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1.
Pharmazie ; 76(12): 614-617, 2021 12 05.
Artículo en Inglés | MEDLINE | ID: mdl-34986959

RESUMEN

Water extract from silver fir (Abies alba) wood represents a rich source of lignans and other phenols that are effective in different pathological conditions, such as diabetes, cardiovascular diseases and psoriasis. Its interaction with the gastrointestinal environment is crucial when the extract is orally administered. In this study we tested the in-vitro interaction between water extract of silver fir wood and ten different Lactobacillus species that are found in the gastrointestinal tract, vagina or are used in food industry. We tested both ways of interaction: 1) the bacterial influence on the chemical composition of the extract and 2) influence of the extract on the bacterial growth. We demonstrated that the extract is compatible with all of the bacteria and does not impair their growth. Furthermore the extract acted as a prebiotic for some bacteria including: L. paracasei, L. acidophilus, L. rhamnosus, L. gasseri, L. crispatus and L. bulgaricus, suggesting that the compounds in the extract can stimulate their growth. However, the ten lactobacilli did not show any chemical changes in lignan metabolism and the production of enterodiol and enterolactone, which are considered the final metabolic products of lignans and are produced by different gut bacteria. This study indicates that the silver fir wood extract is nutritious for some Lactobacillus bacteria and can be used as a prebiotic.


Asunto(s)
Abies , Lignanos , Abies/química , Lactobacillus , Agua , Madera/química
2.
Eur J Pediatr ; 171(12): 1775-85, 2012 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-22903357

RESUMEN

UNLABELLED: Familial Mediterranean fever (FMF) is an autoinflammatory disease and belongs to the heterogeneous group of hereditary recurrent fever syndromes (HRFs). AIMS: The aims of the study were to determine the incidence of FMF in Germany and to describe the spectrum of pyrin mutations and the clinical characteristics in children. A prospective surveillance of children with HRF including FMF was conducted in Germany during a time period of 3 years by the German paediatric surveillance unit for rare paediatric diseases (ESPED). Monthly inquiries were sent to 370 children's hospitals (Clinic-ESPED, n1) and to 23 laboratories (Laboratory-ESPED, n2). Inclusion criteria were children ≤ 16 years of age, disease-associated pyrin mutations, and more than three self-limiting episodes of fever >38.5 °C with increased inflammation markers. In n1, 122 patients with FMF and 225 pyrin mutations were identified. Ninety-two of 122 (75 %) children were of Turkish origin. The minimum incidence of FMF was estimated to be 3 (95 % CI: 2.48-3.54) per 10(6) person-years in the whole children population and 55 (95 % CI: 46-66) per 10(6) person-years in Turkish children living in Germany. N1 U n2 amounted to 593 asymptomatic and symptomatic carriers of 895 mutations (overlap of 73 cases with 134 mutations). p.Met694Val (45 %), p.Met680Ile (14 %), p.Val726Ala (12 %), and p.Glu148Gln (11.5 %) were the most common pyrin mutations. CONCLUSIONS: Despite FMF being the most frequent of the HRFs, its incidence in Germany is low. Twenty-five to 50 FMF patients ≤ 16 years are newly diagnosed per year. The disease is most commonly observed in individuals of Turkish ancestry.


Asunto(s)
Proteínas del Citoesqueleto/genética , Fiebre Mediterránea Familiar/diagnóstico , Fiebre Mediterránea Familiar/etnología , Mutación , Biomarcadores/sangre , Fiebre Mediterránea Familiar/genética , Alemania/epidemiología , Humanos , Incidencia , Polimorfismo Genético , Vigilancia de la Población , Estudios Prospectivos , Pirina , Turquía/etnología
3.
Rheumatol Int ; 32(10): 3253-60, 2012 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-22038276

RESUMEN

Autoinflammatory diseases (AIDs) are characterized by recurrent, self-limiting systemic inflammation. Disorders include hereditary recurrent fever (HRF) syndromes such as hyperimmunoglobulinemia D and periodic fever syndrome (HIDS). To determine the incidence of HIDS and report clinical and genetic characteristics together with the underlying MVK genotypes in German children, a prospective active surveillance was conducted in Germany during a period of 3 years. Monthly inquiries were sent to 370 children's hospitals by the German Paediatric Surveillance Unit (Clinic-ESPED, n1) and to two laboratories (Laboratory-ESPED, n2) performing genetic analyses. Inclusion criteria were a MVK mutation-positive patient ≤16 years of age with more than three self-limiting episodes of fever >38.5°C associated with increased inflammation markers. Clinical, epidemiological, and genetic data were assessed via questionnaires. Eight out of 16 patients were identified in Clinic-ESPED (n1) and 15 of 16 in Laboratory-ESPED (n2). Clinical and laboratory surveys overlapped in 7 of 16 cases. Incidence of HIDS was estimated to be 0.39 (95% CI: 0.22, 0.64) per 10(6) person-years. HIDS symptoms generally started in infancy with recurrent fever episodes lasting 3-12 (median, 4.5) days and recurring every 1-12 weeks. Fever was accompanied by abdominal pain, vomiting, diarrhea, cervical lymphadenopathy, and sometimes by headache, skin and joint symptoms. The patients carried 11 different MVK mutations mostly in compound heterozygosity (75%, 12 out of 16). The most frequent mutation was p.Val377Ile (81%, 13 out of 16). In Germany, the incidence of HIDS is very low with 0.39 per 10(6) person-years.


Asunto(s)
Deficiencia de Mevalonato Quinasa/genética , Mutación , Fosfotransferasas (Aceptor de Grupo Alcohol)/genética , Adolescente , Edad de Inicio , Niño , Preescolar , Análisis Mutacional de ADN , Femenino , Predisposición Genética a la Enfermedad , Alemania/epidemiología , Heterocigoto , Humanos , Incidencia , Lactante , Masculino , Deficiencia de Mevalonato Quinasa/diagnóstico , Deficiencia de Mevalonato Quinasa/enzimología , Deficiencia de Mevalonato Quinasa/epidemiología , Deficiencia de Mevalonato Quinasa/terapia , Fenotipo , Pronóstico , Estudios Prospectivos , Encuestas y Cuestionarios , Factores de Tiempo
4.
Klin Padiatr ; 222(6): 356-61, 2010 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-21058222

RESUMEN

BACKGROUND: Cryopyrin-associated periodic syndromes (CAPS) are rare disorders belonging to the group of hereditary periodic fever (HPF)syndromes. These auto-inflammatory diseases(AID) are characterized by recurrent episodes of inflammation with attacks of fever variably associated with serosal, synovial and / or cutaneous inflammation, usually in a self-limiting manner, and with a mostly monogenic origin. The aims were to determine the incidence of CAPS and the spectrum of mutations in the NLRP3 (formerly= CIAS1) gene and to describe the clinical manifestations. PATIENTS AND METHODS: A prospective surveillance of children with CAPS was conducted in Germany during a time period of 3 years(2003-2006). Monthly inquiries were sent to 370 children's hospitals by the German Paediatric Surveillance Unit (Clinic-ESPED, n1) and to 2 laboratories (Laboratory-ESPED, n2). Inclusion criteria were children ≤ 16 years of age, disease-associated NLRP3 mutation, more than 3 self-limiting episodes of fever > 38.5 ° C, and increased inflammation markers. Clinical, epidemiological and genetic data were evaluated via questionnaires. FINDINGS: 6 out of 14 patients were identified in Clinic-ESPED (n1) and 13 / 14 in Laboratory-ESPED(n2). Clinical and laboratory surveys overlapped in 5 of 14 cases. The incidence of CAPS in German children was estimated to be 3.43 per 107 person-years. The patients carried 11 different NLRP3 mutations and were classified as MWS(n = 6), CINCA (n = 4), FCAS (n = 1) and undefined CAPS (n = 3). INTERPRETATION: The incidence of CAPS in Germany is very low and corresponds to 2-7 newly diagnosed patients ≤ 16 years per year.


Asunto(s)
Síndromes Periódicos Asociados a Criopirina/epidemiología , Síndromes Periódicos Asociados a Criopirina/genética , Adolescente , Edad de Inicio , Niño , Preescolar , Estudios Transversales , Síndromes Periódicos Asociados a Criopirina/diagnóstico , Análisis Mutacional de ADN , Femenino , Tamización de Portadores Genéticos , Alemania , Humanos , Incidencia , Lactante , Masculino , Vigilancia de la Población , Estudios Prospectivos
5.
Rheumatol Int ; 30(2): 207-12, 2009 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-19381634

RESUMEN

The objectives of this study are autoinflammatory syndromes which are usually characterized by repeated attacks of fever, especially in children. The presentation of these diseases, however, varies between entities and between patients of a particular syndrome. We report a 16-year-old female patient, who suffered from periodic erythema and myositis/fasciitis. She experienced at least nine attacks of dermatitis and myositis, while no fever episodes were noted over a 3-year period. A delay of puberty with amenorrhea and a short stature were also present. Laboratory investigations consistently showed markedly increased inflammatory parameters (especially a high serum amyloid A) and dysproteinemia. Because the patient's mother complained about chronic and periodic abdominal pain with also persistently elevated inflammatory parameters, the differential diagnosis included hereditary disorders resulting in chronic inflammation. The diagnosis of an inherited tumor necrosis factor receptor (TNFR) 1-associated periodic syndrome (TRAPS) was confirmed by genetic analyses. Long-term anti-inflammatory treatment with etanercept resulted in a significant clinical improvement and reduction of the inflammatory parameters ESR, CRP, interleukin-6, TNF-α, and soluble TNF-α receptor 1, but not of interleukin-12. Monitoring of the cytokine profile suggested partial effectiveness of etanercept in the treatment of TRAPS. Hereditary fever syndromes have to be considered in case of chronic unexplained inflammation even if fever is no presenting symptom.


Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Citocinas/sangre , Inmunoglobulina G/uso terapéutico , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Dolor Abdominal/diagnóstico , Dolor Abdominal/tratamiento farmacológico , Dolor Abdominal/genética , Adolescente , Eritema/sangre , Eritema/tratamiento farmacológico , Eritema/genética , Etanercept , Fascitis/sangre , Fascitis/tratamiento farmacológico , Fascitis/genética , Femenino , Fiebre/sangre , Fiebre/diagnóstico , Fiebre/genética , Enfermedades Autoinflamatorias Hereditarias/sangre , Enfermedades Autoinflamatorias Hereditarias/tratamiento farmacológico , Enfermedades Autoinflamatorias Hereditarias/genética , Humanos , Mutación , Miositis/sangre , Miositis/tratamiento farmacológico , Miositis/genética , Receptores Tipo I de Factores de Necrosis Tumoral/genética , Proteína Amiloide A Sérica/metabolismo
6.
Vaccine ; 26(25): 3142-52, 2008 Jun 13.
Artículo en Inglés | MEDLINE | ID: mdl-18502545

RESUMEN

AIM OF THE STUDY: To evaluate the immunogenicity, safety and reactogenicity of a seven-valent pneumococcal conjugate vaccine (PCV7) when given concomitantly with a fully liquid DTaP-IPV-HBV-Hib combination vaccine. METHODS: Two hundred and sixty-six healthy infants in France (n=136) and Germany (n=130) were randomized to receive DTaP-IPV-HBV-Hib and PCV7 (test group) at the age of 2, 3 and 4 months (primary series) and 12-15 months (booster dose), or to receive DTaP-IPV-HBV-Hib at the same time points but PCV7 at the ages of 5, 6, 7 and 13-16 months (control group). Antibody levels to all vaccine antigens were measured before dose 1, 1 month after dose 3, at the time of booster, and 1 month later. Safety data were collected after each vaccine dose. RESULTS: Two hundred and fifty-seven infants (test group, 131; control group, 126) completed the primary immunization series and two hundred and forty-five received the booster dose (test group, 125; control group, 120). Depending on the serotype, 92.8-100% of subjects in the test group achieved antibody levels >or=0.15 microg/mL for PCV7 antigens at 5 months of age, and 89.7-99.1% of them antibody levels >or=0.50 microg/mL 1 month after booster. For DTaP-IPV-HBV-Hib, there was no statistically significant difference between the two groups in the proportion of infants that achieved pre-defined seroprotective levels for each antigen at 5 months and 1 month after booster. Frequency of local and systemic reactions was similar in both groups except for fever above 38.0 degrees C, which was more frequent in the test group after dose 1, 2 or 4. Fever >39.0 degrees C was only reported from three children in each group. CONCLUSION: The PCV7 vaccine was highly immunogenic, well tolerated, and safe when coadministered with the DTPa-IPV-HBV-Hib vaccine at 2, 3, and 4 months of age and a booster dose at 12-15 months. In this study, PCV7 did not show any relevant influence on the immunogenicity and safety of the concurrently administered DTPa-IPV-HBV-Hib vaccine.


Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacunas contra Haemophilus/administración & dosificación , Vacunas contra Haemophilus/inmunología , Vacunas contra Hepatitis B/administración & dosificación , Vacunas contra Hepatitis B/inmunología , Inmunización Secundaria , Vacunas Conjugadas/administración & dosificación , Vacunas/inmunología , Preescolar , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Femenino , Francia , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Hepatitis B/efectos adversos , Humanos , Esquemas de Inmunización , Lactante , Masculino , Seguridad , Vacunas/administración & dosificación , Vacunas/efectos adversos , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/inmunología , Vacunas Conjugadas/efectos adversos
7.
Ann Rheum Dis ; 67(9): 1292-8, 2008 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-18180277

RESUMEN

OBJECTIVES: To study the clinical outcome, treatment response, T-cell subsets and functional consequences of a novel tumour necrosis factor (TNF) receptor type 1 (TNFRSF1A) mutation affecting the receptor cleavage site. METHODS: Patients with symptoms suggestive of tumour necrosis factor receptor-associated periodic syndrome (TRAPS) and 22 healthy controls (HC) were screened for mutations in the TNFRSF1A gene. Soluble TNFRSF1A and inflammatory cytokines were measured by ELISAs. TNFRSF1A shedding was examined by stimulation of peripheral blood mononuclear cells (PBMCs) with phorbol 12-myristate 13-acetate followed by flow cytometric analysis (FACS). Apoptosis of PBMCs was studied by stimulation with TNFalpha in the presence of cycloheximide and annexin V staining. T cell phenotypes were monitored by FACS. RESULTS: TNFRSF1A sequencing disclosed a novel V173D/p.Val202Asp substitution encoded by exon 6 in one family, the c.194-14G>A splice variant in another and the R92Q/p.Arg121Gln substitution in two families. Cardiovascular complications (lethal heart attack and peripheral arterial thrombosis) developed in two V173D patients. Subsequent etanercept treatment of the V173D carriers was highly effective over an 18-month follow-up period. Serum TNFRSF1A levels did not differ between TRAPS patients and HC, while TNFRSF1A cleavage from monocytes was significantly reduced in V173D and R92Q patients. TNFalpha-induced apoptosis of PBMCs and T-cell senescence were comparable between V173D patients and HC. CONCLUSIONS: The TNFRSF1A V173D cleavage site mutation may be associated with an increased risk for cardiovascular complications and shows a strong response to etanercept. T-cell senescence does not seem to have a pathogenetic role in affected patients.


Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Fiebre Mediterránea Familiar/genética , Inmunoglobulina G/uso terapéutico , Mutación , Receptores Tipo I de Factores de Necrosis Tumoral/genética , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Adolescente , Adulto , Secuencia de Aminoácidos , Apoptosis/inmunología , Secuencia de Bases , Linfocitos T CD4-Positivos/inmunología , Linfocitos T CD8-positivos/inmunología , Enfermedades Cardiovasculares/genética , Enfermedades Cardiovasculares/inmunología , Células Cultivadas , Senescencia Celular/inmunología , Análisis Mutacional de ADN/métodos , Etanercept , Fiebre Mediterránea Familiar/complicaciones , Fiebre Mediterránea Familiar/tratamiento farmacológico , Fiebre Mediterránea Familiar/inmunología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Datos de Secuencia Molecular , Monocitos/inmunología , Linaje , Receptores Tipo I de Factores de Necrosis Tumoral/sangre , Receptores Tipo II del Factor de Necrosis Tumoral/sangre , Subgrupos de Linfocitos T/inmunología , Resultado del Tratamiento , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Factor de Necrosis Tumoral alfa/inmunología
8.
Vaccine ; 25(43): 7549-58, 2007 Oct 23.
Artículo en Inglés | MEDLINE | ID: mdl-17905486

RESUMEN

BACKGROUND: Administration of two doses of hepatitis A (HA) vaccine to children > or = 2 years of age has been shown to be protective. The present study assessed whether HA vaccine can be administered as early as 6 months of age and whether it can be administered concomitantly with a hexavalent (HV) vaccine at this age. METHODS: In an open label, randomized, parallel group study, the liquid HV vaccine (HEXAVAC) (diphtheria, tetanus, 2-component acellular pertussis, inactivated poliomyelitis vaccine, Haemophilus influenzae type b conjugated to tetanus protein and hepatitis B) was administered at 2, 4, 6, and 12 months of age to all children. HA vaccine (VAQTA) was given at 7 and 13 months in the separate administration group (Group 1) and at 6 and 12 months in the concomitant administration group (Group 2). Serum samples were obtained at 2, 7, 12, and 14 months in Group 1 and at 2, 7, 12, and 13 months in Group 2. The primary immunogenicity outcomes were the seroconversion rates for HA 1 month after the second dose of HA vaccine in initially seronegative subjects, and the seroconversion rates for each HV antigen 1 month after the third dose of the HV vaccine (both at 7 months of age). RESULTS: HA seropositivity rates 1 month after the second dose were 100% in both groups, regardless of initial serostatus. The responses to each HV antigen 1 month after the third dose were similar in both groups. The vaccines were generally well tolerated in both groups regardless of vaccine(s) administered. CONCLUSIONS: A schedule of two doses of HA vaccine, 6 months apart beginning at 6 months of age is highly immunogenic and well tolerated when administered alone or concomitantly with HV vaccine at 6 and 12 months of age.


Asunto(s)
Vacunas contra la Hepatitis A/inmunología , Vacunas Combinadas/inmunología , Factores de Edad , Preescolar , Femenino , Anticuerpos de Hepatitis A/sangre , Vacunas contra la Hepatitis A/administración & dosificación , Vacunas contra la Hepatitis A/efectos adversos , Humanos , Esquemas de Inmunización , Lactante , Recién Nacido , Masculino , Vacunas Combinadas/administración & dosificación , Vacunas Combinadas/efectos adversos
10.
Arch Dis Child ; 88(8): 684-7, 2003 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-12876162

RESUMEN

AIMS: To investigate the clinical picture and frequency of Bordetella pertussis and B parapertussis infections after introduction of acellular pertussis (acP) vaccines in Germany. METHODS: Prospective surveillance for B pertussis and B parapertussis in 14 144 toddlers. Pertussis vaccination coverage was 86%, either with acP (75%) or whole cell pertussis (wcP) vaccine (11%). All children presenting with cough for more than seven days were examined for B pertussis and B parapertussis by culture, PCR, and serology (for cough duration > or =21 days). RESULTS: There were 180 Bordetella infections; 116 (64%) were caused by B pertussis and 64 (36%) by B parapertussis. Incidence rates were 4.8 and 2.8 per 1000 person-years, respectively. Paroxysmal cough, post-tussive whooping, and vomiting > or = 21 days was found in 53%, 22%, and 8% of all B pertussis cases and in 22%, 5%, and 0% of all B parapertussis cases, respectively. A total of 81/116 (70%) B pertussis cases and 56/64 (87.5%) B parapertussis cases had received at least one dose of pertussis vaccine. Typical pertussis with paroxysmal cough > or = 21 days was present in 29/35 (83%) unvaccinated B pertussis cases, in contrast to 33/81 (41%) vaccinated B pertussis cases. CONCLUSION: Following the increase of pertussis vaccination coverage, we observed a relative increase of B parapertussis cases in comparison to B pertussis cases. In vaccinated children B pertussis disease frequently presented as a mild disease, clinically difficult to distinguish from diseases associated with coughing caused by B parapertussis and other viral or bacterial infections.


Asunto(s)
Infecciones por Bordetella/epidemiología , Infecciones por Bordetella/prevención & control , Vacuna contra la Tos Ferina , Infecciones por Bordetella/complicaciones , Niño , Preescolar , Tos/microbiología , Alemania/epidemiología , Humanos , Incidencia , Vigilancia de la Población , Estudios Prospectivos , Ruidos Respiratorios/etiología , Vómitos/microbiología , Tos Ferina/complicaciones , Tos Ferina/epidemiología , Tos Ferina/prevención & control
11.
Pediatr Infect Dis J ; 20(10): 981-8, 2001 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-11642633

RESUMEN

OBJECTIVES: To evaluate the safety and immunogenicity of Biken acellular pertussis vaccine in combination with diphtheria and tetanus toxoid (Biken DTaP) vaccine administered to children 4 to 6 years of age who had previously received four doses of Biken DTaP. METHODS: 580 children were enrolled to receive one dose of Biken DTaP. Local and systemic reactions were collected by parent diary for all subjects within 3 days after vaccination and in a subset for 14 days. All adverse events occurring within 30 days after vaccination were recorded. RESULTS: Any redness and swelling occurred in 59.8 and 61.4%, respectively. Redness or swelling larger than 5 cm/10 cm occurred in 31%/6.1% and 25%/6.5% of the children, respectively. Any pain was reported in 58.8%, but clinically significant pain occurred in 2.1% of the children. Fever >38.0 degrees C occurred in 3.8% of the children. Fussiness, drowsiness, anorexia and vomiting were experienced by 19.7, 15.5, 7.3 and 2.2%, respectively. Sixty-three of 247 adverse events (25%) occurring within 30 days after vaccination were assessed to possibly be vaccine-related. Fifty-eight of the 63 possibly related events (92%) were caused by local reactions as redness, swelling or itchiness. The remaining 5 events included hematoma, headache, stomachache and sleep disturbance. All local and systemic reactions and adverse events resolved without sequelae. Immunogenicity analysis showed a 4-fold antibody increase to pertussis toxin in 97% of subjects and to filamentous hemagglutinin in 82%. All subjects had postvaccination antibody titers of 0.1 IU/ml or greater against diphtheria and tetanus. Higher prevaccination antibody titers against diphtheria toxoid, pertussis toxin and filamentous hemagglutinin were associated with a higher frequency of large local reactions. CONCLUSION: In comparison with a fourth dose of Biken DTaP administered at 18 to 24 months of age in the same population, the rate of local reactions increased after the fifth dose, whereas systemic reactions remained similarly low or decreased.


Asunto(s)
Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Factores de Edad , Niño , Preescolar , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Humanos , Inmunización Secundaria/efectos adversos , Inmunización Secundaria/estadística & datos numéricos , Resultado del Tratamiento , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/inmunología
12.
Vaccine ; 20(3-4): 448-54, 2001 Nov 12.
Artículo en Inglés | MEDLINE | ID: mdl-11672908

RESUMEN

A study was conducted to assess the safety of a new, liquid hexavalent vaccine (Hexavac, Aventis Pasteur MSD, Lyon, France) in a large population of 1783 children in Germany vaccinated at 2, 4, 6 and 12-14 months of age. Immediate reactions, local and systemic reactions, and serious adverse events (SAEs) were monitored. The frequencies of redness > or = 2 cm and swelling > or = 2 cm were 6.7 and 7.1% after all doses of the primary series combined and 13.4 and 12.0% following the booster dose, respectively. Transient swelling of the entire thigh was reported in seven infants after all doses of the primary series (0.1%) and in four children after the booster dose (0.2%). The most frequent systemic adverse events within 3 days after vaccination were irritability (19.3% after primary series and 13.2% after booster) and fever > or = 38.0 degrees C (15.4% after primary series and 28.5% after booster). Fever above 40.0 degrees C was reported in 0.1% of the infants post-primary series and in 0.9% of the children after the booster immunization. Only 3 of 144 SAE were considered to be vaccine related and were seen to resolve spontaneously and without sequelae. The liquid hexavalent vaccine was generally well tolerated when given to children as a primary immunization series at 2, 4 and 6 months and as a booster dose at 12-14 months.


Asunto(s)
Vacunas Combinadas/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina , Femenino , Vacunas contra Hepatitis B , Humanos , Lactante , Masculino , Vacuna Antipolio de Virus Inactivados , Seguridad , Factores de Tiempo , Vacunación
14.
Pediatr Infect Dis J ; 19(6): 516-21, 2000 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-10877165

RESUMEN

OBJECTIVE: To compare the immunogenicity and safety of a trivalent tetanus-diphtheria (low toxoid content)-inactivated poliomyelitis vaccine, Td-IPV (Revaxis; Pasteur Merièux), with a tetanus-diphtheria (low toxoid content) vaccine, Td (Td-Impfstoff Mérieux; Pasteur Merièux), when administered as a booster to children age 6 to 9 years. METHODS: A group of 301 children were randomized and vaccinated with Td-IPV (n = 150) or Td (n = 151) in this open, controlled, multicenter trial. Serum specimens were obtained before and 28 days after vaccination. Safety was assessed for up to 28 days postvaccination by parental diary cards. Solicited local and systemic reactions were recorded for 7 days after vaccination. RESULTS: Seroprotection (enzyme-linked immunosorbent assay titer, > or =0.10 IU/ml) against tetanus and diphtheria was induced by either Td-IPV or Td in all subjects. Tetanus and diphtheria geometric mean titer were higher after Td (34.0 and 5.74 IU/ml) than after Td-IPV (15.9 and 4.38 IU/ml). All subjects boosted with Td-IPV were seroprotected against each type of poliovirus (neutralizing antibody titer, > or =5/dilution). The most frequently reported solicited local and systemic symptoms were pain triggered by movement of the arm (54% vs. 39.1%) and headache (17.3% vs. 7.3%), after Td-IPV and Td, respectively. All other events were similar between the two groups. Reactions were generally mild and all were temporary. CONCLUSIONS: A booster dose of Td-IPV induced in all children seroprotection against tetanus, diphtheria and poliomyelitis. The overall safety profile of the two vaccines was acceptable.


Asunto(s)
Toxoide Diftérico/inmunología , Vacuna Antipolio de Virus Inactivados/inmunología , Toxoide Tetánico/inmunología , Vacunas Combinadas/inmunología , Niño , Toxoide Diftérico/efectos adversos , Femenino , Humanos , Inmunización Secundaria , Masculino , Vacuna Antipolio de Virus Inactivados/efectos adversos , Toxoide Tetánico/efectos adversos , Vacunas Combinadas/efectos adversos , Vacunas de Productos Inactivados/efectos adversos , Vacunas de Productos Inactivados/inmunología
15.
Infection ; 28(2): 106-10, 2000.
Artículo en Inglés | MEDLINE | ID: mdl-10782397

RESUMEN

We prospectively followed 725 children under 2 years of age with laboratory-diagnosed Bordetella pertussis infection to investigate the hospitalization rate and complications. Diagnosis was made by culture and polymerase chain reaction (PCR) from nasopharyngeal swabs in 11,016 children who presented with > or = 7 days of cough at 63 pediatric practices in Germany. Of these children, 33 (4.5%) were hospitalized at a mean age of 4.8 months (range, 17 days to 19.5 months). Complications occurred in 16 (48%) of the 33 patients. Pneumonia developed in two (6%) children and a convulsion was observed in one (3%). Intensive care monitoring was required for 23 (70%) children. Further complications were bradycardia (21%), apnea (12%), conjunctivitis (12%), loss of weight (12%), otitis media (6%), atelectasis (3%) and dehydration (3%). Children aged 6-24 months who had not received any dose of pertussis vaccine had a ten-fold increased risk of hospitalization compared to those who had been partially or fully immunized (p < 0.05). Pertussis immunization should be given at an early point in time and completely in order to prevent severe courses of pertussis and hospitalization in young children.


Asunto(s)
Bordetella pertussis/aislamiento & purificación , Hospitalización/estadística & datos numéricos , Tos Ferina/epidemiología , Bordetella pertussis/genética , Niño Hospitalizado , Femenino , Alemania/epidemiología , Humanos , Lactante , Recién Nacido , Masculino , Reacción en Cadena de la Polimerasa , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Tos Ferina/complicaciones
17.
Pediatr Infect Dis J ; 16(11): 1038-44, 1997 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-9384336

RESUMEN

OBJECTIVE: This case-control study investigated the protective efficacy against pertussis of three doses of a two-component acellular pertussis vaccine (manufactured by Biken in Japan) combined with diphtheria and tetanus toxoids (manufactured by Connaught Laboratories in the US) in infants. METHODS: A case-control study was performed in 63 pediatric practices in Germany. Prospective recruitment of 16,780 infants ages 6 to 17 weeks took place between February, 1993, and July, 1994. According to parental choice infants received either Biken acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTacP) (74.6%) at approximately 2, 4 and 6 months of age, or a licensed German diphtheria-tetanus toxoids-whole cell pertussis vaccine (10.9%), diphtheria-tetanus toxoids vaccine (12.5%) or no vaccine (2.0%). Prospective surveillance of pertussis cases between February, 1993, and May, 1995, was accomplished by culturing all infants < or =2 years of age presenting with cough > or = 7 days. A pertussis case was defined as any cough of 21 days or longer plus a positive Bordetella pertussis culture or household contact exposure. RESULTS: We identified 241 pertussis cases prospectively by 11,017 B. pertussis cultures and 949 controls matched for age were selected from the same pediatric practices. Medical history and demographic and vaccine status data were collected from each case and for four controls. Data were analyzed through conditional logistic regression taking into account individual matching and adjusting for potential confounding variables. DTacP combined with diphtheria and tetanus toxoids vaccine was 82% protective (95% confidence interval, 68 to 90), diphtheria-tetanus toxoids-whole cell pertussis vaccine was 96% protective (95% confidence interval, 78 to 99). Protection against typical B. pertussis infection characterized by paroxysmal cough lasting > or =21 days was 96% (95% confidence interval, 87 to 99) for DTacP and was 97% (95% confidence interval, 79 to 100) for diphtheria-tetanus toxoids-whole cell pertussis vaccine. Adjustment for potentially confounding variables did not change the results significantly. CONCLUSIONS: Three doses of the two-component acellular pertussis vaccine protected infants against pertussis disease during the period before the recommended booster vaccination. For typical pertussis disease as defined by the WHO efficacy was high and similar to that of a licensed German diphtheria-tetanus toxoids-whole cell pertussis vaccine.


Asunto(s)
Vacuna contra la Tos Ferina/inmunología , Estudios de Casos y Controles , Humanos , Lactante , Vacuna contra la Tos Ferina/efectos adversos , Estudios Prospectivos , Factores de Riesgo , Vacunación
18.
Fortschr Med ; 115(24): 22-7, 1997 Aug 30.
Artículo en Alemán | MEDLINE | ID: mdl-9410815

RESUMEN

Pertussis is one of the most common infectious diseases in children, affecting in particular nonimmunized babies and young children, but increasingly also adolescents and adults. Complications occur for the most part in infants and in addition to infectious complications may also even lead to death from apnea. Since 1991, general pertussis vaccination has been recommended again, but because of the relatively high rate of side effects associated with the whole-cell vaccines available, has remained at a low level. This led to the development of acellular pertussis vaccines with appreciably improved tolerability. A number of these acellular vaccines offer good protection, and are approved for immunization. Owing to their excellent tolerability and the resulting better acceptance, acellular pertussis vaccines can considerably improve the immunization rate. Only in this way will it be possible to reduce the incidence of one of the most common infectious diseases of childhood that is also associated with the highest rate of complications.


Asunto(s)
Vacuna contra la Tos Ferina/efectos adversos , Toxoides/efectos adversos , Tos Ferina/prevención & control , Adulto , Anticuerpos Antibacterianos/sangre , Niño , Preescolar , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Humanos , Programas de Inmunización , Lactante , Vacuna contra la Tos Ferina/administración & dosificación , Vacuna contra la Tos Ferina/inmunología , Toxoides/administración & dosificación , Toxoides/inmunología , Resultado del Tratamiento , Tos Ferina/inmunología
19.
Zentralbl Gynakol ; 106(9): 107-10, 1984.
Artículo en Alemán | MEDLINE | ID: mdl-6741332

RESUMEN

Combined clomiphene-dexamethasone-treatment was applied to 20 patients and 5 pregnancies were successfully induced. The women received 150-200 mg/die clomiphene from the fifth through the ninth days of their cycles, and 2 mg/die dexamethasone from the fifth to the fourteenth days of cycle. Three of the 5 pregnancies were closed successfully and two by caesarean section, one of them with twins. The combined clomiphene-dexamethasone-treatment is recommended as a sterility therapy.


Asunto(s)
Clomifeno/uso terapéutico , Dexametasona/uso terapéutico , Infertilidad Femenina/tratamiento farmacológico , Inducción de la Ovulación , Adulto , Clomifeno/administración & dosificación , Dexametasona/administración & dosificación , Quimioterapia Combinada , Femenino , Humanos
20.
Zentralbl Gynakol ; 105(18): 1194-6, 1983.
Artículo en Alemán | MEDLINE | ID: mdl-6637249

RESUMEN

The vaginal smear of 500 women was investigated by the fluorescence method and a vaginal trichomoniasis was found in 6.8 per cent of the cases. The fluorescence staining was successful. The incidence of the infection was higher, 9.1 per cent, at women with IUP, 9.1 per cent at probands with normal ovary cycle and 10.5 per cent during a pregnancy. The various causes are discussed.


PIP: The vaginal smears of 500 women were investigated by fluorescence and vaginal trichomoniasis was found in 6.8% of the cases. The fluorescence staining was successful. The incidence of infection was higher, 9.1%, in women wearing IUDs, in 9.1% of the subjects with normal menstrual cycles, and in the 10.5% of women who were pregnant. Various causes are discussed. (author's modified)


Asunto(s)
Vaginitis por Trichomonas/patología , Adolescente , Adulto , Anciano , Conducta Anticonceptiva , Femenino , Humanos , Microscopía Fluorescente , Persona de Mediana Edad , Embarazo , Vagina/patología , Frotis Vaginal
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