Effectiveness of Functional Electrical Stimulation - Cycling Treatment in Children with Cerebral Palsy

AimThe purpose of this study was to evaluate the effects of functional electrical stimulation (FES) bicycle therapy system on motor function, gait pattern, spasticity, daily living activities, and aerobic capacity in children with cerebral palsy (CP) and to compare the results with sham stimulation and standard treatment.MethodsPatients with cerebral palsy who received botulinum toxin type-A injections to lower extremities and those with Gross Motor Function Measure Classification System (GMFCS) levels I – III, were included in the study. Twenty-five patients were randomly assigned into three treatment groups for 4-weeks: Group 1, FES-cycling and standard treatment; Group 2, Sham stimulus FES-cycling and standard treatment; Group 3, Standard treatment. Clinical assessment tools included the Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS), Pediatric Functional Independence Measure (WeeFIM), GMFCS, Gross Motor Function Measure-88 (GMFM-88), selective motor control tests, 6-minute walk test, and Visual Gait Analysis (VGA).ResultsIn all groups, there were significant improvements in MAS, MTS, WeeFIM, GMFM-88, 6-minute walk test, and VGA scores. No changes in GMFCS levels were observed in any group. At the end of the study, there was no significant difference among the groups in terms of any clinical assessment parameter.ConclusionsAll groups showed statistically significant improvements in motor function, walking pattern, spasticity, daily living activities, and aerobic capacity in patients with CP following the rehabilitation period. Although FES-cycling demonstrated no superiority over the other approaches and provided no additional benefit to the results, FES appears to be safe and well-tolerated in children with CP, at least as much as standard exercise treatment.

Outcome of Using Intravenous Immunoglobulin (IVIG) in Critically Ill COVID-19 Patients’: A ‎Retrospective, ‏Multi-Centric Cohort Study

Background: To access the effect of Intravenous immunoglobulin ‎‎(IVIG) in critically ill corona virus disease 2019 (COVID-19) patients.Method: In this retrospective matched cohort study, records of three tertiary centers with large number of COVID-19 admissions were evaluated and used. Based on treatment options, ‎patients were divided into two groups, standard COVID-19 treatment (109 patients) and IVIG treatment (74 patients) patients. Also, the effect of IVIG in different dosages was evaluated. Patients with IVIG treatment were divided into three groups of ‎low (0.25 gr/kg), medium (0.5 gr/kg), and high (1 gr/kg) dose. Data analysis was performed using independent t-test and ‎One-way analysis of variance (ANOVA) to compare the ‎outcomes between two groups, including duration of hospitalization, intensive care unit (ICU) length of stay, and mortality rate.‎Result: The duration of hospitalization in the IVIG group ‎were significantly longer than standard treatment (13.74 days vs. 11.10 days, p<0.05). There was not a significant difference between the two groups in ICU length of stay, number of intubated patients and duration of mechanical ventilation (P>0.05).‎ Also initial ‎outcomes in IVIG subgroups were compared separately with the standard ‎treatment group. The results indicated that only the duration of hospitalization ‎in the IVIG subgroup with medium dose is significantly longer than the standard ‎treatment group (P<0.01).Conclusion: Using IVIG is not beneficial for COVID-19 patients based on no remarkable differences in duration of hospitalization, ICU length of stay, duration of mechanical ventilation and even mortality rate.

Mortality Comparison of Using Anti Interleukin-6 Therapy and Using Standard Treatment in Severe Covid-19

Severe Coronavirus Disease 19 (COVID-19) can cause serious lung inflammation and death. COVID-19 is characterized by a high mortality rate. This severity is associated with the overproduction of proinflammatory cytokines called "cytokine storms". One of the cytokines that play a central role is Interleukin-6 (IL-6). High IL-6 levels are associated with mortality. Expectedly, the IL-6 blockade could reduce cytokine storms and thus reduce deaths in severe COVID-19 patients. This systematic review aimed to summarize the comparison between mortality using anti-IL-6 therapy and mortality using standard treatment in severe COVID-19 patients. We systematically searched the PubMed, ScienceDirect, and ProQuest databases until 13 August 2020. After screening, twelve studies matched the inclusion criteria. The mortality of the anti-IL-6 therapy group was lower than the standard treatment group without anti-IL-6 therapy in COVID-19 patients in 10 of the 12 studies obtained. Four of the ten studies statistically found a significant difference in mortality of the anti-IL-6 therapy group and the standard treatment group. Confirmation of anti-IL-6 therapy effectiveness in reducing mortality in severe COVID-19 patients will require randomized controlled trials.

Spironolactone Improves the All-Cause Mortality and Re-Hospitalization Rates in Acute Myocardial Infarction with Chronic Kidney Disease Patients

Background: Mineralocorticoid receptor antagonists (MRA) improve outcomes in chronic kidney disease (CKD) and acute myocardial infarction (AMI) patients. However, the lack of evidence regarding long-term clinical outcomes in the use of MRA, including spironolactone, in patients with AMI combined with CKD.Objectives: This study aimed to investigate whether spironolactone could significantly reduce the risk of all-cause mortality and re-admission in patients with AMI and CKD.Methods: In this single center, observational, retrospective, registry based clinical study, a total of 2,465 AMI patients were initially screened; after excluding patients with estimated glomerular filtration rate more than 60 ml/min/1.73 m2, 360 patients in the standard treatment group and 200 patients in the spironolactone group met the criteria. All enrolled patients follow-up for 30 months. The primary outcomes were all-cause mortality and re-admission. The key safety outcome was hyperkalemia rates during the 30 months follow-up period.Results: 160 (44.4%) and 41 (20.5%) patients in the standard treatment and spironolactone groups died, respectively [hazard ratio (HR): 0.389; 95% confidence interval (CI): 0.276–0.548; p &lt; 0.001]. Re-admission occurred in 217 (60.3%) and 95 (47.5%) patients in the standard treatment and spironolactone groups, respectively (HR: 0.664; 95% CI: 0.522–0.846; p = 0.004). The spironolactone group was divided into two based on the daily dose, low dose group (no more than 40 mg) and high dose group (more than 40 mg); the differences in the mortality rate between low dose group (16.7%) and the standard treatment group (44.4%) (HR: 0.309; 95% CI: 0.228–0.418; p &lt; 0.001) and high dose group (34.1%) (HR: 0.429; 95% CI: 0.199–0.925; p = 0.007) were significant. The differences in re-hospitalization rate between low dose group (43.6%) and the standard treatment group (60.3%) (HR: 0.583; 95% CI: 0.457–0.744; p &lt; 0.001) and high dose group (61.4%) (HR: 0.551; 95% CI: 0.326–0.930; p = 0.007) was significant. Hyperkalemia occurred in 18 (9.0%) and 18 (5.0%) patients in the spironolactone group and standard treatment group, respectively (HR: 1.879; 95% CI: 0.954–3.700; p = 0.068). Whereas, Hyperkalemia occurred in high dose group (20.5%) significantly more often than in the standard treatment group (p &lt; 0.001) and low dose group (5.8%) (p = 0.003).Conclusion: Using MRA, such as spironolactone, may substantially reduce the risk of both all-cause mortality and re-admission in patients with AMI and CKD; the use of low-dose spironolactone has the best efficacy and safety. However, this was a relatively small sample size, single center, observational, retrospective, registry based clinical study and further prospective evaluation in adequately powered randomized trials were needed before further use of spironolactone in AMI with CKD population.

Experience in use of L­-carnitine in treatment of patients with epidermolysis bullosa

Objective — to study the effectiveness of L-carnitine in patients with various forms of congenital epidermolysis bullosa (CEB).Materials and methods. We observed 120 patients with CEB aged 1 to 12 years. A simple form of the disease was diagnosed in 60, dystrophic form — in 60 children. According to genealogical maps, 17 (28.3 %) of 60 patients with dystrophic CEB had an autosomal dominant type of inheritance, and 43 (71.7 %) of 60 had autosomal recessive inheritance. In the autosomal dominant type, the multiple blisters, miliums and atrophic scarrings, mainly on the extremities, as well as anonychias were dominant as clinical manifestations. In the autosomal recessive type, multiple blisters, erosions, crusts, atrophic scars, onychodystrophy, pseudosyndactylies on the upper and lower extremities, as well as disabling contractures of the hands, feet, elbows and knees were observed.L-carnitine at a dose of 1 ml/kg during 3 months was prescribed as part of the complex therapy to patients with CEB. The standard treatment for patients with CEB was the correct use of external means and dressings to reduce trauma to the foci and accelerate the epithelialization of erosive rashes.Results and discussion. For clinical evaluation of the efficacy of L-carnitine, patients with CEB were divided into groups comparable by sex, age, duration and form of the disease: group I consisted of 30 patients with simple CEB who received standard treatment, group II — of 30 patients with simple CEB who received standard treatment in combination with L-carnitine, group III — of 30 patients with dystrophic form of CEB who received standard treatment, group IV — of 30 patients with dystrophic form of CEB who received standard treatment in combination with L-carnitine. The positive result of therapy (epithelialization of erosions and the absence of new rashes) was achieved in 19 (63.3 %) of 30 patients of group I, in 26 (86.7 %) of 30 patients of group II, in 11 (36.7 %) of 30 patients of group III, in 16 (53.3 %) of 30 patients of group IV. This confirms the effectiveness and feasibility of using L-carnitine in various forms of CEB.Conclusions. The use of L-carnitine in the complex therapy of patients with CEB allows accelerating the epithelialization of erosive formations on the skin and visible mucous membranes.

Adjunctive IgM-enriched immunoglobulin therapy with a personalised dose based on serum IgM-titres versus standard dose in the treatment of septic shock: a randomised controlled trial (IgM-fat trial)

IntroductionIn patients with septic shock, low levels of circulating immunoglobulins are common and their kinetics appear to be related to clinical outcome. The pivotal role of immunoglobulins in the host immune response to infection suggests that additional therapy with polyclonal intravenous immunoglobulins may be a promising option in patients with septic shock. Immunoglobulin preparations enriched with the IgM component have largely been used in sepsis, mostly at standard dosages (250 mg/kg per day), regardless of clinical severity and without any dose adjustment based on immunoglobulin serum titres or other biomarkers. We hypothesised that a personalised dose of IgM enriched preparation based on patient IgM titres and aimed to achieve a specific threshold of IgM titre is more effective in decreasing mortality than a standard dose.Methods and analysisThe study is designed as a multicentre, interventional, randomised, single-blinded, prospective, investigator sponsored, two-armed study. Patients with septic shock and IgM titres <60 mg/dL will be randomly assigned to an IgM titre-based treatment or a standard treatment group in a ratio of 1:1. The study will involve 12 Italian intensive care units and 356 patients will be enrolled. Patients assigned to the IgM titre-based treatment will receive a personalised daily dose based on an IgM serum titre aimed at achieving serum titres above 100 mg/dL up to discontinuation of vasoactive drugs or day 7 after enrolment. Patients assigned to the IgM standard treatment group will receive IgM enriched preparation daily for three consecutive days at the standard dose of 250 mg/kg. The primary endpoint will be all-cause mortality at 28 days.Ethics and disseminationThe study protocol was approved by the ethics committees of the coordinating centre (Comitato Etico dell’Area Vasta Emilia Nord) and collaborating centres. The results of the trial will be published within 12 months from the end of the study and the steering committee has the right to present them at public symposia and conferences.Trial registration detailsThe trial protocol and information documents have received a favourable opinion from the Area Vasta Emilia Nord Ethical Committee on 12 September 2019. The trial protocol has been registered on EudraCT (2018-001613-33) on 18 April 2018 and on ClinicalTrials.gov (NCT04182737) on 2 December 2019.

Erythropoetin stimulates tissue repair in experimental wounds

The efficacy of recombinant human erythropoietin (EPO) is being studied in the context of wound management. The ability of EPO to stimulate cell proliferation was found, which is of great importance in the complex process of wound healing. The aim of this study is to evaluate the results of using EPO for wound healing in a rat model. Material and methods. We examined 24 wounds simulated in the interscapular region of a rat, which were divided into 2 groups: a group with standard treatment, a group with EPO treatment at a dosage of 400 IU/kg, s/c. Planimetry of the wound was performed at the appointed time. Also, histological examination of wound tissue samples was carried out. Results. Differences in reduction and change in wound size in the EPO group were more significant than in the standard treatment group. Conclusions. The experiment demonstrated an improvement in wound healing with EPO treatment compared with standard treatment, which led to a decrease in wound size and a shorter healing period. Keywords: erythropoietin, EPO, angiogenesis, wound treatment.

Benefits of post-stroke telerehabilitation

Introduction: Stroke was responsible for 139.4 million cases of global disability in 2019, many of which require rehabilitation. Telerehabilitation has emerged as a promising remote therapy aimed at improving the deficits resulting from stroke. Objective: To compare the benefits of telerehabilitation with the usual methods of rehabilitation in post-stroke patients. Methodology: In April 2021, a literature review including systematic reviews of studies in humans, available in full and published in the last 5 years was executed on MedLine using the descriptors “stroke”, “telerehabilitation” and their MeSH variations. Results: The first selected article revealed that post-stroke telerehabilitation resulted in less expenses and was associated with comparable improvements to the standard treatment group in the recovery of motor deficits, cortical dysfunction and depression. The second review concluded that telerehabilitation was equal to or greater than usual rehabilitation for improvements in daily living and psychological status and restoration of quality of life and motor performance. The third study found that telerehabilitation achieved similar results to face-to-face therapy and usual care on improving daily life. The fourth article reinforced the benefits of telerehabilitation on several outcomes, although current evidence is limited. Conclusion: Telerehabilitation can be an adequate alternative to the care of post-stroke patients, however, further studies are needed to establish the benefits it provides.

Effects of different ablation points of renal denervation on the efficacy of resistant hypertension

Objective To explore the blood pressure response to different ablation points of renal denervation (RDN) in patients with resistant hypertension Methods A total of 42 cases with resistant hypertension treated by RDN in our center from 2013 to 2015 were retrospectively analyzed. The patients were divided into two groups according to the different ablation points of RDN: the standard treatment group (spiral ablation from near to proximal, with less than 8 points per artery) and the intensive treatment group (from near to far by spiral ablation, with at least 8 points per artery), with 21 patients in each group. The ablation parameters, including points, impedance, actual wattage, and actual temperature, were recorded intraoperatively. Renal angiography was performed again after RDN. Ambulatory blood pressure (ABP) images were taken for all patients at the baseline and 6 months after operation. Results The mean 24-h blood pressure of the standard treatment group was lower than that of the baseline (24-h systolic blood pressure decreased by 7.4 ± 10.6 mmHg and 24-h diastolic blood pressure decreased by 4.6 ± 6.1 mmHg), and the mean 24-h blood pressure decreased significantly from baseline to 6 months in the intensive treatment group (24–h systolic blood pressure decreased by 27.4 ± 11.4 mmHg, P < 0.0001; 24–h diastolic blood pressure decreased by 10.9 ± 9.6 mmHg, P = 0.005). There was a positive correlation between the decrease of systolic/diastolic 24-hour mean and the number of ablation points used in the procedure. The mean value of systolic and diastolic blood pressure was positively correlated with ablation points at 24-hour (R2 = 0.777 and 0.633 respectively, P < 0.01). There were no adverse events in either group after the operation and during the follow-up. Conclusions RDN could significantly reduce BP in patients with resistant hypertension. Our study showed that the antihypertensive effect appeared to be positively correlated with the number of ablation points.

Consolidation chemotherapy may improve pathological complete response for locally advanced rectal cancer after neoadjuvant chemoradiotherapy: a retrospective study

Background Patients with locally advanced rectal cancer (LARC) have an improved prognosis if achieved a pathological complete response (pCR) on account of neoadjuvant chemoradiation therapy (nCRT). However, the proportion of patients achieving pCR is only 8–24%. The purpose of this study was to explore whether the addition of consolidation chemotherapy to nCRT could improve pCR rate in patients with LARC. Materials and Methods The subjects were 144 individuals with clinical stage II (T3–4, N0) or III (any T, N1–2) LARC who had received neoadjuvant CRT followed by total mesorectal excision (TME). Eighty-three patients in the consolidation chemotherapy group received two cycles XELOX between CRT and TME, while 61 patients in the standard treatment group without consolidation chemotherapy. The pCR (ypT0N0), tumor downstaging (ypT0-2N0) after TME and adverse events (AEs) during and post treatment were compared between the treatment groups using multivariable logistic regression analysis. To adjust the unbalanced variables for the primary endpoint, logistic regression analysis and stratified analysis were performed. Results The consolidation chemotherapy group improved pCR rate (19.3% vs 4.9%, p = 0.01) and tumor downstaging rate (45.8% vs 24.6%, p = 0.009) compared to the standard treatment group. After adjustment for clinical tumor stage, clinical nodal stage and time interval to surgery, patients with consolidation chemotherapy were more likely to reach pCR (adjusted odds ratio 4.91, 95% CI [1.01–23.79], p = 0.048). AEs during and post treatment in the two groups were 54.1% vs 49.3% (p = 0.57), respectively. In addition, the incidence of any grade 1–2 AEs in the two groups was 93.4% vs 95.1% (p = 0.93), while the incidence of grade 3 AEs was 1.6% versus 2.4% (p = 0.74), respectively. No grade 4 AEs occurred in two groups. Conclusions The addition of neoadjuvant consolidation chemotherapy after CRT significantly increased the pCR rate and did not increase the AEs during and post treatment and in patients with LARC.