Ensayo clínico fase III para evaluar la eficacia y seguridad del uso de plasma rico en plaquetas frente a ácido hialurónico en coxartrosis / Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis

OBJETIVOS: Comparar la eficacia y seguridad de la infiltración de plasma rico en plaquetas preparado respecto a ácido hialurónico en pacientes con coxartrosis refractaria a tratamiento conservador. Así como correlacionar el impacto clínico entre las diferentes concentraciones celulares. MATERIALES Y MÉTODOS: Ensayo clínico fase III, doble-ciego, controlado, en el que se aleatorizaron a los pacientes en dos grupos de tratamiento (PRP o AH) con una única infiltración de cadera ecoguiada. El seguimiento fue de 12 meses, registrando escala de dolor (EVA) y escalas funcionales (HHS y WOMAC), analgesia consumida, respondedores (criterios OARSI) y efectos adversos. Se analizaron, en el grupo experimental, las concentraciones celulares en sangre periférica y en el PRP infiltrado. RESULTADOS: Se incluyeron un total de 74 pacientes. Ambos grupos de tratamiento presentaron mejoría en las escalas EVA, WOMAC, HHS y reducción del consumo de analgesia en el tiempo (p < 0,05). Únicamente encontramos diferencias significativas entre grupos al año de tratamiento en los valores de HHS (Grupo PRP 70,9 [3,7-58] grupo AH 60,2[43-74,2] p < 0,05). No se registraton efectos adversos en ninguno de los grupos. Encontramos correlación entre la concentración de plaquetas en pacientes respondedores (un mes postratamiento; no respondedores 449[438-578] x103 plaquetas/μl, respondedores 565 [481-666] x103 plaquetas/μl, p < 0,044). Se correlaciona la concentración de leucocitos con las escalas clínico-funcionales (EVA 6 meses, r=0,748, p < 0,013, subescala rigidez WOMAC 6 meses, r=0,748, p < 0,013). Los pacientes con estadios de coxartrosis iniciales (KL 1 y 2) tienen mayor probabilidad de responder al tratamiento con plasma rico en plaquetas (11,51 OR, IC 95% 2,34-50,65, p < 0,03). CONCLUSIONES: La infiltración única de PRP es eficaz en términos de mejoría funcional, reducción del dolor y disminución del consumo de analgesia en coxartrosis. Los sistemas de preparación abiertos, son un procedimiento seguro para la obtención de PRP. Se deben indicar las infiltraciones de cadera en estadios evolutivos iniciales. Se debe tener en cuenta la composición celular para garantizar una repuesta clínica positiva

AIMS OF THE STUDY: To compare efficacy and safety of a home-made platelet-rich plasma (PRP) solution versus hyaluronic acid in patients with hip osteoarthritis not responding to conservative treatment and to correlate cellular composition of PRP to clinical outcomes. MATERIAL AND METHODS: This is a phase III clinical trial, double-blinded, controlled and randomised into two treatment groups (PRP and hyaluronic acid). Patients received one hip ultrasound-guided injection. Follow up was 12 months. Pain was assessed using VAS score, HHS and WOMAC were used as functional scores, analgesia, adverse events, cellular components (PRP group) in peripheral blood and in PRP were recorded. Clinical response was assessed using OARSI criteria. RESULTS: Seventy-four patients were included. Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05). Significant differences were seen at 1 year post-treatment in HHS score (PRP 70.9 [3.7-58], hyaluronic acid 60.2[43-74.2] p<.05). No adverse events were observed in none of the groups. Platelet concentration was different between responders and non-responders (at 1 month, non-responders 449[438-578] x103 platelets/μl versus responders 565 [481-666] x103 platelets/μl, p<.044). There was a correlation between leukocytes concentration and clinical scores (VAS at six months, r=0.748, p<.013, WOMAC at 6 months r=0.748, p <.013). Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03). CONCLUSIONS: Platelet-rich plasma injection improved hip function, reduced pain and the use of analgesia. It is important to bear in mind the cellular composition in order to achieve a better clinical response

Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis. / Ensayo clínico fase III para evaluar la eficacia y seguridad del uso de plasma rico en plaquetas frente a ácido hialurónico en coxartrosis.

AIMS OF THE STUDY: To compare efficacy and safety of a home-made platelet-rich plasma (PRP) solution versus hyaluronic acid in patients with hip osteoarthritis not responding to conservative treatment and to correlate cellular composition of PRP to clinical outcomes. MATERIAL AND METHODS: This is a phase III clinical trial, double-blinded, controlled and randomised into two treatment groups (PRP and hyaluronic acid). Patients received one hip ultrasound-guided injection. Follow up was 12 months. Pain was assessed using VAS score, HHS and WOMAC were used as functional scores, analgesia, adverse events, cellular components (PRP group) in peripheral blood and in PRP were recorded. Clinical response was assessed using OARSI criteria. RESULTS: Seventy-four patients were included. Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05). Significant differences were seen at 1 year post-treatment in HHS score (PRP 70.9 [3.7-58], hyaluronic acid 60.2[43-74.2] p<.05). No adverse events were observed in none of the groups. Platelet concentration was different between responders and non-responders (at 1 month, non-responders 449[438-578] x103 platelets/µl versus responders 565 [481-666] x103 platelets/µl, p<.044). There was a correlation between leukocytes concentration and clinical scores (VAS at six months, r=0.748, p<.013, WOMAC at 6 months r=0.748, p <.013). Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03). CONCLUSIONS: Platelet-rich plasma injection improved hip function, reduced pain and the use of analgesia. It is important to bear in mind the cellular composition in order to achieve a better clinical response.

Low percentages of regulatory T cells in common variable immunodeficiency (CVID) patients with autoimmune diseases and its association with increased numbers of CD4+CD45RO+ T and CD21low B cells.

BACKGROUND: Common variable immunodeficiency (CVID) is a heterogeneous group of primary antibody deficiencies defined by marked reductions in serum IgG, IgA and/or IgM levels and recurrent bacterial infections. Some patients are associated with defects in T cells and regulatory T cells (Tregs), resulting in recurrent viral infections and early-onset autoimmune disease. METHODS: We analyzed whether there is an association between Tregs cells (CD4+CD25+CD127low and CD4+CD25+FoxP3+); memory T cells (CD4+CD45RO+); memory B cells (CD19+CD27-IgD-); and CD21low B cells (CD19+CD38lowCD21low); as well as autoimmune manifestations in 36 patients with CVID (25 women and 11 men, mean age 24 years), all by flow cytometry. RESULTS: Fourteen patients presented with autoimmune diseases (AI) (39%), including 11 with autoimmune thrombocytopenia (ITP) (31%); two with vitiligo (6%); one with systemic lupus erythematosus (LES) (3%); and one with multiple sclerosis (MS) (3%). CVID patients with AI had a reduced proportion of Tregs (both CD4+CD25+CD127low and FoxP3+ cells) compared with healthy controls. CVID patients with AI had expanded CD21low B cell populations compared with patients who did not have AI. A correlation between increased CD4+CD45RO T cell populations and reduced Tregs was also observed. CONCLUSIONS: Our results showed that 39% of patients with CVID had AI and reduced Tregs populations. Research in this area might provide noteworthy data to better understand immune dysfunction and dysregulation related to CVID.

The methodology of surveillance for antimicrobial resistance and healthcare-associated infections in Europe (SUSPIRE): a systematic review of publicly available information.

OBJECTIVES: Surveillance is a key component of any control strategy for healthcare-associated infections (HAIs) and antimicrobial resistance (AMR), and public availability of methodologic aspects is crucial for the interpretation of the data. We sought to systematically review publicly available information for HAIs and/or AMR surveillance systems organized by public institutions or scientific societies in European countries. METHODS: A systematic review of scientific and grey literature following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines was performed. Information on HAIs and/or AMR surveillance systems published until 31 October 2016 were included. RESULTS: A total of 112 surveillance systems were detected; 56 from 20 countries were finally included. Most exclusions were due to lack of publicly available information. Regarding AMR, the most frequent indicator was the proportion of resistant isolates (27 of 34 providing information, 79.42%); only 18 (52.9%) included incidence rates; the data were only laboratory based in 33 (78.5%) of the 42 providing this information. Regarding HAIs in intensive care units, all 22 of the systems providing data included central line-associated bloodstream infections, and 19 (86.3%) included ventilator-associated pneumonia and catheter-associated urinary tract infections; incidence density was the most frequent indicator. Regarding surgical site infections, the most frequent procedures included were hip prosthesis, colon surgery and caesarean section (21/22, 95.5%). CONCLUSIONS: Publicly available information about the methods and indicators of the surveillance system is frequently lacking. Despite the efforts of European Centre for Disease Control and Prevention (ECDC) and other organizations, wide heterogeneity in procedures and indicators still exists.

BCG vaccination in patients with severe combined immunodeficiency: complications, risks, and vaccination policies.

BACKGROUND: Severe combined immunodeficiency (SCID) is a syndrome characterized by profound T-cell deficiency. BCG vaccine is contraindicated in patients with SCID. Because most countries encourage BCG vaccination at birth, a high percentage of patients with SCID are vaccinated before their immune defect is detected. OBJECTIVES: We sought to describe the complications and risks associated with BCG vaccination in patients with SCID. METHODS: An extensive standardized questionnaire evaluating complications, therapeutics, and outcomes regarding BCG vaccination in patients given a diagnosis of SCID was widely distributed. Summary statistics and association analysis was performed. RESULTS: Data on 349 BCG-vaccinated patients with SCID from 28 centers in 17 countries were analyzed. Fifty-one percent of the patients had BCG-associated complications, 34% disseminated and 17% localized (a 33,000- and 400-fold increase, respectively, over the general population). Patients receiving early vaccination (≤1 month) showed an increased prevalence of complications (P = .006) and death caused by BCG-associated complications (P < .0001). The odds of experiencing complications among patients with T-cell numbers of 250/µL or less at diagnosis was 2.1 times higher (95% CI, 1.4-3.4 times higher; P = .001) than among those with T-cell numbers of greater than 250/µL. BCG-associated complications were reported in 2 of 78 patients who received antimycobacterial therapy while asymptomatic, and no deaths caused by BCG-associated complications occurred in this group. In contrast, 46 BCG-associated deaths were reported among 160 patients treated with antimycobacterial therapy for a symptomatic BCG infection (P < .0001). CONCLUSIONS: BCG vaccine has a very high rate of complications in patients with SCID, which increase morbidity and mortality rates. Until safer and more efficient antituberculosis vaccines become available, delay in BCG vaccination should be considered to protect highly vulnerable populations from preventable complications.

Respiratory allergy in Mexican patients with cystic fibrosis.

BACKGROUND: the purpose of this study was to investigate the presence of respiratory allergy in 30 Mexican patients bearing cystic fibrosis (CF). METHODS AND RESULTS: all patients completed a clinical history, had a physical examination, total serum IgE, nasal and blood eosinophils determinations and evaluation of skin prick tests for 36 allergens. In 26.6% of the patients included in the study was detected respiratory allergy diagnosed on clinical and laboratory analyses. Skin prick tests of 11 (36.6%) of the patients were positive to at least one allergen and Aspergillus fumigatus (A. fumigatus) was the most frequently observed allergen in 23% of the cases. CONCLUSIONS: we have demonstrated in this study that Mexican patients also present a coexistence of respiratory allergy in patients bearing CF.

[In vitro and in vivo acari tests]. / Pruebas in vitro e in vivo a ácaros.

We studied 40 children with one o more perennial allergic diseases (bronchial asthma, allergic rhinitis, and/or atopic dermatitis) to assess the value in our country of in vivo and in vitro tests more frequently used in the diagnosis of allergy, such as total serum IgE, specific allergen IgE (RAST) and prick skin test in patients sensitives to D. pteronissinus, D. farinae or both. All patients had positive prick skin tests. Total serous IgE was elevated in 95% of cases with poor correlation coefficient (r) between prick skin test reactivity and total serous IgE concentration with no statistical significance. On the other hand, 95% of patients showed a positive RAST with a correlation coefficient of 0.31 (p less than 0.05). We concluded that in our country clinical history and prick skin tests are sufficiently accurate in a reasonable way to make a diagnosis of allergic etiology in patients sensitives to mites of the house dust.