Reviews on recent clinical trials最新文献

Introduction: Hyponatremia is the most frequently occurring electrolyte disorder in neurocritical care and traumatic brain injury, aneurysmal subarachnoid hemorrhage (SAH), neurosurgery, and ischemic stroke are the clinical conditions more often associated with this condition. SIADH and CSWS are the main causes of hyponatremia in neurologically ill patients. Since hyponatremia is a negative prognostic factor for neurocritical patients, early diagnosis and consequent targeted therapy are of fundamental importance. The present review was carried out to provide a brief recap on the main causes and management of hyponatremia in the neurocritical patient.

Methods: A methodical search of the medical literature using the online database MEDLINE was carried out and studies comprising case reports, prospective and retrospective observational studies, or randomized controlled clinical trials in which there is a diagnosis of hyponatremia in neurocritical patients were included.

Results: 18 articles were analyzed, consisting of 8 case reports, 4 case series, 3 prospective trials, 1 retrospective study, and 1 multicenter trial. A total of 1371 patients from 18 studies were included. Patients' average age was 29.28 ± 20.9, respectively. TBI was the main cause of hyponatremia in the literature reviewed; 12 studies were about the relationship between TBI and hyponatremia, 2 studies about stroke, 2 studies about SAH and 1 about hyponatremia postneurosurgical procedure.

Discussion: Hyponatremia is the most common electrolyte disorder in hospitalized patients and the main scenarios of hyponatremic neurocritical patients are subarachnoid hemorrhage, ischemic stroke, traumatic brain injury and iatrogenic hyponatremia due to neurosurgical cases.

Conclusion: Hyponatremia is a frequent finding in neurocritical care and is also a recognized negative prognostic factor leading to increased mortality and ICU length hospitalization. Its diagnosis and therapy are essential for correct neurocritical management. The most common cause of serum sodium abnormality is SIADH, and an early diagnosis for target treatment is paramount to prevent delayed symptoms and complications.

Background: In older patients, prevention of acute respiratory tract infections (RTIs) is challenging. Experimental studies have consistently underlined an immune-potentiating effect of the bacterial lysates product OM85, on both cellular and humoral responses.

Objective: This work aimed to assess the potential efficacy of OM-85 for RTIs' prevention in older individuals.

Methods: This explorative longitudinal study included 24 patients aged 65 years or older recruited in the GeroCovid Observational Study- home and outpatient care cohort. For the study purposes, we included 8 patients treated with OM-85 from December 2020 to June 2021 (group A), and a control group of 16 patients, matched for sex and age, who did not receive bacterial lysates (group B). RTIs were recorded from the participants' medical documentation in an e-registry from March 2020 to December 2021.

Results: In 2020, group A experienced a total of 8 RTIs, which affected 6 out of 8 patients (75%); group B reported 21 RTIs, with at least one event in 11 out of 16 patients (68.7%). In 2021, RTIs affected 2 out of 8 patients (25%) in group A (p < 0.02), and 13 out of 16 patients (81.2%) in group B (within this group, 5 patients had two RTIs). The RTIs' cumulative incidence over the observation period significantly differed between groups (66.7% in group A vs. 24.3% in group B; p < 0.002), as well as the decrease in RTIs frequency from 2020 to 2021. No patients in group A were affected by COVID-19 during the observation period, while among controls, two patients had SARS-CoV-2 infection, notwithstanding three doses of vaccine.

Conclusion: This study suggests that bacterial lysates may provide clinical benefits for preventing RTIs. Additional research involving larger cohorts is required to verify the effectiveness of OM-85 in preventing RTIs in older adults.

Patients affected by inflammatory bowel disease (IBD) frequently report impaired quality of sexual life and complain of sexual dysfunctions. Both disease-specific features and psychological factors can be held responsible for these conditions. However, sexuality and all matters relating to sexual health are often wrongfully considered unrelated to IBD and, therefore, overlooked during medical visits. To overcome these difficulties and to best assess patients' perceptions about their sexual health status, the use of patient-reported outcomes (PROs) could represent a valid strategy. In real-world studies, several non-IBD specific questionnaires, exploring different domains of sexuality, have been applied and validated for the IBD population. This review summarizes the available evidence on sexual health among IBD patients and the data supporting the application of PROs to screen the quality of sexual life, as well as the rate and types of sexual dysfunctions, among IBD patients.

Background: Tonsillectomy is one of the most common surgical procedures. This study compared the effect of Pregabalin and Clonidine on postoperative pain in adult patients undergoing elective tonsillectomy.

Methods: This randomized, double-blind, prospective clinical trial was conducted among 92 patients aged 20 to 50. The clonidine group (C) was given 150 µg of clonidine tablet 90 minutes before surgery, and the pregabalin group (P) was given 300 mg of pregabalin tablet 90 minutes before surgery. The results were analyzed by SPSS 25, and statistical analysis consisted of chisquare, T-test, and χ2 tests, and a p-value less than 0.05 was considered significant.

Results: The mean pain score and analgesic consumption scores in the pregabalin group were lower than in the clonidine group. According to the t-test, there was a significant difference between the two groups regarding pain score and analgesic consumption (p <0.05). Hemodynamic variation in both groups had no significant differences (p >0.05).

Conclusion: The present study showed that pregabalin reduced postoperative pain and analgesic consumption more effectively than clonidine.

Background: Highly Active Antiretroviral Therapy (HAART) is composed of several drugs in the antiretroviral class to better treat human immunodeficiency virus type 1 (HIV-1) patients. The estimation of CD4+ T cell counts and HIV-1 viral load in plasma is required to evaluate the treatment success of a specific HAART.

Methodology: The study included the effects of NRTIs (nucleoside reverse transcriptase inhibitors) and novel protease inhibitors (HAART) on normal control subjects and HIV-1 positive subjects from SGPGIMS, Lucknow, with different age groups and genders. Furthermore, the study was conducted by the estimation of HIV through ELISA, measurement of absolute CD4+ cell count, and the measurement of viral load through qRT-PCR. Furthermore, NRTIs (Retrovir and Epivir) were administered orally one tablet daily in the morning followed by newly FDA-approved protease inhibitors (fosamprenavir and darunavir) orally in the evening at the same dose. Furthermore, CD4+T cell counts and HIV-1 viral load were investigated and correlated in patients with different genders and age groups.

Result: Administration of NRTIs and novel protease inhibitors (HAART) in HIV patients had a significant effect on the CD4+ cell count in various age intervals among males and females. The mean comparison of viral load distribution based on gender in CD4 +ve patients in the case group exhibited a viral load higher in females compared to males, indicating a statistically significant difference between males and females (p<0.05). A notable association between virological and immunological parameters was observed with a reciprocal relationship between viral load and CD4 cell count in CD4 +ve patients, demonstrating multiple correlation coefficients with an R-value of 0.853.

Conclusion: The administration of specific HAART (NRTIs and novel protease inhibitors) in HIV patients had a notable improvement in the CD4+ cell count and viral load with significant age and gender disparity.

Background Anxiety and depression are the most common psychological disorders found in Inflammatory Bowel Disease (IBD) patients. Accurate measuring of these disorders should be proposed for a prompt management. Patient-reported outcome measurements (PROMs) allow patients to self-report their psychological symptoms. Objective To highlight the presence of PROMs measuring anxiety and depression in IBD setting evaluating the most used psychometric tools. Methods We reviewed the literature from 2010 up to September 2021. Articles on adult IBD patients assessing depression and anxiety by PROMs in English language were included. Results Thirty-six studies, including 11 psychometric tools were found. Hospital Anxiety and Depression Scale (21 studies), Beck Depression Inventory II (5 studies), Spielberg State-Trait Anxiety Inventory (3 studies), Patient-Reported Outcomes Measurement Information System (3 studies), Symptom Checklist-90 (2 studies), Euro Quality of Life (2 studies) mostly used psychometric tools for anxiety and depression in IBD settings. Conclusion Our review analyzed psychometric tools used for PROMs evaluating anxiety and depression in IBD setting. No chronological differences have emerged, all have been used in the last ten years, highlighting a lack of specificity. The strong association between IBD and mood disorders suggests that clinicians should consider the evaluation of depression and anxiety as integral parts of IBD clinical care. It is essential to identify tools enabling these items to be detected better. A global view of IBD patients, accounting not only for physical but also for psychical symptoms with an early and feasible assessment of unrecognized psychiatric disorders, can have a strong impact on their management strategy.

Background: Psoriasis is a chronic relapsing immune-mediated disease leading to a strong impact on patient's quality of life. The treatment of psoriasis has undergone a revolution with the advent of biologic therapies. Currently, Psoriasis Area and Severity Index [PASI] and Dermatology Life Quality Index [DLQI] scores are in use to assess the overall severity of pathology. A new self- administered questionnaire, the Psoriasis Symptoms and Signs Diary (PSSD), assesses severity of six psoriasis symptoms (itch, skin tightness, burning, stinging, and pain,) and five signs (dryness, cracking, scaling, shedding/flaking, redness, and bleeding).

Objective: To evaluate and compare the efficacy of biologic therapies through PSSD in patients with moderate to severe psoriasis Methods: The PSSD questionnaire was administered to all the patients at the beginning and after 6 months of biologic therapy (anti-TNFalpha, anti- IL17, anti-IL23, anti-IL12/23 and phhosphodiesterase-4 Inhibitors).

Results: The study population included 417 adult patients with moderate to severe psoriasis in treatment with biologic drugs. All the drugs contributed to a significant improvement of mean total PSSD at t 24; anti-IL17 and anti-IL23 led to a significantly greater reduction at t 24 mean PSSD when compared to other therapies.

Conclusion: The PSSD, is a new validated instrument useful for capturing psoriasis patient's quality of life and evaluating treatments efficacy. In our study this score has been useful to put in evidence significant differences between biologic drugs.

Stroke is defined as an acute cerebrovascular accident characterized by an interruption of vascular supply lasting more than 24 hours. Therapeutic goal, reassumed at the well-known "time is brain", is strictly focused on achieving timely restoration of cerebral blood flow at risk of infarction to reduce neurological complications. Consequently, time to treatment is the most important determinant of the efficacy of reperfusion. Current guidelines strongly recommend the use of intravenous thrombolysis with tissue plasminogen activator and endovascular thrombectomy to reach that goal. These therapies allow to obtain 1.9 million neurons saved per each minute of onset-to-reperfusion time and 4.2 days of extra healthy life and are crucial in the reduction of mortality and morbidity of ischemic stroke. Multidisciplinary collaboration involving a coordinated prehospital management and stroke team composed of physicians with expertise in emergency medicine, neurologists, radiologists, nurses, technicians, and laboratory personnel are essential for rapid triage and should guide clinical decisions to deliver the appropriate reperfusion therapy for each patient.

Background: Hepatic encephalopathy is defined as a spectrum of neuropsychiatric disorders in patients with liver dysfunction, usually cirrhosis, after exclusion of brain disease. This study reports the role of manganese in brain alterations and therefore in clinical manifestations of hepatic encephalopathy.

Case presentation: Male patient, 67 years old, suffering from alcoholic liver cirrhosis and two previous episodes of hepatic encephalopathy, developed drowsiness, asterixis, amnesia, disorientation in time and space, and psychomotor retardation. Brain MRI without contrast showed: initial signs of cerebral atrophy, a hyperintense signal of globi pallidi and bilateral substantia nigra. The hyperintense signal of globi pallidi is the result of manganese deposition in the brain.

Conclusion: The case report presented supports the data reported in the literature indicating that the increase in plasma manganese levels in subjects with liver dysfunction is correlated with the onset of extrapyramidal symptoms.

Background: Recent literature suggests that the respiratory rate oxygenation (ROX) index may be a useful parameter in predicting intubation indication in hypoxemic patients.

Objective: In this study, we evaluated the accuracy of the ROX index in predicting intubation, length of stay in the ICU, and mortality in ICU patients with hypoxemic respiratory failure with and without hypercapnia.

Methods: Single-centre retrospective cohort study of 290 patients, with a preliminary diagnosis of respiratory failure, who were treated with low flow oxygen systems. Demographics, medical history, clinical, laboratory, treatment, and prognostic data were obtained from the electronic records of the hospital. The ROX index was calculated at the time of ICU admission.

Results: Thirty-seven percent of non-hypercapnic and 69% of hypercapnic patients were intubated (p:0.005). In hypercapnic patients, ROX: 6.9 had highest sensitivity (81%) and specificity (65%) values for intubation (p:0.005). In non-hypercapnic patients, ROX: 6.2 had the highest sensitivity (81%) and specificity (40%) values. While 11% of hypercapnic patients and 30% of non-hypercapnic patients were died (p:0.05), 22% of hypercapnic patients and 33% of non-hypercapnic patients stayed in the ICU longer than 14 days (p:0.044). The highest sensitivity and specificity values were found for mortality in hypercapnic patients; for ROX value of 5.94 (sensitivity:86%, specificity:61%) and for ICU stay longer than 14 days; for ROX value of 7.4 (sensitivity:71%, specificity:68%).

Conclusion: Results of our study suggest that ROX index calculated during ICU admission can be helpful in predicting intubation indication and length of ICU stay in patients with respiratory failure and hypercapnia may influence the cutoff values.