RESUMEN
Summary: Since December 2020, in various countries of the world, many cases of severe allergic reactions after administration of PfizerBioNTech COVID-19 vaccine, were reported. A great concern has arisen among the doctors who administer the vaccine and the allergic patients who undergo vaccinations. In Italy guidelines were published in order to stratify the risk in the allergic population. In mRNA vaccines, the component currently suspected of causing allergic reactions is the polyethylene glycol excipient (PEG or macrogol). In patients who have shown an immediate allergic reaction to vaccine and who are negative to skin tests for PEG, desensitization with the same vaccine is proposed. In this paper we describe two cases of asthma after the first COVID vaccine administration in which desensitization has failed.
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Asma , COVID-19 , Hipersensibilidad , Vacunas , Asma/diagnóstico , Vacuna BNT162 , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Humanos , PolietilenglicolesRESUMEN
SUMMARY: We described a case of a 56 year old homosexual HIV positive man who presented a history of CSU since one year (2012). All the allergologic, immunologic and microbiologic tests to evaluate the pathogenesis of wheals resulted negative. Therefore in June 2015 we decided to start therapy with Omalizumab while the patient kept on effective antiretroviral therapy with 310 cells/mm3 TCD4 counts and undetectable HIV viremia. After two monthly subcutaneuous injection of 150 mg of Omalizumab the patient had no more urticarial symptoms. UAS7 (Urticaria Activity Score over 7 days) and Cu-Q2oL (chronic urticarial quality of life questionnaire) dropped respectively to 14 from 42 and to 0 from 40 with increase of TCD4 counts while viral load remained undetectable. In November 2015, i.e. 4 months after the end of Omalizumab therapy, the patient was still asymptomatic with persistent effective immune-virological response to antiretroviral therapy. This case report confirms the excellent tolerability and efficacy of anti-IgE therapy in the treatment of spontaneous chronic urticarial even in an immunodepressed patient for HIV infection. Omalizumab therapy shows a remarkable clinical success and had no effect on peripheral TCD4 counts and HIV viral load.
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Antialérgicos/uso terapéutico , Fármacos Anti-VIH/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Huésped Inmunocomprometido , Omalizumab/uso terapéutico , Urticaria/tratamiento farmacológico , Recuento de Linfocito CD4 , Enfermedad Crónica , Infecciones por VIH/diagnóstico , Infecciones por VIH/inmunología , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Urticaria/diagnóstico , Urticaria/inmunología , Carga ViralRESUMEN
BACKGROUND AND OBJECTIVE: Skin prick testing (SPT) with commercial extracts is the first step in the diagnosis of shrimp allergy, although its clinical efficiency is unknown. Objective: To analyze the clinical usefulness of all commercial crustacean extracts available for SPT in Italy. METHODS: We performed a multicenter study of 157 shrimp-allergic patients who underwent SPT with 5 commercial crustacean extracts and with house dust mite (HDM) extract. Commercial extracts were analyzed using SDS-PAGE and compared with a freshly prepared in-house shrimp extract. IgE to Pen a 1/Pen m 1, Pen m 2, and Pen m 4 was determined, and immunoblot analysis was performed on a large number of sera. RESULTS: The skin reactions caused by commercial crustacean extracts were extremely heterogeneous, resulting in 32 clinical profiles, with marked differences in protein content and missing proteins at molecular weights corresponding to those of major shrimp allergens. Only strong Pen a 1/Pen m 1 reactors reacted to both HDM and all 5 commercial extracts in SPT. Most patients, including those who were tropomyosin-negative, reacted to HDM. Patients reacted to a large and variable array of proteins, and IgE reactivity was common at high molecular weights (>50 kDa). CONCLUSIONS: The in vivo diagnosis of shrimp allergy must continue to be based on SPT with fresh material. Shrimp-allergic patients frequently react to a number of ill-defined high-molecular-weight allergens, thus leaving currently available materials for component-resolved diagnosis largely insufficient. Mites and crustaceans probably share several allergens other than tropomyosin.
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Alérgenos/inmunología , Proteínas de Artrópodos/inmunología , Inmunoglobulina E/inmunología , Hipersensibilidad a los Mariscos/diagnóstico , Adolescente , Adulto , Anciano , Animales , Niño , Preescolar , Electroforesis en Gel de Poliacrilamida , Femenino , Humanos , Immunoblotting , Italia , Masculino , Persona de Mediana Edad , Pyroglyphidae/inmunología , Hipersensibilidad a los Mariscos/inmunología , Pruebas Cutáneas , Tropomiosina/inmunología , Adulto JovenRESUMEN
HIV infection is a relative contraindication for allergic immunotherapy (AIT). In the last decade, highly active antiretroviral therapy (HAART) has improved the immune function and life expectancy in HIV-infected patients whose respiratory allergic incidence is similar to the general population. We evaluated the safety and clinical effectiveness of sublingual immunotherapy in a group of grass pollen-allergic HAART-treated HIV-positive patients. Thirteen patients received sublingual immunotherapy (SLIT) tablet (Oralair, Stallergenes©) and symptomatic therapy and were compared with nine patients receiving symptomatic therapy alone. Clinical benefits were evaluated by the analysis of total combined score (TCS), sum of symptom-medication score, and a quality of life (QoL) questionnaire. HIV viral load and peripheral TCD4 lymphocytes were analyzed at the beginning and at the end of the study. Clinical efficacy data showed a significant improvement in SLIT-treated patients compared to controls (TCS: P = 0.0001; QoL: P = 0.03). We did not observe any significant alteration of TCD4 cell counts and viral load (VL) in both groups. Our preliminary data showed that SLIT therapy in viro-immunological controlled HAART treated HIV positive patients was efficacious, safe and well tolerated.
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Infecciones por VIH/complicaciones , Rinitis Alérgica Estacional/complicaciones , Rinitis Alérgica Estacional/terapia , Inmunoterapia Sublingual , Adulto , Alérgenos/administración & dosificación , Alérgenos/inmunología , Terapia Antirretroviral Altamente Activa , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , Infecciones por VIH/inmunología , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Rinitis Alérgica Estacional/epidemiología , Rinitis Alérgica Estacional/inmunología , Inmunoterapia Sublingual/métodosRESUMEN
A case of immediate and definitive response to a single dose of omalizumab in a child with severe ciclosporin-resistant chronic urticaria is reported.
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Antialérgicos/uso terapéutico , Anticuerpos Antiidiotipos/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Urticaria/tratamiento farmacológico , Niño , Enfermedad Crónica , Humanos , Masculino , OmalizumabRESUMEN
We described the first case reported in literature of anaphylactic shock after administration of pollen extract vaccine chemically modified (allergoid) adsorbed onto L-Tyrosine depot adjuvanted with monophosphoryl lipid A (Pollinex® Quattro MPL-4).
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Anafilaxia/inducido químicamente , Lípido A/análogos & derivados , Vacunas/efectos adversos , Humanos , Lípido A/efectos adversos , Masculino , Persona de Mediana EdadRESUMEN
Atopic dermatitis (AD) is a common inflammatory skin disease characterized by xerosis, pruritus and eczema. The role of probiotics in the prevention and the treatment of AD have been extensively studied in children with controversial results while there are few studies on an adult population. The aim of this randomized, double-blind, placebo-controlled study is to evaluate the clinical efficacy of the intake of a probiotic strain (Lactobacillus salivarius LS01) in the treatment of adult patients with AD. A group of 38 patients was treated with probiotics or placebo (maltodextrin) for 16 weeks. The study was performed from January (T0) to May, 2009 (T16). The assessment of efficacy was based on change in SCORAD (SCORing Atopic Dermatitis) index, dermatology life quality index (DLQI) improvement, cytokine production by PBMCs and ability to modify faecal microbial flora. No significant adverse events were recorded during the study. Patients treated with probiotics showed a statistically improvement of both clinical parameters (SCORAD p<0.0001 and DLQI p= 0.021) at the end of treatment (T16) compared with the placebo group. Furthermore, after four months of treatment there was a significant reduction of Th1 cytokines (IL-12+IFNgamma) (p= 0.03) and Th1/Th2 ratio (IL-12+IFNgamma/IL-4+IL-5) (p= 0.019) only in placebo-treated patients. A statistically relevant decrease of staphylococci in faeces of the probiotictreated group was also observed at the end of treatment. In our study, the administration of L. salivarius LS01 was well tolerated and was associated with a significant improvement of clinical manifestation and QoL. This probiotic strain could have an important role in modulating Th1/Th2 cytokine profiles and could be considered as an important adjunctive therapy in the treatment of adult AD.
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Dermatitis Atópica/terapia , Lactobacillus/crecimiento & desarrollo , Probióticos/uso terapéutico , Piel/microbiología , Adulto , Células Cultivadas , Citocinas/metabolismo , Dermatitis Atópica/inmunología , Dermatitis Atópica/microbiología , Dermatitis Atópica/patología , Método Doble Ciego , Heces/microbiología , Femenino , Humanos , Inmunoglobulina E/sangre , Italia , Masculino , Persona de Mediana Edad , Placebos , Calidad de Vida , Índice de Severidad de la Enfermedad , Piel/inmunología , Piel/patología , Staphylococcus/aislamiento & purificación , Encuestas y Cuestionarios , Células TH1/inmunología , Células TH1/microbiología , Células Th2/inmunología , Células Th2/microbiología , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
We describe a case of chronic idiopathic urticaria in which symptoms improved dramatically after treatment with omalizumab. This drug, which is approved for the treatment of asthma, has been studied in other allergic conditions and a number of reports have described its efficacy as an immunomodulator in chronic and physical urticaria. Immunopathologic mechanisms are poorly understood. In chronic autoimmune urticaria, it has been postulated that this monoclonal antibody against immunoglobulin (Ig) E might reduce FcepsilonRI expression on the surface of basophils, thus preventing IgG antibody-mediated crosslinking and the release of mast cell mediators. We analyzed activation and homing molecules of B cells and type 1 and type 2 cytokine production by T cells and document a new immunomodulator mechanism characterized by a reduction in B-cell activation and homing and in tumor necrosis factor-alpha and interleukin 4 production and an increase in interferon-gamma synthesis.
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Antialérgicos/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Urticaria/tratamiento farmacológico , Anticuerpos Antiidiotipos , Anticuerpos Monoclonales Humanizados , Linfocitos B/efectos de los fármacos , Linfocitos B/inmunología , Femenino , Humanos , Interferón gamma/sangre , Interleucina-4/sangre , Activación de Linfocitos/efectos de los fármacos , Persona de Mediana Edad , Omalizumab , Factor de Necrosis Tumoral alfa/sangre , Urticaria/inmunologíaRESUMEN
BACKGROUND: The natural history of respiratory allergy is commonly characterized by a worsening of symptom severity, frequent comorbidity of rhinitis and asthma, and polysensitization to aeroallergens. The polysensitization phenomenon starts since childhood and is rare to find monosensitized adult patients. However, there are few studies investigating the characteristics of polysensitized patients. METHODS: This study was performed on a large cohort of patients with allergic rhinitis (assessed by ARIA criteria) and/or mild to moderate asthma (assessed by GINA). The kind and the number of sensitizations, their patterns, and the relation with quality of life (QoL) measured by the Juniper's RQLQ guestionnaire, were evaluated. RESULTS: Globally 418 patients (50.2% males, 49.8% females, mean age 26.4 years, range 3.5-65 years, 64 smokers, 371 non-smokers) were enrolled: 220 had allergic rhinitis alone, and 198 allergic rhinitis and asthma. The mean number ofsensitizations was 2.6. Three hundred-five patients (73%) had persistent rhinitis (PER), 220 of them with moderate-severe form. There was no significant derence in rate of rhinitis and asthma in monosensitized or polysensitized patients. Most patients were sensitized to pollens, whereas only 24.2% of them were sensitized to perennial allergens. Polysensitization was significantly associated with some issues of QoL, confirming previous findings, but not with number ofsensitizations. CONCLUSIONS: This study provides data confirming for poly-sensitized patients the relevance of ARIA classification of AR. PER is the most common form of AR in this cohort, symptoms are frequently moderate-severe, and asthma is present in about the half of patients with AR.
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Alérgenos/efectos adversos , Adolescente , Adulto , Factores de Edad , Anciano , Animales , Antialérgicos/uso terapéutico , Antígenos de Plantas/efectos adversos , Asma/tratamiento farmacológico , Asma/epidemiología , Asma/etiología , Gatos , Niño , Preescolar , Estudios de Cohortes , Perros , Femenino , Hongos , Humanos , Inmunización , Italia/epidemiología , Masculino , Persona de Mediana Edad , Polen/efectos adversos , Estudios Prospectivos , Pyroglyphidae , Calidad de Vida , Rinitis Alérgica Perenne/tratamiento farmacológico , Rinitis Alérgica Perenne/epidemiología , Rinitis Alérgica Perenne/etiología , Rinitis Alérgica Estacional/tratamiento farmacológico , Rinitis Alérgica Estacional/epidemiología , Rinitis Alérgica Estacional/etiología , Pruebas Cutáneas , Fumar/epidemiología , Adulto JovenRESUMEN
Highly active antiretroviral therapy (HAART) greatly reduces the risk of developing tuberculosis for HIV-infected persons. Nonetheless, HIV-associated tuberculosis continues to occur in countries where HAART is widely used. To identify the characteristics of HIV-infected persons who develop tuberculosis in the context of the availability of HAART, the current authors analysed data taken from 271 patients diagnosed, in Italy, during 1999-2000. These patients represent 0.7% of the 40,413 HIV-infected patients cared for in the clinical units participating in this current study. From the data it was observed that 20 patients (7.4%) had a previous episode of tuberculosis whose treatment was not completed. Eighty-one patients (29.9%) were diagnosed with HIV at tuberculosis diagnosis, 108 (39.8%) were aware of their HIV status but were not on antiretroviral treatment and 82 (30.3%) were on antiretroviral treatment. Patients on antiretroviral treatment were significantly less immunosuppressed than patients with HIV diagnosed concurrently with tuberculosis, or other patients not on antiretrovirals (median CD4 lymphocytes count: 220 cells x mm(-3) versus 100 cells x mm(-3), and 109 cells x mm(-3), respectively). No significant differences in clinical presentation of tuberculosis according to antiretroviral therapy status were recorded. Failure of tuberculosis control interventions (e.g. noncompletion of treatment) and of HIV care (delayed diagnosis of HIV infection and suboptimal uptake of therapy) may contribute to continuing occurrence of HIV-associated tuberculosis in a country where highly active antiretroviral therapy is largely available. However, a significant proportion of cases occur in patients who are on antiretroviral treatment.
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Infecciones Oportunistas Relacionadas con el SIDA/tratamiento farmacológico , Infecciones Oportunistas Relacionadas con el SIDA/epidemiología , Terapia Antirretroviral Altamente Activa/métodos , Tuberculosis Pulmonar/epidemiología , Infecciones Oportunistas Relacionadas con el SIDA/diagnóstico , Adulto , Distribución por Edad , Antituberculosos/uso terapéutico , Distribución de Chi-Cuadrado , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Italia/epidemiología , Modelos Logísticos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Distribución por Sexo , Estadísticas no Paramétricas , Tasa de Supervivencia , Resultado del Tratamiento , Tuberculosis Pulmonar/diagnósticoRESUMEN
The incidence of latex allergy has increased in the last decade in particular for medical and health care staff. The "L. Sacco" Hospital in Milan has developed an organisational model for dealing with clinical problems of patients allergic to latex who need to be admitted in hospital. Guidelines have been drawn up to handle the problem of latex allergy in hospital. An Interdisciplinary Working Group has systematically re-examined the epidemiological, etiopathogenetic, clinical diagnostic and therapeutic aspects of this important medical problem. This last topic has been particularly developed to facilitate doctors with emergency drugs. Nevertheless the most efficient method against the sensitisation is the elimination and reduction in hospital of the allergens causing the disease.
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Hipersensibilidad al Látex/etiología , Enfermedades Profesionales/etiología , Personal de Salud , Humanos , Hipersensibilidad al Látex/diagnóstico , Hipersensibilidad al Látex/epidemiología , Hipersensibilidad al Látex/terapia , Enfermedades Profesionales/diagnóstico , Enfermedades Profesionales/epidemiología , Enfermedades Profesionales/terapia , Factores de RiesgoRESUMEN
OBJECTIVE: To evaluate short-term toxicity from and discontinuation of antiretroviral combination prophylaxis in HIV-exposed individuals in Italy. DESIGN: Longitudinal, open study conducted by prospective collection of data in the National Registry of PEP. SETTING: All the Italian centres dedicated to HIV related care and licensed by the Ministry of Health to dispense antiretroviral drugs. STUDY POPULATION: Health care workers and other persons consenting to be treated with post exposure prophylaxis (PEP) after exposures to HIV. RESULTS: Until October, 2000, 207 individuals receiving two nucleoside reverse transcriptase inhibitors (NRTIs), and 354 receiving two NRTIs plus a protease inhibitor (PI) were enrolled. More individuals experienced side-effects in the 3-drug group (53% and 62%, respectively; OR 0.68, (95% CI 0.48-0.98), p < 0.03). However, the proportion of individuals discontinuing prophylaxis because of side-effects did not differ significantly between the 2 groups (21% and 25% respectively; OR 0.82 (95% CI 0.53-1.26); p=0.4). The 43 individuals in the 2 NRTI group discontinued PEP after a mean of 10.4 days of treatment (median 8, range 1-27), similarly to the 88 discontinuations observed in the 3-drug group (mean duration 10.5 days, median 7.5, range 1-26). Type and incidence of specific adverse effects were similar to those reported in the literature. CONCLUSION: Our study indicates that the difference in the proportion of individuals developing side effects and discontinuing PEP is not significant. The rate of discontinuation because of protease inhibitor side-effects does not justify per se the initial use of a less potent PEP regimen. We suggest initiating PEP with a three-drug regimen and discontinuing the protease inhibitor in the case of adverse effects.
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Fármacos Anti-VIH/efectos adversos , Infecciones por VIH/prevención & control , Personal de Salud , Exposición Profesional , HumanosRESUMEN
The aim of our study is to compare the tolerability of zidovudine/lamivudine/indinavir when used in post-exposure prophylaxis (PEP) subjects and in HIV-infected patients. HIV-negative patients were enrolled as part of the surveillance protocol for professional exposure at the Luigi Sacco Hospital in Milan. HIV-positive patients were selected among all subjects undergoing treatment with zidovudine/lamivudine/indinavir from the CISAI cohort, an Italian cohort for the evaluation of adverse reactions to HAART. In both studies patients were followed prospectively and the severity of the reactions was evaluated using the AIDS Clinical Trial Group adverse experience grading scales. Up to September 1999, 37 HIV-seronegative subjects had undergone treatment with zidovudine/ lamivudine/indinavir. From a total of 1207 patients belonging to the CISAI cohort, 199 were identified as being treated with the same regimen. The frequency of adverse events in the PEP subjects was 70.3% compared to 11.1% for HIV-infected patients. In the first group, adverse events caused treatment interruption in 21 subjects (56.7%) versus 14 patients (7%) among the HIV-infected group. Only one case of a severe event (grade 3-4) was observed in the prophylaxis group against 12 in the treatment group. Our study shows that treatment interruption is eight times higher in HIV-negative subjects compared to HIV-seropositive patients, and that the incidence of adverse events is approximately six times higher, though such events, are for the most part, not severe.
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Fármacos Anti-VIH/efectos adversos , Fármacos Anti-VIH/uso terapéutico , Terapia Antirretroviral Altamente Activa/efectos adversos , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Personal de Salud , Adulto , Quimioprevención , Femenino , Humanos , Indinavir/efectos adversos , Indinavir/uso terapéutico , Lamivudine/efectos adversos , Lamivudine/uso terapéutico , Masculino , Persona de Mediana Edad , Inhibidores de la Transcriptasa Inversa/efectos adversos , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Zidovudina/efectos adversos , Zidovudina/uso terapéuticoRESUMEN
Among 324 cases of culture-proven tuberculosis from 1988 to 1996 in a hospital in Milan, Italy, 90 (27.8%) were due to Mycobacterium tuberculosis strains resistant to isoniazid and rifampin. Sixty-one of 69 isolates tested had identical restriction fragment length polymorphism patterns. The prevalent strain tested susceptible only to ethionamide and was also resistant to ethambutol, streptomycin, cycloserine, amikacin, kanamycin, terizodone, ofloxacin, rifabutin, rifapentin, and KRM 1648. The median survival time was 94 days. Multivariate analysis showed a trend toward better outcome in the period 1994-1996 (hazard ratio, 4.16; P<.001), and extrapulmonary localization of tuberculosis was the only other independent predictor of a negative outcome (hazard ratio, 2.1; P = .019). The delay from symptoms to beginning of therapy did not seem to be a determining factor in survival time. Standard antituberculosis therapy with four drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) had a higher efficacy than did other regimens with fewer drugs but without a statistically significant difference.
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Infecciones Oportunistas Relacionadas con el SIDA/tratamiento farmacológico , Infecciones Oportunistas Relacionadas con el SIDA/mortalidad , Antituberculosos/uso terapéutico , Resistencia a Múltiples Medicamentos , Tuberculosis Resistente a Múltiples Medicamentos/tratamiento farmacológico , Tuberculosis Resistente a Múltiples Medicamentos/mortalidad , Infecciones Oportunistas Relacionadas con el SIDA/diagnóstico , Adulto , Análisis de Varianza , Infección Hospitalaria/diagnóstico , Infección Hospitalaria/tratamiento farmacológico , Infección Hospitalaria/mortalidad , Femenino , Hospitales/estadística & datos numéricos , Humanos , Italia/epidemiología , Masculino , Pruebas de Sensibilidad Microbiana , Persona de Mediana Edad , Reacción en Cadena de la Polimerasa , Modelos de Riesgos Proporcionales , Análisis de Supervivencia , Tasa de Supervivencia , Resultado del Tratamiento , Tuberculosis Resistente a Múltiples Medicamentos/diagnósticoRESUMEN
OBJECTIVE: To describe an outbreak of multidrug-resistant tuberculosis (MDR-TB), amongst HIV-infected patients, spread from one hospital in Milan to another. DESIGN: Descriptive epidemiological investigation and molecular typing. METHODS: All cases identified by intensive case-finding were described in terms of clinical characteristics, previous nosocomial exposure to an infectious MDR-TB patient, previous stays in other institutional settings where exposure to MDR-TB could have occurred, and restriction fragment length polymorphism (RFLP) pattern. RESULTS: Between October 1991 and July 1995, 116 cases of MDR-TB were identified (85 at hospital A and 31 at hospital B). A single case patient, infected at hospital A, introduced the strain into hospital B. Eighty-two of the 92 strains available for fingerprinting revealed an identical pattern; 10 strains had unique RFLP patterns. Nosocomial exposure to an infectious MDR-TB patient was ascertained for 39 of the 56 patients with the 'outbreak' RFLP strain at hospital A (69.6%) and for 24 of the 26 patients at hospital B (92.3%). The median duration of exposure was 32 days at hospital A and 40 days at hospital B. For eight patients with the outbreak strain, exposure was determined to have probably occurred in other hospitals, in the community or in prison. CONCLUSIONS: This is the largest nosocomial outbreak of MDR-TB reported in Europe. Exposure to MDR-TB cases in other institutions caring for HIV-infected patients probably contributed to the spread of this epidemic. Strict control measures should be immediately adopted in order to prevent the spread of TB amongst HIV-infected patients in institutional settings in Europe.
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Infecciones Oportunistas Relacionadas con el SIDA/epidemiología , Infección Hospitalaria/epidemiología , Mycobacterium tuberculosis , Tuberculosis Resistente a Múltiples Medicamentos/epidemiología , Infecciones Oportunistas Relacionadas con el SIDA/microbiología , Infecciones Oportunistas Relacionadas con el SIDA/transmisión , Adulto , Infección Hospitalaria/microbiología , Infección Hospitalaria/transmisión , Femenino , Hospitales Urbanos , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Mycobacterium tuberculosis/efectos de los fármacos , Mycobacterium tuberculosis/genética , Polimorfismo de Longitud del Fragmento de Restricción , Tuberculosis Resistente a Múltiples Medicamentos/microbiología , Tuberculosis Resistente a Múltiples Medicamentos/transmisiónRESUMEN
BACKGROUND: Injective immunotherapy is a well-known and recognized treatment for allergic diseases, but its safety has been questioned during recent years. Alternative administration routes have been proposed and there is a growing interest and experience in sublingual therapy. The safety of alternative routes is nonetheless a real advantage, so long as it is not counterbalanced by a loss of clinical benefit. OBJECTIVE: We have compared the efficacy of the same biologically standardized grass pollen extract administered through the injective or the sublingual route, in a group of 20 patients followed for two pollen seasons. METHODS: Both therapies were administered for 12 months according to a double-blind (double-dummy) plan; at the end of the trial the cumulative dosage of the sublingual therapy was 2.4 times higher than that of the injective therapy. Data about skin reactivity, symptoms and drugs scores during the pollen season, as well as total specific IgG and specific IgG4, during and after the trial, were obtained. RESULTS: Our data show that sublingual and injective therapy are equally effective according to subjective clinical parameters, with a statistically highly significant reduction of symptoms and drugs (P = 0.002 for symptoms and drugs in SLIT-treated patients; P = 0.002 for symptoms and P = 0.0039 for drugs in patients given injections). On the other hand, objective parameters (total specific IgG, specific IgG4, skin reactivity) changed only in patients treated with active injective therapy, with P < 0.001, P < 0.001 and P = 0.021, respectively. CONCLUSIONS: The discrepancies observed could be interpreted as a consequence of different mechanisms of actin of the two therapies or to the lack of close relationships between the clinical and the objective parameters which were considered here.