Publications by authors named "Javier Pinilla"

18 Publications

  • Page 1 of 1

Tumor Microenvironment Composition and Severe Cytokine Release Syndrome (CRS) Influence Toxicity in Patients with Large B-Cell Lymphoma Treated with Axicabtagene Ciloleucel.

Clin Cancer Res 2020 09 15;26(18):4823-4831. Epub 2020 Jul 15.

Department of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.

Purpose: One of the challenges of adoptive T-cell therapy is the development of immune-mediated toxicities including cytokine release syndrome (CRS) and neurotoxicity (NT). We aimed to identify factors that place patients at high risk of severe toxicity or treatment-related death in a cohort of 75 patients with large B-cell lymphoma treated with a standard of care CD19 targeted CAR T-cell product (axicabtagene ciloleucel).

Experimental Design: Serum cytokine and catecholamine levels were measured prior to lymphodepleting chemotherapy, on the day of CAR T infusion and daily thereafter while patients remained hospitalized. Tumor biopsies were taken within 1 month prior to CAR T infusion for evaluation of gene expression.

Results: We identified an association between pretreatment levels of IL6 and life-threatening CRS and NT. Because the risk of toxicity was related to pretreatment factors, we hypothesized that the tumor microenvironment (TME) may influence CAR T-cell toxicity. In pretreatment patient tumor biopsies, gene expression of myeloid markers was associated with higher toxicity.

Conclusions: These results suggest that a proinflammatory state and an unfavorable TME preemptively put patients at risk for toxicity after CAR T-cell therapy. Tailoring toxicity management strategies to patient risk may reduce morbidity and mortality.
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http://dx.doi.org/10.1158/1078-0432.CCR-20-1434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7501265PMC
September 2020

[Basic questionnaire and methodological criteria for Surveys on Working Conditions, Employment, and Health in Latin America and the Caribbean].

Cad Saude Publica 2016 Oct 10;32(9):e00210715. Epub 2016 Oct 10.

Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.

This article aimed to present a basic questionnaire and minimum methodological criteria for consideration in future Surveys on Working Conditions, Employment, and Health in Latin America and the Caribbean. A virtual and face-to-face consensus process was conducted with participation by a group of international experts who used the surveys available up until 2013 as the point of departure for defining the proposal. The final questionnaire included 77 questions grouped in six dimensions: socio-demographic characteristics of workers and companies; employment conditions; working conditions; health status; resources and preventive activities; and family characteristics. The minimum methodological criteria feature the interviewee's home as the place for the interview and aspects related to the quality of the fieldwork. These results can help improve the comparability of future surveys in Latin America and the Caribbean, which would in turn help improve information on workers' heath in the region.
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http://dx.doi.org/10.1590/0102-311X00210715DOI Listing
October 2016

Liver fibrosis progression despite HCV cure with antiviral therapy in HIV-HCV-coinfected patients.

Antivir Ther 2015 5;20(3):329-34. Epub 2014 Nov 5.

Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain.

Background: Accelerated liver fibrosis and more frequent hepatic decompensation events and liver-related deaths are characteristically seen in chronic hepatitis C patients coinfected with HIV compared with HCV-monoinfected individuals. Quantitative estimates of long-term clinical benefits derived from curing HCV with antiviral therapy in coinfected patients are scarce, despite being needed for accurate cost-effectiveness decisions using expensive direct-acting antivirals in this population.

Methods: We retrospectively examined all HIV-HCV-coinfected patients followed at one reference clinic in Madrid since 2004. Liver fibrosis was measured longitudinally using elastometry; changes above 30% in kilopascal units were considered as significant.

Results: A total of 568 HIV-HCV-coinfected patients were examined. Pegylated interferon/ribavirin therapy had been given to 396 (69.7%) of whom 138 (34.8%) had achieved sustained virological response (SVR). Mean follow-up was of 6.8 (±1.5) years for hepatic events and 4.4 (±0.8) years for liver fibrosis. Hepatic decompensation events, liver-related deaths and significant liver fibrosis progression occurred less frequently in SVR than in non-treated/treatment failures. Although regression of liver fibrosis occurred in most SVR patients, fibrosis significantly progressed in 7.2% of them, in association with higher plasma HIV RNA (P=0.005) and longer exposure to HIV protease inhibitors (P=0.009).

Conclusions: Achievement of SVR dramatically reduces the risk of hepatic decompensation events and liver-related deaths in HIV-HCV-coinfected patients. Although liver fibrosis generally improves following HCV cure, worsening may occur in association with uncontrolled HIV replication and prolonged exposure to protease inhibitors. Thus, periodic assessment of liver fibrosis is warranted after SVR and screening for liver cancer should continue in coinfected patients with advanced liver fibrosis.
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http://dx.doi.org/10.3851/IMP2909DOI Listing
February 2016

Working conditions and health in Central America: a survey of 12,024 workers in six countries.

Occup Environ Med 2014 Jul 20;71(7):459-65. Epub 2014 Mar 20.

Centro de Investigación en Salud Laboral (CISAL), Universitat Pompeu Fabra, Barcelona, Spain Instituto Sindical Trabajo, Ambiente y Salud (ISTAS), CCOO, Valencia, Spain.

Objective: To describe the survey methodology and initial general findings of the first Central American Survey of Working Conditions and Health.

Methods: A representative sample of 12,024 workers was interviewed at home in Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama. Questionnaire items addressed worker demographics, employment conditions, occupational risk factors and self-perceived health.

Results: Overall, self-employment (37%) is the most frequent type of employment, 8% of employees lack a work contract and 74% of the workforce is not covered by social security. These percentages are higher in Guatemala, Honduras and El Salvador, and lower in Costa Rica, Panama and Nicaragua. A third of the workforce works more than 48 h per week, regardless of gender; this is similar across countries. Women and men report frequent or usual exposures to high ambient temperature (16% and 25%, respectively), dangerous tools and machinery (10%, 24%), work on slippery surfaces (10%, 23%), breathing chemicals (12.1%, 18%), handling toxic substances (5%, 12.1%), heavy loads (6%, 20%) and repetitive movements (43%, 49%). Two-thirds of the workforce perceive their health as being good or very good, and slightly more than half reports having good mental health.

Conclusions: The survey offers, for the first time, comparable data on the work and health status of workers in the formal and informal economy in the six Spanish-speaking Central American countries, based on representative national samples. This provides a benchmark for future monitoring of employment and working conditions across countries.
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http://dx.doi.org/10.1136/oemed-2013-101908DOI Listing
July 2014

Optimizing premedications in the prevention of bendamustine infusion-related reactions.

Cancer Control 2012 Jul;19(3):245-7

Department of Pharmacy, Moffitt Cancer Center, Tampa, FL 33612, USA.

Background: Bendamustine is indicated for the treatment of chronic lymphocytic leukemia (CLL) and rituximab refractory indolent non-Hodgkin lymphoma. Clinical trials have reported a 25% incidence of infusion-related reactions (IRRs) in patients receiving bendamustine. While these reactions are well documented, there is no consensus on the optimal premedication regimen for the prevention of these adverse effects. At our center, we utilize a regimen of ondansetron 16 mg orally and dexamethasone 10 mg IV push prior to each infusion of bendamustine. This report describes our experience with our current premedication regimen with regard to IRRs and the incidence of febrile neutropenia (FN).

Methods: We retrospectively analyzed 73 consecutive patients receiving bendamustine infusions at our institute from June 2008 to June 2010 to determine the incidence of IRRs and FN. The primary objective was to determine the incidence of IRRs. Secondary objectives included incidence of FN and hospital admission rate.

Results: A total of 478 infusions of bendamustine were administered to 73 consecutive patients. The median patient age was 69 years. IRRs affected 19% of our population, and 10.9% experienced FN. Notably, all IRRs were attributed to rituximab infusions and no patients experienced an IRR when receiving bendamustine alone. This compares favorably to the initial reported IRRs of 25% with bendamustine alone.

Conclusions: Based on our experience with bendamustine, ondansetron and dexamethasone provide a safe and effective prevention of IRRs associated with bendamustine. By avoiding the use of other premedications, the likelihood of additional complications or adverse affects can be minimized.
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http://dx.doi.org/10.1177/107327481201900309DOI Listing
July 2012

Impact of IL28B polymorphisms on response to peginterferon and ribavirin in HIV–hepatitis C virus-coinfected patients with prior nonresponse or relapse.

AIDS 2011 May;25(8):1131-3

Hospital Carlos III, Madrid, Spain.

IL28B polymorphisms predict treatment response in chronic hepatitis C. However, no information exists in prior treatment failures. A total of 62 HIV/hepatitis C virus (HCV) patients who completed retreatment with peginterferon-α/ribavirin were examined, of whom 25 (40%) had been cured. Predictors of response [odds ratio, OR (95% confidence interval, CI)] were HCV genotypes 2/3 [16.1 (2.7-90.9)], prior relapse [9.6 (1.5-62.4)] and ribavirin plasma trough concentrations at week 4 [4.9 (1.3-18.4)]. IL28B-CC only predicted response in prior nonresponders carrying HCV genotypes 1/4 [25.1 (1.9-337)].
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http://dx.doi.org/10.1097/QAD.0b013e3283471d83DOI Listing
May 2011

Eligibility for and outcome of treatment of latent tuberculosis infection in a cohort of HIV-infected people in Spain.

BMC Infect Dis 2010 Sep 14;10:267. Epub 2010 Sep 14.

Unidad de Epidemiología del VIH/SIDA, Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain.

Background: Previous studies have demonstrated the efficacy of treatment for latent tuberculosis infection (TLTBI) in persons infected with the human immunodeficiency virus, but few studies have investigated the operational aspects of implementing TLTBI in the co-infected population.The study objectives were to describe eligibility for TLTBI as well as treatment prescription, initiation and completion in an HIV-infected Spanish cohort and to investigate factors associated with treatment completion.

Methods: Subjects were prospectively identified between 2000 and 2003 at ten HIV hospital-based clinics in Spain. Data were obtained from clinical records. Associations were measured using the odds ratio (OR) and its 95% confidence interval (95% CI).

Results: A total of 1242 subjects were recruited and 846 (68.1%) were evaluated for TLTBI. Of these, 181 (21.4%) were eligible for TLTBI either because they were tuberculin skin test (TST) positive (121) or because their TST was negative/unknown but they were known contacts of a TB case or had impaired immunity (60). Of the patients eligible for TLTBI, 122 (67.4%) initiated TLTBI: 99 (81.1%) were treated with isoniazid for 6, 9 or 12 months; and 23 (18.9%) with short-course regimens including rifampin plus isoniazid and/or pyrazinamide. In total, 70 patients (57.4%) completed treatment, 39 (32.0%) defaulted, 7 (5.7%) interrupted treatment due to adverse effects, 2 developed TB, 2 died, and 2 moved away. Treatment completion was associated with having acquired HIV infection through heterosexual sex as compared to intravenous drug use (OR:4.6; 95% CI:1.4-14.7) and with having taken rifampin and pyrazinamide for 2 months as compared to isoniazid for 9 months (OR:8.3; 95% CI:2.7-24.9).

Conclusions: A minority of HIV-infected patients eligible for TLTBI actually starts and completes a course of treatment. Obstacles to successful implementation of this intervention need to be addressed.
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http://dx.doi.org/10.1186/1471-2334-10-267DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2945350PMC
September 2010

Rate and predictors of success in the retreatment of chronic hepatitis C virus in HIV/hepatitis C Virus coinfected patients with prior nonresponse or relapse.

J Acquir Immune Defic Syndr 2010 Mar;53(3):364-8

Department of Infectious Diseases, Hospital Carlos III, Calle Sinesio Delgado 10, Madrid 28029, Spain.

Background: In hepatitis C virus (HCV)/HIV-coinfected patients who failed a course of suboptimal hepatitis C therapy, retreatment with adequate doses and duration of pegylated interferon (pegIFN) plus ribavirin (RBV) is advisable in the presence of compensated advanced liver fibrosis.

Methods: The efficacy and safety of pegIFN-alpha2a (180 microg/wk) plus RBV (<75 kg: 1000 mg/d; > or = 75 kg: 1200 mg/d) given for 12 months was prospectively assessed in HIV/HCV patients with nonresponse or relapse to a prior course of suboptimal hepatitis C therapy. The main endpoint was the achievement of sustained virological response (SVR).

Results: A total of 52 patients were enrolled in the study (78% HCV genotypes 1 or 4; 56% with advanced liver fibrosis). Prior suboptimal regimens were IFN monotherapy (20%), IFN plus RBV (29%), and pegIFN plus RBV 800 mg/d (51%). Overall, 61% were nonresponders and 39% relapsers. Retreatment provided SVR in 30.8% of patients (19.5% for genotypes 1/4 vs. 72.7% for genotypes 2/3; P = 0.002). In multivariate analysis, HCV genotypes 2/3 [OR 22.2, 95% confidence interval (CI), 2.9-166.7, P = 0.003] and RBV plasma trough concentrations at week 4 [OR 3.9 (95% CI, 1.3-11.8), P = 0.01] were the only independent predictors of SVR.

Conclusions: Retreatment with pegIFN-alpha2a plus weight-based RBV for 12 months permits to achieve HCV clearance in nearly onethird of HIV/HCV-coinfected patients who failed a prior suboptimal course of hepatitis C therapy. Patients with HCV genotypes 2/3 and those with RBV plasma trough levels above 2.07 microg/mL show the highest chances of SVR.
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http://dx.doi.org/10.1097/QAI.0b013e3181bd5ce1DOI Listing
March 2010

Reproducibility measuring the angle of proximal junctional kyphosis using the first or the second vertebra above the upper instrumented vertebrae in patients surgically treated for scoliosis.

Spine (Phila Pa 1976) 2009 Dec;34(25):2787-91

Department of Orthopedic Surgery, Hospital Universitario de Canarias, University of La Laguna, La Laguna, Santa Cruz de Tenerife, Spain.

Study Design: A historical cohort study.

Objective: To evaluate the reproducibility of this measure in proximal junctional kyphosis (PJK) and to determine whether differences exist between first and second vertebrae angles.

Summary Of Background Data: There are no previous studies on the precision and accuracy of selecting the first or the second vertebra above the upper instrumented vertebrae to determine the degree of spinal angulation after surgery.In several studies, the first or the second vertebrae above the upper instrumented vertebrae (UIV) have been selected to measure the angle of PJK in a surgical setting. However, to our knowledge, no studies have addressed the reliability of this measure.We aimed to evaluate the reproducibility of this measure in PJK and to determine whether differences exist between first and second vertebrae angles.

Methods: A total of 38 randomly ordered radiologic digital images were obtained at 2 different times from 19 consecutive patients (aged 18.4 +/- 6.0 years at intervention) surgically treated for scoliosis. Using these images in a blinded manner, 2 surgeons independently measured angles at both the first and second vertebrae above the UIV. The measures were repeated in different periods to test intra- and intersurgeon concordances.

Results: For 152 measures, intrasurgeon concordance correlation coefficients ranged from 0.78 to 0.92 (high to very high reproducibility) and comparative intersurgeon concordance correlation coefficients ranged from 0.55 to 0.80 (moderate to high reproducibility). No differences were found between the first and the second vertebrae angles.

Conclusion: Good reproducibility and agreement using the first and second vertebrae above the UIV to measure the angle of PJK was found in this study.
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http://dx.doi.org/10.1097/BRS.0b013e3181b61955DOI Listing
December 2009

[Factors related to non-prescription of tuberculin skin testing in a cohort of HIV-infected people].

Enferm Infecc Microbiol Clin 2010 Apr 15;28(4):215-21. Epub 2009 Aug 15.

Unidad de Epidemiología del VIH/SIDA, Instituto de Salud Carlos III, Madrid, España.

Introduction: Tuberculin skin testing (TST) for tuberculosis (TB) is recommended for all patients with HIV infection because of the known relationship between these two conditions. In this report we analyze the incidence and variables associated with non-prescription of TST in a cohort of HIV-infected people.

Patients And Methods: Longitudinal study conducted between 2000 and 2002 at 10 HIV hospital-based clinics. All HIV-infected patients who had not been regularly followed-up previously in dedicated clinics were identified. Data about TST and other variables related to TB were obtained from the clinical records. We calculated the percentage of patients who did not undergo TST and the associated factors, using odds ratios (ORs) and the 95% CI to investigate associations. A multivariate logistic regression analysis was performed.

Results: A total of 1242 patients met the inclusion criteria. TST was not performed in 185 patients (17.6% of those eligible). The fact of being an intravenous drug abuser was associated with a higher probability of TST non-prescription (OR: 2.6, 95% CI 1.1-6.5), whereas being unemployed (OR: 0.6, 95% CI 0.3-1.0), having a CD4 cell count >200 (CD4 200-499: OR 0.5, 95% CI 0.3-0.9. CD4> or =500: OR 0.3, 95% CI 0.2-0.6), and contact with persons with TB (OR 0.2, 95% CI 0.1-0.5) were associated with a lower probability.

Conclusions: In this study, the percentage of TST non-prescription was quite high. The results suggest that TST non-prescription in this population is related to the clinicians' expectations regarding the results of the test and the patients' adherence to treatment for latent TB infection.
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http://dx.doi.org/10.1016/j.eimc.2009.06.008DOI Listing
April 2010

Effectiveness and safety of simplification therapy with once-daily tenofovir, lamivudine, and efavirenz in HIV-1-infected patients with undetectable plasma viral load on HAART.

HIV Clin Trials 2007 Sep-Oct;8(5):328-36

Unit of Infectious Diseases, Hospital Donostia, Donostia-San Sebastián, Spain.

Objective: To evaluate the effectiveness and tolerability of a simplification regimen with tenofovir DF (TDF), lamivudine (3TC), and efavirenz (EFV) in HAART-experienced HIV-1-infected subjects with sustained viral suppression.

Method: Patients with HIV-1 RNA <200 copies/mL during the previous 6 months and who switched their current twice-daily or three-times-daily HAART to a simplified once-daily regimen of TDF (300 mg), 3TC (300 mg), and EFV (600 mg) were included.

Results: 154 patients (70% males, mean age 42 years) were included. Previous HAART included a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen in 55% of the patients and a thymidine analog in 87%. The percentage of patients with viral load <200 copies/mL in the intent-to-treat (ITT) data set was 83% at 6 months and 75% at 12 months (98% and 96%, respectively, in the on-treatment [OT] analysis). Five patients (3%) were identified as virologic failures according to the study protocol. The mean CD4 T-cell count increased significantly 12 months after simplification (from 570 to 632 cells/mm3; p < .01). At 12 months, mean triglyceride levels decreased from 233 to 170 mg/dL (p < .01) and mean cholesterol levels decreased from 205 to 189 mg/dL (p < .01). Thirty-three patients (21%) discontinued the study treatment prior to completing the 12-month follow-up.

Conclusion: Simplification to a once-daily regimen containing TDF, 3TC, and EFV is virologically and immunologically effective, well-tolerated, and safe with benefits in the lipid profile in the majority of patients.
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http://dx.doi.org/10.1310/hct0805-328DOI Listing
December 2007

Infant of 22 months of age with no anomalies born from a HCV- and HIV-infected mother under treatment with pegylated interferon, ribavirin and antiretroviral therapy during the first 16 weeks of pregnancy.

Reprod Toxicol 2007 Nov-Dec;24(3-4):414-6. Epub 2007 Jul 7.

Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain.

The product label of ribavirin states that it is contraindicated during pregnancy, so the risk in its administering during pregnancy is concerned. We show a case of an infant of 22 months of age with no anomalies born from an HCV- and HIV-infected mother under treatment with pegylated interferon, ribavirin and antiretroviral therapy during the first 16 weeks of pregnancy. The infant is neither HIV- nor HCV-infected.
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http://dx.doi.org/10.1016/j.reprotox.2007.07.002DOI Listing
January 2008

Hepatotoxicity of antiretroviral drugs is reduced after successful treatment of chronic hepatitis C in HIV-infected patients.

J Infect Dis 2007 Sep 13;196(5):670-6. Epub 2007 Jul 13.

Department of Infectious Diseases, Hospital Carlos III, Madrid 28029, Spain.

Background: The risk of liver toxicity during antiretroviral drug use in human immunodeficiency virus (HIV)-positive patients increases in the presence of chronic hepatitis C virus (HCV) infection. It is unknown whether sustained HCV clearance after interferon (IFN)-based therapy might reduce this complication.

Methods: The incidence of severe elevations in liver enzyme levels during antiretroviral therapy was retrospectively analyzed in a group of HIV/HCV-coinfected patients after completion of a full course of IFN-based therapy. Hepatic events were recorded according to the achievement of a sustained virological response (SVR), and the presence of advanced liver fibrosis was assessed by transient elastometry.

Results: A total of 132 HIV/HCV-coinfected patients were analyzed (66% men; mean age, 38 years). Overall, 33% achieved an SVR and 40% had advanced liver fibrosis after IFN therapy. A total of 49 episodes of liver toxicity occurred during a mean of 35 months of follow-up (9.7% per year) after IFN therapy. The yearly incidence of hepatic events was greater in patients who did not achieve an SVR than in those who did (12.9% vs. 3.1%; P<.001) and in patients with advanced liver fibrosis than in those without it (14.4% vs. 7.6%; P=.003). Drugs involved in hepatic events were dydeoxynucleoside analogues (namely, didanosine and stavudine; 40%) nevirapine (30%), efavirenz (11%), and protease inhibitors (PIs; 8%). In logistic regression analysis, lack of an SVR (odds ratio [OR], 6.13 [95% confidence interval {CI}, 1.83-37.45]; P=.003) and the use of dydeoxynucleosides (OR, 3.59 [95% CI, 1.23-10.42]; P=.02) were independent predictors of hepatotoxicity after IFN therapy. Conversely, regimens containing PIs (OR, 0.07 [95% CI, 0.02-0.30]; P<.01) or efavirenz (OR, 0.13 [95% CI, 0.04-0.44]; P=.001) were associated with a diminished risk of hepatic events.

Conclusion: Sustained HCV clearance after IFN-based therapy reduces the risk of liver toxicity during antiretroviral therapy, which should further encourage the treatment of chronic hepatitis C in HIV-coinfected patients. In this population, prescription of PIs or efavirenz decreases and use of dydeoxynucleoside analogues increases the risk of hepatotoxicity.
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http://dx.doi.org/10.1086/520092DOI Listing
September 2007

American Society of Hematology - 45th annual meeting and exposition.

Authors:
Javier Pinilla

IDrugs 2004 Feb;7(2):128-32

Memorial Sloan Kettering Cancer Center, Laboratory of Hematopoetic Immunocytochemistry, Leukemia Service, 1275 York Avenue, Room K718C, Box 531, New York, NY 10021, USA.

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February 2004

[Fever and papular eruption with generalized lymph adenopathy and pharyngeal-tonsillar inflammation].

Enferm Infecc Microbiol Clin 2003 Feb;21(2):103-4

Servicios de Medicina Interna. Complejo Hospitalario San Millán-San Pedro. Logroño. España.

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http://dx.doi.org/10.1016/s0213-005x(03)72892-4DOI Listing
February 2003

[Fever and headache of 5 days' duration, progressing to psychomotor agitation in 48 hours].

Enferm Infecc Microbiol Clin 2003 Mar;21(3):155-6

Servicios de Medicina Interna. Complejo Hospitalario san Millán-San Pedro. Logroño. España.

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http://dx.doi.org/10.1016/s0213-005x(03)72906-1DOI Listing
March 2003