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1.
Arch Phys Med Rehabil ; 98(6): 1165-1173, 2017 06.
Article in English | MEDLINE | ID: mdl-27993583

ABSTRACT

OBJECTIVE: To assess depression in a sample of individuals with spinal cord injury (SCI) living in the community, and to determine the prevalence of probable major depressive disorder (PMDD) among those with traumatic spinal cord injury (T-SCI) and those with nontraumatic spinal cord injury (NT-SCI). DESIGN: Cross-sectional. SETTING: Data were collected on individuals with SCI now living in the community, who completed a comprehensive follow-up assessment at the hospital. PARTICIPANTS: Individuals with T-SCI or NT-SCI (N=831) completed the Patient Health Questionnaire-9 (PHQ-9) and were included. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The PHQ-9 was used to detect the presence of PMDD and to measure the severity of the depression. RESULTS: The most frequent etiology of SCI was T-SCI (66.9%). Overall, 16.2% of participants met the criteria for PMDD; however, a higher prevalence was noted for individuals with NT-SCI (21.1%) than for individuals with T-SCI (13.8%). Risk factors between T-SCI and NT-SCI did not differ greatly. Female sex, chronic pain, and lower levels of/difficulties in participation were associated with the presence of PMDD. CONCLUSIONS: PMDD appears to occur at a higher rate in individuals with NT-SCI, with greater symptom severity. The finding that problems with participation are directly associated with depression raises the need for specific treatment goals, with the aim of empowering individuals with SCI to reintegrate into the community. Potential stress factors (eg, environmental barriers, limited participation options) should be addressed accordingly.


Subject(s)
Depression/epidemiology , Depression/psychology , Quality of Life , Spinal Cord Injuries/epidemiology , Spinal Cord Injuries/psychology , Adolescent , Adult , Aged , Chronic Pain/epidemiology , Chronic Pain/psychology , Cross-Sectional Studies , Disabled Persons/psychology , Female , Humans , Male , Middle Aged , Sex Factors , Trauma Severity Indices , Young Adult
2.
Psicothema (Oviedo) ; 28(2): 143-149, mayo 2016. ilus, tab
Article in English | IBECS | ID: ibc-151670

ABSTRACT

BACKGROUND: Visuo-spatial neglect predicts longer hospitalization, poorer recovery of motor skills and greater functional limitation. The aim of the present study was to analyze whether the combined administration of computerized cognitive rehabilitation with right hemifield eye-patching in patients with left spatial neglect following a right hemisphere stroke is more effective than computerized cognitive rehabilitation applied in isolation. METHOD: Randomized clinical trial conducted in 28 patients. These were grouped into two experimental groups: single treatment group (ST) (n= 15) and combined treatment group (CT) (n= 13). All received an average of 15 one-hour sessions of computerized cognitive rehabilitation using the Guttmann, NeuroPersonalTrainer® telerehabilitation platform. Those patients in the TC group performed the sessions wearing a visual device with which the right hemifield of each eye was occluded. RESULTS: Following treatment, both the ST and the TC group showed improvements in neuropsychological examination protocol although there were no differences pre- and post-treatment on the functional scale in either group. Likewise, no statistically significant differences were observed in intergroup comparison. CONCLUSIONS: The results from this study indicate that combination treatment is not more effective than rehabilitation applied in isolation


ANTECEDENTES: la negligencia visuo-espacial predice mayor tiempo de hospitalización, peor recuperación de las habilidades motoras y limitaciones funcionales. El objetivo fue analizar si la administración combinada de rehabilitación cognitiva informatizada junto con el right hemifield eye patching, en participantes que presentan negligencia espacial izquierda como consecuencia de un ictus hemisférico derecho, es más eficaz que la rehabilitación cognitiva informatizada aplicada de forma aislada. MÉTODO: ensayo clínico aleatorizado realizado con 28 participantes. Dos grupos experimentales: grupo tratamiento único (TU) (n= 15) y grupo tratamiento combinado (TC) (n= 13). Todos ellos recibieron una media de 15 sesiones de rehabilitación cognitiva informatizada de una hora de duración mediante la plataforma de telerehabilitación Guttmann, NeuroPersonalTrainer®. Los participantes del grupo TC las ejecutaron con un dispositivo visual que llevaba el hemicampo derecho de cada ojo ocluido. RESULTADOS: tras el tratamiento, tanto el grupo TU como el TC mostraron mejoras en el protocolo de exploración neuropsicológica aunque no hubo diferencias pre- y post-tratamiento en la escala funcional en ninguno de los dos grupos. Asimismo, no se observaron diferencias estadísticamente significativas en la comparación intergrupal. CONCLUSIONES: los resultados derivados de este estudio indican que el tratamiento combinado no es más eficaz que la rehabilitación aplicada de forma aislada


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Stroke/diagnosis , Stroke/etiology , Stroke/prevention & control , Cognitive Behavioral Therapy/instrumentation , Cognitive Behavioral Therapy/methods , 50230 , Telerehabilitation/instrumentation , Telerehabilitation/methods , Telerehabilitation , Neuropsychology/instrumentation , Neuropsychology/methods , Randomized Controlled Trials as Topic
3.
Psicothema ; 28(2): 143-9, 2016 May.
Article in English | MEDLINE | ID: mdl-27112810

ABSTRACT

BACKGROUND: Visuo-spatial neglect predicts longer hospitalization, poorer recovery of motor skills and greater functional limitation. The aim of the present study was to analyze whether the combined administration of computerized cognitive rehabilitation with right hemifield eye-patching in patients with left spatial neglect following a right hemisphere stroke is more effective than computerized cognitive rehabilitation applied in isolation. METHOD: Randomized clinical trial conducted in 28 patients. These were grouped into two experimental groups: single treatment group (ST) (n= 15) and combined treatment group (CT) (n= 13). All received an average of 15 one-hour sessions of computerized cognitive rehabilitation using the Guttmann, NeuroPersonalTrainer® telerehabilitation platform. Those patients in the TC group performed the sessions wearing a visual device with which the right hemifield of each eye was occluded. RESULTS: Following treatment, both the ST and the TC group showed improvements in neuropsychological examination protocol although there were no differences pre- and post-treatment on the functional scale in either group. Likewise, no statistically significant differences were observed in intergroup comparison. CONCLUSIONS: The results from this study indicate that combination treatment is not more effective than rehabilitation applied in isolation.


Subject(s)
Perceptual Disorders/rehabilitation , Stroke Rehabilitation/methods , Adult , Aged , Combined Modality Therapy , Female , Humans , Male , Middle Aged , Perceptual Disorders/etiology , Stroke/complications
4.
Int J Environ Res Public Health ; 12(8): 9832-47, 2015 Aug 18.
Article in English | MEDLINE | ID: mdl-26295252

ABSTRACT

The objective of this research is to provide a standardized platform to monitor and predict indicators of people with traumatic brain injury using the International Classification of Functioning, Disability and Health, and analyze its potential benefits for people with disabilities, health centers and administrations. We developed a platform that allows automatic standardization and automatic graphical representations of indicators of the status of individuals and populations. We used data from 730 people with acquired brain injury performing periodic comprehensive evaluations in the years 2006-2013. Health professionals noted that the use of color-coded graphical representation is useful for quickly diagnose failures, limitations or restrictions in rehabilitation. The prognosis system achieves 41% of accuracy and sensitivity in the prediction of emotional functions, and 48% of accuracy and sensitivity in the prediction of executive functions. This monitoring and prognosis system has the potential to: (1) save costs and time, (2) provide more information to make decisions, (3) promote interoperability, (4) facilitate joint decision-making, and (5) improve policies of socioeconomic evaluation of the burden of disease. Professionals found the monitoring system useful because it generates a more comprehensive understanding of health oriented to the profile of the patients, instead of their diseases and injuries.


Subject(s)
Brain Injuries/diagnosis , Disability Evaluation , Disabled Persons , Adolescent , Adult , Aged , Aged, 80 and over , Brain Injuries/etiology , Female , Humans , Male , Middle Aged , Prognosis , Young Adult
5.
Brain Inj ; 29(4): 501-7, 2015.
Article in English | MEDLINE | ID: mdl-25565480

ABSTRACT

OBJECTIVE: To assess whether, following a right-hemisphere stroke, the combined administration of computer-based cognitive rehabilitation and right hemifield eye-patching in patients with visuo-spatial neglect is more effective than computer-based cognitive rehabilitation alone. METHODS: Twelve patients were randomized into two treatment groups: a single treatment group (n = 7) and a combination treatment group (n = 5). In both cases, the treatment consisted of a mean number of 15 sessions, each lasting 1 hour. Visuo-spatial neglect was assessed using a specific exploration protocol (Bell Cancellation Test, Figure Copying of Odgen, Line Bisection, Baking Tray Task and Reading Task). The functional effects of the treatment were assessed using the Catherine Bergego Scale. RESULTS: Significant between-group differences were observed when comparing the pre- and post-treatment scores for the Reading Task. No differences were observed in either group in the Catherine Bergego Scale administered at baseline and at the final intervention. CONCLUSION: The results obtained do not allow one to conclude that the combination treatment with cognitive rehabilitation and right hemifield eye-patching is more effective than cognitive rehabilitation alone. Although partial improvement in the performance of neuropsychological tests was observed, this improvement is not present at functional level.


Subject(s)
Agnosia/rehabilitation , Cognition Disorders/rehabilitation , Stroke Rehabilitation , Adult , Agnosia/physiopathology , Agnosia/psychology , Cognition , Cognition Disorders/physiopathology , Cognition Disorders/psychology , Female , Humans , Male , Middle Aged , Perceptual Disorders/physiopathology , Perceptual Disorders/psychology , Perceptual Disorders/rehabilitation , Spain , Stroke/physiopathology , Stroke/psychology , Therapy, Computer-Assisted
6.
Disabil Rehabil ; 36(1): 82-8, 2014.
Article in English | MEDLINE | ID: mdl-23596999

ABSTRACT

PURPOSE: A worldwide internet survey was conducted (1) to identify problems of individuals with traumatic brain injury (TBI) addressed by health professionals and (2) to summarize these problems using the International Classification of Functioning, Disability and Health (ICF). METHOD: A pool of professionals involved in the TBI rehabilitation process that included physicians, nurses, physical therapists, occupational therapists, social workers and psychologists were surveyed to identify problems in functioning and contextual factors of individuals with TBI using open-ended questions. All answers were translated ("linked") to the ICF based on established rules. The frequencies of the linked ICF categories were reported stratified based on context. RESULTS: One-hundred thirty seven professionals from the six World Health Organization regions identified 5656 concepts. 92.66% could be linked to the ICF; 33.03% were related to the domain of body functions, 27.28% to activities and participation, 10.98% to structures and 21.38% to environmental factors. CONCLUSIONS: The complexity of TBI was described through the identification of a wide variety of ICF categories. ICF language proved to be a neutral framework allowing the comparison of answers between different professionals in different world regions. IMPLICATIONS FOR REHABILITATION: People that suffered a traumatic brain injury (TBI) may have a variety of sequelae that impair functioning. The International Classification of Functioning, Disability and Health (ICF) can help in providing information regarding the identification of patients problems and needs as well as planning, implementing and coordinating the rehabilitation process. The ICF provides a frame of reference process illustrated as the rehabilitation cycle that can help during the rehabilitation process in goal setting bringing together the clinicians' and patient's perspectives in a patient oriented biopsychosocial approach. In the field of TBI rehabilitation, activity limitations and participation restrictions are broadly affected as reported by the professionals interviewed and highly influenced by cognitive and moreover behavioral problems.


Subject(s)
Brain Injuries/rehabilitation , Disability Evaluation , Disabled Persons/classification , Health Personnel , International Classification of Functioning, Disability and Health , Activities of Daily Living , Adult , Disabled Persons/rehabilitation , Electronic Mail , Female , Health Care Surveys , Health Status , Humans , Internet , Interviews as Topic , Male , Middle Aged , Severity of Illness Index , Surveys and Questionnaires , World Health Organization
7.
J Biomed Inform ; 46(6): 1006-29, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24050902

ABSTRACT

OBJECTIVES: This research is concerned with the study of a new social-network platform, which (1) provides people with disabilities of neurological origin, their relatives, health professionals, therapists, carers and institutions with an interoperable platform that supports standard indicators, (2) promotes knowledge democratization and user empowerment, and (3) allows making decisions with a more informed opinion. METHODS: A new social network, Circles of Health, has been designed, developed and tested by end-users. To allow monitoring the evolution of people's health status and comparing it with other users and with their cohort, anonymized data of 2675 people from comprehensive and multidimensional medical evaluations, carried out yearly from 2006 to 2010, have been standardized to the International Classification of Functioning, Disability and Health, integrated into the corresponding medical health records and then used to automatically generate and graphically represent multidimensional indicators. These indicators have been integrated into Circles of Health's social environment, which has been then evaluated via expert and user-experience analyses. RESULTS: Patients used Circles of Health to exchange bio-psycho-social information (medical and otherwise) about their everyday lives. Health professionals remarked that the use of color-coding in graphical representations is useful to quickly diagnose deficiencies, difficulties or barriers in rehabilitation. Most people with disabilities complained about the excessive amount of information and the difficulty in interpreting graphical representations. CONCLUSIONS: Health professionals found Circles of Health useful to generate a more integrative understanding of health based on a comprehensive profile of individuals instead of being focused on patient's diseases and injuries. People with disabilities found enriching personal knowledge with the experiences of other users helpful. The number of descriptors used at the same time in the graphical interface should be reduced in future versions of the social-network platform.


Subject(s)
Disabled Persons , Nervous System Diseases , Social Support , Humans
8.
Neurorehabil Neural Repair ; 27(5): 421-9, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23322551

ABSTRACT

OBJECTIVE: Incomplete spinal cord injury (SCI) patients have the potential to regain some ambulatory function, and optimal reorganization of remaining circuits can contribute to this recovery. We hypothesized that repetitive transcranial magnetic stimulation (rTMS) may promote active recovery of motor function during gait rehabilitation. METHODS: A total of 17 incomplete SCI patients were randomized to receive active rTMS or sham stimulation coupled with rehabilitation therapy; 3 patients who began in the sham group crossed over to the active rTMS group after a washout period of more than 3 weeks. Active rTMS consisted of 15 daily sessions over the leg motor area (at 20 Hz). We compared lower-extremity motor score (LEMS), 10-m walking test for walking speed, timed up and go, Walking Index for SCI Scale, Modified Ashworth Scale, and Spinal Cord Injury Spasticity Evaluation Tool at baseline, after the last session, and 2 weeks later in the active rTMS and sham stimulation groups. RESULTS: A significant improvement was observed after the last rTMS session in the active group for LEMS, walking speed, and spasticity. Improvement in walking speed was maintained during the follow-up period. Sham stimulation did not induce any improvement in LEMS, gait assessment, and spasticity after the last session and neither during follow-up. CONCLUSION: In incomplete SCI, 15 daily sessions of high-frequency rTMS can improve motor score, walking speed, and spasticity in the lower limbs. The study provides evidence for the therapeutic potential of rTMS in the lower extremities in SCI rehabilitation.


Subject(s)
Functional Laterality/physiology , Gait Disorders, Neurologic/therapy , Movement Disorders/therapy , Spinal Cord Injuries/therapy , Transcranial Magnetic Stimulation/methods , Adolescent , Adult , Double-Blind Method , Electromyography , Female , Follow-Up Studies , Gait Disorders, Neurologic/etiology , Humans , Knee/physiopathology , Male , Middle Aged , Movement Disorders/etiology , Outcome Assessment, Health Care , Spinal Cord Injuries/complications , Statistics as Topic , Young Adult
9.
Clin Neurol Neurosurg ; 114(6): 645-50, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22245447

ABSTRACT

OBJECTIVE: To identify the most frequently used outcome measurement instruments reported in clinical studies on TBI and to provide a content comparison in the framework of the International Classification of Functioning, Disability and Health (ICF). PATIENTS AND METHODS: A systematic literature review of clinical studies in TBI was performed using Medline, EMBASE and PsychINFO. The items of the measurement instruments present in more than 20% of the studies were linked to the ICF language. RESULTS: 193 papers fulfilled the eligibility criteria. The frequency analysis identified six instruments: Functional Independence Measure (50%), Glasgow Outcome Scale (34%), Disability Rating Scale (32%), Wechsler Adult Intelligence Scale (29%), Trail Making Test (26%) and Community Integration Questionnaire (22%). The analysed instruments focus on different aspects of body functions (especially DRS, WAIS and TMT) and aspects of activities and participation in life (especially CIQ and FIM). Inter-researcher agreement for the ICF linking process was 0.83. CONCLUSIONS: Translating the items of different measurement instruments into the ICF language provides a practical tool to facilitate content comparisons among different outcome measures. The comparison can assist clinical researchers to integrate information acquired from different studies and different tools.


Subject(s)
Brain Injuries/classification , Disability Evaluation , Activities of Daily Living , Attention/physiology , Brain Injuries/rehabilitation , Cognition Disorders/etiology , Cognition Disorders/psychology , Glasgow Outcome Scale , Humans , Independent Living , International Classification of Diseases , Neurologic Examination , Neuropsychological Tests , Observer Variation , Social Behavior , Surveys and Questionnaires , Terminology as Topic , Treatment Outcome , World Health Organization
10.
Arch Phys Med Rehabil ; 93(3): 404-12, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22209475

ABSTRACT

OBJECTIVE: To report the clinical improvements in spinal cord injury (SCI) patients associated with intensive gait training using electromechanical systems according to patient characteristics. DESIGN: Prospective longitudinal study. SETTING: Inpatient SCI rehabilitation center. PARTICIPANTS: Adults with SCI (n=130). INTERVENTION: Patients received locomotor training with 2 different electromechanical devices, 5 days per week for 8 weeks. MAIN OUTCOME MEASURES: Lower-extremity motor score, Walking Index for Spinal Cord Injury, and 10-meter walking test data were collected at the baseline, midpoint, and end of the program. Patients were stratified according to the American Spinal Injury Association (ASIA) category, time since injury, and injury etiology. A subgroup of traumatic ASIA grade C and D patients were compared with data obtained from the European Multicenter Study about Human Spinal Cord Injury (EM-SCI). RESULTS: One hundred and five patients completed the program. Significant gains in lower-limb motor function and gait were observed for both types of electromechanical device systems, to a similar degree. The greatest rate of improvement was shown in the motor incomplete SCI patients, and for patients <6 months postinjury. The positive response associated with training was not affected by injury etiology, age, sex, or lesion level. The trajectory of improvement was significantly enhanced relative to patients receiving the conventional standard of care without electromechanical systems (EM-SCI). CONCLUSIONS: The use of electromechanical systems for intensive gait training in SCI is associated with a marked improvement in lower-limb motor function and gait across a diverse range of patients and is most evident in motor incomplete patients, and for patients who begin the regimen early in the recovery process.


Subject(s)
Exercise Therapy/instrumentation , Gait , Spinal Cord Injuries/rehabilitation , Adult , Age Factors , Aged , Disability Evaluation , Female , Humans , Male , Middle Aged , Prospective Studies , Sex Factors , Walking , Young Adult
11.
NeuroRehabilitation ; 29(1): 99-110, 2011.
Article in English | MEDLINE | ID: mdl-21876302

ABSTRACT

OBJECTIVE: To describe functioning and health of individuals with traumatic brain injury (TBI) based on the International Classification of Functioning, Disability and Health (ICF). METHODS: A cross-sectional, prospective study was conducted in a neurorehabilitation hospital. Data collection included socio-demographic factors, single interviews based on the extended ICF Checklist 2.1 for TBI, patient ratings on general health and functioning status, WHOQoL, EQ5D and the Comorbidity Questionnaire. RESULTS: 103 patients (81%males) were included in the study. The mean of age was 34 yrs. 24% were inpatients whereas 76% were outpatients. 130 out of 150 categories (87%) of the extended checklist were relevant in > 10% of patients. Differences in functioning and disability between patients in the shorter versus long term situation were noted to be predominantly in the ICF domains of Activities and Participation as well as in Body Functions. Correlations between EQ5D and ICF-based data collections were all p < 0.01. CONCLUSIONS: This study identified the most common problems in patients with TBI receiving Neurorehabilitation services based on the ICF. Results emphasize the need to describe disability and rehabilitation standards from a comprehensive perspective that not only includes Body Functions and Structures but also the ICF domains of Activities and Participation and Environmental factors.


Subject(s)
Activities of Daily Living , Brain Injuries , Disability Evaluation , International Classification of Diseases , Adolescent , Adult , Aged , Brain Injuries/classification , Brain Injuries/epidemiology , Brain Injuries/rehabilitation , Checklist , Child , Cross-Sectional Studies , Female , Glasgow Outcome Scale , Humans , Inpatients/statistics & numerical data , Male , Middle Aged , Outpatients/statistics & numerical data , Spain/epidemiology , Surveys and Questionnaires , Young Adult
12.
J Antimicrob Chemother ; 61(1): 191-4, 2008 Jan.
Article in English | MEDLINE | ID: mdl-17977910

ABSTRACT

OBJECTIVES: To provide evidence for the long-term effect of highly active antiretroviral therapy (HAART) on the incidence of cervical squamous intraepithelial lesions (SILs) among HIV-positive women with normal cytology test and CD4 count above 350 cells/mm(3). PATIENTS AND METHODS: A retrospective cohort study was carried out in HIV-positive women with two consecutive normal cervical cytological tests (Papanicolaou test) and at least one subsequent test, without previous cervical history of SIL or cancer diagnosis, and with an immunological status >350 CD4 cells/mm(3). The patients were divided into two groups: treated with HAART (HAART group) or not treated with HAART (NO-HAART group), during the period of time between cytology tests included in the survival analysis and time until SIL. RESULTS: Between January 1997 and December 2006, 127 women were included: 90 in the HAART group and 37 in the NO-HAART group. Both groups of patients were similar with respect to demographic data, except for HIV viral load and previous HAART inclusion (P < 0.001). SIL was diagnosed in 27 of 90 (30%) patients in the HAART group and in 7 of 37 (19%) patients in the NO-HAART group (OR = 1.84, 95% CI: 0.72-4.69, P = 0.202). The actuarial probability of remaining free of SIL at 3 years was 70% in the HAART group and 78% in the NO-HAART group. No variable was associated with an increased risk of developing SILs. CONCLUSIONS: These results suggest that when the patients' immunological status is above 350 CD4 cells/mm(3), the HIV-infected women treated with HAART present a similar cervical SIL incidence to women not on HAART.


Subject(s)
Anti-HIV Agents/therapeutic use , Cervix Uteri/pathology , HIV Infections/drug therapy , Uterine Cervical Dysplasia , Adult , Anti-HIV Agents/administration & dosage , Antiretroviral Therapy, Highly Active , CD4 Lymphocyte Count , Cohort Studies , Female , HIV Infections/complications , HIV Infections/epidemiology , HIV Infections/immunology , Humans , Incidence , Papanicolaou Test , Retrospective Studies , Uterine Cervical Neoplasms/epidemiology , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/virology , Vaginal Smears , Viral Load , Uterine Cervical Dysplasia/epidemiology , Uterine Cervical Dysplasia/pathology , Uterine Cervical Dysplasia/virology
13.
AIDS Res Hum Retroviruses ; 23(8): 965-71, 2007 Aug.
Article in English | MEDLINE | ID: mdl-17725412

ABSTRACT

The influence of HAART on the evolution to cervical squamous intraepithelial lesions (SIL) among HIV(+) women with a normal cytological test in the HAART era was studied. A retrospective cohort study (1997-2005) of HIV-infected women treated with HAART was conducted. Those with a normal cervical cytology (Papanicolaou test) and at least one subsequent test were included. Survival (time until diagnosis of SIL), univariate, and multivariate analyses were performed. A total of 133 HIV-infected patients treated with HAART were included. The incidence of SIL was 35% (47 patients). SIL was diagnosed in 36 of 110 (33%) patients with a baseline and final immunological status of >200 CD4 cells/microl and in 6 of 9 (67%) patients with a baseline and final immunological status of < or =200 CD4 (OR: 0.24, 95% CI: 0.06-1.03, p = 0.041). SIL was diagnosed in 10 of 60 (17%) patients with an undetectable baseline and final HIV viral load and in 36 of 70 (51%) patients with a detectable HIV viral load (OR: 0.19, 95% CI: 0.07-0.46, p < 0.001). A high incidence of SIL (cancer precursor lesions) was observed among HIV(+) women without a background of cervical pathology. The effect of HAART on the control of HIV replication and of immunological status (>200 CD4) through the follow-up was associated with a reduction of SIL.


Subject(s)
Antiretroviral Therapy, Highly Active , Cervix Uteri/pathology , HIV Infections/complications , HIV Infections/drug therapy , Uterine Cervical Dysplasia/complications , Adult , CD4 Lymphocyte Count , Cohort Studies , Female , HIV/physiology , HIV Infections/immunology , HIV Infections/virology , Humans , Papanicolaou Test , Retrospective Studies , Vaginal Smears , Viral Load , Uterine Cervical Dysplasia/drug therapy , Uterine Cervical Dysplasia/pathology , Uterine Cervical Dysplasia/virology
14.
AIDS ; 20(17): 2159-64, 2006 Nov 14.
Article in English | MEDLINE | ID: mdl-17086055

ABSTRACT

OBJECTIVE: To assess the efficacy, safety, and pharmacokinetic interactions of ezetimibe in HIV-infected patients with poorly controlled antiretroviral-associated dyslipidaemia while taking pravastatin alone. DESIGN: A prospective, open-label, one-arm study of 24 weeks duration. PATIENTS AND SETTING: Nineteen patients (18 on stable HAART), with low density lipoprotein (LDL)-cholesterol values of > or = 130 mg/dl despite the use of pravastatin. METHODS: Ezetimibe, 10 mg/day, was added to pravastatin 20 mg/day, while patients maintained the same antiretroviral regimen. Determinations of total, LDL-, and high density lipoprotein (HDL)-cholesterol, triglycerides, apoproteins, and inflammatory factors (homocystein and C-reactive protein) were performed at baseline, and at weeks 6, 12, and 24. Liver enzymes and creatinine phosphokinase were also assessed. Protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) Cmin was determined just before and 12 weeks after ezetimibe introduction. RESULTS: At week 24, 61.5% of patients achieved the endpoint of the study (LDL-cholesterol < 130 mg/dl). Significant declines in mean total and LDL-cholesterol levels were observed between baseline and weeks 6, 12, and 24, irrespective of antiretroviral type (PI or NNRTI). Mean HDL-cholesterol and apoprotein A increased significantly. No patients discontinued therapy due to intolerance or presented toxicity of grade 2 or more. No differences were observed in lopinavir or nevirapine Cmin measured just before and 12 weeks after ezetimibe introduction. CONCLUSION: The addition of ezetimibe to ongoing pravastatin seems to be an effective and safe option for HIV-infected patients not achieving the NCEP ATPIII LDL-cholesterol goals while receiving a statin alone. Its high tolerability and the lack of interactions with the cytochrome CYP3A4 indicate that ezetimibe will not increase the risk of toxicity or pharmacokinetic interactions with antiretrovirals.


Subject(s)
Anticholesteremic Agents/therapeutic use , Azetidines/therapeutic use , Dyslipidemias/drug therapy , HIV Infections/drug therapy , HIV-1 , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Adult , Antiretroviral Therapy, Highly Active/adverse effects , Dyslipidemias/chemically induced , Ezetimibe , Female , Humans , Male , Pilot Projects , Prospective Studies , Treatment Outcome
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