RESUMO
AIMS: The objective of this study was to evaluate the safety and efficacy of pregabalin at flexible doses of 150-600 mg/day in Latin American patients with neuropathic pain. METHODS: A prospective, multicentre, open-label, non-comparative study included patients age >or= 18 years diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, chemotherapy-induced peripheral neuropathic pain (PNP), or human immunodeficiency virus-related PNP. Eligible patients (N = 121) had a score of >or= 40 mm on the visual analogue scale and a daily pain rating scale (DPRS) score of >or= 4 throughout screening. Patients received flexible-dose pregabalin (150-600 mg/day) for 12 weeks, which included a 4-week dose-adjustment phase. The primary efficacy measure was change from baseline to end of treatment/last observation carried forward (EOT/LOCF) in weekly mean pain score on the DPRS. Secondary efficacy measures included pain, anxiety, sleep interference, treatment satisfaction and Patient and Clinician Global Impression of Change. RESULTS: Pregabalin significantly reduced the weekly mean pain score on DPRS from baseline to EOT/LOCF [-3.8 (95% CI: -4.2 to -3.3); p < 0.0001]. Reductions from baseline to EOT/LOCF were observed for all secondary efficacy outcomes (p < 0.0001). Pain and sleep interference were significantly improved compared with baseline across all weeks of the study, as early as 1 week after initiation of pregabalin (p < 0.0001). The most common adverse events (AEs) were somnolence, dizziness, weight gain and peripheral oedema. Nine (7.4%) patients discontinued the study because of AEs and 25 (20.7%) temporarily stopped or reduced their pregabalin dose because of AEs. CONCLUSIONS: Flexible-dose pregabalin (150-600 mg/day) significantly reduced pain and anxiety and improved sleep and was generally well tolerated in Latin American patients with neuropathic pain.
Assuntos
Analgésicos/administração & dosagem , Neuralgia/tratamento farmacológico , Ácido gama-Aminobutírico/análogos & derivados , Adulto , Idoso , Idoso de 80 Anos ou mais , Analgésicos/efeitos adversos , Colômbia , Relação Dose-Resposta a Droga , Equador , Feminino , Humanos , Masculino , México , Pessoa de Meia-Idade , Medição da Dor , Peru , Pregabalina , Estudos Prospectivos , Resultado do Tratamento , Venezuela , Adulto Jovem , Ácido gama-Aminobutírico/administração & dosagem , Ácido gama-Aminobutírico/efeitos adversosRESUMO
Se presentan los resultados de la biopsia de ganglio centinela en 77 mujeres portadoras de cáncer ductal in situ (CDIS) multifocal o cáncer de mama T1-2 , todas con axila clínicamente negativa, utilizando inyección periareolar intradérmica de 99mTc-Dextran, linfocintigrafía y detección radioisotópica intraoperatoria. En 72/77 pacientes además se usó colorante azul de Isosulfan. Se obtuvo al menos un ganglio centinela en la totalidad de las pacientes. Se encontró 1 o 2 ganglios metastásicos en 14 pacientes. En 13 de ellas el ganglio centinela estaba comprometido y en 6/10 con disección axilar (DA) el resto de los ganglios estaban negativos.
Sentinel lymph node biopsy (SLNB) was performed in 77 consecutive women with clinically node-negative T1 and T2 breast cancer or multifocal ductal carcinoma in situ (DCIS). They had periareolar subdermal injection of 99mTc-Dextran, preoperative lymphoscintigraphy and intraoperative handheld probe detection. Isosulfan blue dye was also used in 72/77 patients. At least one sentinel node was found at surgery for all patients. In 14 patients one or two metastatic nodes were found, 13 of them in the sentinel node(s). Axillary lymph node dissection was otherwise negative in 6/10 positive SLNB patients.
Assuntos
Feminino , Adulto , Pessoa de Meia-Idade , Humanos , Biópsia de Linfonodo Sentinela/métodos , Carcinoma Intraductal não Infiltrante , Compostos de Organotecnécio , Neoplasias da Mama/patologia , Linfonodos , Axila/patologia , Dextranos , Estadiamento de Neoplasias , Seguimentos , Fatores de Tempo , Metástase Linfática , Linfonodos/cirurgia , Linfonodos/patologia , Resultado do TratamentoRESUMO
Diversa evidencia sugiere que las litotripsias a menor frecuencia son más eficientes en el tratamiento de las urolitiasis al aumentar la fragmentación en modelos experimentales y en algunas series clínicas. El objetivo de este trabajo es comparar la eficiencia del tratamiento con 60 respecto a 120 golpes por minuto (gpm) en un estudio prospectivo randomizado. Materiales y métodos: Pacientes con litiasis radioopaca, sin tratamiento previo, fueron prospectivamente sometidos a litotripsia a 60gpm (grupo 1) o 120 gpm (grupo 2), en forma randomizada. Se registró la ubicación (renal o ureteral) y tamaño (en mm) del cálculo. Se definió como éxito la ausencia del cálculo tratado al mes de seguimiento, controlado con radiografía simple. En el análisis estadístico se utilizó test chi cuadrado, con intervalo de confianza de 95 por ciento, considerando significativo p<0,05. Resultados: Se trataron 92 pacientes, de los cuales 46 recibieron litotripsia a 60 gpm y 46 a 120 gpm. Ambos grupos no presentan diferencias estadísticas en cuanto a la ubicación y tamaño del cálculo. El éxito global del tratamiento fue de 67,4 por ciento. El grupo 1 presentó mayor éxito (78 por ciento) que el grupo 2 (56 por ciento), siendo diferencias significativas (p=0,0008). En los cálculos renales, el grupo 1 tuvo un éxito de un 70,8 por ciento y el grupo 2 un 58,6 por ciento (p<0,05). En los cálculos ureterales, el grupo 1 tuvo un éxito de un 86,4 por ciento y el grupo 2 un 52,9 por ciento (p<0,05). El número de golpes promedio por litotripsia en el grupo 1 fue de 2326 y en el grupo 2 fue de 2842 (p<0,05). El tiempo requerido para realizar la litotripsia fue mayor en el grupo 1, sin diferencias significativas. Conclusiones: Las litotripsias a bajas frecuencias presentan una mayor efectividad en comparación con las realizadas a mayor frecuencia, requiriendo incluso un menor número de golpes para lograr una fragmentación exitosa, con una duración comparable.
Several experimental and clinical trials have shown that slow rate shock wave lithotripsy (SWL) improves stone fragmentation with a better outcome. The purpose of this trial is to compare the efficiency of slow versus fast rate SWL in a prospective randomized study. Materials and Methods: Previously untreated patients with radiopaque calculi were randomized to undergo treatment with SWL at 60 (group 1) or 120 (group 2) shocks per minute (spm). The location (renal uretheral) and size (mm) of the stone was registered. Treatment success was considered as stone-free patients at one month follow-up with simple x-rays. For statistical analysis we used the chi-square test. Results: 92 patients were treated, 46 patients with SWL at 60 spm and 46 at 120 spm. There were significant differences in location and size between both groups. Global treatment success was 67,4 percent. Group 1 had a success rate (78 percent) higher than group 2 (56 percent), that was stadistically significant. In renal stones, group 1 showed a higher success rate (70,8 percent) than group 2 (58,6 percent). In uretheral stones, group showed a higher success rate (86,4 percent) than group 2 (52,9 percent). Both renal and uretheral locations showed statistical difference (p<0,05). The average number of shock waves used in group 1 was 2326 and 2842 group 2 (p<0,05). The time required to complete the SWL was longer in group 1, without statistical difference. Conclusions: Slow rate SWLs are more efficient than ones performed at fast rates, with a greater success in fragmentation of stones at a lower number of total shock waves, and with a similar treatment time.