Autologous haematopoietic stem cell transplantation (HSCT) with CD34(+) cell selection has recently been used in the treatment of refractory Crohn's disease, showing good safety and promising ...efficacy. We investigated the safety and efficacy of HSCT with unselected peripheral blood stem cells (PBSCs) in moderate-severe refractory Crohn's disease.
Four patients (three male, one female; age range 26-45 years) with active moderate-severe Crohn's disease (median Crohn's Disease Activity Index (CDAI) 319, range 272-345), refractory or intolerant to multiple drugs including infliximab, were enrolled.
Unselected PBSCs were collected after mobilisation with cyclophosphamide (CTX) 1.5 g/m2 and granulocyte-colony stimulating factor (G-CSF) 10 microg/kg. The conditioning regimen included CTX 50 mg/kg on days -5 to -2 and rabbit anti-thymocyte globulin (ATG) 2.5 mg/kg on days -4 to -2.
Primary endpoints were toxicity and clinical remission (CDAI<150) at 3 months. Secondary endpoints were clinical and endoscopic response at 3 months and toxicity, clinical and endoscopic remission at 12 months.
No improvement or slight deterioration was observed following mobilisation (median CDAI 339, range 258-404). At the third month, the primary endpoint of clinical remission was achieved in all patients, with a median CDAI of 91 (range 56-102), and complete endoscopic remission was achieved in 2/3 patients. After a median follow-up of 16.5 months, 3/4 patients maintained both clinical and endoscopic remission, despite withdrawal of all drugs, and complete fistula closure was observed in all affected patients. No deaths or life-threatening infection occurred. Unexpected adverse events included a perianal abscess after mobilisation in one patient, pleural and pericardial effusions in another and BK virus-related macrohaematuria in another, all rapidly resolved with conservative treatment.
Autologous HSCT with unselected PBSC appears to be safe and can induce and maintain remission in previously refractory Crohn's disease patients.
COVID-19 pandemic has underlined that unknown viral infections, which jump from animals to humans, can be extremely dangerous. In case of new viruses as SARS-CoV2, available drugs can fail to ...contrast the virus aggressiveness leading patients to death. Long time is necessary to create a vaccine, but immediate solutions are necessary to stop the mortality COVID-19 related. We have learned that the immune-system is the key to reduce the severity of COVID-19 and, through its modulation, it has been possible saving people's life. In this short communication, we discuss the use of nutraceuticals to modulate and stimulate the immune answer for reducing the severity of COVID-19 symptoms. The nutraceuticals are safe and can be administered to all ages. In addition, combination of natural anti-viral elements and immune-stimulating molecules already successfully tested against others upper-respiratory tract infections-could be efficient against SARS-CoV2. We believe that these natural molecules could really be a valid ally against COVID-19, especially in this moment in which a SARS-CoV2 vaccine is still not available.
The aim of this work is to reexamine our experience with the treatment of conductive and mixed hearing loss using the Baha system. The system was implanted in 47 patients (16 adults and 31 children ...under the age of 14), bilaterally in two cases. The causes of hypoacusis were bilateral congenital aural atresia (31 patients), bilateral chronic otitis media or outcomes of middle-ear surgery (Gillett et al. in J laryngol Otol 120:537–542,
2006
), and otosclerosis (Pazzaglia et al. in Acta Orthop Scand 54:574–579,
1983
). The following parameters were assessed: mean preoperative air- and bone-conduction thresholds for the frequencies of 500, 1,000, 2,000 and 4,000 Hz; mean postoperative threshold with the Baha; hearing improvement calculated by subtracting the postoperative threshold with the Baha from the preoperative threshold for air conduction in the better ear; speech audiometry test; improvement in the quality of life, calculated using the Glasgow Benefit Inventory for the adult patients and the Glasgow Children’s Benefit Inventory for paediatric patients; frequency and type of surgical complications. Follow-up ranged from 6 to 38 months. The audiological results were satisfactory, with air–bone gap closure in 85.1% of cases. In terms of quality of life, assessment using the Glasgow Benefit Inventory showed a clear-cut improvement in health for all the 45 patients that answered to the questionnaires in our study. Out of the 49 operations that were performed, complications were reported in 3 cases (6.1%): 2 cases of skin regrowth around the titanium screw and one in which the abutment was not osseointegrated. The data from this study show that the Baha system offers a high percentage of success, which can significantly improve the patient’s quality of life, and a low rate of complications.
Previous studies have shown that tryptophan and vitamin B6 used in conjunction with melatonin induce sleep more effectively than melatonin alone. This study aims at evaluating the efficacy of ...different dosages and timings of administration of a solution containing melatonin, tryptophan, and vitamin B6 for inducing sleep in children undergoing ABR testing.
294 children scheduled for Auditory Brain Response (ABR) evaluation were administered a solution containing melatonin, tryptophan, and vitamin B6 to induce sleep before the exam. Two different administration timings (pre-treatment and single shot treatment) and three dosages (0.5 ml in pre-treatment, 1.5 ml in pre-treatment, and 3 ml in single shot) were tested. The following parameters were evaluated: time needed for the subject to fall asleep before ABR testing, subject sl'eep features during ABR testing (quality, stability, duration), recorded ABR quality (including presence of abnormalities in amplitude and latency), subject waking up modality, and time needed for the subject to wake up at the end of the ABR exam.
Quality of ABR signals was similar across treatments, and subjects responded in a similar manner in terms of time needed to wake-up and wake-up modality. However, pretreatment with the 1.5 ml dose induced sleep faster than the two other dosages, and the length of the induced sleep was longer than that induced by pre-treatment with 0.5 ml. In general, the pre-treatment with 1.5 ml led to a shorter ABR exam, because reduces the time for inducing sleep, allows a long sleeping phase with a good quality, without variation in the wakening up times.
Melamil Tripto® is an alternative to sedative drugs for inducing sleep in pediatric subjects undergoing ABR testing. A pre-medication with 1.5 ml of MT 1 week before ABR testing further improves the strength of the solution.
Abstract Objective Otitis media with effusion (OME) is an ear disorder defined by the presence of fluid in the middle ear without signs or symptoms of acute infection. The current randomized, ...double-blind, controlled study aimed to evaluate whether Sinuclean Nebules treatment, administered by nasal douche (Rinowash), could induce ear healing better than isotonic saline in children with OME. Methods The study was randomized, double-blind, and controlled. Group A (30 children) was treated with Sinuclean Nebules 45 and Group B (31 children) was treated with isotonic saline; both compounds were administered by nasal nebulization with Rinowash nasal douche twice/day in the morning and in the evening for 10 days, followed by a one-week suspension, and after by a second course as the first. Tympanogram and audiometry were performed at baseline and after treatment. Results Considering the global evaluation of the treatment: in Group A, 28 (93.3%) patients had complete resolution and 2 (6.7%) had partial resolution; in Group B, all patients had failure of treatment. There was a significant difference between groups (p < 0.0001). Conclusion The current randomized-controlled study demonstrated that Sinuclean Nebules was effective and in the treatment of children with OME.
During angiography, an oval-shaped formation with smooth calcified margins was observed (B to D) Cardiac computed tomography showed the pseudoaneurysmatic lesion (60 x 53 mm) close to the mitral ...valve annulus, directly communicating to the LV chamber through a 3-cm breach (E to J;Online Video 2).