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1.
J Clin Endocrinol Metab ; 86(2): 475-7, 2001 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-11157993

RESUMEN

We report the first case of repaglinide-induced factitious hypoglycemia in a young male. This case posed a challenging diagnostic dilemma because commercial assays for repaglinide are not available. Furthermore, the patient had a series of positive diagnostic tests such as high proinsulin and localizing intra-arterial calcium stimulation suggestive of insulinoma. This case, again, demonstrates the importance of pure clinical judgment in the face of often-conflicting laboratory data in making a correct diagnosis and the requirement of definitive data for an appropriate therapeutic resolution.


Asunto(s)
Carbamatos/envenenamiento , Hipoglucemia/inducido químicamente , Hipoglucemiantes/envenenamiento , Piperidinas/envenenamiento , Intoxicación/diagnóstico , Adolescente , Glucemia/metabolismo , Diagnóstico Diferencial , Ayuno , Humanos , Insulina/sangre , Insulina/metabolismo , Secreción de Insulina , Masculino , Trastornos Mentales , Intoxicación/sangre
2.
Medicine (Baltimore) ; 79(1): 9-26, 2000 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-10670406

RESUMEN

Systematic review of the available information with a modified, largely quantitative method of research synthesis disclosed that an initial trial of thyroid hormone suppression therapy leads to clinically significant (> or = 50%) reduction of nodule size or arrest of nodule growth in a subset of patients with benign solitary thyroid nodules. In fact, in addition to objective improvements due to decreasing nodule size, L-T4 suppression therapy may benefit patients by reducing perinodular thyroid volume. Consequently, both pressure symptoms and cosmetic complaints may improve (9, 68). Additional studies for the assessment of the risks versus benefits of supraphysiologic doses of L-T4, the optimal level of thyroid suppression and the dose needed to achieve this magnitude of reduction, the optimal length of the initial trial, and the conditions for the continuation of L-T4 thyroid suppression therapy, as well as the identification of markers for patients most likely to respond to this therapy, are warranted. Finally, quantitative assessment of available evidence as described here may be applicable to the review of other controversial issues as well.


Asunto(s)
Antitiroideos/administración & dosificación , Nódulo Tiroideo/tratamiento farmacológico , Adulto , Ensayos Clínicos como Asunto , Consensus Development Conferences, NIH as Topic , Humanos , Investigación , Tiroxina/antagonistas & inhibidores , Estados Unidos
3.
Pharmacotherapy ; 8(1): 52-68, 1988.
Artículo en Inglés | MEDLINE | ID: mdl-3287356

RESUMEN

Herpes zoster is a cutaneous vesicular eruption resulting from recrudescence of the chickenpox virus. It is mainly a disease of adults, with a predisposition for the elderly or immunocompromised. Although usually localized, the disease can disseminate to visceral organs. Diagnosis is often made based on the characteristic pattern of the lesion and clinical features. Tzanck smear, viral isolation, seroconversion, antibody titers, and monoclonal antibodies may further aid or confirm the diagnosis. Clinical features of herpes zoster may follow a progression through 3 stages, prodromal, acute, and chronic. The prodromal and acute phases seldom require more than symptomatic management. The chronic pain syndrome, postherpetic neuralgia (PHN), demands a more aggressive approach. Pharmacologic intervention, neuroaugmentation, and/or surgery may prevent or alleviate PHN, but universal response to any of these therapeutic approaches is unlikely. Tricyclic antidepressants remain the first choice in treating this pain syndrome. A trial of antiviral therapy may be warranted in patients with disseminated disease or in immunocompromised patients with localized disease. Of the antiviral agents, acyclovir is considered the drug of choice by most clinicians.


Asunto(s)
Analgésicos/uso terapéutico , Antivirales/uso terapéutico , Herpes Zóster , Aciclovir/uso terapéutico , Terapia por Estimulación Eléctrica , Herpes Zóster/diagnóstico , Herpes Zóster/etiología , Herpes Zóster/terapia , Humanos , Aislamiento de Pacientes , Vidarabina/uso terapéutico
4.
Pharmacotherapy ; 9(1): 34-8, 1989.
Artículo en Inglés | MEDLINE | ID: mdl-2922358

RESUMEN

Alprazolam, an anxiolytic benzodiazepine, has a pharmacologic profile similar to that of diazepam. An intermediate half-life of 10-12 hours and a comparatively brief duration of activity relative to other anxiolytic benzodiazepines justified evaluation of a 0.5-mg test dose in an anxious patient with chronic obstructive lung disease. Subjective indexes, breath-by-breath respiratory drive response to hypercapnia, and blood alprazolam concentrations were determined before and after dosing. Subjective testing included a visual analog dyspnea scale, the state anxiety inventory, and subjective feelings visual analog scales (represented by alertness, calmness, and level of contentment). After dosing, the patient was better able to tolerate the rebreathing study technique. Statistically significant improvements in dyspnea (t - 10.20; p 0.0005), anxiety (t - 45.85; p less than 0.0001), alertness (t - 13.04; p less than 0.0001), cententedness (t - 12.27; p less than 0.0001), and calmness (t - 8.05; p less than 0.0001) occurred after alprazolam administration. Drive to breathe, as determined by mouth occlusion pressure and minute ventilation, was not statistically different before and after dosing. No adverse effects were reported or observed. Further study is warranted.


Asunto(s)
Alprazolam/farmacología , Ansiedad , Disnea/inducido químicamente , Enfermedades Pulmonares Obstructivas/fisiopatología , Respiración/efectos de los fármacos , Alprazolam/farmacocinética , Semivida , Humanos , Enfermedades Pulmonares Obstructivas/metabolismo , Enfermedades Pulmonares Obstructivas/psicología , Masculino , Persona de Mediana Edad
5.
Pharmacotherapy ; 21(5): 528-33, 2001 May.
Artículo en Inglés | MEDLINE | ID: mdl-11349741

RESUMEN

STUDY OBJECTIVE: To compare the pharmacokinetics of subcutaneous and intravenous fludarabine in patients with lupus nephritis. DESIGN: Open-label, randomized, crossover trial conducted with a phase I-II trial. SETTING: Government research hospital. PATIENTS: Five patients with lupus nephritis. INTERVENTION: Fludarabine 30 mg/m2/day was administered either subcutaneously or as a 0.5-hour intravenous infusion for 3 consecutive days. All patients received oral cyclophosphamide 0.5 g/m2 on the first day of each cycle. MEASUREMENTS AND MAIN RESULTS: Plasma samples were collected before and 0.5, 1, 1.5, 2, 4, 8, and 24 hours after the first dose. Urine was collected at 6-hour intervals for 24 hours. Plasma and urine were analyzed for fluoro-arabinofuranosyladenine (F-ara-A), fludarabine's main metabolite, using high-performance liquid chromatography. Compartmental techniques were used to determine the pharmacokinetics of F-ara-A; a linear two-compartment model best described them. Comparison of the pharmacokinetics between subcutaneous and intravenous administration was done by using a Wilcoxon signed rank test. No significant differences were found between subcutaneous and intravenous administration in median (interquartile range) maximum concentrations of 0.51 (0.38-0.56) and 0.75 (0.52-0.91) mg/L, respectively, or in fitted area under the concentration-time curves from 0-24 hours of 4.65 (4.17-4.98) and 4.55 (3.5-4.94) mg x hour/L, respectively. Bioavailability of F-ara-A after subcutaneous dosing was approximately 105% of the bioavailability after intravenous administration. Differences in renal clearance and percentage of dose excreted in urine for subcutaneous and intravenous administration were nonsignificant. No injection site reactions were seen with subcutaneous dosing. CONCLUSION: Subcutaneous and intravenous administration of fludarabine appear to have similar pharmacokinetics in patients with lupus nephritis. Subcutaneous injection may offer a convenient alternative to intravenous administration.


Asunto(s)
Antineoplásicos/farmacocinética , Nefritis Lúpica/metabolismo , Vidarabina/farmacocinética , Adulto , Antineoplásicos/administración & dosificación , Intervalos de Confianza , Estudios Cruzados , Ciclofosfamida/administración & dosificación , Femenino , Humanos , Infusiones Intravenosas , Inyecciones Subcutáneas , Nefritis Lúpica/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Estadísticas no Paramétricas , Vidarabina/administración & dosificación , Vidarabina/análogos & derivados
6.
Pharmacotherapy ; 21(11): 1425-35, 2001 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-11714217

RESUMEN

A 22-year-old man with hypogonadotropic hypogonadism was receiving monthly intramuscular injections of testosterone replacement therapy. The patient refused to self-administer the injections because of discomfort, so the therapy was switched to testosterone patches. He experienced a pruritic, macular, erythematous rash underneath the reservoir area of two different transdermal formulations, which did not improve after pretreatment with topical corticosteroids. Eventually, he tolerated application of a testosterone gel and his serum testosterone levels returned to normal after 1 month of therapy. Commercially available and investigational testosterone products and therapeutic monitoring guidelines for androgen replacement are reviewed.


Asunto(s)
Terapia de Reemplazo de Hormonas/métodos , Prurito/inducido químicamente , Testosterona/administración & dosificación , Testosterona/efectos adversos , Administración Cutánea , Adulto , Geles , Terapia de Reemplazo de Hormonas/estadística & datos numéricos , Humanos , Inyecciones Intradérmicas , Masculino , Testosterona/farmacocinética
7.
Pharmacotherapy ; 19(3): 349-55, 1999 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-10221374

RESUMEN

Because of lack of well-documented laboratory criteria, we assessed the usefulness of measuring free thyroxine (FT4) levels for monitoring levothyroxine replacement therapy in patients with central hypothyroidism. This consisted of a retrospective review from 1991-1997 of patient profiles extracted into a Macintosh 4th Dimension data base from the medical information system at a tertiary care biomedical research facility. Information was also retrieved from medical records of 135 ambulatory patients treated by 42 endocrinology practitioners, and 52 ambulatory patients treated by 20 endocrinology practitioners for central and primary hypothyroidism, respectively. Patient profiles were reviewed for most recent thyroid function test results and levothyroxine dosing information. Of 112 (83%) patients with central hypothyroidism who had FT4 levels within the laboratory's reference interval, only 2 had a dosage change. The FT4 concentration was concordant with physician-assessed thyroid status in 65 (82%) of 79 patients (95% CI 72-90, p<0.02) for whom clinical assessment was available in medical records. Thyrotropin, total thyroxine, and triiodothyronine levels were not significantly associated with clinical status (p>0.12) in patients with central hypothyroidism. Despite similar demographic and levothyroxine dosing profiles, patients with central hypothyroidism had significantly lower serum FT4 and thyrotropin concentrations than those with primary hypothyroidism. The appropriateness of levothyroxine replacement therapy in most patients with central hypothyroidism is reflected by a normal FT4 concentration measured with a valid assay. Whether midnormal or upper normal values are necessary for optimal therapy, and whether the therapeutic goal should be different in children than in adults, require prospective studies with independent, objective assessment of thyroid status.


Asunto(s)
Hipotiroidismo/tratamiento farmacológico , Tiroxina/uso terapéutico , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Pruebas de Función de la Tiroides , Tiroxina/sangre
8.
Pharmacotherapy ; 8(3): 183-8, 1988.
Artículo en Inglés | MEDLINE | ID: mdl-3174487

RESUMEN

Thirty-one medically stable, elderly males (age 75 +/- 8.3 yrs) participated in a prospective study evaluating the accuracy of 16 methods of estimating creatinine clearance. Serum creatinine values were determined on the mornings of days 1, 4, and 5 to assure stable renal function. On the morning of day 3, a 24-hour urine collection was initiated. A statistically significant correlation existed between the measured and estimated clearance values for all 16 formulas. The correlation (r less than 0.65) was lower than that in previously published studies, however. Five of the formulas (1A, 5A, 5B, 7A, 7B) demonstrated no statistical difference between mean measured and estimated values. In this population, formula 2B was the least biased and formula 9B the most accurate. For all 16 methods, the bias was minimal and the relative accuracy of the estimated methods was comparable. The results support using methods to estimate creatinine clearance only as a rough bedside prediction of renal function in elderly males.


Asunto(s)
Creatinina/farmacocinética , Anciano , Ritmo Circadiano , Humanos , Pruebas de Función Renal , Masculino , Tasa de Depuración Metabólica
9.
Pharmacotherapy ; 5(6): 314-26, 1985.
Artículo en Inglés | MEDLINE | ID: mdl-3909117

RESUMEN

The elderly comprise one of the fastest growing populations in the United States. By the year 2020, an estimated 45 million will be classified as elderly. Aging is a highly variable process as declines occur in physiologic functions. Alterations in cardiovascular, renal and hepatic function have the greatest effect on drug therapy. All pharmacokinetic and pharmacodynamic variables may be altered by age. Adverse drug reactions, drug interactions and poor compliance are frequent and may further complicate drug therapy. A review of those processes that commonly influence pharmacologic response and patient compliance to drug therapy is appropriate.


Asunto(s)
Envejecimiento , Quimioterapia , Geriatría , Preparaciones Farmacéuticas/metabolismo , Anciano , Biotransformación , Composición Corporal , Enfermedades Óseas/epidemiología , Interacciones Farmacológicas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Oftalmopatías/epidemiología , Femenino , Enfermedades Gastrointestinales/epidemiología , Trastornos de la Audición/epidemiología , Humanos , Absorción Intestinal , Cinética , Masculino , Trastornos Mentales/epidemiología , Tasa de Depuración Metabólica , Enfermedades Musculares/epidemiología , Cooperación del Paciente , Unión Proteica , Disfunciones Sexuales Fisiológicas/epidemiología , Estados Unidos , Trastornos Urinarios/epidemiología , Enfermedades Vasculares/epidemiología
10.
Pharmacotherapy ; 16(6): 1103-10, 1996.
Artículo en Inglés | MEDLINE | ID: mdl-8947984

RESUMEN

We conducted a prospective, randomized, controlled trial to assess whether hospital formulary restrictions involving limiting dosage strengths of levothyroxine affect physicians' ability to manage patients effectively and provide pharmacy cost savings in a tertiary care federal government research hospital. Thirty-three endocrinologists were randomly assigned to prescribe levothyroxine from a restrictive (dosage strengths of 25, 50, 100, 125, and 150 micrograms) or a nonrestrictive (dosage strengths of 25, 50, 75, 100, 112, 125, 150, 175, 200, and 300 micrograms) formulary through a central computer system. Their 241 respective outpatients' laboratory results and drug compliance were outcome measures. Achievement of treatment objectives was measured by thyroid function tests (free and total thyroxine, total triiodothyronine, thyrotropin), number of clinic visits, and compliance (survey method). Additional measures were drug distribution patterns, drug costs, and pharmacy inventory costs. Restriction of levothyroxine's dosage strength did not significantly alter therapeutic outcomes. However, the restricted formulary was associated with more complex dosing regimens, and resulted in no significant cost savings. It is not known whether such restriction would adversely affect the care of patients of nonspecialists. Prospective studies are required to verify presumed cost-containment measures before such measures are adopted for widespread application.


Asunto(s)
Hospitales Federales/economía , Pautas de la Práctica en Medicina/economía , Enfermedades de la Tiroides/tratamiento farmacológico , Tiroxina/administración & dosificación , Tiroxina/economía , Adulto , Control de Costos , Femenino , Formularios de Hospitales como Asunto , Humanos , Masculino , Maryland , Persona de Mediana Edad , National Institutes of Health (U.S.) , Cooperación del Paciente , Estudios Prospectivos , Estados Unidos
11.
Pharmacotherapy ; 18(6): 1224-9, 1998.
Artículo en Inglés | MEDLINE | ID: mdl-9855320

RESUMEN

STUDY OBJECTIVE: To describe the pharmacokinetics and pharmacodynamics of fludarabine in patients with rheumatoid arthritis (RA). DESIGN: Open-label, staggered trial conducted in conjunction with a phase I-II clinical trial. SETTING: Government research hospital. PATIENTS: Twenty-six patients with refractory RA. INTERVENTION: Fludarabine 20 or 30 mg/m2/day was administered as a 0.5-hour infusion for 3 consecutive days (1 cycle) for 6 months (1 cycle/mo). MEASUREMENTS AND MAIN RESULTS: Serial plasma samples were collected for pharmacokinetic analysis on day 2 of the first cycle of therapy. Relationships between pharmacokinetic parameters and hematologic and efficacy parameters were examined. The disposition of fludarabine was characterized by a two-compartment model. There were no differences in pharmacokinetics between the low- and high-dose groups. The mean+/-SD total clearance, volume of distribution at steady state, and beta-half-life were 13.68+/-5.1 L/hour, 170.08+/-86.5 L, and 10.9+/-3.1 hours, respectively. The volume of the peripheral compartment was approximately twice as large as the volume of the central compartment, indicating a significant amount of tissue distribution. No significant pharmacodynamic relationships were observed between pharmacokinetic parameters and hematologic and efficacy parameters. CONCLUSION: Fludarabine pharmacokinetics in patients with RA are characterized by an intermediate-length distribution phase (approximately 40 min), terminal half-life of 10.9 hours, and significant amount of tissue distribution.


Asunto(s)
Artritis Reumatoide/tratamiento farmacológico , Inmunosupresores/farmacocinética , Vidarabina/análogos & derivados , Adulto , Área Bajo la Curva , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Inmunosupresores/administración & dosificación , Inmunosupresores/uso terapéutico , Masculino , Tasa de Depuración Metabólica , Persona de Mediana Edad , Análisis de Regresión , Vidarabina/administración & dosificación , Vidarabina/farmacocinética , Vidarabina/uso terapéutico
12.
Thyroid ; 3(2): 81-5, 1993.
Artículo en Inglés | MEDLINE | ID: mdl-8369656

RESUMEN

Patients receiving exogenous levothyroxine are reported to have higher total and free serum thyroxine levels than euthyroid controls. This may be an artifact of the serum collection time. We explored the effect of collection time on serum levels of thyroid hormones in outpatients receiving levothyroxine for replacement therapy (26 patients) or suppression of thyrotropin (25 patients). Blood samples, obtained during regular clinic visits (random samples) and at more than 22 h from ingestion of levothyroxine (trough samples), were assayed for total and free thyroxine, triiodothyronine, and thyrotropin. Four athyreotic patients on levothyroxine therapy had serial blood sampling over 24 h. Compared to corresponding trough samples, random samples had elevated total thyroxine levels in patients receiving replacement (8.1 +/- 1.2%, mean +/- SE, p = 0.0001) and in patients undergoing suppression (8.8 +/- 1.6%, p = 0.0001). Free thyroxine was increased by 12.7 +/- 2.6% (p = 0.0003) and 14.5 +/- 2.3% (p = 0.0001), respectively, compared with trough samples. Thyrotropin levels were 18.9 +/- 6.8% (p = 0.003) lower in patients receiving replacement and triiodothyronine levels showed small or no changes. Time-course analysis showed that free and total thyroxine levels remained significantly elevated above baseline for 9 and 5 h, respectively, after a levothyroxine dose. In conclusion, there is a transient increase in thyroid hormone levels for 9 h after an oral levothyroxine dose. Accurate assessment of thyroid hormone levels in patients receiving levothyroxine therapy should take this into account. This has greatest significance in selecting minimal levothyroxine dosages for suppression of thyrotropin.


Asunto(s)
Ritmo Circadiano/fisiología , Tiroxina/sangre , Tiroxina/uso terapéutico , Triyodotironina/sangre , Administración Oral , Análisis de Varianza , Artefactos , Femenino , Humanos , Hipotiroidismo/sangre , Hipotiroidismo/tratamiento farmacológico , Hipotiroidismo/etiología , Masculino , Radioinmunoensayo , Neoplasias de la Tiroides/sangre , Neoplasias de la Tiroides/complicaciones , Nódulo Tiroideo/sangre , Nódulo Tiroideo/complicaciones , Tirotropina/sangre , Tiroxina/administración & dosificación , Factores de Tiempo
13.
Clin Nephrol ; 52(2): 67-75, 1999 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-10480216

RESUMEN

BACKGROUND: Lymphocytes are believed to play a role in the induction and perpetuation of membranous nephropathy. Fludarabine is a purine nucleoside analog with selective activity against both dividing and resting lymphocytes. We evaluated the tolerance, toxicity, pharmacokinetics, immunologic, and clinical effects of fludarabine in patients with membranous nephropathy in an single arm pilot study. PATIENTS AND METHODS: Eight patients with idiopathic (n = 7) or lupus (n = 1) membranous nephropathy who had failed high-dose prednisone (n = 8) and/or alkylating agents (n = 2), or cyclosporine (n = 1) were treated with 6-monthly cycles of fludarabine (cycles 1-2, 20 mg/m2/day x 2 days, cycles 3-6, 20 mg/m2/day x 3 days). Mean proteinuria was 9 g/day with a mean duration of disease of 25 months (range 12-48). Proteinuria, GFR and effective renal plasma flow were compared before and after completing the treatment. RESULTS: Seven patients completed the protocol. CD3, CD4, CD8 and B cell counts decreased by 53%, 46%, 61% and 84%, respectively, at the end of treatment and remained at lower than pretreatment levels 6 months after completing the trial. Despite lymphopenia, serum immunoglobulin levels remained unchanged. Both naive (CD45RA+) and memory CD4+ T cells (CD45RO+) were reduced (naive > memory). Proteinuria decreased by > or = 50% in 5 out of 7 patients (p = 0.11). Filtration fraction improved in all patients with decreased filtration fraction at baseline. The only side-effect observed was one episode of acute bacterial sinusitis that responded promptly to antibiotic therapy. CONCLUSION: We conclude that low-dose fludarabine treatment in patients with membranous nephropathy is well tolerated and results in significant lymphopenia involving B more than T cells. In this pilot study improvement in proteinuria and filtration rate were observed. Additional studies are required to determine the optimal dose and clinical efficacy of fludarabine.


Asunto(s)
Glomerulonefritis Membranosa/tratamiento farmacológico , Inmunosupresores/uso terapéutico , Vidarabina/análogos & derivados , Adulto , Alquilantes/uso terapéutico , Antiinflamatorios/uso terapéutico , Linfocitos B/efectos de los fármacos , Linfocitos T CD4-Positivos/efectos de los fármacos , Linfocitos T CD8-positivos/efectos de los fármacos , Ciclosporina/uso terapéutico , Esquema de Medicación , Femenino , Estudios de Seguimiento , Tasa de Filtración Glomerular/efectos de los fármacos , Glomerulonefritis Membranosa/inmunología , Humanos , Inmunoglobulina G/sangre , Memoria Inmunológica/efectos de los fármacos , Inmunosupresores/administración & dosificación , Inmunosupresores/efectos adversos , Inmunosupresores/farmacocinética , Nefritis Lúpica , Recuento de Linfocitos/efectos de los fármacos , Linfocitos/efectos de los fármacos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Prednisona/uso terapéutico , Proteinuria/tratamiento farmacológico , Proteinuria/orina , Flujo Plasmático Renal Efectivo/efectos de los fármacos , Sinusitis/microbiología , Vidarabina/administración & dosificación , Vidarabina/efectos adversos , Vidarabina/farmacocinética , Vidarabina/uso terapéutico
14.
J Altern Complement Med ; 6(5): 429-35, 2000 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-11059505

RESUMEN

OBJECTIVE: To identify and characterize patterns of use of herbal products among patients participating in selected research clinics. DESIGN: Survey of three National Institutes of Health (NIH) ambulatory care research clinics. SUBJECTS: Convenience sample of 490 adult patients (168 male, 322 female) attending rheumatology, liver, and endocrinology/metabolic research clinics. RESULTS: Of the patients surveyed, 16.7%: (n = 82) reported using herbs. There were no significant sociodemographic differences between herb and nonherb users. Indications for herb use differed among the disease groups; patients in the endocrine and rheumatology clinics were taking herbs predominantly for "energy" or "wellness"; those attending the liver clinic tended to use herbal therapies as treatment for their disease. Mean and median monthly expenditure for herbal products was $30 and $10, respectively. There was a significant positive correlation between number of herbs used and use of other dietary supplements (p < 0.0001). CONCLUSIONS: One in six patients in ambulatory clinical research settings may be taking herbal products in addition to prescribed treatment. This figure is lower than in the general population, possibly because the patients may stop using herbs when participating in a research project. Although empirical evidence on the beneficial or adverse effects of herb therapy alone or in combination with drug therapies is limited, clinical researchers should be aware of the potential for confounding clinical trial results.


Asunto(s)
Fitoterapia , Plantas Medicinales , Adulto , Anciano , Anciano de 80 o más Años , Atención Ambulatoria , Femenino , Humanos , Masculino , Persona de Mediana Edad , National Institutes of Health (U.S.) , Encuestas y Cuestionarios , Estados Unidos/epidemiología
15.
Aliment Pharmacol Ther ; 35(1): 66-75, 2012 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-22050199

RESUMEN

BACKGROUND: Thiazolidinediones (TZDs) have been used in the treatment of non-alcoholic steatohepatitis (NASH). However, the magnitude of treatment response associated with TZDs in improving liver histology in NASH has not been quantified systematically. AIM: To conduct a meta-analysis of randomised, placebo-controlled clinical trials (RPCTs) using pioglitazone and rosiglitazone in the treatment of NASH. METHODS: Pubmed/MEDLINE and Cochrane Central Register of Controlled Trials 2010 were searched until September 2010 and four RPCTs were identified. Peto odds ratios (ORs) and their respective 95% confidence intervals (CIs) were used to assess the efficacy of TZDs in improving liver histological parameters. RESULTS: Four good quality RPCTs derived from three continents were included. The meta-analysis showed that TZDs (n = 169) were significantly better than placebo (n = 165) in improving ballooning degeneration, lobular inflammation and steatosis with combined ORs of 2.11 (95% CI, 1.33-3.36), 2.58 (95% CI, 1.68-3.97) and 3.39 (95% CI, 2.19-5.25) respectively. The improvement in combined necroinflammation with TZD (n = 58) vs. placebo (n = 52) was also statistically significant (combined OR 6.52[95% CI, 3.03-14.06]), but improvement in fibrosis was not. When pioglitazone (n = 137) was analysed alone, the improvement in fibrosis with pioglitazone (n = 137) vs. placebo (n = 134) (combined OR 1.68 [95% CI, 1.02-2.77]) was statistically significant. The total body fat slightly decreased in the control, while it markedly and highly significantly increased with TZD treatment. CONCLUSIONS: Thiazolidinediones significantly improve ballooning degeneration, lobular inflammation, steatosis and combined necroinflammation in patients with NASH. Pioglitazone may improve fibrosis. Larger randomised, placebo-controlled clinical trials are needed to examine the efficacy of thiazolidinediones in improving NASH fibrosis.


Asunto(s)
Hígado Graso/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Cirrosis Hepática/tratamiento farmacológico , Hígado/efectos de los fármacos , Tiazolidinedionas/uso terapéutico , Hígado Graso/complicaciones , Humanos , Enfermedad del Hígado Graso no Alcohólico , Pioglitazona , Ensayos Clínicos Controlados Aleatorios como Asunto
17.
DICP ; 24(1): 26-7, 1990 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-2301185

RESUMEN

Various brands of over-the counter (OTC) exogenous thyroid hormones are available in health food stores and retail pharmacies. Two commercially available OTC thyroid products were analyzed for total thyroxine (T4) and triiodothyronine (T3) content. The strength of a liquid thyroid gland extract was unlabeled and that of the solid oral preparation was 45 mg per table. The T4 concentration of the liquid preparation was less than 10 micrograms/dL; that of T3 was below the analytical sensitivity of our assay (less than 15 ng/dL). Tablet content of T4 and of T3 was up to 0.5 micrograms and up to 50 ng, respectively. Preliminary data on these OTC thyroid gland extracts cannot be extrapolated to all OTC thyroid products, but they suggest that such products generally contain concentrations of T4 and T3 below clinical effectiveness. Further analytical study is warranted.


Asunto(s)
Hormonas Tiroideas/análisis , Extractos de Tejidos/análisis , Medicamentos sin Prescripción , Glándula Tiroides/fisiología , Hormonas Tiroideas/uso terapéutico , Tiroxina/análisis , Tiroxina/uso terapéutico , Extractos de Tejidos/uso terapéutico , Triyodotironina/análisis , Triyodotironina/uso terapéutico
18.
Ann Pharmacother ; 26(7-8): 890-6, 1992.
Artículo en Inglés | MEDLINE | ID: mdl-1504394

RESUMEN

OBJECTIVE: To develop a comprehensive list of symptoms categorized by body system as part of a questionnaire for detecting potential adverse drug reactions. DATA SOURCES: A preliminary list of symptoms in lay terminology was extracted from the "Side Effects" section of all drug monographs contained in the United States Pharmacopeia Dispensing Information (USP DI) computerized database (Volume II, Advice for the Patient) using natural language processing software. The list was sorted alphabetically and duplicate terms were eliminated. Symptoms were then categorized by body system or anatomic region. A preferred term for each symptom was selected when multiple synonyms and related words were listed. Finally, all of the symptom terms were incorporated into a thesaurus from which the questionnaire was derived. RESULTS: The questionnaire will be used as part of a computer-assisted interview, developed to solicit information from patients regarding their medication regimens and to systematically query them regarding the presence of salient symptoms or complaints. The computer system will eventually interface with the USP DI database to identify drugs from a patient's regimen that may be associated with adverse symptoms. The symptom thesaurus will provide the link to the USP DI database. Preliminary experience with the questionnaire in a limited number of patients has been encouraging. CONCLUSIONS: The questionnaire can assist clinicians in identifying drug-related symptoms including unreported adverse clinical effects of newly marketed or investigational therapeutic agents. When the questionnaire is computerized and linked to a comprehensive database, it can be more widely used to alert healthcare providers of potential adverse drug reactions that may otherwise go undetected.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Monitoreo de Drogas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Encuestas y Cuestionarios , Servicios de Información sobre Medicamentos , Humanos
19.
Ann Pharmacother ; 35(12): 1578-83, 2001 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-11793625

RESUMEN

OBJECTIVE: To describe a patient with primary hypothyroidism in whom ingestion of levothyroxine with calcium carbonate led to markedly elevated serum thyrotropin concentrations. CASE SUMMARY: A 61-year-old white woman with primary hypothyroidism, systemic lupus erythematosus, celiac disease, and history of Whipple resection for pancreatic cancer was euthyroid with levothyroxine 175-188 micrograms/d. After taking a high dose of calcium carbonate (1250 mg three times daily) with levothyroxine, she developed biochemical evidence of hypothyroidism (thyrotropin up to 41.4 mU/L) while remaining clinically euthyroid. Delaying calcium carbonate administration by four hours returned her serum thyrotropin to a borderline high concentration (5.7 mU/L) within a month. Serum concentrations of unbound and total thyroxine and triiodothyronine tended to decrease, but remained borderline low to normal while the patient concomitantly received levothyroxine and calcium carbonate. DISCUSSION: Concomitant administration of levothyroxine and calcium carbonate often results in levothyroxine malabsorption. While in most patients the clinical consequences of this interaction, even with prolonged exposure, are relatively small, overt hypothyrodism may develop in patients with preexisting malabsorption disorders. However, as the current case illustrates, the clinical manifestations of the initial levothyroxine deficit may not always be apparent and, of all usual laboratory thyroid function tests, only thyrotropin measurement will reliably uncover the exaggerated levothyroxine malabsorption. CONCLUSIONS: Decreased absorption of levothyroxine when given with calcium carbonate may be particularly pronounced in patients with preexisting malabsorption disorders. Once recognized, a change in drug administration schedule usually minimizes or eliminates this interaction.


Asunto(s)
Antiácidos/efectos adversos , Carbonato de Calcio/efectos adversos , Hipotiroidismo/tratamiento farmacológico , Síndromes de Malabsorción/inducido químicamente , Tiroxina/uso terapéutico , Enfermedad Celíaca/complicaciones , Femenino , Humanos , Hipotiroidismo/complicaciones , Absorción Intestinal/efectos de los fármacos , Lupus Eritematoso Sistémico/complicaciones , Persona de Mediana Edad , Tirotropina/sangre , Tiroxina/metabolismo
20.
Ann Pharmacother ; 30(7-8): 752-5, 1996.
Artículo en Inglés | MEDLINE | ID: mdl-8826554

RESUMEN

OBJECTIVE: To evaluate the antiemetic efficacy of a modified regimen of oral ondansetron and dexamethasone in patients with lupus nephritis undergoing treatment with cyclophosphamide whose conventional antiemetic regimen had failed. DESIGN: A before-after prospective observational pilot project. SETTING: A federal research hospital. PATIENTS: Fourteen outpatients with lupus nephritis receiving intravenous cyclophosphamide 0.75-1.0 g/m2 had previously experienced chemotherapy-induced emetic events (vomiting or retching) while receiving a standard combination intravenous antiemetic regimen. The regimen consisted of four doses of thiethylperazine 10 mg and diphenhydramine 25 mg every 6 hours, and two doses of lorazepam 0.5 mg every 6 hours starting at 1 hour prior to cyclophosphamide. A subset of 8 patients previously completed a blinded study in which they received the intravenous formulation of ondansetron (4 doses of 4-16 mg q4h) administered orally beginning 30 minutes prior to the cyclophosphamide infusion. MAIN OUTCOME MEASURES: The number of emetic events and cost of drug administration were assessed for the modified ondansetron intervention and compared with those of the standard antiemetic regimen. The incidence of emetic events and visual analog nausea scores for the subset of eight patients were also evaluated. INTERVENTIONS: To account for the delayed onset of emesis associated with cyclophosphamide, patients received both ondansetron 8 mg orally every 4 hours (3 doses) and dexamethasone 10 mg orally (1 dose) beginning 4 hours after the cyclophosphamide infusion. This is different from the manufacturer's recommended dose schedule, in which ondansetron is administered prior to chemotherapy. RESULTS: No emetic events were observed following the administration of oral ondansetron/dexamethasone. The 95% confidence interval for the true rate of emesis was 0% to 19.3%. There was a significant difference in efficacy between ondansetron/dexamethasone and the triple antiemetic regimen (p < 0.0002). None of the patients experienced adverse effects while receiving the ondansetron/dexamethasone regimen. Cost comparisons (including admixture and nursing administration times) for standard combination therapy and oral ondansetron/dexamethasone were $109.09 and $70.24, respectively. No difference in emetic events or nausea ratings was observed between oral ondansetron/dexamethasone tablets and oral administration of ondansetron using the intravenous formula. CONCLUSIONS: This study suggests that a modified oral ondansetron/dexamethasone regimen is safe and efficacious, and costs less than alternative regimens to prevent cyclophosphamide-induced emesis in patients with lupus nephritis.


Asunto(s)
Antieméticos/efectos adversos , Antineoplásicos/efectos adversos , Ciclofosfamida/efectos adversos , Nefritis Lúpica/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Administración Oral , Adulto , Antieméticos/administración & dosificación , Antieméticos/economía , Dexametasona/administración & dosificación , Dexametasona/efectos adversos , Quimioterapia Combinada , Femenino , Humanos , Nefritis Lúpica/economía , Masculino , Ondansetrón/administración & dosificación , Ondansetrón/efectos adversos , Proyectos Piloto , Estudios Prospectivos , Vómitos/economía
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