Vaccine ; 36(32 Pt B): 4935-4938, 2018 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-29980387

RESUMO

BACKGROUND: To attain high coverage during polio vaccination campaigns, an outreach house-to-house strategy is used to administer oral poliovirus vaccine. Administering an injectable vaccine house-to-house requires a skilled work force and increases risks of needle stick injuries. Needle-free injection devices provide a safer alternative to needles and syringes for administering injectable vaccines. We evaluated the feasibility and acceptability of a needle-free injection device to administer injectable poliovirus vaccine during a house-to-house vaccination outreach activity. METHODS: Vaccination teams administered injectable poliovirus vaccine using the Pharmajet® needle-free intramuscular jet injector to children ages 6-59 months in 766 homes. Data on the feasibility of using the jet injector in an outreach campaign setting and the acceptability of the jet injector by caregivers and vaccinators were collected. RESULTS: A total of 993 injections were administered. Vaccinators faced challenges during device preparation in 16% (n = 158) of injections; challenges were related to problems loading the injector and not having a flat surface to use for setup of the injector. Among 32 vaccinators interviewed after the vaccination campaign, the main reported advantage of the device was absence of sharps disposal (91%) while the main reported disadvantage was unacceptability by parents (90%) which was related to the vaccine, not the device. CONCLUSIONS: The needle-free jet injector was feasible for use in house-to-house campaigns. Acceptability by vaccinators was low as 81% stated that the jet injector was not easier to use than needle and syringe. Parental refusal related to frequent polio vaccination campaigns was the biggest challenge. In addition, novelty of the device posed a challenge to teams as they needed to reassure parents about safety of the device. To take full advantage of the ability to take injectable vaccines door-to-door during vaccination campaigns using a needle-free jet injector device, tailored social mobilization efforts are needed ahead of campaigns.


Assuntos
Injeções a Jato/métodos , Poliomielite/prevenção & controle , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacina Antipólio de Vírus Inativado/uso terapêutico , Poliovirus/patogenicidade , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Poliomielite/imunologia , Poliovirus/imunologia
12.
J Control Release ; 280: 51-57, 2018 06 28.
Artigo em Inglês | MEDLINE | ID: mdl-29723614

RESUMO

Jet injection presents a promising alternative to needle and syringe injection for transdermal drug delivery. The controllability of recently-developed jet injection devices now allows jet speed to be modulated during delivery, and has enabled efficient and accurate delivery of volumes up to 0.3 mL. However, recent attempts to inject larger volumes of up to 1 mL using the same methods have highlighted the different requirements for successful delivery at these larger volumes. This study aims to establish the jet speed requirements for delivery of 1 mL of liquid using a controllable, voice coil driven injection device. Additionally, the effectiveness of a two-phase jet speed profile is explored (where jet speed is deliberately decreased toward the end of the injection) and compared to the constant jet speed case. A controllable jet injection device was developed to deliver volumes of 1 mL of liquid at jet speeds >140 m/s. This device was used to deliver a series of injections into post-mortem porcine tissue in single and two-phase jet speed profiles. Single-phase injections were performed over the range 80 m/s to 140 m/s. Consistent delivery success (>80% of the liquid delivered) was observed at a jet speed of 130 m/s or greater. Consistent penetration into the muscle layer coincided with delivery success. Two-phase injections of 1 mL were performed with a first phase volume of 0.15 mL, delivered at 140 m/s, while the injection of the remainder of fluid was delivered at a second phase speed that was varied over the range 60 m/s to 120 m/s. Ten two-phase injections were performed with a second phase speed of 100 m/s producing a mean delivery volume of 0.8 mL ±â€¯0.2 mL, while the single-phase injections at 100 m/s achieved a mean delivery volume of 0.4 mL ±â€¯0.3 mL. These results demonstrate that a reduced jet speed can be used in the later stages of a 1 mL injection to achieve delivery success at a reduced energy cost. We found that a jet speed approaching 100 m/s was required following initial penetration to successfully deliver 1 mL, whereas speeds as low as 50 m/s have been used for volumes of <0.3 mL. These findings provide valuable insight into the effect of injection volume and speed on delivery success; this information is particularly useful for devices that have the ability to vary jet speed during drug delivery.


Assuntos
Sistemas de Liberação de Medicamentos/instrumentação , Preparações Farmacêuticas/administração & dosagem , Administração Cutânea , Animais , Desenho de Equipamento/instrumentação , Injeções a Jato/instrumentação , Músculos/metabolismo , Permeabilidade/efeitos dos fármacos , Pele/metabolismo , Suínos , Fatores de Tempo
13.
J Cosmet Laser Ther ; 20(7-8): 454-461, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29543523

RESUMO

BACKGROUND: Pneumatic injections of non-cross-linked hyaluronic acid are effective in skin rejuvenation, however, the associated biophysical parameters and appearance have not been evaluated. OBJECTIVES: To determine the changes in skin biophysical parameters after facial pneumatic injections of non-cross-linked hyaluronic acid. PATIENTS AND METHODS: Twenty-eight healthy female volunteers received pneumatic injections of non-cross-linked hyaluronic acid into the face for consecutive 5 weeks. Skin biophysical parameter assessment and clinical evaluation were performed using the CK Multi-Probe Adapter and Visia system. Five of the volunteers also underwent retroauricular skin biopsy before and after the last treatment. The skin tissues were all stained with Masson-trichrome, Verhoeff-van Gieson stain, and hematoxylin-eosin to evaluate the changes in collagen, elastic fibers, and the epidermis, before and after the last treatment. RESULTS: Transepidermal water loss was significantly lower in week 4 (18.46 ± 4.70 g/h/m2) than at the baseline (22.03 ± 7.15 g/h/m2, p < 0.05). Skin texture was better in week 4 (599.29 ± 354.32) than at the baseline (668.43 ± 342.55, p < 0.05). Skin pores also improved significantly at week 4 (934.07 ± 458.78) compared to the baseline (1024.57 ± 415.31, p < 0.05). Skin wrinkles were improved at the 3-month follow-up (29.29 ± 11.11) compared to the baseline (35.83 ± 16.05, p < 0.05). CONCLUSION: Pneumatic injections of non-cross-linked hyaluronic acid improved skin TEWL, texture, pores, and wrinkles.


Assuntos
Técnicas Cosméticas/instrumentação , Ácido Hialurônico/uso terapêutico , Envelhecimento da Pele , Adulto , Idoso , Colágeno/efeitos dos fármacos , Técnicas Cosméticas/efeitos adversos , Tecido Elástico/efeitos dos fármacos , Epiderme/efeitos dos fármacos , Feminino , Humanos , Ácido Hialurônico/administração & dosagem , Injeções a Jato , Pessoa de Meia-Idade , Satisfação do Paciente , Rejuvenescimento , Método Simples-Cego
14.
Vaccine ; 36(9): 1220-1226, 2018 02 21.
Artigo em Inglês | MEDLINE | ID: mdl-29395526

RESUMO

BACKGROUND: We conducted a randomized, non-inferiority, clinical study of MMR vaccine by a disposable-syringe jet injector (DSJI) in toddlers in India in comparison with the conventional administration. METHODS: MMR vaccine was administered subcutaneously by DSJI or needle-syringe (N-S) to toddlers (15-18 months) who had received a measles vaccine at 9 months. Seropositivity to measles, mumps, and rubella serum IgG antibodies was assessed 35 days after vaccination. Non-inferiority was concluded if the upper limit of the 95% CI for the difference in the percent of seropositive between groups was less than 10%. Solicited reactions were collected for 14 days after vaccination by using structured diaries. RESULTS: In each study group, 170 subjects received MMR vaccine. On day 35, seropositivity for measles was 97.5% [95% CI (93.8%, 99.3%)] in the DSJI group and 98.7% [95% CI (95.5%, 99.8%)] in the N-S group; for mumps, 98.8% [95% CI (95.6%, 99.8%)] and 98.7% [95% CI (95.5%, 99.8%)]; and for rubella, 98.8% [95% CI (95.6%, 99.8%)] and 100% [95% CI (97.7%, 100.0%)]; none of the differences were significant. The day 35 post-vaccination GMTs in DSJI and N-S groups were measles: 5.48 IU/ml [95% CI (3.71, 8.11)] and 5.94 IU/ml [95% CI (3.92, 9.01)], mumps: 3.83 ISR [95% CI (3.53, 4.14)] and 3.66 ISR [95% CI (3.39, 3.95)] and rubella: 95.27 IU/ml [95% CI (70.39, 128.95)] and 107.06 IU/ml [95% CI (79.02, 145.06)]; none of the differences were significant. The DSJI group reported 173 solicited local reactions and the N-S group reported 112; most were mild grade. Of the total of 156 solicited systemic adverse events, most were mild, and incidence between the two groups was similar. CONCLUSIONS: MMR vaccination via DSJI is as immunogenic as vaccination by N-S. Safety profile of DSJI method is similar to N-S except for injection site reactions which are more with DSJI and are well-tolerated. Registration US National Institutes of Health clinical trials identifier - NCT02253407. Clinical trial registry of India identifier - CTRI/2013/05/003702.


Assuntos
Injeções a Jato/instrumentação , Vacina contra Sarampo-Caxumba-Rubéola/administração & dosagem , Vacina contra Sarampo-Caxumba-Rubéola/imunologia , Equipamentos Descartáveis , Feminino , Humanos , Imunogenicidade da Vacina , Lactente , Injeções a Jato/métodos , Masculino , Sarampo/prevenção & controle , Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos , Caxumba/prevenção & controle , Rubéola (Sarampo Alemão)/prevenção & controle , Seringas
15.
Diabetes Obes Metab ; 20(1): 165-172, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28685973

RESUMO

AIMS: To simplify administration of aqueous exenatide once weekly, which requires reconstitution, the exenatide microspheres have been reformulated in a ready-to-use autoinjector with a Miglyol diluent (exenatide QWS-AI). This study compared the efficacy and safety of exenatide QWS-AI with the first-in-class glucagon-like peptide-1 receptor agonist exenatide twice daily (BID). MATERIALS AND METHODS: This randomized, open-label, controlled study in patients with type 2 diabetes using diet and exercise or taking stable oral glucose-lowering medication randomized patients 3:2 to either exenatide QWS-AI (2 mg) or exenatide BID (10 µg) for 28 weeks. The primary outcome was the 28-week change in glycated haemoglobin (HbA1c). A subset of patients completed a standardized meal test for postprandial and pharmacokinetic assessments. RESULTS: A total of 375 patients (mean HbA1c, 8.5% [69 mmol/mol]; body mass index, 33.2 kg/m2 ; diabetes duration, 8.5 years) received either exenatide QWS-AI (n = 229) or exenatide BID (n = 146); HbA1c was reduced by -1.4% and -1.0%, respectively (least-squares mean difference, -0.37%; P = .0072). More patients achieved HbA1c <7.0% with exenatide QWS-AI (49.3%) than with exenatide BID (43.2%; P = .225). Body weight was reduced in both groups (P = .37 for difference). Gastrointestinal adverse events (AEs) were reported in 22.7% (exenatide QWS-AI) and 35.6% (exenatide BID) of patients; fewer patients in the exenatide QWS-AI group withdrew because of AEs than in the exenatide BID group. Minor hypoglycaemia occurred most often with concomitant sulfonylurea use. CONCLUSIONS: Exenatide QWS-AI was associated with a greater reduction in HbA1c, similar weight loss and a favorable gastrointestinal AE profile compared with exenatide BID.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Hiperglicemia/prevenção & controle , Hipoglicemia/prevenção & controle , Hipoglicemiantes/administração & dosagem , Incretinas/administração & dosagem , Peptídeos/administração & dosagem , Peçonhas/administração & dosagem , Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Estudos de Coortes , Terapia Combinada/efeitos adversos , Preparações de Ação Retardada/administração & dosagem , Preparações de Ação Retardada/efeitos adversos , Preparações de Ação Retardada/farmacocinética , Preparações de Ação Retardada/uso terapêutico , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/metabolismo , Diabetes Mellitus Tipo 2/terapia , Angiopatias Diabéticas/epidemiologia , Angiopatias Diabéticas/prevenção & controle , Cardiomiopatias Diabéticas/epidemiologia , Cardiomiopatias Diabéticas/prevenção & controle , Esquema de Medicação , Exenatida , Feminino , Receptor do Peptídeo Semelhante ao Glucagon 1/metabolismo , Hemoglobina A Glicada/análise , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/fisiopatologia , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/farmacocinética , Hipoglicemiantes/uso terapêutico , Incretinas/efeitos adversos , Incretinas/farmacocinética , Incretinas/uso terapêutico , Injeções a Jato , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Pacientes Desistentes do Tratamento , Peptídeos/efeitos adversos , Peptídeos/farmacocinética , Peptídeos/uso terapêutico , Fatores de Risco , Índice de Gravidade de Doença , Suspensões , Estados Unidos/epidemiologia , Peçonhas/efeitos adversos , Peçonhas/farmacocinética , Peçonhas/uso terapêutico
16.
Mol Cells ; 40(11): 828-836, 2017 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-29113428

RESUMO

Eukaryotic cells consist of a complex network of thousands of proteins present in different organelles where organelle-specific cellular processes occur. Identification of the subcellular localization of a protein is important for understanding its potential biochemical functions. In the post-genomic era, localization of unknown proteins is achieved using multiple tools including a fluorescent-tagged protein approach. Several fluorescent-tagged protein organelle markers have been introduced into dicot plants, but its use is still limited in monocot plants. Here, we generated a set of multicolored organelle markers (fluorescent-tagged proteins) based on well-established targeting sequences. We used a series of pGWBs binary vectors to ameliorate localization and co-localization experiments using monocot plants. We constructed different fluorescent-tagged markers to visualize rice cell organelles, i.e., nucleus, plastids, mitochondria, peroxisomes, golgi body, endoplasmic reticulum, plasma membrane, and tonoplast, with four different fluorescent proteins (FPs) (G3GFP, mRFP, YFP, and CFP). Visualization of FP-tagged markers in their respective compartments has been reported for dicot and monocot plants. The comparative localization of the nucleus marker with a nucleus localizing sequence, and the similar, characteristic morphology of mCherry-tagged Arabidopsis organelle markers and our generated organelle markers in onion cells, provide further evidence for the correct subcellular localization of the Oryza sativa (rice) organelle marker. The set of eight different rice organelle markers with four different FPs provides a valuable resource for determining the sub-cellular localization of newly identified proteins, conducting co-localization assays, and generating stable transgenic localization in monocot plants.


Assuntos
Marcadores Genéticos , Proteínas Luminescentes/metabolismo , Organelas/genética , Oryza/crescimento & desenvolvimento , Biomarcadores/metabolismo , Núcleo Celular/genética , Núcleo Celular/metabolismo , Clonagem Molecular , Retículo Endoplasmático/genética , Retículo Endoplasmático/metabolismo , Injeções a Jato , Mitocôndrias/genética , Mitocôndrias/metabolismo , Cebolas/metabolismo , Organelas/metabolismo , Oryza/genética , Oryza/metabolismo , Plastídeos/genética , Plastídeos/metabolismo
17.
J Biomed Opt ; 22(10): 1-9, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29030942

RESUMO

This is a study motivated by the need to develop a needle-free device for eliminating major global healthcare problems caused by needles. The generation of liquid jets by means of a continuous-wave laser, focused into a light absorbing solution, was studied with the aim of developing a portable and affordable jet injector. We designed and fabricated glass microfluidic devices, which consist of a chamber where thermocavitation is created and a tapered channel. The growth of a vapor bubble displaces and expels the liquid through the channel as a fast traveling jet. Different parameters were varied with the purpose of increasing the jet velocity. The velocity increases with smaller channel diameters and taper ratios, whereas larger chambers significantly reduce the jet speed. It was found that the initial position of the liquid-air meniscus interface and its dynamics contribute to increased jet velocities. A maximum velocity of 94±3 m/s for a channel diameter of D=120 µm, taper ratio n=0.25, and chamber length E=200 µm was achieved. Finally, agarose gel-based skin phantoms were used to demonstrate the potential of our devices to penetrate the skin. The maximum penetration depth achieved was ∼1 mm, which is sufficient to penetrate the stratum corneum and for most medical applications. A meta-analysis shows that larger injection volumes will be required as a next step to medical relevance for laser-induced jet injection techniques in general.


Assuntos
Sistemas de Liberação de Medicamentos/métodos , Injeções a Jato , Lasers , Desenho de Equipamento , Gases , Géis , Humanos , Microfluídica , Agulhas , Imagens de Fantasmas , Sefarose/química , Pele
18.
Conf Proc IEEE Eng Med Biol Soc ; 2017: 292-295, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-29059868

RESUMO

Controllable jet injection could provide a fast, repeatable method for delivery of small volume, high viscosity drugs to the dermis. We have developed a compact, lightweight jet injector that uses a small commercial rotary motor and differential screw to create a jet of fluid with sufficient force to deliver drug into tissue. Clear tissue analogue and ex vivo tissue were used to demonstrate repeatable delivery of <;10 µL of fluid using the device. The fluid when forced through a narrow orifice (108 µm) reaches a velocity of >250 m/s with an injection time of <;3 ms.


Assuntos
Desenho de Equipamento , Sistemas de Liberação de Medicamentos , Injeções a Jato , Agulhas , Preparações Farmacêuticas
19.
Conf Proc IEEE Eng Med Biol Soc ; 2017: 296-299, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-29059869

RESUMO

The effect of varying velocity during jet injection on the dispersion of fluid into tissue is investigated using a custom-built X-ray imaging system. Injections are performed into ex-vivo porcine abdominal tissue using a voice coil actuated injection device. Single velocity and two-phase velocity injections reveal the complex nature of the dispersion of the fluid jet in layered tissue and highlight the effects of changing the jet velocity following the initial penetration of the liquid into the tissue.


Assuntos
Injeções a Jato , Animais , Sistemas de Liberação de Medicamentos , Radiografia , Suínos , Raios X
20.
Conf Proc IEEE Eng Med Biol Soc ; 2017: 304-308, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-29059871

RESUMO

A rigid, compact, multi-piece ampoule has been designed and fabricated as a platform to conveniently house different nozzle inserts one at a time to offer increased jet consistency and functional flexibility. Three different nozzle geometries that respectively produce a single axial jet, radial jets, and intersecting jets are designed and fabricated. Through high-speed imaging and injection into tissue analog and ex vivo porcine tissue, these nozzles are demonstrated to have potential for a range of injection applications including intradermal, intratympanic, and traditional uses. The presented ampoule is more successful than a commercial jet injection ampoule in adhering to desired position and velocity trajectories and the energy efficiencies of jet ejections are compared.


Assuntos
Sistemas de Liberação de Medicamentos , Animais , Injeções a Jato , Suínos
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