Recommendations for the prevention and diagnosis of asthma in children: Evidence from international guidelines adapted for Mexico

BACKGROUND: With the availability of high-quality asthma guidelines worldwide, one possible approach of developing a valid guideline, without re-working the evidence, already analysed by major guidelines, is the ADAPTE approach, as was used for the development of National Guidelines on asthma. METHODS: The guidelines development group (GDG) covered a broad range of experts from medical specialities, primary care physicians and methodologists. The core group of the GDG searched the literature for asthma guidelines 2005 onward, and analysed the 11 best guidelines with AGREE-II to select three mother guidelines. Key clinical questions were formulated covering each step of the asthma management. RESULTS: The selected mother guidelines are British Thoracic Society (BTS), GINA and GEMA 2015. Responses to the questions were formulated according to the evidence in the mother guidelines. Recommendations or suggestions were made for asthma treatment in Mexico by the core group, and adjusted during several rounds of a Delphi process, taking into account: 1. Evidence; 2. Safety; 3. Cost; 4. Patient preference - all these set against the background of the local reality. Here the detailed analysis of the evidence present in BTS/GINA/GEMA sections on prevention and diagnosis in paediatric asthma are presented for three age-groups: children with asthma ≤5 years, 6-11 years and ≥12 years. CONCLUSIONS: For the prevention and diagnosis sections, applying the AGREE-II method is useful to develop a scientifically-sustained document, adjusted to the local reality per country, as is the Mexican Guideline on Asthma

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Recommendations for the prevention and diagnosis of asthma in children: Evidence from international guidelines adapted for Mexico.

BACKGROUND: With the availability of high-quality asthma guidelines worldwide, one possible approach of developing a valid guideline, without re-working the evidence, already analysed by major guidelines, is the ADAPTE approach, as was used for the development of National Guidelines on asthma. METHODS: The guidelines development group (GDG) covered a broad range of experts from medical specialities, primary care physicians and methodologists. The core group of the GDG searched the literature for asthma guidelines 2005 onward, and analysed the 11 best guidelines with AGREE-II to select three mother guidelines. Key clinical questions were formulated covering each step of the asthma management. RESULTS: The selected mother guidelines are British Thoracic Society (BTS), GINA and GEMA 2015. Responses to the questions were formulated according to the evidence in the mother guidelines. Recommendations or suggestions were made for asthma treatment in Mexico by the core group, and adjusted during several rounds of a Delphi process, taking into account: 1. Evidence; 2. Safety; 3. Cost; 4. Patient preference - all these set against the background of the local reality. Here the detailed analysis of the evidence present in BTS/GINA/GEMA sections on prevention and diagnosis in paediatric asthma are presented for three age-groups: children with asthma ≤5 years, 6-11 years and ≥12 years. CONCLUSIONS: For the prevention and diagnosis sections, applying the AGREE-II method is useful to develop a scientifically-sustained document, adjusted to the local reality per country, as is the Mexican Guideline on Asthma.

Real life study of three years omalizumab in patients with difficult-to-control asthma

BACKGROUND: Even though there are multiple options for the treatment of asthma, there still exists a fair group of patients with difficult-to-control asthma. We describe for the first time the real-world effects of three-year omalizumab treatment on patients with difficult-to-control asthma, seen in a social security hospital in a Latin American country. METHODS: Difficult-to-control asthmatic patients from the out-patient clinic of a regional hospital were recruited to receive a three-year omalizumab course. Efficacy parameters were asthma control test (ACT) score; FEV1; daily beclomethasone maintenance dose; and unplanned visits for asthma exacerbations (emergency room (ER), hospitalisations, intensive care). RESULTS: 52 patients were recruited, 47 completed the three-year treatment (42 female, 15-67 years, mean age 43.5). Comparing efficacy parameters of the year before omalizumab with the 3rd year of omalizumab: mean ACT improved from 12.4 to 20.5, mean FEV1 from 66.3% (standard deviation (SD) 19.1%) to 88.4% (SD 16.2%) of predicted, while mean beclomethasone dose reduced from 1750 to 766 mcg/day and there was a significant reduction in patients experiencing ER visits (from 95% to 19%, p < 0.0001), hospitalisation (38% to 2%, p < 0.0001) and intensive care (4% to 0, NS). Five patients discontinued omalizumab, two because of an adverse event (anaphylaxis, severe headache, both resolved without sequelae). CONCLUSION: Omalizumab improved most clinical parameters of Mexican patients with difficult-to-control asthma. Especially the rates of ER visits and hospitalisation were significantly reduced, thus reducing costs. Omalizumab was generally well tolerated

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Real life study of three years omalizumab in patients with difficult-to-control asthma.

BACKGROUND: Even though there are multiple options for the treatment of asthma, there still exists a fair group of patients with difficult-to-control asthma. We describe for the first time the real-world effects of three-year omalizumab treatment on patients with difficult-to-control asthma, seen in a social security hospital in a Latin American country. METHODS: Difficult-to-control asthmatic patients from the out-patient clinic of a regional hospital were recruited to receive a three-year omalizumab course. Efficacy parameters were asthma control test (ACT) score; FEV1; daily beclomethasone maintenance dose; and unplanned visits for asthma exacerbations (emergency room (ER), hospitalisations, intensive care). RESULTS: 52 patients were recruited, 47 completed the three-year treatment (42 female, 15-67 years, mean age 43.5). Comparing efficacy parameters of the year before omalizumab with the 3rd year of omalizumab: mean ACT improved from 12.4 to 20.5, mean FEV1 from 66.3% (standard deviation (SD) 19.1%) to 88.4% (SD 16.2%) of predicted, while mean beclomethasone dose reduced from 1750 to 766 mcg/day and there was a significant reduction in patients experiencing ER visits (from 95% to 19%, p<0.0001), hospitalisation (38% to 2%, p<0.0001) and intensive care (4% to 0, NS). Five patients discontinued omalizumab, two because of an adverse event (anaphylaxis, severe headache, both resolved without sequelae). CONCLUSION: Omalizumab improved most clinical parameters of Mexican patients with difficult-to-control asthma. Especially the rates of ER visits and hospitalisation were significantly reduced, thus reducing costs. Omalizumab was generally well tolerated.

Juvenile rheumatoid arthritis and asthma, but not childhood-onset systemic lupus erythematosus are associated with FCRL3 polymorphisms in Mexicans.

A regulatory single nucleotide polymorphism located in the 5' region (-169T/C) of the Fc receptor-like 3 (FCRL3_3) gene has been associated with both susceptibility and protection in immune diseases. This case-control study aimed to evaluate the association between FCRL3 polymorphisms and juvenile rheumatoid arthritis (JRA), asthma, and childhood-onset systemic lupus erythematosus (SLE) in a Mexican population. We performed PCR-based genotyping to identify four FCRL3 single nucleotide polymorphisms (FCRL3_3 to FCRL3_6) in patients with JRA (n=202), asthma (n=239), or childhood-onset SLE (n=377), and healthy controls (n=400). The case-control analysis showed a male-gender dependent association between the FCRL3_3C, FCRL3_5C, and FCRL3_6A alleles and either JRA (OR=0.57, p=0.003; OR=0.55, p=0.002; OR=0.53, p=0.0007, respectively) or asthma (OR=0.72, p=0.04; OR=0.74, p=0.05; OR=0.70, p=0.02, respectively). As expected, minor alleles of these SNPs with the CGCA haplotype were also significantly associated with JRA (OR=0.35, p=0.00005) and asthma (OR=0.61, p=0.007). We found no association between FCRL3 SNPs or haplotypes and childhood-onset SLE. These results supported the notion that FCRL3 is involved in the etiology of several immune diseases. Our results also suggested that SNPs located in the FCRL3 gene were protective against JRA and asthma in male Mexican patients.

[Hereditary angioedema. A report of a case and literature review]. / Angioedema hereditario. Comunicación de un caso y revisión de la bibliografía.

Hereditary angioedema is a congenital disorder with recurrent attacks of localized swelling of submucosal and subcutaneous tissue, or both caused by a deficiency of the plasma protein C1 inhibitor. It is caused by heterozygous defects in the C1 inhibitor gene located on chromosome 11q, and it has an autosomal dominant inheritance pattern. This disease afflicts 1 in 10,000 to 1 in 150,000 persons. Hereditary angioedema has been reported in all races, and no sex predominance has been found. Skin and visceral organs may be involved by the typically massive local edema. The most commonly involved viscera are the respiratory and gastrointestinal systems, and it can affect the upper airways resulting in severe life-threatening symptoms, including the risk of asphyxiation. There are three types of hereditary angioedema, which difference lies in the inheritance pattern and in the C1 esterase inhibitor and C4 concentrations. The treatment is complicated and it should be treated with intravenous purified C1 inhibitor concentrate; corticosteroids, antihistamines and epinephrine can be useful adjuncts but they are not effective. We report a patient with hereditary angioedema type 1 and make a review of the medical literature.

[Transfer factor as specific immunomodulator in the treatment of moderate-severe atopic dermatitis]. / Factor de transferencia como inmunomodulador específico en el tratamiento de la dermatitis atópica moderada a severa.

BACKGROUND: Atopic dermatitis is a skin inflammatory disease which has been associated to high levels of IgE, eosinophiles and change of T lymphocytes. The transfer factor is an immunomodulator active substance and decreases the number of inflammatory cells and the severity of the symptoms of atopic dermatitis. OBJECTIVE: To determine the efficacy of the transfer factor as treatment of moderate and severe atopic dermatitis. MATERIAL AND METHODS: Articles related to treatment with transfer factor in the atopic dermatitis were looked up in Medline and EMBASE, and the ones referring to controlled studies in patients with moderate and severe atopic dermatitis in accord to SCORAD. RESULTS: We found seven articles with 121 patients and 88 controls demonstrating significant decrease in the symptoms of the SCORAD index, decreased IgE, and eosinophils in patients treated with transfer factor. CONCLUSIONS: The transfer factor is a choice treatment for moderate and severe atopic dermatitis.

[Safety and efficacy of specific sublingual immunotherapy in patients with asthma and allergy to Dermatophagoides pteronyssinus]. / Inocuidad y eficacia de la inmunoterapia sublingual específica en pacientes con asma y alergia a Dermatophagoides pteronyssinus.

BACKGROUND: First reports on sublingual immunotherapy were published in 1980. OBJECTIVE: To compare safety and effectiveness of sublingual immunotherapy, as compared with placebo, in asthmatic patients. MATERIALS: In a blinded randomized controlled trial asthmatic patients with positive skin prick tests to Dermatophagoides pteronyssinus, and with serum IgE at least 200 UI were included. According to GINA, asthma severity was mild persistent and moderate. All patients improved their baseline FEV1 at least by 14% after inhaled albuterol. Spirometry was performed again after three and six months after initiating treatment. Patients were randomized to receive for six months either sublingual immunotherapy with Der p 1 standardized allergens (IPI-ASAC, México) at a total dose of 10,469 UBE or identically looking and tasting placebo. Both groups received conventional pharmacological therapy. RESULTS: Sixty four patients enter the study; four were excluded because of systemic oral steroid therapy. Sixty patients underwent randomization. Both groups (30 patients in each one) were similar in their baseline characteristics. After six months, patients that received sublingual immunotherapy had less exacerbations than those in the control group (61 vs 123, T 2.61, p<0.001, IC 1.8-7.2), better FEV1 as compared with baseline values (25% vs 9%, Z=0.66, p=0.03), and less need of albuterol (50% of initial dose, vs 21% (Z=1.4, p=0.03, IC 1.39-1.49). CONCLUSION: Sublingual immunotherapy improves patient symptoms and pulmonary functional tests, makes exacerbations less frequent, and reduces albuterol needs. It may improve asthma related quality of life.

[Skin tests with high and minor determinants in patients with doubtful allergy to penicillin]. / Pruebas cutáneas con determinantes mayores y menores en pacientes con alergia dudosa a la penicilina.

BACKGROUND: Currently, the skin tests are the most accepted methods for the diagnosis of allergy to penicillin. OBJECTIVE: To evaluate the efficacy and diagnosis security of the skin tests with high and minor determinants of penicillin, crystalline and penicillin, in patients with hypersensitivity reaction to penicillin. METHODS: Patients with doubtful antecedents of reaction to penicillin (problem group) and healthy patients (control group) were included. Both groups were submitted at the following tests: 1) Skin tests with high and minor determinants of penicillin, and crystalline penicillin, by prick and intradermoreaction methods. 2) In case of negativity, tests of direct challenge with penicillin were practiced. The formation of wheal with or without erythema 3 mm related to the negative control or systemic reaction, was considered positive test. RESULTS: 47 patients were included (24 for problem group, and 23 for control group), 50% of the group problem showed positive reactions with the method of prick, none patient of the control group (p < 0.001); with the intradermoreaction method, 79% in the problem group and only 13.4% in the control group showed positive reaction (p < 0.001). Cutaneous tests showed local adverse effects. Clinical history showed a sensitivity or 88%, method of prick, 50%, and intradermoreaction method, 95%.

[Asthma and gastroesophageal reflux. Diagnostic correlation between gammography and digestive endoscopy]. / Asma y reflujo gastroesofágico. Correlación diagnóstica entre gamagrafía y endoscopía digestiva.

AIMS: Incidence of gastroesophageal reflux (RGE) in asthmatic it is considered be of the rang of 33% until 89%. RGE can be classic or atypical and 30% will be payees of silent reflux. It considers at the moment so much as standard of gold to 24 hours pH esophagus like endoscopic digestive and biopsy, being determined a smaller sensibility to gastric gammagraphic but maybe a bigger utility in relation to their readiness and access easiness. OBJECTIVE: Comparative study is presented that reports sensibility/specificity of gastric gammagraphic, relating it with digestive endoscopic study and biopsy report. METHOD: All asthmatic patient of difficult control and of up to 6 years, selected of the External Consultation of the Service. Gastric gammagraphic was determined and later on the panendoscopic study with taking of biopsy. It integrated sensibility specificity for gammagraphic gastric. RESULTS: Study that understood 8 months, with a total of 44 patients, with a range of 1.4 year-old age to 6 years. Gastric gammagram was reported positive in 25 patients, (56.8%) and negative in 19,(43.18%). Endoscopic studies demonstrated incompetent hiatus in 33 (75%), esophagitis of variable degree in 20 patients, (45.4%), Gastritis in 8 (18.1%) and normal study in 8, (18.1%). Histopathologies: Esophagitis of variable degree in 33 patients (75%), chronic gastritis in 2 patients, (4.5%), Esophagus of Barrett in 2 patients, (4.5%), and normal histopathologic study in 7,(15.9%). Of the 44 patients, 81.5% showed significant reflux. It is integrated a sensibility and specificity of the gastric gammagraphic of 71.4% and 54.2%, respectively. CONCLUSIONS: Gastric gammagraphic contributes sensibility it mediates but acceptable for diagnose of RGE. In asthmatic of difficult control, it should be considered initially endoscopic study. The probability of RGE should always take into account in all asthmatic patient.

[Comparative treatment between thalidomide and transfer factor in severe atopic dermatitis]. / Tratamiento comparativo entre talidomida y factor de transferencia en dermatitis atópica severa.

AIMS: The atopic dermatitis is an chronic inflammatory illness of the skin. It exists an interrelation complex of factors gene, environmental, and psychological that contribute to the development and severity of the illness. The immunol aberrations significant is the answer increased of IgE specific antibodies toward antigens common, the liberation is increased of immunol mediators by the basophils and mast cells, eosinophils peripheral and local, besides enlarges the biphasic activity Th1/Th2 with liberation of cytokines (IL-4, IL-5, IL-13), GM-C5F, and decrease of IFN-gamma by the cells Th1. Leung to report a knowledge upon the bases immunopathologies of it atopic dermatitis has immunopathologies clinical important for the diagnosis and processing. Alternatives multiples of processing by the same complexity of the illness exist. OBJECTIVE: To compare the security and the clinical efficacy of the thalidomide and the factor of transfer in the atopic dermatitis severe. MATERIAL AND METHOD: Were studied patient with diagnosis of atopic dermatitis severe in agreement with the criterions of Hanifin and Rajka that they entered to the service of Allergy and Immunology Clinical of the Hospital Regional Lic. Adolfo López Mateos (public hospital). They were included 19 patient (women 12 and men 7, with age average 30 +/- 4 years). They were distributed in two groups. The first group of 5 patient administration thalidomide 200 mg/d during six months. The second group am administered the factor of transfer a total of 15 units by road oral during six months. Studies of laboratory for appraisal were requested immunology and metabolic pretreatment and pretreatment. RESULTS: In the group A dealt with thalidomide 5 patient and the group B dealt with FT, both presented a statistically significant decrease, as for the extension of the wounds (p < 0.01), and 1 am observed greater reduction in the intensity of the symptoms, the SCORAD total (p < 0.001 and p < 0.001 respectively) with statistical difference among them. None presented alterations immunologies and metabolic secondary to the use of the two drugs and not there was the need to suspend the processing. During the period of study, the patient were maintained controlled to the allergic rhinitis and the asthma. DISCUSSION: In the atopic dermatitis by its secondary clinical complexity to the multifactors etiologic, the alternatives of processing utilized in the present study are an option the security and efficacy, I am observed better clinical.

La ambigüedad en una publicación ¿es o no un ensayo clínico? / The ambiguous writing: Is it a clinical trial?

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[Respiratory function tests in aspirin-induced asthma]. / Pruebas de función respiratoria en asma inducida por aspirina.

INTRODUCTION: Aspirin induced Asthma (AIA) is a syndrome, with typical clinical features. Aspirin and Nsaids induced Asthma is its distinctive characteristic. OBJECTIVE: Was to determine challenge and bronchodilator test usefulness, as well as its complications, in patients with Aspirin induced Asthma. MATERIAL AND METHODS: Prospective, open, transversal and comparative study of 20 patients divided in two groups of ten people each one group with an Aspirin induced Asthma antecedent, undertook a challenge and bronchodilator test, and the second group was composed of patients with extrinsic asthma which were exposed to a challenge test. All patients had a physical exam and laboratory test, besides paranasal and chest X-ray, allergic skin test and spirometry. Criteria used to make diagnosis of AIA were defined as a 15% decrease of FEV-1 in the both groups. Laboratory and other paraclinic studies were made in order to assess diagnosis and/or complications. RESULTS: In the first group it was observed a 15% statistically significant decrease of FEV-1 and FEF 25-75 values (p < 0.05), on second group an statistically significant increase in FEV-1 values of more than 15% was observed in 7 patients (p < 0.05). In the control group no statistically significative changes were observed in the patients. The more frequent complications after challenge test were wheeze, dyspnea, cough and severe bronchospasm. Zero defunctions were reported. CONCLUSION: The minimum dose to realize the diagnosis of AIA are 100 mg of aspirin. The FEV-1 decrease depend of dose of aspirin in patients with AIA. Patients with extrinsic asthma without an aspirin intolerance history, have non adverse effects with aspirin ingestion. Severe bronchospasm was the most severe complication in patients who underwent Aspirin challenge test who had an idiosyncrasy history.

[Cell surface markers in patients with allergic rhinitis versus Der p and Der f challenge]. / Estudio de marcadores de superficie celular en pacientes con rinitis alérgica frente a reto con Der p y Der f.

The allergic condition is determined genetically and they affect of the general population's 20-30% in developed countries, in the last decade have been increased the prevalence. Inside the imbalance that is manifested in the atopic patients it is on one hand the antigen-presenting cells (monocytes and B cells) and on the other hand, the lymphocytes T CD4+. The association of molecules like CD80, CD 86 (co-stimulatory molecules) in monocytes and B cells and CD30, CD62L, ALL, CD11a, CD28, CD124 and CD152 in CD4+, they have shown to be of particular interest in allergic sufferings. However we don't find a difference statistically significant among patient and controls and among nasal challenges with saline solution with specific allergen. For what we suggest that the changes in the activation, proliferation and cooperation are given in the les ion place, without an apparent repercussion in cells of peripheral blood.

[Asthma phenotype during the first six years of life]. / Fenotipos de asma durante los primeros seis años de vida.

UNLABELLED: Asthma is one of the main wheezing causes during the first years of life. In our country it is a common respiratory chronic illness but insufficient studies still exist on the asthma phenotypes during the first years of life. OBJECTIVE: To know the phenotype of asthma in a group of children younger than 6 years old. MATERIAL AND METHODS: 185 children of both sexes were studied with antecedent of having presented wheezing (tree episodes or more) and it registered data about the antecedents of family and personal allergy, dietary habits during the first year of life, infections, data on the beginning and the evolution of the condition, and they were practiced determinations of peripheral eosinophilia, total serum IgE and gastric gammagram to discard illness for gastroesophageal reflux. All were carried out skin tests for foods and aeroallergens. RESULTS: In the group of 185 patients of both sexes, they had data that supported the allergic process, in 137. It was correlated the atopy antecedents significantly, positive skin tests, eosinophilia (more than 300), with elevated IgE for the age (p < 0.05). The gastric gamagrama was carried out in 144 patients, of which were positive results for gastroesophageal reflux in 64 (44%) and in 79 (54%) it was reported doubtful or negative. It was related the gastroesophageal reflux presence and the positive skin tests significantly (p < 0.05). CONCLUSIONS: The more common phenotype of asthma in our patients corresponds to a wheezing pattern that persist after the 3 years old, in relation to an allergic component. Furthermore in most of those children a positive gastroesophageal reflux was an important finding.

Emergence and dissemination of quinolone-resistant Escherichia coli in the community.

We studied the evolution of resistance to quinolones in Escherichia coli from 1992 to 1997 in Barcelona, Spain. An increasing proportion of quinolone-resistant E. coli (QREC) infections was observed. QREC strains were more common in patients with nosocomial infections but also increased in patients with community-acquired infections (9% in 1992 to 17% in 1996). Seventy (12%) of 572 episodes of E. coli bacteremia were due to QREC. Factors significantly associated with QREC bacteremia were the presence of underlying disease, recent exposure to antibiotics, and bacteremia of unknown origin. In the multivariate analysis, only prior exposure to antimicrobial agents (P < 0.001; odds ratio [OR] = 2), specifically, to quinolones (P < 0. 001; OR = 14), and the presence of a urinary catheter (P < 0.001; OR = 2) were significantly associated with QREC bacteremia. Among 16 QREC isolates from cultures of blood of community origin selected at random, 13 different pulsed-field gel electrophoresis patterns were recognized, showing the genetic diversity of these isolates and in turn indicating the independent emergence of QREC in the community. The prevalence of QREC in the feces of healthy people was unexpectedly high (24% in adults and 26% in children). A survey of the prevalence of QREC of avian and porcine origin revealed a very high proportion of QREC in animal feces (up to 90% of chickens harbored QREC). The high prevalence of QREC in the stools of healthy humans in our area could be linked to the high prevalence of resistant isolates in poultry and pork.

Fenotipos de asma durante los primeros seis años de vida / The asthma phenotypes during the first six years of life

El asma es una de las primera causas de sibilancias durante los primeros años de vida. En nuestro medio es una enfermedad crónica cada vez más frecuente; sin embargo, aún existen insuficientes estudios sobre los fenotipos de asma durante los primeros años de vida. Objetivo. Conocer el fenotipo del asma en un grupo de niños menores de seis años. Material y métodos. Se estudiaron 185 niños de uno y otro sexo con antecedentes de haber presentado sibilancias (tres ocasiones o más) en quienes se recabaron datos sobre los antecedentes familiares y personales de alergia, hábitos dietéticos durante el primer año de vida, infecciones, datos sobre el inicio y la evolución del padecimiento, y se les practicaron determinaciones de eosinófilos periféricos. IgE sérica total y gamagrama gástrico para descartar enfermedad por reflujo gastroesofágico. A todos se les realizaron pruebas cutáneas para alimentos e inhalables. Resultados. Del grupo de 185 pacientes se encontraron datos que apoyaban el proceso alérgico en 137. Se correlacionaron significativamente los antecedentes de atopia, positividad en las pruebas cutáneas, elevación de eosinófilos periféricos (más de 300) con nivel de IgE por arriba de los esperados para la edad (p<0.05). El gamagrama gástrico se realizó en 144 pacientes, de los cuales se encontraron resultados positivos para reflujo gastroesofágico en 64 (44 por ciento) y en los restantes 79 (54 por ciento) se reporto dudoso o negativo. El reflujo se relacionó significativamente y las pruebas cutáneas positivas (p<0.05). Conclusiones. El fenotipo de la mayoría de nuestros pacientes corresponde a un patrón de sibilancias que persisten después de los tres años, y se relacionan con un componente alérgico, además de que una proporción importantes de ellos se relaciona con datos de reflujo gastroesofágico

[Clinical and immuno-virologic efficacy of the expanded access use of protease inhibitors for HIV-1 advanced disease]. / Eficacia clínica e inmunovirológica del uso compasivo de los inhibidores de proteasas en pacientes con infección avanzada por el VIH-1.

OBJECTIVE: To compare the efficacy and tolerance of additive therapy with protease inhibitors (PI) in patients with advanced HIV infection previously treated with retro-transcriptase inhibitors (RTI). METHODS: Eighty patients with prior antiretroviral therapy with RTI (zidovudine, ddI or ddc) for more than 6 months were included. Fifteen patients received indinavir, 42 ritonavir and 23 saquinavir. Data were collected at 4, 12 and 24 weeks and included clinical events, tolerability, plasma HIV-1 RNA viral load and CD4+ cell counts. Virologic response was defined if a viral load reduction > 1 log was achieved. RESULTS: Virological response was observed in 45 patients (56.5%) at 4 weeks and was maintained in most of them at 24 weeks. Viral load below limit of detection was achieved in 11 (15%) patients at 12 weeks. Adverse effects were not uncommon, specially with ritonavir, and 10 patients (12.5%) discontinued treatment. Indinavir was the most efficient drug and statistical differences in decreasing viral load were reached in pairwaise comparison with saquinavir at any time and with ritonavir at 12 and 24 weeks. CD4+ cell counts increased with all three drugs parallel with the decrease of viral load. Four patients died and 12 had opportunistic infections. Proportion of patients without infections in the follow-up was associated with virological response over treatment (p < 0.01). CONCLUSIONS: The additive therapy with PI in advanced HIV patients can achieve a sustained reduction of viral load and a persistent recovery of CD4+ cell counts with clinical benefits. Within the limits of this study, indinavir seems more interesting in this group of patients in terms of probability pursuit of treatment because of better efficiency and fewer adverse effects.