Reviews on recent clinical trials最新文献

Background: In the era of novel agents, many multiple myeloma patients can achieve a complete remission, but most of them relapse, and minimal residual disease detection can play a crucial role. Next-generation flow (NGF) can detect monoclonal plasma cells with a sensitivity of 10^-6. Little is known about long-term remission patients (> 2 years) and in particular, if more sensitive techniques such as NGF can still detect minimal disease in those patients.

Objective: Aim of the study was to analyze patients with MM in response to NGF at > 2 years of sustained remission after several treatments.

Methods: MRD was studied by NGF in bone marrow aspirates according to Euroflow Consortium indications.

Results: 62 patients with sustained CR at >2 years were studied, MRD+ status was detected at a threshold cut-off of 10^-6 in 32/62 (52%); 4/15 (27%) patients were MRD positive at >5 years of remission and they displayed a prevalence of normal vs abnormal monoclonal plasma cell immune-phenotype (MGUS-like).

Conclusion: NGF is a powerful technique to detect MRD. Myeloma patients in prolonged sustained complete remission can show in high percentage an MRD negative status or MGUS like.

Background: Ulcerative colitis may impair anorectal function, causing disabling symptoms such as incontinence and/or increase in the stool frequency, urgency and tenesmus. Data on anorectal function in these patients evaluated by conventional anorectal manometry are conflicting.

Objectives: The aim of this prospective study was to assess by means of high resolution anorectal manometry the anorectal function in patients with mild-to-moderate ulcerative colitis at presentation and after remission. Anorectal function of ulcerative colitis patients was compared to that observed in healthy volunteers.

Methods: 20 patients with mild to moderate left-sided ulcerative colitis or proctitis and 20 healthy volunteers were prospectively enrolled. All ulcerative colitis patients underwent high resolution anorectal manometry before treatment and after clinical remission.

Results: Ulcerative colitis patients showed similar values for anal sphincter function as healthy volunteers, whereas rectal threshold volume for the first sensation, desire to defecate, urgency to defecate and maximum discomfort were significantly lower than in healthy volunteers (p<0.05). Rectal compliance was significantly lower in ulcerative colitis than in healthy volunteers (p<0.05). After remission, rectal threshold volumes, as well as rectal compliance, significantly increased. An inverse linear correlation was found between regression of urgency and stool frequency and rectal compliance (r=0.811; p<0.05).

Conclusion: Ulcerative colitis patients show altered rectal function, with increased rectal sensitivity and lower compliance, compared to controls. This altered function is restored after successful treatment of the underlying inflammatory process. Finally high resolution anorectal manometry provides useful information on anorectal functionality and, in our opinion, should be preferred over conventional manometry.

Background: Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by progressive destruction of the intrahepatic bile ducts, followed by fibrous substitution of the ducts and potential evolution in cirrhosis. The geographical disparity in the prevalence of PBC suggests a possible role of environmental factors in developing the disease. We analyzed two groups of patients with different geographical prevalence.

Methods: This study concerned the analysis of 14 Caucasian patients in two groups: ten patients enrolled in the Digestive Diseases Unit, University of Catanzaro (Italy), and four patients enrolled in the Department of Hepatology, University Hospital Kràlovskè Vinohrady of Prague (Czech Republic). The statistical analysis was performed using the software IBM SPSS (v. 20, Windows).

Results: The Italian group showed a statistically significant difference in the total bilirubin values at diagnosis and during the last control (0.74±0.267 vs. 0.56±0.246; p-value: 0.013). Moreover, the comparison between the two groups showed a statistically significant difference in the serum albumin values at the time of the last control (4.6±0.231 vs. 4.15±0.532; p-value: 0.048).

Conclusion: Our data indicate an effective difference in the onset and clinical presentation between our two groups. More epidemiologic, prospective, and multicenter research projects are warranted to advance PBC knowledge in Europe.

The gut microbiota is one of the great innovations of modern medicine. In the modern microbiota revolution era, more comprehensive and in-depth studies have been performed regarding the microbial gut communities and their impact on acute and chronic diseases, including those of the nervous system as acute neurological diseases. The microbiota has changed our knowledge of medical conditions; in particular, considering stroke (both ischemic and hemorrhagic), literature studies, experimental and clinical researches indicate that the individual's risk and outcomes are substantially impacted by the gut microbiota. The aim of our review article is to investigate and discuss the recent insights into the emerging role of this complex "gut microbiota-brain axis" in affecting some acute neurological diseases, such as stroke, responsible for a significant number of deaths worldwide. We performed electronic research on PubMed® and collected articles published in the last ten years, finding that changes in the gut microbiota composition could affect various aspects of stroke pathophysiology and individual predisposition, risk, and outcomes. Our review article suggests that there is a strong connection between the gut microbiota and the brain, both in health and in acute neurological diseases such as stroke. Investigating and exploring this relationship can be a challenge useful to learn more about this disabling/deadly condition, and it can be a useful tool to identify novel potential therapeutic approaches, improving an individual's outcomes and life.

Background: Type 2 diabetes is a metabolic disease characterized by hyperglycemia as a result of insulin resistance and decreased insulin secretion. A relatively large number of patients with this type of diabetes have abdominal obesity, which also affects insulin resistance development. Chronic hyperglycemia can lead to damage and dysfunction of various organs, and a striking example is diabetic nephropathy. Diabetic nephropathy is a specific kind of kidney damage that occurs due to complications of diabetes and is accompanied by the formation of diffuse or nodular glomerulosclerosis, which can lead to terminal renal failure and requires immediate substitution through renal therapy or renal transplantation. Diabetic nephropathy is diagnosed with albuminuria and a decrease in the rate of glomerular filtration.

Methods: This review was based on a literature search for the most important evidence of vitamin D as a possible method of prevention for obesity, type 2 diabetes, and diabetic nephropathy. Collected published articles were summarized according to their overall themes.

Results: In this review, we considered vitamin D as a possible method of treatment for type 2 diabetes, as well as its complications, including diabetic nephropathy.

Conclusion: Studies show that vitamin D inhibits the renin-angiotensin-aldosterone system, resulting in improved renal function in diabetic nephropathy. Vitamin D also has antiinflammatory, antiproliferative, and anti-metastatic effects, which improve endothelial function.

Background: During general anesthesia, mechanical ventilation can cause pulmonary damage through mechanism of ventilator-induced lung injury, which is a major cause of post-operative pulmonary complications, which varies between 5 and 33% and increases the 30-day mortality of the surgical patient significantly.

Objective: The aim of this review is to analyze different variables which played a key role in the safe application of mechanical ventilation in the operating room and emergency setting.

Methods: Also, we wanted to analyze different types of the population that underwent intraoperative mechanical ventilation like obese patients, pediatric and adult population and different strategies such as one lung ventilation and ventilation in trendelemburg position. The peer-reviewed articles analyzed were selected according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) from Pubmed/Medline, Ovid/Wiley and Cochrane Library, combining key terms such as: "pulmonary post-operative complications", "protective ventilation", "alveolar recruitment maneuvers", "respiratory compliance", "intraoperative paediatric ventilation", "best peep", "types of ventilation". Among the 230 papers identified, 150 articles were selected, after title - abstract examination and removing the duplicates, resulting in 94 articles related to mechanical ventilation in operating room and emergency setting that were analyzed.

Results: Careful preoperative patient's evaluation and protective ventilation (i.e., use of low tidal volumes, adequate PEEP and alveolar recruitment maneuvers) has been shown to be effective not only in limiting alveolar de-recruitment, alveolar overdistension and lung damage, but also in reducing the onset of Pulmonary Post-operative Complications (PPCs).

Conclusion: Mechanical ventilation is like "Janus Bi-front" because it is essential for surgical procedures, for the care of critical care patients and in life-threatening conditions, but it can be harmful to the patient if continued for a long time and where an excessive dose of oxygen is administered into the lungs. Low tidal volume is associated with a minor rate of PPCs and other complications and every complication can increase the length of Stay, adding cost to NHS between 1580 € and 1650 € per day in Europe and currently the prevention of PPCS is the only weapon that we possess.

Background: The international health emergency caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which, at the end of 2019, hit the world, forced the governments of all countries to adopt stringent restrictive measures to contain the spread of the virus. Several studies have revealed worsening levels of anxiety, depression and perceived stress related to these restrictions and the resulting lifestyle changes. Some studies have also confirmed the presence of a relationship between SARS-CoV-2-related emotional distress and drinking behavior. Indeed, is a wellknown fact that alcohol consumption is one of the behavioral strategies used to reduce negative emotional states. However, it was documented that young people developed different responses to alcohol use during the pandemic than adults.

Objective: The aim of this work was to investigate the consumption habits of young Italians and how the consumption and purchase of alcoholic beverages have changed following the pandemic. New ways of drinking alcohol were also interesting to observe, such as online.

Methods: Young people between 18 and 35 years old were subjected to an anonymous questionnaire of 22 questions on the adoption of forms of behavior at risk through alcohol consumption, the quantity and occasions of preferential consumption, and on the methods and quantities of alcoholic beverage purchase, before and during the SARS-CoV-2 pandemic. The subjects who declared themselves "non-drinkers" were not included in the statistical survey.

Results: About 33% of the enrolled "drinkers" (268/823), adopted risky forms of alcoholic behavior. Males reported a higher average habit of drinking wine or alcohol (M = 1.9953 ± 1.39743, F = 1.7373 ± 1.36688, p <0.005); an increased frequency of drinking (M = 2.3025 ± 0.80610 F = 2.0494 ± 0.75043 p <0.001); a higher average number of drinks consumed (M = 1.5182 ± 0.85646, F = 1.2618 ± 0.53292, p <0.001) and binge drinking to the greatest extent (M = 1.1933 ± 0.96522 F = 0.8176 ± 0.85446 p <0.001). Education and employment were significantly correlated with the frequency of alcohol consumption (r = 0.107 p <0.005 and r = 0.120 p = 0.001 respectively). Subjects reported buying alcoholic beverages during the pandemic with a frequency of "less than once a month" (N = 291, 35.36%) and mainly in shops (N = 556, 67.56%), while before the pandemic they mainly bought alcohol once a week (N = 431, 52.37%) and predominantly in bars / clubs (N = 619, 75.21%). New ways of drinking alcohol such as online drinking, have not been significantly identified.

Conclusion: A change in alcohol consumed and alcohol purchased before and during the SARSCoV- 2 pandemic was revealed.

Background: During the COVID-19 pandemic in Italy, decisions were taken to adopt restrictive legislative measures, such as the first half of the 2020 lockdown. In those months, patients with inflammatory bowel disease experienced social isolation and reduced access to health care.

Objective: We aimed to evaluate, in this condition, the presence of remission subgroups that were most impacted by the lockdown.

Methods: During the first Italian lockdown, we recruited patients with remission of inflammatory bowel disease by administering an online questionnaire including patient demographics, the Beck Anxiety Questionnaire Inventory, the Beck Depression Inventory questionnaire, and the Pittsburg Sleep Quality Index, all validated standardized questionnaires for anxiety symptom levels, depression, and sleep quality.

Results: Our results showed how female patients (p<0.0001) with Crohn's disease (p<0.001) experienced worse levels of anxiety symptoms. Female patients (p<0.0001) between 50 and 60 years of age (p=0.013) with Crohn's disease (p=0.047) experienced worse levels of depressive symptoms. Females also experienced significantly worse sleep levels (p<0.001). We found a correlation between the number of sleeping hours (p<0.001) and the time taken to fall asleep (p<0.001) and the Beck Anxiety Questionnaire Inventory,which showed a linear worsening of the number of minutes it took to fall asleep, and the Beck Depression Inventory questionnaire.

Conclusion: Among patients with remission of inflammatory bowel disease, female patients, patients with Crohn's disease, and people aged between 50 and 70 years should be considered for screening for anxiety and depression disorders and an assessment of sleep quality.

Introduction: The present article reports an overview of the studies about combination treatment with citicoline of Alzheimer's (AD) and mixed dementia (MD).

Methods: A Medline search was carried out by using the keywords Alzheimer's dementia, mixed dementia, older people, treatment with citicoline, memantine, and acetylcholinesterase inhibitors (AchEIs).

Results: Six studies were found to match the combination treatment of citicoline with AcheIs and/or memantine. The CITIRIVAD and CITICHOLINAGE studies were the first to report the potential benefits of adding citicoline to acetylcholinesterase inhibitors (AchEIs). Then, we added citicoline to memantine in the CITIMEM study, and finally, we demonstrated benefits in terms of delay in cognitive worsening with the triple therapy (citicoline + AchEIs + memantine). Other authors also reinforced our hypothesis through two further studies.

Conclusion: Open, prospective studies are advised to confirm the utility of combination therapy with citicoline for the treatment of AD and MD.

Background: In men with low levels of testosterone in the blood, it is believed that the symptoms can be regarded as an association between testosterone deficiency syndrome and related comorbidities.

Aim: To investigate the effectiveness of testosterone therapy in patients with type 2 diabetes (T2D) and androgen deficiency.

Materials and methods: Testosterone replacement therapy was carried out in 26 men with T2D and clinically or laboratory-confirmed androgen deficiency. The age of the subjects ranged from 35 to 69 years old. Laboratory studies included determinations of the concentration of the hormones estradiol, luteinizing hormone (LH), and prostate-specific antigen (PSA). The observation period was 9 months.

Results: The average level of total blood testosterone in the subjects before treatment was 9.4 mol/l and was likely lower than that of the control group (19.3 ± 1.6 nmol/l). The levels of total testosterone in the subjects ranged from 3.9 nmol/l to 10.7 nmol/l, and hormone levels measuring less than 8.0 nmol/l were observed in only 11 patients. After a course of testosterone replacement therapy, a stabilization in total testosterone levels at the level of reference values (as compared to the start of treatment) was observed in the blood of men with T2D after 9 months of observation and the administration of the fourth injection (16.83 ± 0.75 nmol/l).

Conclusion: The use of long-acting injectable testosterone undecanoate leads to normalization of total testosterone levels in the blood of men with T2D and androgen deficiency, and LH levels in these patients are unlikely to change.