Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage:the Dutch Intracerebral haemorrhage Surgery Trial pilot study

Background: Previous randomised controlled trials could not demonstrate that surgical evacuation of intracerebral haemorrhage (ICH) improves functional outcome. Increasing evidence suggests that minimally invasive surgery may be beneficial, in particular when performed early after symptom onset. The aim of this study was to investigate safety and technical efficacy of early minimally invasive endoscopy-guided surgery in patients with spontaneous supratentorial ICH. Methods: The Dutch Intracerebral Haemorrhage Surgery Trial pilot study was a prospective intervention study with blinded outcome assessment in three neurosurgical centres in the Netherlands. We included adult patients with spontaneous supratentorial ICH ≥10mL and National Institute of Health Stroke Scale (NIHSS) score ≥2 for minimally invasive endoscopy-guided surgery within 8 h after symptom onset in addition to medical management. Primary safety outcome was death or increase in NIHSS ≥4 points at 24 h. Secondary safety outcomes were procedure-related serious adverse events (SAEs) within 7 days and death within 30 days. Primary technical efficacy outcome was ICH volume reduction (%) at 24 h. Results: We included 40 patients (median age 61 years; IQR 51–67; 28 men). Median baseline NIHSS was 19.5 (IQR 13.3–22.0) and median ICH volume 47.7mL (IQR 29.4–72.0). Six patients had a primary safety outcome, of whom two already deteriorated before surgery and one died within 24 h. Sixteen other SAEs were reported within 7 days in 11 patients (of whom two patients that already had a primary safety outcome), none device related. In total, four (10%) patients died within 30 days. Median ICH volume reduction at 24 h was 78% (IQR 50–89) and median postoperative ICH volume 10.5mL (IQR 5.1–23.8). Conclusions: Minimally invasive endoscopy-guided surgery within 8 h after symptom onset for supratentorial ICH appears to be safe and can effectively reduce ICH volume. Randomised controlled trials are needed to determine whether this intervention also improves functional outcome. Trial registration: Clinicaltrials.gov : NCT03608423, August 1st, 2018.</p

Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study

Background: Since the late ‘90s, infliximab (Remicade®) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima® were introduced in clinical practice. Aim: To investigate the interchangeability of Remicade® (originator infliximab) and its biosimilar Remsima® in patients with rare immune-mediated inflammatory diseases (IMIDs). Methods: This two-phased prospective open label observational study was designed to monitor the transition from Remicade® to Remsima® in patients with rare IMIDs. All included patients were followed during the first 2 years. The primary endpoint was the demonstration of non-difference in quality of life and therapeutic efficacy, as measured by parameters including a safety monitoring program, physicians perception of disease activity (PPDA) and patient self-reported outcomes (PSROs). Secondary outcomes included routine blood analysis, pre-infusion serum drug concentration values and anti-drug antibody formation. Results: Forty eight patients treated with Remicade® were switched to Remsima® in June-July 2016 and subsequently monitored during the first 2 years. The group consisted of patients with sarcoidosis (n = 17), Behçet's disease (n = 12), non-infectious uveitis (n = 11), and other diagnoses (n = 8). There were no significant differences in PPDA, PSROs, clinical and laboratory assessments and pre-infusion serum drug concentrations between the groups. De novo anti-drug antibodies were observed in two patients. Seven patients with sarcoidosis and five with another diagnosis developed a significant disease relapse (n = 7) or adverse events (n = 5) within 2 years; 10 of these patients discontinued Remsima® treatment, one withdrew from the study and one received additional corticosteroid therapy. Conclusions: We observed no significant differences in PSROs, PPDA and laboratory parameters after treatment was switched from Remicade® to Remsima®. However, disease relapse or serious events were observed in 12 out of 48 patients when treatment was switched from Remicade® to Remsima®. The choice to switch anti-TNF alpha biologics in patients with rare IMIDs, particularly in sarcoidosis, requires well-considered decision-making and accurate monitoring due to a possibly higher incidence of disease worsening

Gênero Pimenta: aspectos botânicos, composição química e potencial farmacológico Pimenta genus: botanical aspects, chemical composition and pharmacological potential

A família Myrtaceae possui representantes de grande interesse medicinal e o gênero Pimenta é um dos que merecem destaque. A maioria das espécies desse gênero é nativa da América Central, com exceção da Pimenta pseudocaryophyllus (Gomes) L. R. Landrum, nativa nas regiões centro-oeste e sudeste do Brasil. O presente estudo teve como objetivo revisar aspectos botânicos, químicos e farmacológicos descritos na literatura sobre o gênero Pimenta. Os dados foram obtidos de artigos originais e revisões indexadas nas bases Periódicos Capes, ISI Web of Knowledge, Bireme e SciELO. As espécies desse gênero podem ser arbustivas ou arbóreas, possuem pelos unicelulares, folhas usualmente coriáceas, inflorescência em dicásio ou panícula e são distinguidas, principalmente, pela estrutura do ovário. As propriedades farmacológicas são conferidas, principalmente, pelos óleos essenciais que são constituídos, na maioria, por derivados fenilpropanóides, monoterpenos, aldeídos monoterpênicos e alcoóis monoterpênicos. Dentre as propriedades farmacológicas apresentadas por espécies desse gênero destacam-se as anti-hipertensivas, anti-inflamatórias, analgésicas, antimicrobianas e antioxidantes. Das quinze espécies de Pimenta conhecidas, a Pimenta dioica (L.) Merrill e a Pimenta racemosa (Miller) J. Moore são as espécies de maior importância econômica e, por esse motivo são as mais estudadas do ponto de vista químico e farmacológico.The family Myrtaceae has representatives of great medical interest, and the genus Pimenta deserves attention. Most species of this genus are native to the Central America, except Pimenta pseudocaryophyllus (Gomes) L. R. Landrum, which is native to the Central-West and Southeast Brazilian Regions. This study aimed to review botanical, chemical and pharmacological aspects described in the literature for Pimenta genus. Information was obtained from original papers and reviews indexed in the databases "Periódicos Capes", ISI Web of Knowledge, "Bireme" and SciELO. This genus can present shrubs or trees, which have unicellular hairs, usually coriaceous leaves and dichasium or panicle inflorescence, and are mainly distinguished by the ovary structure. The pharmacological properties are mostly due to essential oils, mainly consisted of phenylpropanoid, monoterpene, monoterpenic aldehyde and alcohol derivatives. Among these properties, antihypertensive, anti-inflammatory, analgesic, antimicrobial and antioxidant ones are highlighted. Of the fifteen known Pimenta species, Pimenta dioica (L.) Merrill and Pimenta racemosa (Miller) J. Moore have the greatest economic importance and consequently have been the most chemically and pharmacologically studied