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1.
Medicine (Baltimore) ; 99(11): e19510, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32176097

RESUMEN

Performing a head-up tilt test can be of great value for the diagnosis of vasovagal syncope. The European Society of Cardiology recommends a drug challenge phase duration of 15 to 20 minutes, with either Isoprenaline or Nitroglycerin administration.We sought to investigate the outcome of a ten-minute active phase with Nitroglycerin in patients suspected of vasovagal syncope and determine the percentage of loss in the positivity rate, using this short duration approach.We consecutively enrolled patients presenting with syncope undergoing the head-up tilt test (HUTT), with a clinical suspicion of vasovagal syncope between the years 2009 to 2019. The HUTT consisted of 2 successive phases: passive and active. During the passive phase, the patients were tilted at 70° for 20 minutes. If negative, the test was continued after administration of 0.4 mg sublingual Nitroglycerin. Applying the (VASIS) Vasovagal Syncope International Study classification of the vasovagal syncope international study and comparing for age and gender, positive responses were categorized into 3 types.A number of 306 patients (age = 43.5 +/-20.3; male = 140 [45.7%]) with suspected vasovagal syncope, undergoing HUTT, were enrolled in the years of 2009 to 2019. Of those, 245 (80.2%) presented a positive test, with 200 patients (82.0%) during the being positive during the active phase of the test. The results were as follows: 116 subjects (47.2%) presented with a mixed response (VASIS I), 52 (21.3%) showed a cardio inhibitory response (VASIS II), and 77 (31.5%) displayed a vasodepressor response (VASIS III). We found no relationship between the type of syncope with neither gender, nor age of the patient. Three minutes represented the median time to positivity, after Nitroglycerine administration. The time distribution showed a peak incidence appearing between minutes 3 and 5, ranging from 1 to 20 minutes. Only 3 patients tested positive after minute 10.Shortening the active phase to 10 minutes would result in a positivity rate loss of 1.5%.


Asunto(s)
Nitroglicerina/administración & dosificación , Síncope Vasovagal/diagnóstico , Pruebas de Mesa Inclinada , Vasodilatadores/administración & dosificación , Administración Sublingual , Adulto , Esquema de Medicación , Femenino , Humanos , Masculino , Valor Predictivo de las Pruebas , Factores de Tiempo
2.
Zhonghua Jie He He Hu Xi Za Zhi ; 43(3): 185-188, 2020 Mar 12.
Artículo en Chino | MEDLINE | ID: mdl-32164085

RESUMEN

At the end of December 2019, a novel coronavirus (COVID-19) caused an outbreak in Wuhan, and has quickly spread to all provinces in China and 26 other countries around the world, leading to a serious situation for epidemic prevention. So far, there is still no specific medicine. Previous studies have shown that chloroquine phosphate (chloroquine) had a wide range of antiviral effects, including anti-coronavirus. Here we found that treating the patients diagnosed as novel coronavirus pneumonia with chloroquine might improve the success rate of treatment, shorten hospital stay and improve patient outcome. In order to guide and regulate the use of chloroquine in patients with novel coronavirus pneumonia, the multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia developed this expert consensus after extensive discussion. It recommended chloroquine phosphate tablet, 500mg twice per day for 10 days for patients diagnosed as mild, moderate and severe cases of novel coronavirus pneumonia and without contraindications to chloroquine.


Asunto(s)
Antiinflamatorios no Esteroideos/administración & dosificación , Cloroquina/análogos & derivados , Infecciones por Coronavirus/complicaciones , Neumonía Viral/complicaciones , China , Cloroquina/administración & dosificación , Consenso , Esquema de Medicación , Humanos , Tiempo de Internación , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/etiología , Guías de Práctica Clínica como Asunto
3.
J Korean Med Sci ; 35(5): e33, 2020 Feb 10.
Artículo en Inglés | MEDLINE | ID: mdl-32030921

RESUMEN

BACKGROUND: Although Helicobacter pylori is a key cause of gastric cancer development, its eradication rate has been decreasing by standard regimens. For successful eradication, duration of treatment has been issued for overcoming antibiotics resistance. We were to compare the eradication rate of 7-day vs. 14-day treatment in first- and second-line regimens. METHODS: This study was an open-label randomized controlled trial. A total of 369 H. pylori-infected patients were enrolled and assigned either to 7-day or 14-day proton pump inhibitor (PPI)-based standard triple therapy (STT; PPI-clarithromycin-amoxicillin). Bismuth-containing quadruple therapy was used as second-line therapy. Eradication success was defined as a negative 13C-urea breath test. RESULTS: In first-line treatment, eradication rate was 78.5% (106/135) and 78.6% (114/143) in the 7-day and 14-day treatment in per-protocol (PP) analysis (P = 0.805). In intention-to-treat (ITT) analysis, eradication rate was 64.0% (114/178) and 66.0% (126/191), respectively (P = 0.924). There was no significant difference in drug compliance (81.5% vs. 84.3%, P = 0.320). In second-line therapy, eradication rate was not significantly different in both treatments of PP analysis (91.7% [33/36] vs. 100% [45/45], P = 0.084). In the ITT analysis, eradication rate was 79.6% (35/44) and 90.4% (47/52), respectively (P = 0.080). Drug compliances were not significantly different between the two groups (95.5% vs. 98.1%, P = 0.728). CONCLUSION: PPI-based STT for H. pylori is not efficient as a first-line therapy both in 7 days and 14 days in Korea. Although bismuth-containing quadruple therapy for 14 days as a second line therapy tend to show higher eradication rate compared to 7-day therapy, this should be elucidated by further larger scaled studies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02487511.


Asunto(s)
Antibacterianos , Bismuto , Infecciones por Helicobacter , Helicobacter pylori , Inhibidores de la Bomba de Protones , Adulto , Anciano , Amoxicilina/uso terapéutico , Antibacterianos/uso terapéutico , Bismuto/uso terapéutico , Pruebas Respiratorias , Claritromicina/uso terapéutico , Esquema de Medicación , Quimioterapia Combinada , Femenino , Infecciones por Helicobacter/tratamiento farmacológico , Helicobacter pylori/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de la Bomba de Protones/uso terapéutico
4.
Artículo en Chino | MEDLINE | ID: mdl-32086889

RESUMEN

Objective:There is no standard algorithm for the modulation of pharmacologic treatment of allergic rhinitis. This study aimed to recruited allergic rhinitis patients caused by cypress pollens, and compare the step-down pharmacotherapy guided by pollen count and the maintaining therapy which keeps the previous medicine dose when the pollen count decreased. Method:This was a randomized, open-labelled, parallel control study. During the period after the pollen peak when the cypress pollen count decreased and stayed at a low level, allergic rhinitis patients were randomly divided into two groups. In the step-down group(n=67) medicine dose was reduced, while the maintaining group(n=68) kept taking the same dose as in the peak season. The rhinitis symptom score and medicine score of these two groups were recorded and compared. Result:The daily rhinitis symptom score of the step-down group showed no significant difference with the symptom score of the maintaining group, 2.45±0.32 vs 2.43±0.41, P=0.788. But the medicine score of step-down group(3.67±0.98) was significantly lower than that of maintaining group(4.78±0.70), P<0.001. The compliance of step-down group(80.6%) was also better than maintaining group(60.3%), P=0.014. However, in the subgroup of patients with severe rhinitis symptoms, the symptoms of patients taking step-down therapy tended to be more severe than those maintaining the same dose. Conclusion:During the later period of the pollen season when the pollen count was relatively low, the step-down pharmacotherapy guided by pollen count could reduce the medication use, increase the compliance of patients while controlling their rhinitis symptoms effectively. But this strategy might be more suitable for patients with milder symptoms, the severe rhinitis sufferers should be cautious before reducing their medicine dose.


Asunto(s)
Esquema de Medicación , Rinitis Alérgica Estacional/tratamiento farmacológico , Alérgenos , Cupressus , Humanos , Polen , Estaciones del Año
5.
Nurse Pract ; 45(3): 50-55, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32068658

RESUMEN

Bisphosphonates have been safely used to treat osteoporosis, effectively reducing fracture risk after 3 to 5 years of treatment. Recent concerns about long-term safety coupled with posttreatment fracture risk reduction have increased support for drug holidays. The decision to start low-risk patients on drug holidays must be based on current fracture risk assessment.


Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Difosfonatos/uso terapéutico , Privación de Tratamiento , Conservadores de la Densidad Ósea/efectos adversos , Difosfonatos/efectos adversos , Esquema de Medicación , Fracturas Óseas/prevención & control , Humanos , Osteoporosis/tratamiento farmacológico , Medición de Riesgo
9.
Br J Anaesth ; 124(3): 281-291, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32000975

RESUMEN

BACKGROUND: Many patients use opioids chronically before surgery; it is unclear if surgery alters the likelihood of ongoing opioid consumption in these patients. METHODS: We performed a population-based matched cohort study of adults in Ontario, Canada undergoing one of 16 non-orthopaedic surgical procedures and who were chronically using opioids, defined as (1) an opioid prescription that overlapped the index date and (2) either a total of 120 or more cumulative calendar days of filled opioid prescriptions, or 10 or more prescriptions filled in the prior year. Each surgical patient was matched based on age, sex, Charlson comorbidity index, and daily preoperative opioid dose to three non-surgical patients who were also chronic opioid users. The primary outcome was time to opioid discontinuation. RESULTS: The cohort included 4755 surgical and 14 265 matched non-surgical patients. After adjustment for sociodemographic characteristics and comorbidities, surgery was associated with an increased likelihood of opioid discontinuation (adjusted hazard ratio: 1.34, 95% confidence interval [CI]: 1.27, 1.42). Among surgical patients, factors associated with a reduced odds of discontinuation included a mean preoperative opioid dose above 90 morphine milligram equivalents (adjusted odds ratio [aOR]: 0.39; 95% CI: 0.32, 0.49) or filling a prescription for oxycodone (aOR: 0.73; 95% CI: 0.56, 0.98). Receipt of an in-patient Acute Pain Service consultation (aOR: 1.34; 95% CI: 1.06, 1.69) or residing in the highest neighbourhood income quintile (aOR: 1.35; 95% CI: 1.04, 1.79) were associated with a greater odds of opioid discontinuation. CONCLUSIONS: For chronic opioid users, surgery was associated with an increased likelihood of discontinuation of opioids in the following year compared with non-surgical chronic opioid users.


Asunto(s)
Analgésicos Opioides/administración & dosificación , Trastornos Relacionados con Opioides/epidemiología , Dolor Postoperatorio/tratamiento farmacológico , Procedimientos Quirúrgicos Operativos/métodos , Anciano , Analgésicos Opioides/uso terapéutico , Estudios de Casos y Controles , Enfermedad Crónica , Estudios de Cohortes , Esquema de Medicación , Prescripciones de Medicamentos/estadística & datos numéricos , Utilización de Medicamentos/estadística & datos numéricos , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Ontario/epidemiología , Periodo Posoperatorio , Privación de Tratamiento/estadística & datos numéricos
10.
Medicine (Baltimore) ; 99(7): e19012, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32049796

RESUMEN

Immunoglobulins are 2nd or 3rd-line treatments in dermatomyositis (DM) or polymyositis (PM) refractory to high-dose corticosteroids and immunosuppressants. Immunoglobulins (2 g/kg/mo) are usually administered intravenously (IVIg) once a month and the patients stay at hospital for a few days. Recently, subcutaneous injections (SCIg) were proposed 2 to 3 times per week, in some dysimmune diseases. SCIg are administered at home preferably by the patient or by a nurse. We investigated the needs and attitudes of DM and PM patients with experience of IVIg and SCIg.Seven patients (6 PM and 1 DM) from a single center participated in a focus group (N = 6) or underwent in-depth interview (N = 1). Six had the experience of both IVIg at hospital and SCIg at home; 1 has received only IVIg at hospital. Verbatim was recorded and transcribed for further content analysis and computer-aided textual analysis.Clinical profiles and stories were heterogeneous. At diagnosis, muscle weakness, severe pain, and fatigue were at the forefront of patients' complaints impairing daily life. Patients reported considerable improvement with immunoglobulins. SCIg were described as easy, less disruptive for daily life, well tolerated, and less time-consuming. SCIg self-administration at home restored the feeling of autonomy and control.Interviews of DM and PM patients revealed that recovering autonomy and control was a central advantage of home-based SCIg that were efficient, well tolerated, and perceived as a good compromise between treatment burden and efficacy.


Asunto(s)
Dermatomiositis/tratamiento farmacológico , Inmunización Pasiva/métodos , Inmunoglobulinas/administración & dosificación , Polimiositis/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Esquema de Medicación , Femenino , Grupos Focales , Humanos , Inmunoglobulinas/uso terapéutico , Inyecciones Subcutáneas/enfermería , Masculino , Persona de Mediana Edad , Investigación Cualitativa , Autoadministración , Resultado del Tratamiento
11.
Br J Anaesth ; 124(3): 299-307, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31980156

RESUMEN

BACKGROUND: Pain after anterior cruciate ligament reconstruction (ACLR) with autologous hamstring graft can be attributed to both arthroscopic surgery and the graft donor site. This study investigated whether donor site pain control was superior with the addition of either peri-hamstring injection or anterior division obturator nerve block in comparison with adductor canal block (ACB) alone. METHODS: Patients scheduled to undergo knee arthroscopy with ACLR using a graft from the ipsilateral hamstring were randomised to one of three groups. All patients received ACB and multimodal analgesia. Subjects in Group H received peri-hamstring local anaesthetic injection while subjects in Group O received an anterior division of the obturator nerve block, and subjects in Group C served as a control group (ACB alone). RESULTS: In 105 subjects undergoing ACLR, there was no significant difference between groups H, O, and C for the primary outcome of pain on movement as assessed by numerical rating scale (NRS) on knee flexion at 2 h after operation (P=0.11). There was no difference in NRS at any time point in the first 48 h after operation, nor was there a difference in oxycodone consumption between the three groups at 24 h (P=0.2). Worst knee pain was initially at the graft donor site in all three groups, which transitioned to anterior knee pain after 12 h. CONCLUSIONS: The addition of ultrasound-guided peri-hamstring injection or anterior division of obturator nerve block to ACB did not result in a significant reduction in pain or opioid consumption after ACLR with ipsilateral hamstring graft. CLINICAL TRIAL REGISTRATION: NCT01868282.


Asunto(s)
Reconstrucción del Ligamento Cruzado Anterior/efectos adversos , Tendones Isquiotibiales/trasplante , Bloqueo Nervioso/métodos , Dolor Postoperatorio/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/administración & dosificación , Ligamento Cruzado Anterior/cirugía , Lesiones del Ligamento Cruzado Anterior/cirugía , Reconstrucción del Ligamento Cruzado Anterior/métodos , Artroscopía/efectos adversos , Artroscopía/métodos , Método Doble Ciego , Esquema de Medicación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Nervio Obturador , Dimensión del Dolor/métodos , Dolor Postoperatorio/etiología , Recolección de Tejidos y Órganos/efectos adversos , Recolección de Tejidos y Órganos/métodos , Adulto Joven
13.
Plast Reconstr Surg ; 145(2): 507-516, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31985649

RESUMEN

BACKGROUND: Cleft repair requires multiple operations from infancy through adolescence, with repeated exposure to opioids and their associated risks. The authors implemented a quality improvement project to reduce perioperative opioid exposure in their cleft lip/palate population. METHODS: After identifying key drivers of perioperative opioid administration, quality improvement interventions were developed to address these key drivers and reduce postoperative opioid administration from 0.30 mg/kg of morphine equivalents to 0.20 mg/kg of morphine equivalents. Data were retrospectively collected from January 1, 2015, until initiation of the quality improvement project (May 1, 2017), tracked over the 6-month quality improvement study period, and the subsequent 14 months. Metrics included morphine equivalents of opioids received during admission, administration of intraoperative nerve blocks, adherence to revised electronic medical record order sets, length of stay, and pain scores. RESULTS: The final sample included 624 patients. Before implementation (n =354), children received an average of 0.30 mg/kg of morphine equivalents postoperatively. After implementation (n = 270), children received an average of 0.14 mg/kg of morphine equivalents postoperatively (p < 0.001) without increased length of stay (28.3 versus 28.7 hours; p = 0.719) or pain at less than 6 hours (1.78 versus 1.74; p = 0.626) or more than 6 hours postoperatively (1.50 versus 1.49; p = 0.924). CONCLUSIONS: Perioperative opioid administration after cleft repair can be reduced in a relatively short period by identifying key drivers and addressing perioperative education, standardization of intraoperative pain control, and postoperative prioritization of nonopioid medications and nonpharmacologic pain control. The authors' quality improvement framework has promise for adaptation in future efforts to reduce opioid use in other surgical patient populations. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.


Asunto(s)
Analgésicos Opioides/administración & dosificación , Labio Leporino/cirugía , Fisura del Paladar/cirugía , Derivados de la Morfina/administración & dosificación , Dolor Postoperatorio/prevención & control , Dolor Asociado a Procedimientos Médicos/prevención & control , Adolescente , Anestesia de Conducción/estadística & datos numéricos , Niño , Preescolar , Protocolos Clínicos , Esquema de Medicación , Humanos , Lactante , Cuidados Intraoperatorios , Tiempo de Internación/estadística & datos numéricos , Dimensión del Dolor , Satisfacción del Paciente , Mejoramiento de la Calidad , Estudios Retrospectivos , Adulto Joven
15.
J Zoo Wildl Med ; 50(4): 993-996, 2020 Jan 09.
Artículo en Inglés | MEDLINE | ID: mdl-31926534

RESUMEN

Seven anesthesia events were performed over 6 wk on a 1.5-yr-old female okapi (Okapia johnstoni) being managed for a fetlock injury. A combination of butorphanol (B) (median; range) (0.045; 0.031-0.046 mg/kg), medetomidine (M) (0.037; 0.031-0.037 mg/kg), ketamine (K) (0.553; 0.536-1.071 mg/kg), and thiafentanil (T) (0.0045; 0.0040-0.0046 mg/kg) was administered in a padded stall. One dart containing all drugs was used for the first two anesthesias. Subsequently, BM was administered 10 min prior to KT using two darts. Time (median; range) from initial injection to first effects (6; 3-7 min) and recumbency (14; 4-20 min) were recorded. Induction quality with the one-dart protocol was poor or fair and was good or excellent with the two-dart protocol. Following recumbency, the okapi was intubated and ventilated, and physiological parameters were recorded. Anesthesia was consistently achieved with BMKT, but induction was smoother with the staged two-dart approach. Neither resedation nor renarcotization was observed post-reversal.


Asunto(s)
Antílopes/fisiología , Butorfanol/farmacología , Fentanilo/análogos & derivados , Ketamina/farmacología , Medetomidina/farmacología , Analgésicos/administración & dosificación , Analgésicos/farmacología , Anestesia/veterinaria , Animales , Butorfanol/administración & dosificación , Esquema de Medicación , Especies en Peligro de Extinción , Femenino , Fentanilo/administración & dosificación , Fentanilo/farmacología , Hipnóticos y Sedantes/administración & dosificación , Hipnóticos y Sedantes/farmacología , Ketamina/administración & dosificación , Medetomidina/administración & dosificación
17.
Medicine (Baltimore) ; 99(2): e18591, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31914038

RESUMEN

This analysis aimed to investigate whether the long-term administration of temozolomide (TMZ) claimed a survival advantage for patients with glioblastoma in China.A total of 75 patients with newly diagnosed glioblastoma at the Department of Radiation Oncology, Shenzhen People's Hospital between August 2008 and August 2016 were retrospectively evaluated during analysis. A propensity-matched analysis was performed to balance the basic characteristics of patients between compared groups. Kaplan-Meier method and Cox proportional hazards model were used to assess progression-free survival (PFS) and overall survival (OS) of patients receiving 6 adjuvant TMZ cycles compared with patients treated with more than 6 cycles.Twenty of 75 patients received more than 6 cycles of TMZ, and the other 55 patients were treated with a median of 6 cycles ranging from 1 to 6. The patients with long-term administration of TMZ had better OS (47.0 months, 95% CI 20.0-73.9 vs 20.6 months, 95% CI 17.9-23.2, P = .014) but not PFS (17.0 months, 95% CI 10.1-24.5 vs 14.2 months, 95% CI 11.8-16.6, P = .133). Balancing the clinical factors with a propensity-matched analysis also showed the significant advantage of prolonged TMZ application in terms of OS but not PFS.Prolonged administration of TMZ beyond 6 cycles did demonstrate survival benefits for patients with initially diagnosed glioblastoma.


Asunto(s)
Antineoplásicos Alquilantes/uso terapéutico , Neoplasias Encefálicas/tratamiento farmacológico , Neoplasias Encefálicas/mortalidad , Glioblastoma/tratamiento farmacológico , Glioblastoma/mortalidad , Temozolomida/uso terapéutico , Adolescente , Adulto , Anciano , Antineoplásicos Alquilantes/administración & dosificación , Neoplasias Encefálicas/terapia , Quimioterapia Adyuvante , Esquema de Medicación , Femenino , Glioblastoma/terapia , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Puntaje de Propensión , Estudios Retrospectivos , Temozolomida/administración & dosificación , Adulto Joven
18.
N Engl J Med ; 382(4): 341-352, 2020 01 23.
Artículo en Inglés | MEDLINE | ID: mdl-31971679

RESUMEN

BACKGROUND: Thyroid eye disease is a debilitating, disfiguring, and potentially blinding periocular condition for which no Food and Drug Administration-approved medical therapy is available. Strong evidence has implicated the insulin-like growth factor I receptor (IGF-IR) in the pathogenesis of this disease. METHODS: In a randomized, double-masked, placebo-controlled, phase 3 multicenter trial, we assigned patients with active thyroid eye disease in a 1:1 ratio to receive intravenous infusions of the IGF-IR inhibitor teprotumumab (10 mg per kilogram of body weight for the first infusion and 20 mg per kilogram for subsequent infusions) or placebo once every 3 weeks for 21 weeks; the last trial visit for this analysis was at week 24. The primary outcome was a proptosis response (a reduction in proptosis of ≥2 mm) at week 24. Prespecified secondary outcomes at week 24 were an overall response (a reduction of ≥2 points in the Clinical Activity Score plus a reduction in proptosis of ≥2 mm), a Clinical Activity Score of 0 or 1 (indicating no or minimal inflammation), the mean change in proptosis across trial visits (from baseline through week 24), a diplopia response (a reduction in diplopia of ≥1 grade), and the mean change in overall score on the Graves' ophthalmopathy-specific quality-of-life (GO-QOL) questionnaire across trial visits (from baseline through week 24; a mean change of ≥6 points is considered clinically meaningful). RESULTS: A total of 41 patients were assigned to the teprotumumab group and 42 to the placebo group. At week 24, the percentage of patients with a proptosis response was higher with teprotumumab than with placebo (83% [34 patients] vs. 10% [4 patients], P<0.001), with a number needed to treat of 1.36. All secondary outcomes were significantly better with teprotumumab than with placebo, including overall response (78% of patients [32] vs. 7% [3]), Clinical Activity Score of 0 or 1 (59% [24] vs. 21% [9]), the mean change in proptosis (-2.82 mm vs. -0.54 mm), diplopia response (68% [19 of 28] vs. 29% [8 of 28]), and the mean change in GO-QOL overall score (13.79 points vs. 4.43 points) (P≤0.001 for all). Reductions in extraocular muscle, orbital fat volume, or both were observed in 6 patients in the teprotumumab group who underwent orbital imaging. Most adverse events were mild or moderate in severity; two serious events occurred in the teprotumumab group, of which one (an infusion reaction) led to treatment discontinuation. CONCLUSIONS: Among patients with active thyroid eye disease, teprotumumab resulted in better outcomes with respect to proptosis, Clinical Activity Score, diplopia, and quality of life than placebo; serious adverse events were uncommon. (Funded by Horizon Therapeutics; OPTIC ClinicalTrials.gov number, NCT03298867, and EudraCT number, 2017-002763-18.).


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Oftalmopatía de Graves/tratamiento farmacológico , Receptor IGF Tipo 1/antagonistas & inhibidores , Adulto , Anciano , Anticuerpos Monoclonales Humanizados/efectos adversos , Diplopía/tratamiento farmacológico , Método Doble Ciego , Esquema de Medicación , Exoftalmia/tratamiento farmacológico , Oftalmopatía de Graves/diagnóstico por imagen , Humanos , Análisis de Intención de Tratar , Imagen por Resonancia Magnética , Persona de Mediana Edad , Órbita/diagnóstico por imagen , Receptor IGF Tipo 1/inmunología , Autoinforme
19.
Int J Radiat Oncol Biol Phys ; 106(2): 320-328, 2020 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-31669562

RESUMEN

PURPOSE: Oral mucositis (OM) is a frequent and painful sequela of concomitant chemoradiation (CRT) used for the treatment of head and neck cancer (HNC) for which there is no effective intervention. This randomized, placebo-controlled study evaluated the efficacy of a novel, mucoadhesive topical tablet formulation of clonidine in mitigating CRT-induced OM in patients with HNC. METHODS AND MATERIALS: Patients with HNC undergoing adjuvant radiation therapy (60-66 Gy; 5 × 1.8-2.2 Gy/wk) with concomitant platinum-based chemotherapy received daily local clonidine at 50 µg (n = 56), 100 µg (n = 65), or placebo (n = 62) via a topical mucobuccal tablet starting 1 to 3 days before and continuing during treatment. The primary endpoint was the incidence of severe OM (severe OM [SOM], World Health Organization grade 3/4). RESULTS: SOM developed in 45% versus 60% (P = .06) of patients treated with clonidine compared with placebo and occurred for the first time at 60 Gy as opposed to 48 Gy (median; hazard ratio, 0.75 [95% confidence interval, 0.484-1.175], P = .21); median time to onset was 45 versus 36 days. Opioid analgesic use, mean patient-reported mouth and throat soreness, and CRT compliance were not significantly different between treatment arms. Adverse events were reported in 90.8% versus 98.4%, nausea in 49.6% versus 71.0%, dysphagia in 32.8% versus 48.4%, and reversible hypotension in 6.7% versus 1.6% of patients on clonidine versus placebo, respectively. CONCLUSIONS: Although the primary endpoint was not met, the positive trends of OM-associated outcomes suggest that the novel mucoadhesive tablet delivery of clonidine might favorably affect the course and severity of CRT-induced SOM and support further evaluation.


Asunto(s)
Quimioradioterapia/efectos adversos , Clonidina/administración & dosificación , Neoplasias de Cabeza y Cuello/radioterapia , Protectores contra Radiación/administración & dosificación , Carcinoma de Células Escamosas de Cabeza y Cuello/radioterapia , Estomatitis/prevención & control , Administración Bucal , Adulto , Anciano , Analgésicos Opioides/administración & dosificación , Clonidina/efectos adversos , Intervalos de Confianza , Trastornos de Deglución/etiología , Método Doble Ciego , Esquema de Medicación , Femenino , Neoplasias de Cabeza y Cuello/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Placebos/administración & dosificación , Protectores contra Radiación/efectos adversos , Dosificación Radioterapéutica , Estomatitis/etiología , Comprimidos , Adulto Joven
20.
J Stroke Cerebrovasc Dis ; 29(1): 104481, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31699575

RESUMEN

OBJECTIVE: This study examined how the effects of botulinum toxin therapy changed over time by sequential evaluation of clinical improvements in spasticity and contracture in 24 chronic-stage stroke patients on repeated botulinum toxin therapy who were receiving fewer rehabilitation interventions. METHODS: Botulinum toxin injection was administered into the spastic muscle of the paralyzed upper or lower limb 5 times with at least 3-month intervals. Modified Ashworth Scale and range of motion were measured before and 2 weeks after each dose in the extremities to compare the first measurement value with subsequent values. Each predose value was also compared with the first predose value. RESULTS: Compared with predose scores, Modified Ashworth Scale significantly improved in all flexors after 2 weeks from the first to fifth doses. Range of motion significantly improved in wrist dorsiflexion and ankle dorsiflexion. Comparison of values before each dose versus the first predose value showed significant improvement both in the Modified Ashworth Scale score of wrist flexors, finger flexors, and ankle planter flexors, and the range of motion of elbow extension, wrist dorsiflexion, and ankle dorsiflexion. CONCLUSION: The comparison of predose values versus 2-week postdose values indicated that the effect of botulinum toxin formulation would not lessen after repeated injections with continuous improvements of Modified Ashworth Scale and range of motion. The comparison of predose values versus the first predose value also suggested that multiple injections of botulinum toxin formulation could be more effective in reducing spasticity and increasing the range of motion than a single injection.


Asunto(s)
Inhibidores de la Liberación de Acetilcolina/uso terapéutico , Toxinas Botulínicas Tipo A/administración & dosificación , Contracción Muscular/efectos de los fármacos , Espasticidad Muscular/tratamiento farmacológico , Músculo Esquelético/inervación , Accidente Cerebrovascular/tratamiento farmacológico , Inhibidores de la Liberación de Acetilcolina/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Fenómenos Biomecánicos , Toxinas Botulínicas Tipo A/efectos adversos , Esquema de Medicación , Femenino , Humanos , Inyecciones Intramusculares , Extremidad Inferior , Masculino , Persona de Mediana Edad , Espasticidad Muscular/diagnóstico , Espasticidad Muscular/fisiopatología , Rango del Movimiento Articular , Recuperación de la Función , Estudios Retrospectivos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Extremidad Superior , Adulto Joven
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