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1.
Toxins (Basel) ; 12(12)2020 12 04.
Article in English | MEDLINE | ID: mdl-33291807

ABSTRACT

Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ≥1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ≥1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients received BoNT-A injections at baseline (visit 1) and visit 2 (3-6 months). Primary endpoint was responder rate (achievement of primary goal from Goal Attainment Scaling (GAS)) at visit 2. Overall, 204 patients underwent GAS evaluation at visit 2, mean (SD) age was 56.4 (13.2) years and 90.7% had LL spasticity. Median (range) time between first stroke and onset of spasticity was 3.6 (0-349) months, onset of spasticity and first injection was 22.7 (0-350) months and waiting time for a rehabilitation appointment was 9.0 (1-96) months. At visit 2, 61.3% (95% CI: 54.4, 67.7) of patients were responders, which was similar for UL and LL primary goals (57.8% [95% CI: 49.9, 65.3] vs. 64.1% [95% CI: 48.4, 77.3]). This study provides evidence to support the effectiveness of BoNT-A treatment for chronic post-stroke spasticity.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Muscle Spasticity/drug therapy , Muscle Spasticity/etiology , Neuromuscular Agents/therapeutic use , Stroke/complications , Adolescent , Adult , Aged , Brazil , Chronic Disease , Female , Humans , Male , Middle Aged , Quality of Life , Treatment Outcome , Young Adult
2.
Crit Rev Oncol Hematol ; 141: 163-173, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31306986

ABSTRACT

INTRODUCTION: PARP inhibitors are a new class of drugs that are currently being studied in several malignancies. Olaparib is FDA-approved for advanced breast cancer and advanced ovarian cancer patients. Fatigue and anemia are among the most common cancer and treatment-related symptoms. Therefore, we conducted a meta-analysis of randomized controlled trials (RCT) to characterize the incidence and relative risks (RRs) of fatigue and anemia associated with olaparib. METHODS: PubMed, Cohrane, Embase and abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO) were searched for articles published from 2000 to June 2018. The eligible studies were phase II and III RCT of olaparib. Safety profile from each selected study was evaluated for all-grade and high-grade fatigue and anemia adverse events. Summary incidences and the RR, with 95% confidence intervals, of all-grade and high-grade events were calculated using random-effects or fixed-effects model based on the heterogeneity of selected studies. RESULTS: A total of 9 trials were selected, and included 2074 patients with advanced ovarian, gastric, prostate, lung or breast cancer. 908 patients received placebo/control treatments and 1166 received olaparib alone or combination with other active cancer treatments. The RR of all-grade and high fatigue was 1.24 (95% CI, 1.10-1.39) and 1.71 (95% CI, 1.06-2.77), respectively. The RR of all-grade and high-grade anemia was 2.10 (95% CI, 1.48-2.98) and 3.15 (95% CI, 1.73-5.71), respectively. CONCLUSION: Our findings suggest that the olaparib treatment is associated with an increased risk of fatigue and anemia. Since fatigue and anemia are very common treatment related adverse events, and both can impair the quality of life of patients, it is important to identify them early and manage it accordingly in order to optimize the overall treatment.


Subject(s)
Anemia/etiology , Fatigue/etiology , Neoplasms/drug therapy , Phthalazines/therapeutic use , Piperazines/therapeutic use , Randomized Controlled Trials as Topic/statistics & numerical data , Adult , Aged , Aged, 80 and over , Anemia/chemically induced , Anemia/epidemiology , Disease Progression , Fatigue/chemically induced , Fatigue/epidemiology , Female , Humans , Incidence , Male , Middle Aged , Neoplasms/epidemiology , Neoplasms/pathology , Quality of Life , Risk , Risk Factors , Young Adult
3.
Respir Physiol Neurobiol ; 165(1): 13-21, 2009 Jan 01.
Article in English | MEDLINE | ID: mdl-18930843

ABSTRACT

We investigated the effects of oral tolerance (OT) in controlling inflammatory response, hyperresponsiveness and airway remodeling in guinea pigs (GP) with chronic allergic inflammation. Animals received seven inhalations of ovalbumin (1-5mg/mL-OVA group) or normal saline (NS group). OT was induced by offering ad libitum ovalbumin 2% in sterile drinking water starting with the 1st ovalbumin inhalation (OT1 group) or after the 4th (OT2 group). The induction of OT in sensitized animals decreased the elastance of respiratory system (Ers) response after both antigen and methacholine challenges, peribronchial edema formation, eosinophilic airway infiltration, eosinophilopoiesis, and airways collagen and elastic fiber content compared to OVA group (P<0.05). The number of mononuclear cells and resistance of respiratory system (Rrs) responses after antigen and methacholine challenges were decreased only in OT2 group compared to OVA group (P<0.05). Concluding, our results show that inducing OT attenuates airway remodeling as well as eosinophilic inflammation and respiratory system mechanics.


Subject(s)
Airway Resistance , Disease Models, Animal , Hypersensitivity/immunology , Pneumonia/immunology , Administration, Inhalation , Analysis of Variance , Animals , Chronic Disease , Dose-Response Relationship, Immunologic , Elastic Tissue/metabolism , Eosinophils/pathology , Extracellular Matrix/metabolism , Guinea Pigs , Lung/pathology , Ovalbumin/immunology , Pneumonia/complications , Pneumonia/drug therapy , Respiratory Mechanics/drug effects , Respiratory Mechanics/immunology , Time Factors
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