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PubMedDate not supplied

The latest developments in insulin injection devices.

The next several years promise dramatic changes in the treatment of diabetes, many of which will be driven by rapidly developing technology. Today's patient with diabetes has ready access to more information about the disease and its treatment options. As a result of this increased knowledge base, insulin-treated patients have become more autonomous in the management of their diabetes and may be better prepared to participate in making informed choices regarding insulin delivery devices. As with any insulin regimen, diabetes educators are encouraged to provide ongoing patient education and follow-up to assure optimal use of these new technologies.

Equipment Design↗
PubMed2001

Dendritic cell delivery of plasmid DNA. Applications for controlled genetic immunization.

Positive human clinical data using biolistic-mediated gene transfer (i.e., gene gun) to administer a nucleic acid-based Hepatitis B vaccine has validated genetic immunization as an effective clinical vaccine modality. Although the precise mechanism of action has yet to be determined, preclinical studies using jet injection have indicated that direct targeting of resident antigen presenting cells (Langerhan's cells) in the skin as the primary immunological driving force for the potent and long-lived immune response. Moreover, positive results with topical delivery of genetic vaccines and ex vivo loading of dendritic cells with antigen has strengthened the movement toward directly targeting antigen presenting cells as a means to amplify, control, and mediate the immunological consequences of prophylactic and/or therapeutic genetic vaccines. Despite these encouraging results with the gene gun, it is unclear whether this technology will translate into commercially available vaccines due to potential product development barriers such as cost and convenience. It is clear that safety concerns in using genetic approaches to treat and prevent disease have highlighted the need for strict product requirements for genetic vaccines. A plausible strategy to meet these requirements is to combine controlled plasmid delivery systems with tissue-specific gene expression systems.

Animals↗
PubMed2003

Are needle-free injections a useful alternative for growth hormone therapy in children? Safety and pharmacokinetics of growth hormone delivered by a new needle-free injection device compared to a fine gauge needle.

The clinical safety, use and pharmacokinetics of a new needle-free device for delivery of growth hormone (GH) were compared with those of conventional needle injection devices. In an open-label, randomized, 4-period crossover study, 18 healthy adults received single subcutaneous injections of Genotropin administered by the Genotropin ZipTip needle-free device and by conventional injection. Bioequivalence was established between the devices. In a separate open-label, randomized, multicenter, 2-period crossover study, pediatric patients underwent 2-weeks Genotropin treatment administered by the Genotropin ZipTip and by a fine-gauge needle device (>95% used the Genotropin Pen). In total, 128/133 patients who were treated completed the study. Genotropin ZipTip was well tolerated and >50% of patients found no difference between the devices for all parameters assessed. After study completion, >20% patients preferred to continue using Genotropin ZipTip. Although statistical analyses demonstrated superiority of the Genotropin Pen versus Genotropin ZipTip for bleeding, pain, soreness, and bruising, Genotropin ZipTip was considered to provide a safe and bioequivalent alternative to needle injection.

Adolescent↗
PubMed2001

[Prevalence of and factors associated with hepatitis B virus markers in a rural population of central Brazil].

OBJECTIVE: To carry out a survey of hepatitis B virus seroepidemiology in a municipality in central Brazil, on the border of two large ecosystems, the cerrado (savanna) and the Amazon River basin. METHODS: The municipality studied, Nova Mutum, is located in the north central portion of the Brazilian state of Mato Grosso. The study sample of 754 individuals included persons from families, selected at random, who were living in the municipality's urban center as well as all the individuals living in a nearby rural village. Ages ranged from 2 to 79 years. All eligible individuals were interviewed. Blood was collected and used to assess hepatitis B virus markers by enzyme-linked immunosorbent assay. RESULTS: Hepatitis B virus infection was found in 232 individuals, or 31% of them; 19 of them (3%) were HBsAg-positive. Of the 754 persons, 149 of them (20%) who reported having been vaccinated against hepatitis B and who presented anti-HBs positivity were classified as vaccine responders. With the multivariate analysis, the variables found to be associated with exposure to hepatitis B virus were having begun sexual relations, having been vaccinated against yellow fever with a needle-free jet injection gun (for the age group < 20 years), and being an immigrant from southern Brazil (> 20 years). Vaccine coverage was low among individuals older than 10 years. The largest share of susceptible individuals (74%) were found in the age group of 11 to 20 years. CONCLUSIONS: Our data suggest that hepatitis B virus vaccine coverage in Brazil should be extended to include teenagers in populations that have a low to moderate hepatitis B virus prevalence. It is likely that our results can be extrapolated to other areas of Latin America with a similar epidemiological pattern.

Adolescent↗
PubMed2006

Pharmacokinetic bioequivalence of enfuvirtide using a needle-free device versus standard needle administration.

STUDY OBJECTIVES: To compare the relative bioavailability of enfuvirtide, a human immunodeficiency virus type 1 (HIV-1) fusion inhibitor, injected with the Biojector 2000 (B2000) needle-free device versus a 27-gauge half-inch needle-syringe; and to assess safety, tolerability, and patient preference for the two devices. DESIGN: Open-label, randomized, two-period crossover bioequivalence evaluation. SETTING: Clinical research center. PATIENTS: Twenty-seven adults with HIV-1 viral loads below 1000 copies/ml. INTERVENTION: Each patient received enfuvirtide 90 mg subcutaneously with the B2000 and with the needle-syringe, with a 1-week washout between treatments. MEASUREMENTS AND MAIN RESULTS: Twenty-six and 27 patients were included in the bioequivalence and safety analyses, respectively. Plasma enfuvirtide concentrations were measured at baseline and at several intervals after each injection. The B2000:needle-syringe ratios of maximum concentration (C(max)), area under the concentration-time curve from time zero extrapolated to infinity (AUC(0-infinity)), and AUC from time zero to tau (dosing interval) (AUC(0-tau)) served as criteria for bioequivalence determination. The two drug delivery systems were considered bioequivalent if the 90% confidence intervals (CIs) for the ratios were within 0.8-1.25. Safety and tolerability were evaluated based on documentation of adverse events, graded laboratory toxicities, and local injection-site reactions. Patient surveys provided feedback on device preference. Ratios of C(max), AUC(0-infinity), and AUC(0-tau) were 0.95 (90% CI 0.84-1.09), 0.99 (90% CI 0.93-1.05), and 0.99 (90% CI 0.93-1.05), respectively. The frequency of injection-site reactions was low, and severity was generally mild for both devices. Survey results showed 18 patients (69%) had a positive overall impression of the B2000 and 14 (54%) felt safer injecting with this device. Overall, 17 patients (65%) preferred the B2000 over the needle-syringe. CONCLUSION: Bioavailability of enfuvirtide with the B2000 and needle-syringe was equivalent based on C(max), AUC(0-tau), and AUC(0-infinity). Safety profiles and injection-site reactions were comparable between the devices, but patients preferred the B2000. Delivery of enfuvirtide with the B2000 is a feasible alternative to standard needle administration and warrants further evaluation.

Area Under Curve↗
PubMed1976

Vaccination of chickens against Marek's disease with the turkey herpesvirus vaccine using a pneumatic vaccinator.

A pneumatic vaccinator has been successfully used to administer cell-associated turkey herpesvirus (HVT) vaccine without a loss in titer due to the pressure required to administer the vaccine. Laboratory studies have also shown that chickens vaccinated with graded doses of the HVT vaccine using doses as low as 41 PFU offered protection against Marek's disease (MD) when compared to the unvaccinated controls. The pneumatic vaccinator has also been successful in administering a combination of HVT vaccine and tissue culture fowl pox vaccine. Vaccinated birds were protected against challenge with virulent MD virus as well as fowl pox virus. Antibiotics such as spectinomycin pentahydrate or lincomycin hydrochloride monohydrate and spectinomycin sulfate tetrahydrate were used in combination with the HVT and fowl pox vaccine and none of the antibiotics appear to have an adverse effect on the efficacy of either vaccine.

Animals↗
PubMed1999

[Rush desensitization to drugs: elements for protocol rationalization].

The need for some treatments that are without possible alternatives leads, for allergy or intolerance, to procedures of rapid re-introduction at increasing doses, under the term of rapid habituation (A.R.) which is different from specific immunotherapy. No postulated mechanism has been suggested. The successes reported in the literature are presented here. They raise a discussion on the indications, the rational and empirical elements and the preferable routes of introduction. The authors stress the need for biological studies of A.R.

Administration, Oral↗
PubMed2000

Delivery of low molecular weight heparin for prophylaxis against deep vein thrombosis using a novel, needle-less injection device (J-Tip).

Given daily, low molecular weight (LMW) heparins are established for prophylaxis against deep vein thrombosis (DVT). We describe delivery by a novel, needle-less device that is virtually painless in action. Its use could provide benefits for patients in terms of comfort both psychologically and physically, and for healthcare workers in terms of safety from needle-stick injury. Patients undergoing elective surgery received LMW heparin delivered subcutaneously by either a standard needle and syringe or by the needle-less injection device, J-Tip. Pain was scored at the time of injection and plasma anti-factor Xa levels compared between the two methods of drug delivery 4 h later: 29 patients received LMW heparin delivered by the J-Tip and 31 patients by standard needle and syringe. The J-Tip was significantly more comfortable for the patient as the method of drug delivery (P < 0.001). When delivered by the J-Tip, LMW heparin was equally as efficacious, as plasma anti-factor Xa levels were similar for both methods of delivery (P < 0.42). In summary, delivery of LMW heparin by the J-Tip device was both comfortable and effective. These findings, taken in conjunction with its ease of use and complete freedom from risk of needle-stick injury might encourage further examination and use of this type of product.

Adult↗
PubMed1979

[Assessment of the effectiveness of different methoods of immunization with live plague vaccine EB in aerosol infections].

The work deals with the results of the comparative evaluation of the effectiveness of vaccines developed at the Sanitary Research Institute (Zagorsk) and the Mechnikov Research Institute for Vaccines and Sera (Moscow), as well as two methods of immunization against plague, by inhalation and subcutaneous injection, under the conditions of aerosol infection. The immunogenic effectiveness of both vaccines, when evaluated in terms of LD50, was shown to be approximately the same, but the animals immunized by the inhalation method with the vaccine developed at the Sanitary Research Institute proved to be less susceptible to infection than those immunized with the vaccine developed at the Mechnikov Research Institute for Vaccines and Sera in Moscow. After immunization by the inhalation method the vaccine developed at the Sanitary Research Institute rendered more effective protection (3- to 4-fold) against aerosol infection than after immunization by subcutaneous injection. The animals immunized by the inhalation method proved to be capable of surviving plague in the primary pneumonic form.

Aerosols↗
PubMedDate not supplied

[The results of the therapeutic monitoring of piracetam in parturients and newborn infants].

Overall 30 women in childbirth with preeclampsia and fetoplacental dysfunction received piracetam solution which was given initially in a dose of 5 g by intravenous drip, rapidly since the onset of labour and then every 2 hours till the end of labour in a dose of 2 g by jet injection. This made it possible to increase fetus resistance to hypoxic conditions. The concentrations of piracetam within the range of 60-80 g/l in the blood of women in childbirth should be viewed as minimum therapeutic. A single daily intramuscular injection of piracetam (50 mg/kg) into neonates with encephalopathies may build up blood concentrations equal to 25-60 mg/l after 2 hours. The drug is not detectable in the blood by the moment the next injection is given.

Adolescent↗
PubMed1964

RESPONSE OF VOLTA CHILDREN TO JET INOCULATION OF COMBINED LIVE MEASLES, SMALLPOX AND YELLOW FEVER VACCINES.

An earlier study established that Upper Volta children respond to vaccination with the Enders live attenuated measles strain in the same general fashion as do children in the USA. The present report describes a second pilot project carried out in Ouagadougou, Upper Volta. During this investigation various mixtures of live measles, smallpox and 17D yellow fever vaccines were introduced into susceptible infants by jet injection. Combining the attenuated virus vaccines did not alter or accentuate the characteristic clinical reactions elicited by the individual components, nor was there evidence of significant immunological interference. From this experience it is concluded that combined vaccination with these agents may be safely and effectively employed in larger programmes as the need dictates.

Africa↗
PubMed1977

[Results of studying a live mumps vaccine from strain L-3 manufactured by the Moscow Research Institute of Viral Preparations. The epidemiological effectiveness of the vaccine].

A controlled experiment was carried out to study the epidemiological effectiveness of live mumps vaccine from the L-3 strain, the importance of urgent prophylaxis by vaccination in mumps foci and to evaluate the economic effectiveness of mass prophylaxis of mumps by vaccination. The observations involved 113,967 children of 1 to 12 years. Vaccinations were given to 51,701 subjects and 62,256 subjects were the control group. The groups were formed by random selection. One vaccination dose contained 10(4)HAdU50 of mumps virus. The results attest to high epidemilogical effectiveness of the mumps vaccine. The incidence of mumps among the vaccinees was 29.7-fold lower than among unvaccinated, and the coefficient of protection was 96.6%. The urgent vaccination vaccination prophylaxis carried out in children's institutions during the period of introduction of mumps arrested the outbreak within one month, nad the duration of quarantine was reduced 2-3-fold. As a result of the vaccination the economic effect of 290,000 roubles was achieved.

Child↗
PubMed2005

[Smallpox vaccination techniques: considerations and unresolved issues].

The smallpox vaccine is the oldest--and was, for 90 years, the only--vaccine known to man. Many vaccination techniques have been used over time, with no fewer than ten employed during the 20th century alone. In Israel, two main techniques were used prior to smallpox eradication in 1978--multiple punctures using a standard needle, and jet injection--while most other countries adopted the bifurcated needle as the method of choice. Despite the vaccination experience gained over time, doubt remains today as to the preferred vaccination technique. During 2002, when Israel became the first country to conduct large-scale smallpox vaccination in the 21st century, multiple standard needle puncture was adopted as the method of choice, while at the same time the bifurcated needle was readopted in the United States. The article reviews the various smallpox vaccination techniques, the supporting scientific data, and the current lacunae in knowledge related to the subject. Together, these factors will most likely influence the adoption of a preferred vaccination technique during a smallpox emergency.

Humans↗
PubMed1989

[Substantiation, tactics and effectiveness of frozen plasma-enzyme inhibitor therapy in septicemia and infectious-destructive processes].

Nonvalidated transfusions of fresh frozen plasma (with the aim of blood loss substitution, for parenteral feeding, etc.) are widely used in the current clinical practice. In disseminated intravascular coagulation syndrome (DICS) its use is undoubtedly indicated, but only by jet-injection, combined with low doses of heparin, and simultaneous administration of high doses of protease inhibitors (kontrikal, etc.); such treatment should be conducted at the early stages of the process, and not in the period of complete noncoagulation and profuse hemorrhage. The treatment was applied to 194 patients with sepsis and 147 patients with acute infectious-destructive diseases of the lungs; in 12 patients plasmapheresis was used simultaneously. More rapid, than in the compared group, arrest of fever and decrease of intoxication, recovery of microcirculation in the organs, increased accessibility of the infection foci for antibiotics, more than twofold reduction of lethality were recorded during this treatment. The data obtained have evidenced that infectious-septic DICS is an indication for cryoplasma-antienzyme therapy. Expenditure of fresh frozen plasma for many other purposes could be significantly diminished.

Acute Disease↗
PubMed1989

Does an insulin pen improve the metabolic control of type 1 diabetes mellitus if added to conventional treatment?

This study concerns the metabolic control of 19 type 1 diabetic patients during 3 consecutive periods of 4 months. All patients were well trained in self-control and self-regulation. During the first period, the previous treatment regimen consisting of diet and injections once or twice daily of short-acting and intermediate-acting insulin was intensified. During the 2nd period, an insulin pen, filled with short-acting insulin, was added to the treatment. The patients were advised to use this pen every time the blood glucose concentration exceeded 10 mmol/l or when this was expected; extra attention was paid to the lunch time and afternoon snacks. During the 3rd period, the use of the insulin pen was stopped but, just as in the 1st period, adjustments with short-acting insulin using normal syringes were allowed. The total daily dose of insulin remained unchanged throughout the entire study. The relative proportion of short-acting insulin increased from 25 to 34%, a quarter of which was injected by the insulin pen during period 2. The HbA1 % decreased steadily from 12.8 +/- 2.0 to 10.6 +/- 1.3 (P less than 0.001) during the first 2 periods and remained unchanged thereafter. The blood glucose concentration measured 7 times during the day twice monthly showed the greatest fall during the 1st period with only a minor extra fall during the 2nd period, and no further statistical drop during the last period. None of the patients had any problems using the insulin pen and 15 of 19 patients resumed its use after the end of the study. It is concluded that the improvement of glycaemic control was due to the intensified attention and not to the use of the insulin pen per se.

Adult↗
PubMedDate not supplied

[Diagnostic value of the luliberin test with patients with polycystic ovaries].

Gonadotropic function was investigated and the diagnostic value of the test with luteinizing hormone releasing factor (LHRF) was assessed in patients with polycystic ovaries. For this purpose a 100 micrograms dose of LHRF was intravenously jet injected to 10 patients with nonspecific polycystic ovaries. Levels of luteinizing and follicle stimulating hormones (LH and FSH) were determined before the injection and 15, 30, 60, 90 or 120 minutes after it. Patients with nonspecific polycystic ovaries compared with those who had specific pattern of the disease or with normal women showed elevated basal LH levels which significantly increased in response to LHRF administration. In patients with specific form of the disease the FSH response to the injection was inhibited while LN basal levels as well as its response to LHRF were the same as in healthy women. In 13 out of 15 patients (3 out of 4 amenorrheic females among them) the preparation displayed its ovulatory affect after a single diagnostic dose. Desirability of LHRF use for a differential diagnosis of polycystic ovaries or for therapeutic stimulation of ovulation was suggested.

Diagnosis, Differential↗