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BACKGROUND: Although many studies have explored the correlation between quality of life and survival, none have reported this relationship for specific cancers assessed at distinct time points. This meta-analysis aimed to investigate the impact of pretreatment Global Quality of Life (QOL) and functioning QOL, including physical, social, role, emotional, and cognitive QOLs, on mortality risk in patients with lung cancer. METHODS: A literature search was conducted across the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, and PubMed databases for articles published between their inception and December 2022. Subsequently, 11 studies were selected based on predefined eligibility criteria to investigate the relationship between pretreatment QOLs and mortality risk in patients with lung cancer. RESULTS: Pretreatment global, physical, social, role, and emotional QOLs were significantly associated with mortality risk as follows: Global QOL (hazard ratio [HR] = 1.08 95% confidence interval [CI] = 1.03-1.13); Physical QOL (HR = 1.04 95% CI = 1.02-1.05); Social QOL (HR = 1.02 95% CI = 1.01-1.03; Role QOL (HR = 1.01 95% CI = 1.01-1.02); Emotional QOL (HR = 1.01 95% CI = 1.00-1.03). CONCLUSIONS: These findings underscore the importance of early QOL assessment after diagnosis as well as early provision of physical, social, and psychological support accommodating each patient's demands. TRIAL REGISTRATION: The International Prospective Register of Systematic Reviews registration number CRD42023398206, Registered on February 20, 2023.
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Neoplasias Pulmonares , Humanos , Calidad de Vida , Ansiedad , Depresión , EmocionesRESUMEN
PURPOSE: This systematic review and meta-analysis aimed to examine the impact of global quality of life (QOL) on mortality risk in patients with cancer, considering cancer type and timepoint of QOL assessment. METHODS: A systematic search was conducted using Cumulated Index to Nursing and Allied Health Literature, PubMed/MEDLINE, and Scopus databases from inception to December 2022. Observational studies that assessed QOL and examined mortality risk in patients with cancer were extracted. Subgroup analyses were performed for cancer types and timepoints of QOL assessment. RESULTS: Overall, global QOL was significantly associated with mortality risk (hazard ratio: 1.06, 95% confidence interval: 1.05-1.07; p < 0.00001). A subgroup analysis based on cancer type demonstrated that lung, head and neck, breast, esophagus, colon, prostate, hematologic, liver, gynecologic, stomach, brain, bladder, bone and soft tissue, and mixed type cancers were significantly associated with mortality risk; however, melanoma and pancreatic cancer were not significantly associated with mortality risk. Additionally, global QOL was associated with mortality risk at all timepoints (pretreatment, posttreatment, and palliative phase); pretreatment QOL had the largest impact, followed by posttreatment QOL. CONCLUSION: These findings provide evidence that QOL is associated with mortality risk in patients with cancer at any timepoint. These results indicate the importance of evaluating the QOL and supportive interventions to improve QOL in any phase.
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This systematic review and meta-analysis investigated the impact of quality of life (QoL) on mortality risk in patients with esophageal cancer. A literature search was conducted using the CINAHL, PubMed/MEDLINE, and Scopus databases for articles published from inception to December 2022. Observational studies that examined the association between QoL and mortality risk in patients with esophageal cancer were included. Subgroup analyses were performed for time points of QoL assessment and for types of treatment. Seven studies were included in the final analysis. Overall, global QoL was significantly associated with mortality risk (hazard ratio 1.02, 95% confidence interval 1.01-1.04; p < 0.00004). Among the QoL subscales of QoL, physical, emotional, role, cognitive, and social QoL were significantly associated with mortality risk. A subgroup analysis by timepoints of QoL assessment demonstrated that pre- and posttreatment global and physical, pretreatment role, and posttreatment cognitive QoL were significantly associated with mortality risk. Moreover, another subgroup analysis by types of treatment demonstrated that the role QoL in patients with surgery, and the global, physical, role, and social QoL in those with other treatments were significantly associated with mortality risk. These findings indicate that the assessment of QoL in patients with esophageal cancer before and after treatment not only provides information on patients' condition at the time of treatment but may also serve as an outcome for predicting life expectancy. Therefore, it is important to conduct regular QoL assessments and take a proactive approach to improve QoL based on the results of these assessments.
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Neoplasias Esofágicas , Calidad de Vida , Humanos , Calidad de Vida/psicología , Neoplasias Esofágicas/mortalidad , Neoplasias Esofágicas/psicología , Masculino , Femenino , Persona de Mediana Edad , AncianoRESUMEN
BACKGROUND: Prehabilitation during neoadjuvant therapy has the potential to improve clinical outcomes. However, information on its global dissemination status is limited. This Japanese nationwide survey investigated the implementation status of and barriers to prehabilitation during neoadjuvant chemotherapy (NAC) for patients with locally advanced esophageal cancer in hospitals. METHODS: This multicenter nationwide survey was conducted by post. The eligible facilities were 155 Japanese hospitals that had been certified within the last 10 years as authorized institutes for board-certified esophageal surgeons by the Japan Esophageal Society. We administered an original questionnaire to investigate the current status of prehabilitation during NAC. RESULTS: The response rate was 75% (117/155 facilities). Forty-six facilities (39%) provided prehabilitation during NAC. The most frequently selected reasons for not providing or providing insufficient prehabilitation were lack of human resources, issues with the reimbursement of medical fees, difficulty in providing continuous prehabilitation during repeated inpatient and outpatient care, the lack of established standard prehabilitation programs, challenges in providing multidisciplinary prehabilitation, and difficulty in managing physical symptoms. CONCLUSION: We observed that the implementation rate of prehabilitation during NAC was low. Critical reasons were not only the lack of medical resources but also the lack of evidence-based standard prehabilitation programs during NAC and the lack of evidence for how to continuously deliver prehabilitation during NAC to patients with physical symptoms.
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There is a growing interest in the use of electrocorticographic (ECoG) signals in brain-machine interfaces (BMIs). However, there is still a lack of studies involving the long-term evaluation of the tissue response related to electrode implantation. Here, we investigated biocompatibility, including chronic tissue response to subdural electrodes and a fully implantable wireless BMI device. We implanted a half-sized fully implantable device with subdural electrodes in six beagles for 6 months. Histological analysis of the surrounding tissues, including the dural membrane and cortices, was performed to evaluate the effects of chronic implantation. Our results showed no adverse events, including infectious signs, throughout the 6-month implantation period. Thick connective tissue proliferation was found in the surrounding tissues in the epidural space and subcutaneous space. Quantitative measures of subdural reactive tissues showed minimal encapsulation between the electrodes and the underlying cortex. Immunohistochemical evaluation showed no significant difference in the cell densities of neurons, astrocytes, and microglia between the implanted sites and contralateral sites. In conclusion, we established a beagle model to evaluate cortical implantable devices. We confirmed that a fully implantable wireless device and subdural electrodes could be stably maintained with sufficient biocompatibility in vivo.
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Interfaces Cerebro-Computador , Electrodos Implantados , Animales , Técnicas Biosensibles , Perros , Electrocorticografía , Cabeza , NeuronasRESUMEN
BACKGROUND: Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure, but to our knowledge no placebo-controlled trials have assessed visual function preservation, and the observation periods of previous (unmasked) trials have typically been at least 5 years. We assessed vision preservation in patients given latanoprost compared with those given placebo. METHODS: In this randomised, triple-masked, placebo-controlled trial, we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible patients were randomly allocated (1:1) with a website-generated randomisation schedule, stratified by centre and with a permuted block design, to receive either latanoprost 0·005% (intervention group) or placebo (control group) eye drops. Drops were administered from identical bottles, once a day, to both eyes. The primary outcome was time to visual field deterioration within 24 months. Analyses were done in all individuals with follow-up data. The Data and Safety Monitoring Committee (DSMC) recommended stopping the trial on Jan 6, 2011 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months. This trial is registered, number ISRCTN96423140. FINDINGS: We enrolled 516 individuals between Dec 1, 2006, and March 16, 2010. Baseline mean intraocular pressure was 19·6 mm Hg (SD 4·6) in 258 patients in the latanoprost group and 20·1 mm Hg (4·8) in 258 controls. At 24 months, mean reduction in intraocular pressure was 3·8 mm Hg (4·0) in 231 patients assessed in the latanoprost group and 0·9 mm Hg (3·8) in 230 patients assessed in the placebo group. Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28-0·69; p=0·0003). We noted 18 serious adverse events, none attributable to the study drug. INTERPRETATION: This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma. The study design enabled significant differences in vision to be assessed in a relatively short observation period. FUNDING: Pfizer, UK National Institute for Health Research Biomedical Research Centre.
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Antihipertensivos/administración & dosificación , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Prostaglandinas F Sintéticas/administración & dosificación , Administración Oftálmica , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Glaucoma de Ángulo Abierto/fisiopatología , Humanos , Presión Intraocular/efectos de los fármacos , Estimación de Kaplan-Meier , Latanoprost , Masculino , Persona de Mediana Edad , Soluciones Oftálmicas/administración & dosificación , Resultado del Tratamiento , Campos Visuales/efectos de los fármacos , Adulto JovenAsunto(s)
Antihipertensivos/uso terapéutico , Glaucoma de Ángulo Abierto/diagnóstico por imagen , Glaucoma de Ángulo Abierto/tratamiento farmacológico , Presión Intraocular/efectos de los fármacos , Latanoprost/uso terapéutico , Tomografía de Coherencia Óptica , Humanos , Persona de Mediana Edad , Fibras Nerviosas/patología , Soluciones Oftálmicas , Células Ganglionares de la Retina/patología , Pruebas del Campo Visual , Campos VisualesRESUMEN
PURPOSE: Scar formation is most frequently responsible for the failure of glaucoma filtration surgery. Retinoic acids are vitamin A derivatives that play diverse roles in development, immunity, and tissue repair. The effects of the retinoic acid receptor (RAR) γ agonist R667 on the contractility of human Tenon fibroblasts (HTFs) cultured in a three-dimensional collagen gel as well as on intraocular pressure (IOP) in a rat model of glaucoma filtration surgery were investigated. METHODS: HTFs were cultured in a type I collagen gel, the contraction of which was evaluated by measurement of the gel diameter. The release of matrix metalloproteinases (MMPs) into culture supernatants was assessed with immunoblot analysis and gelatin zymography. Phosphorylation of focal adhesion kinase (FAK) was examined with immunoblot analysis, and production of fibronectin and type I collagen was measured with immunoassays. RESULTS: R667 inhibited transforming growth factor-ß1 (TGF-ß1)-induced collagen gel contraction mediated by HTFs in a concentration- and time-dependent manner, whereas an RARα agonist inhibited this process to a lesser extent and an RARß agonist had no effect. TGF-ß1-induced MMP-1 and MMP-3 release, FAK phosphorylation, and fibronectin and type I collagen production in HTFs were also attenuated by R667. Furthermore, R667 lowered IOP in rats after glaucoma filtration surgery. CONCLUSIONS: R667 inhibited TGF-ß1-induced contraction and extracellular matrix synthesis in HTFs. Such effects might have contributed to the lowering of IOP by R667 in a rat model of glaucoma filtration surgery. RARγ agonists might thus prove effective for inhibition of scar formation after such surgery.
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Fibroblastos/efectos de los fármacos , Fibroblastos/metabolismo , Pirazoles/farmacología , Receptores de Ácido Retinoico/agonistas , Cápsula de Tenon/citología , Cápsula de Tenon/metabolismo , Animales , Cicatriz/prevención & control , Matriz Extracelular/efectos de los fármacos , Matriz Extracelular/metabolismo , Cirugía Filtrante/efectos adversos , Glaucoma/patología , Glaucoma/fisiopatología , Glaucoma/cirugía , Humanos , Presión Intraocular/efectos de los fármacos , Masculino , Complicaciones Posoperatorias/prevención & control , Ratas , Ratas Wistar , Cicatrización de Heridas/efectos de los fármacos , Receptor de Ácido Retinoico gammaRESUMEN
We report herein on a case of ectopic cervical thymus in a 5-year-old boy and the literature is reviewed. Swelling of the right neck was seen in the patient in his newborn period and it was diagnosed as cystic disease of the neck in a previous hospital at 4 months of age. Ultrasonography (US) and MRI revealed a cervical tumor consisting of a solid component in our hospital, and histopathologic examination showed no evidence of malignancy. The lesion revealed almost no change in size but showed a mosaic pattern on US, whereon the parents agreed to the removal of the tumor. Intraoperatively, the tumor could be easily dissected from the surrounding tissue and resected. The pathological diagnosis was normal thymic tissue. The postoperative course was uneventful and no complication or immunological disorders were seen. A cervical ectopic thymus is a congenital lesion that results from abnormal thymic migration during embryogenesis. Most patients are asymptomatic and the condition is found incidentally. Preoperative diagnosis of cervical ectopic thymus in children is rarely made, so surgical treatment is the definitive means of pathological diagnosis. This disease should be listed in the differential diagnosis for neck masses in children, and should be suspected when the mosaic pattern is detected in the lesion on US.
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Quistes , Cuello/patología , Timo/patología , Biopsia , Preescolar , Quistes/cirugía , Humanos , Imagen por Resonancia Magnética , Masculino , Cuello/cirugía , Timo/cirugíaRESUMEN
We fabricate 3D photonic nanostructures by simultaneous multi-directional plasma etching. This simple and flexible method is enabled by controlling the ion-sheath in reactive-ion-etching equipment. We realize 3D photonic crystals on single-crystalline silicon wafers and show high reflectance (>95%) and low transmittance (<-15dB) at optical communication wavelengths, suggesting the formation of a complete photonic bandgap. Moreover, our method simply demonstrates Si-based 3D photonic crystals that show the photonic bandgap effect in a shorter wavelength range around 0.6 µm, where further fine structures are required.
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Sarcopenia is prevalent among 11-25% of adult cancer survivors, depending on the cancer type, although the available data on post-treatment survivors in Japan are limited. If cancer patients develop cachexia, they may experience sustained weight loss as a result, ultimately leading to sarcopenia. Conversely, some patients experience post-treatment weight gain, resulting in sarcopenic obesity. Both sarcopenia and obesity elevate the risk of cardiovascular diseases and mortality; therefore, the importance of sarcopenia prevention and management is undeniable. The Guidelines for Exercise for Cancer Survivors recommend continued physical activity. Recent studies have reported the effectiveness of multimodal interventions, combining pharmacological, nutritional, and exercise approaches, necessitating multidisciplinary care for post-treatment sarcopenia. Innovative health interventions using mobile devices have also gained attention. However, studies on sarcopenia in post-treatment cancer survivors, especially those regarding exercise interventions, remain scarce in Japan, primarily due to limited insurance coverage for such post-treatment interventions and workforce challenges. It is clear that some cancer survivors have sarcopenia, which can lead to worse survival and secondary illness. While the benefits of exercise are clear, a comprehensive approach to sarcopenia is a further challenge for the future.
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Supervivientes de Cáncer , Sarcopenia , Sarcopenia/etiología , Sarcopenia/terapia , Sarcopenia/prevención & control , Humanos , Japón , Neoplasias/complicaciones , Neoplasias/terapia , Ejercicio FísicoRESUMEN
BACKGROUND: Patients with breast cancer present with various problems that have an adverse effect on the quality of life (QOL). However, the association between the QOL and mortality among patients with breast cancer remains controversial. Therefore, this systematic review and meta-analysis aimed to determine whether QOL impacts prognosis in patients with breast cancer. METHODS: The databases of CINAHL, Scopus, and PubMed databases were searched to retrieve observational studies that assessed the QOL and mortality risk in patients with breast cancer published before December 2022. RESULTS: Among the 119,061 articles retrieved, six observational studies were included in the meta-analysis. Physical QOL (hazard ratio [HR]: 1.04, 95% confidence interval [CI]: 1.01-1.07, p = 0.003), emotional QOL (HR: 1.01, 95% CI: 1.00-1.03, p = 0.05), and role QOL (HR: 1.01, 95% CI: 1.00-1.01, p = 0.007) showed significant associations with mortality risk. In contrast, global QOL, cognitive QOL, and social QOL showed no associations with mortality risk. Subgroup analysis performed according to treatment time points revealed that the post-treatment physical QOL was associated with mortality risk. CONCLUSIONS: Physical QOL, emotional QOL, and role QOL are associated with mortality risk in patients with breast cancer. Furthermore, post-treatment physical QOL showed a more significant association with prolonged survival than pre-treatment physical QOL.
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Neoplasias de la Mama , Calidad de Vida , Humanos , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/psicología , Femenino , Pronóstico , Estudios Observacionales como AsuntoRESUMEN
Objectives: The purpose of this study was to investigate switching from brimonidine and ripasudil, and brimonidine or ripasudil, to a fixed combination of brimonidine and ripasudil, and evaluate the associated efficacy and safety in glaucoma patients. Methods: Glaucoma patients undergoing treatment with at least brimonidine and ripasudil (n = 25) or treatment with at least brimonidine or ripasudil (n = 45) were evaluated in this retrospective study. After switching patients taking brimonidine and ripasudil, or brimonidine or ripasudil, to a ripasudil/brimonidine fixed-combination, ophthalmic suspension (RBFC), intra-ocular pressure (IOP), conjunctival hyperemia and superficial punctate keratopathy (SPK) were evaluated before and at 4, 12 and 24 weeks after switching to RBFC. Results: No significant differences in the IOPs were observed after switching from brimonidine and ripasudil to RBFC. However, a significant decrease was observed at 4, 12 and 24 weeks in the baseline IOP, from 17.0 ± 4.4 mmHg to 15.7 ± 3.2 mmHg (p < 0.01), 14.3 ± 3.4 mmHg (p < 0.01) and 14.4 ± 4.1 mmHg (p < 0.01), respectively, after switching from brimonidine or ripasudil to RBFC. No significant changes were noted for the SPK score or conjunctival hyperemia score at any of the visits after switching to RBFC. Conclusions: Throughout the 24-week evaluation period, the IOP was maintained after switching from brimonidine and ripasudil to RBFC. However, there was a significant decrease in the IOP after switching from brimonidine or ripasudil to RBFC. These results demonstrate that RBFC is safe for use in the treatment of glaucoma patients.
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We investigate nanocavities at the surface of three-dimensional (3D) photonic crystals, where the polarization-independent surface-mode gap can be utilized. We consider the formation of various nanocavities by introducing artificial defects utilizing the 3D structures around the surface and discuss the possibilities for increasing the Q-factors of the surface nanocavities with TE-like polarization based on the advanced designs of donor-type defects. We also introduce the design of acceptor-type defects and show that TM-like nanocavities are obtained. We then fabricate the designed nanocavities and examine their resonant characteristics; we successfully demonstrate TE-like nanocavities with Q-factors of ~40,000, which is four-times higher than previous surface cavities and as high as that of the cavities embedded inside 3D photonic crystals. TM-like nanocavities with Q-factors of ~22,000 are also demonstrated for the first time.
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Nanopartículas/química , Nanopartículas/ultraestructura , Nanotecnología/instrumentación , Resonancia por Plasmón de Superficie/instrumentación , Diseño de Equipo , Análisis de Falla de Equipo , Fotones , Propiedades de SuperficieRESUMEN
Background: Subdural electrocorticography (ECoG) signals have been proposed as a stable, good-quality source for brain-machine interfaces (BMIs), with a higher spatial and temporal resolution than electroencephalography (EEG). However, long-term implantation may lead to chronic inflammatory reactions and connective tissue encapsulation, resulting in a decline in signal recording quality. However, no study has reported the effects of the surrounding tissue on signal recording and device functionality thus far. Methods: In this study, we implanted a wireless recording device with a customized 32-electrode-ECoG array subdurally in two nonhuman primates for 15 months. We evaluated the neural activities recorded from and wirelessly transmitted to the devices and the chronic tissue reactions around the electrodes. In addition, we measured the gain factor of the newly formed ventral fibrous tissue in vivo. Results: Time-frequency analyses of the acute and chronic phases showed similar signal features. The average root mean square voltage and power spectral density showed relatively stable signal quality after chronic implantation. Histological examination revealed thickening of the reactive tissue around the electrode array; however, no evident inflammation in the cortex. From gain factor analysis, we found that tissue proliferation under electrodes reduced the amplitude power of signals. Conclusion: This study suggests that subdural ECoG may provide chronic signal recordings for future clinical applications and neuroscience research. This study also highlights the need to reduce proliferation of reactive tissue ventral to the electrodes to enhance long-term stability.
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BACKGROUND: This systematic review and meta-analysis aimed to determine whether chemotherapy-induced peripheral neuropathy (CIPN) affects the risk of falls and physical function in patients with cancer. METHODS: A literature search was conducted in the CINAHL, Scopus, and PubMed databases for articles published from January 1950 to April 2022. Seven review authors retrieved studies using predetermined eligibility criteria, extracted the data, and evaluated the quality. RESULTS: Nine studies were included in the analysis. Patients with CIPN had a significantly higher risk of falls than those without CIPN (risk ratio = 1.38, 95% confidence interval [CI] =1.18-1.62). Patients with CIPN had lower grip strength (standardized mean difference [SMD] =-0.42, 95% CIs = -0.70 to -0.14, P = .003), longer chair stand time (SMD = 0.56, 95% CIs = -0.01 to 1.17, P = .05), worse timed up and go test time (SMD = 0.79, 95% CIs = 0.41 to 1.17, P < .0001), and lower mean Fullerton Advanced Balance scale score (SMD = -0.81, 95% CIs = -1.27 to -0.36, P = .005) than patients without CIPN. There were no significant differences in gait speed (P = .38) or Activities-specific Balance Confidence Scale score (P = .09) between patients with and without CIPN. CONCLUSIONS: This systematic review and meta-analysis demonstrated that patients with CIPN are prone to falls and impaired balance function and muscle strength.
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Antineoplásicos , Neoplasias , Enfermedades del Sistema Nervioso Periférico , Humanos , Antineoplásicos/efectos adversos , Equilibrio Postural , Estudios de Tiempo y Movimiento , Neoplasias/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/inducido químicamenteRESUMEN
OBJECTIVE: Wireless implantable brain machine interfaces (BMIs) are a promising tool to restore communication and motor functions for individuals with severe motor disability. Prior to clinical application, recording performance must be sufficiently confirmed by animal experiments. In this paper, we aimed to evaluate the performance of a novel BMI wireless device for recording brain activity in two nonhuman primates. METHOD: We customized a wireless device for implantable BMIs for clinical application. We used a battery instead of a wireless power charging system. Thirty-two electrodes were subdurally implanted over the left temporoparietal cortex. We evaluated the recording performance of the wireless device by auditory steady-state responses (ASSRs) and ketamine-induced responses. RESULT: The devices successfully recorded broadband oscillatory activities up to the high-frequency band from the temporal cortex in two awake macaque monkeys. Spectral analysis of raw signals demonstrated that the devices detected characteristic results of a 40-Hz ASSR and prominent high-frequency band activity induced by ketamine injection. CONCLUSION: We confirmed the functionality of the wireless device in recording and transmitting electrocorticography (ECoG) signals with both millisecond precision and recording stability. SIGNIFICANCE: These results provide confidence that this wireless device can be a translational tool for other fundamental neuroscientific studies in free-moving models.
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Personas con Discapacidad , Ketamina , Trastornos Motores , Animales , Humanos , Electrocorticografía , Índice de Masa Corporal , Ketamina/farmacología , Vigilia , MacacaRESUMEN
In recent years, the number of cancer survivors has been increasing each year due to advances in the early diagnosis and treatment of cancer. Cancer survivors present a variety of physical and psychological complications due to cancer and its treatment. Physical exercise is an effective nonpharmacological treatment for complications in cancer survivors. Furthermore, recent evidence has shown that physical exercise improves the prognosis of cancer survivors. The benefits of physical exercise have been widely reported, and guidelines for physical exercise for cancer survivors have been published. These guidelines recommend that cancer survivors engage in moderate- or vigorous-intensity aerobic exercises and/or resistance training. However, many cancer survivors have a poor commitment to physical exercise. In the future, it is necessary to promote physical exercise among cancer survivors through outpatient rehabilitation and community support.
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INTRODUCTION: This multicenter, randomized, comparative, and investigator-masked crossover clinical trial sought to compare the efficacy and tolerability of fixed combinations of 0.1% brimonidine/0.5% timolol (BTFC) versus 1% dorzolamide/0.5% timolol (DTFC) as adjunctive therapies to prostaglandin analogues. METHODS: A total of 110 patients with open-angle glaucoma or ocular hypertension previously treated with prostaglandin analogue monotherapy were randomized to receive either BTFC or DTFC as adjunctive therapy for 8 weeks. These patients were then crossed over to the alternative treatment arm for another 8 weeks. The reduction in intraocular pressure (IOP) (primary outcome), occurrence of adverse events, ocular discomfort after instillation, and patient preference (secondary outcomes) were recorded through patient interviews. RESULTS: BTFC instillation for 8 weeks reduced IOP by 3.55 mmHg, demonstrating non-inferiority to DTFC instillation (3.60 mmHg; P < 0.0001, mixed-effects model). Although adverse events were rare with both combinations, patients reported greater discomfort with DTFC than with BTFC (P < 0.0001). More patients preferred BTFC (P < 0.0001) over DTFC, as BTFC caused minimal or no eye irritation. CONCLUSION: As BTFC offered better tolerability than DTFC with comparable reduction in IOP, we recommend it as an alternative for patients who experience ocular discomfort with DTFC-prostaglandin analogue combination therapy. TRIAL REGISTRATION NUMBER: jRCTs051190125.
Patients with glaucoma who require further reduction in intraocular pressure while undergoing monotherapy with prostaglandin analogue ophthalmic solution have been prescribed two enhanced treatment options: 0.1% brimonidine/0.5% timolol fixed combination ophthalmic solution (BTFC) and 1% dorzolamide/0.5% timolol fixed combination ophthalmic solution (DTFC). The Aibeta Crossover Study Group in Japan compared the efficacy and tolerability of fixed combinations of BTFC versus DTFC when an additional fixed combination ophthalmic solution was prescribed in patients with open-angle glaucoma or ocular hypertension who had been treated with prostaglandin analogue monotherapy. We recruited 110 patients previously treated with prostaglandin analogue monotherapy at 20 clinical centers in Japan, then randomly assigned them to two alternative treatment groups: the BTFC to DTFC group or the DTFC to BTFC group, as an adjunctive therapy to prostaglandin analogues for total of 16 weeks. We compared the reduction in intraocular pressure, occurrence of side effects, eye discomfort after instillation, and patient preference between BTFC versus DTFC instillations. The intraocular pressure reduction of BTFC instillation was comparable to that of DTFC instillation, showing non-inferiority to DTFC (3.55 mmHg vs. 3.60 mmHg; P < 0.0001, mixed-effects model). Both eye drops caused few side effects; however, patients felt greater eye discomfort with DTFC than with BTFC (P < 0.0001). Because of less eye irritation, more patients preferred BTFC (P < 0.0001) over DTFC. We can recommend using BTFC for patients who feel eye discomfort with DTFCprostaglandin analogue combination therapy.