Clinical Improvement Rate Research Articles

The clinical efficacy and safety of mesenchymal stromal cells for patients with COVID-19: A systematic review and meta-analysis of randomized controlled trials

ObjectivesThis meta-analysis of randomized controlled trials (RCTs) investigated the usefulness of mesenchymal stromal cells (MSCs) to treat patients with COVID-19. Methods: PubMed, Embase, Ovid MEDLINE, the Cochrane Library, and Clinicaltrials.gov were searched for RCTs published before November 7, 2021. Only RCTs that compared the clinical efficacy and safety of MSCs with other alternative treatments or placebos in the treatment of patients with COVID-19 were included. ResultsSix RCTs were included, in which the MSC and control groups consisted of 158 and 135 patients, respectively. The patients who received MSCs had a significantly lower 28-day mortality rate (7.6% vs 21.5%; OR, 0.18; 95% CI, 0.06–0.52; I2 = 0%) and significantly higher clinical improvement rate (OR, 6.05; 95% CI, 2.31–15.83; I2 = 0%) than the controls. The patients who received MSCs were associated with a similar risk of adverse events (AEs) and serious AEs to the control group (AEs: OR, 33; 95% CI, 0.09–1.18; I2 = 59%; serious AEs: OR, 0.30; 95% CI, 0.02–4.41; I2 = 53%). ConclusionsMSC treatment may help to improve the clinical outcomes of patients with COVID-19. In addition, MSC treatment appears to be a safe therapeutic option for patients with COVID-19.

An mHealth Platform for Augmenting Behavioral Health in Primary Care: Longitudinal Feasibility Study.

BackgroundThe collaborative care model is a well-established system of behavioral health care within primary care settings. There is potential for mobile health (mHealth) technology to augment collaborative behavioral health care in primary care settings, thereby improving scalability, efficiency, and clinical outcomes.ObjectiveWe aimed to assess the feasibility of engaging with and the preliminary clinical outcomes of an mHealth platform that was used to augment an existing collaborative care program in primary care settings.MethodsWe performed a longitudinal, single-arm feasibility study of an mHealth platform that was used to augment collaborative care. A total of 3 behavioral health care managers, who were responsible for coordinating disease management in 6 primary care practices, encouraged participants to use a mobile app to augment the collaborative model of behavioral health care. The mHealth platform’s functions included asynchronous chats with the behavioral health care managers, depression self-report assessments, and psychoeducational content. The primary outcome was the feasibility of engagement, which was based on the number and type of participant-generated actions that were completed in the app. The primary clinical end point was a comparison of the baseline and final assessments of the Patient Health Questionnaire-9.ResultsOf the 245 individuals who were referred by their primary care provider for behavioral health services, 89 (36.3%) consented to app-augmented behavioral health care. Only 12% (11/89) never engaged with the app during the study period. Across all participants, we observed a median engagement of 7 (IQR 12; mean 10.4; range 0-130) actions in the app (participants: n=78). The chat function was the most popular, followed by psychoeducational content and assessments. The subgroup analysis revealed no significant differences in app usage by age (P=.42) or sex (P=.84). The clinical improvement rate in our sample was 73% (32/44), although follow-up assessments were only available for 49% (44/89) of participants.ConclusionsOur preliminary findings indicate the moderate feasibility of using mHealth technology to augment behavioral health care in primary care settings. The results of this study are applicable to improving the design and implementation of mobile apps in collaborative care.

Moderate-to-vigorous group aerobic exercise versus group leisure activities for mild-to-moderate depression in adolescents: study protocol for a multicentre randomised controlled trial

IntroductionDepression is common, increasing among adolescents and carries risk of disability, lower educational achievements, cardiovascular disease, substance abuse, self-harm and suicide. The effects of evidence-based treatments with medication or psychotherapy...

The Additional Economic Burden of Frailty in Adult Cervical Deformity Patients Undergoing Surgical Intervention.

The influence of frailty on economic burden following corrective surgery for the adult cervical deformity (CD) is understudied and may provide valuable insights for preoperative planning. To assess the influence of baseline frailty status on the economic burden of CD surgery. Retrospective cohort. CD patients with frailty scores and baseline and two-year Neck Disability Index data were included. Frailty score was categorized patients by modified CD frailty index into not frail (NF) and frail (F). Analysis of covariance was used to estimate marginal means adjusting for age, sex, surgical approach, and baseline sacral slope, T1 slope minus cervical lordosis, C2-C7 angle, C2-C7 sagittal vertical axis. Costs were derived from PearlDiver registry data. Reimbursement consisted of a standardized estimate using regression analysis of Medicare payscales for services within a 30-day window including length of stay and death. This data is representative of the national average Medicare cost differentiated by complication/comorbidity outcome, surgical approach, and revision status. Cost per quality-adjusted life-year (QALY) at two years was calculated for NF and F patients. There were 126 patients included. There were 68 NF patients and 58 classified as F. Frailty groups did not differ by overall complications, instance of distal junctional kyphosis, or reoperations (all P >0.05). These groups had similar rates of radiographic and clinical improvement by two years. NF and F had similar overall cost ($36,731.03 vs. $37,356.75, P =0.793), resulting in equivocal costs per QALYs for both patients at two years ($90,113.79 vs. $80,866.66, P =0.097). F and NF patients experienced similar complication rates and upfront costs, with equivocal utility gained, leading to comparative cost-effectiveness with NF patients based on cost per QALYs at two years. Surgical correction for CD is an economical healthcare investment for F patients when accounting for anticipated utility gained and cost-effectiveness following the procedure. III.

Extra Anatomic Aorto-Iliac Revascularization Using Descending Thoracic Aorta to Bifemoral Bypass in Selected Cases

When best medical treatment fails to relieve symptoms of aorto-iliac occlusive disease, endovascular treatment or conventional open surgery are the remaining optionsdepending on lesions and patients' characteristics. However, in certain situations bothendovascular tools and abdominal aorta to bifemoral bypass (TFB) are not an option and the use of the descending thoracic aorta may be considered as an inflow site for revascularization. This work is a single-center retrospective study. Between 2008 and 2020, 27 patients were identified who were treated with descending thoracic aorta to TFB for severe aorto-iliac occlusive disease. Primary end point was 30-day postoperative mortality and major cardiovascular events. Secondary end points were primary patency, secondary patency, and all-cause mortality. The mean age of patients was 68years and the majority (88.9%) presented with severe claudication. Eighteen patients underwent isolated TFB and 9 had TFB and concomitant visceral vessel revascularization. The mean length of stay was 14days and there was no postoperative death. Complications, mainly pulmonary, occurred in 29.8% of the cases. After a mean of 26months of follow-up, survival rate was 95% and primary and secondary patency rates were 92.6% and 96.3%, respectively. Mean Rutherford index shifted from 3.1 to 1.2 (P<0.001). TFB is an invasive procedure which provides high clinical improvement and patency rates. This procedure should remain part of the vascular surgeon portfolio.

Real-World Effectiveness and Optimal Dosage of Favipiravir for Treatment of COVID-19: Results from a Multicenter Observational Study in Thailand.

Favipiravir is a broad-spectrum oral antiviral agent that shows in vitro activity against SARS-CoV-2. Presently, data on the real-world effectiveness and optimal dosage of favipiravir for treating COVID-19 are limited. We conducted a retrospective observational study of hospitalized adult patients with COVID-19 at five tertiary care hospitals in Thailand. We reviewed patient charts to obtain all necessary data. Among 247 COVID-19 patients, 63 (23.0%) received ≥1 dose of favipiravir. Of these 63 patients, 61.9% were male with a median age of 48 years (range 22–85 years), 27.0% required an O2 nasal cannula, 9.5% required non-invasive ventilation and/or high-flow O2 therapy, and 6.4% required invasive mechanical ventilation and/or ECMO. The median baseline NEWS2 score was 5 (0–16). The Day-7 clinical improvement rate [95%CI] was 66.7% [53.7–78.0%] in all patients, 92.5% [75.7–99.1%] in patients who did not require O2 supplementation, and 47.2% [0.4–64.5%] in patients who required O2 supplementation. No life-threatening adverse events were identified. The 28-day mortality rate was 4.8%. A multivariate analysis revealed three poor prognostic factors for Day-7 clinical improvement (odds ratio (95%CI); p-value): older age (0.94 (0.89–0.99); p = 0.04), a higher baseline NEWS2 score (0.64 (0.47–0.88); p = 0.006), and a lower favipiravir loading dose (≤45 mg/kg/day) (0.04 (0.005–0.4); p = 0.006). In conclusion, our study reports the promising effectiveness of favipiravir for treating COVID-19 patients. In addition to older age and a high baseline NEWS2 score, a low loading dose of favipiravir (≤45 mg/kg/day) was also identified as a poor prognostic factor for early clinical improvement. Further studies to explore the optimal dose and the optimal timing of drug initiation for favipiravir should be performed.

How should we treat long-standing overt ventriculomegaly in adults (LOVA)? A retrospective cohort study

Long-standing overt ventriculomegaly in adults (LOVA) is a heterogenous group of conditions with differing presentations. Few studies have evaluated success rates of available surgical treatments, or ascertained the natural history. There is a need to assess the efficacy of both endoscopic third ventriculostomy (ETV) and ventriculoperitoneal shunt (VPS) as first-line treatments. We conducted a retrospective, single-centre study of adults with LOVA at a tertiary neurosurgery centre in England, UK, aiming to identify presentation, management strategy, and outcome following treatment. A total of 127 patients were included (mean age 48.1 years, 61/127 male). Most patients were symptomatic (73.2%, n = 93/127, median symptom duration 10 months). The most common symptoms were gait ataxia, headache, and cognitive decline (52.8%, 50.4%, and 33.9%, respectively). Fourteen patients had papilloedema. Ninety-one patients (71.7%) underwent surgery (84 ETV, 7 VPS). Over a median follow-up of 33.0 months (interquartile range [IQR] 19.0–65.7), 82.4% had a clinical improvement after surgery, and 81.3% had radiological improvement. Clinical improvement rates were similar between ETV and VP shunt groups (82.1% vs 85.7%, p = 0.812). Surgical complication rates were significantly lower in the ETV group than the VP shunt group (4.8% vs 42.9%, p < 0.001). Of the patients treated surgically, 20 (22.0%) underwent further surgery, with 14 patients improving. This study demonstrates the efficacy of ETV as a first-line treatment for LOVA.

The Effectiveness and Safety of Hormonal Combinations of Antiepileptic Drugs in the Treatment of Epileptic Electrical Continuity in Children during Sleep: A Meta-Analysis.

Objective A systematic evaluation of the efficacy of hormones in combination with antiepileptic drugs (AEDs) compared to AEDs alone in the treatment of children with encephalopathy related to status epilepticus during slow sleep (ESES). This study provides an evidence-based approach to the treatment of children with ESES. Materials and Methods To find all relevant studies published before March 2022, we searched PubMed, Embase, Web of Science, Clinical Trials, Cochrane Library, CNKI, and Wanfang databases. We explore the difference between AEDs combined with hormones and AEDs alone for ESES treatment. All outcome data, including Wechsler Intelligence Scale for Children, the effective rate, EEG discharges, and adverse effects rate (AER), were compared using Review Manager 5.3. Results There were 805 patients in this study's seven investigations, including 403 in the experimental group and 402 in the control group. Meta-analysis showed that after treatment, compared with the AEDs alone group, the hormone combined with AEDs. The difference in clinical improvement rate [RR = 1.25, 95% CI (1.15, 1.36), p < 0.00001], electroencephalographic (EEG) discharge improvement rate [RR = 1.31, 95% CI (1.22, 1.41), p < 0.00001], and cognitive intelligence score [SMD = 1.02, 95% CI (0.76, 1.28), p < 0.00001] was statistically significant. The differences were statistically significant in terms of 0.00001; the incidence of adverse reactions was higher in the hormone combined with AEDs group than in the AEDs group alone, and the differences were statistically significant [RR = 4.13, 95% CI (1.06, 16.13), p < 0.01], and all adverse reactions improved or disappeared after discontinuation of the drug. Conclusions The combination of hormones with AEDs for the treatment of epileptic electrical continuity in sleep has advantages over AEDs alone in terms of controlling seizures, improving EEG abnormalities, and improving cognition. The combination of hormones with AEDs has advantages over AEDs alone in controlling seizures, improving EEG abnormalities, and improving cognition and is relatively safe.

Colistin Monotherapy versus Colistin plus Meropenem Combination Therapy for the Treatment of Multidrug-Resistant Acinetobacter baumannii Infection: A Meta-Analysis

(1) Introduction: Colistin combination therapy with other antibiotics is a way to enhance colistin activity. The purpose of this meta-analysis was to compare the efficacy and safety of treatment with colistin monotherapy versus colistin plus meropenem combination therapy in patients with drug-resistant Acinetobacter baumannii infection. (2) Methods: All studies were included if they reported one or more of the following outcomes: clinical improvement, complete microbiological response, 14-day mortality, hospital mortality, or nephrotoxicity. (3) Results: Three randomized controlled trials and seven retrospective studies were included in the meta-analysis. Colistin monotherapy has similar rates of clinical improvement, 14-day mortality, hospital mortality, and nephrotoxicity as colistin plus meropenem combination therapy. Regarding complete microbiological response, the colistin plus meropenem combination was better than colistin monotherapy. (4) Discussion: Previous meta-analyses demonstrated heterogeneity in study quality and a lack of evidence supporting the use of colistin-based combination therapy. Our meta-analysis clearly showed that colistin combined with meropenem was not superior to colistin monotherapy for the treatment of Acinetobacter baumannii infection. (5) Conclusions: The efficacy and safety of treatment with colistin monotherapy and that of colistin plus meropenem combination therapy in patients with drug-resistant Acinetobacter baumannii infection were comparable. The majority of the evidence was obtained from nonrandomized studies, and high-quality randomized controlled trials are needed to confirm the role of colistin plus meropenem combination therapy in the treatment of multidrug-resistant Acinetobacter baumannii infection.

Combining Trauma Script Exposure With rTMS to Reduce Symptoms of Post-Traumatic Stress Disorder: Randomized Controlled Trial

BackgroundInnovative therapeutic interventions for post-traumatic stress disorder (PTSD) are required. We opted to facilitate fear extinction by combining trauma script exposure with repetitive transcranial magnetic stimulation (rTMS) to reduce symptoms of PTSD. ObjectiveThe efficacy and safety of 10 Hz rTMS of the right dorsolateral prefrontal cortex simultaneously with exposure to personal traumatic narrative were studied in patients with PTSD. Materials and MethodsThis trial was a single-center randomized controlled trial (NCT02584894). Patients were randomly assigned 1:1 to receive eight daily sessions of 110% of motor threshold high frequency (HF) 10 Hz rTMS (110% HF rTMS) or 70% low frequency (LF) 1 Hz rTMS (70% LF rTMS) with trauma script exposure in both groups. Severity of PTSD, depression, and anxiety were assessed before and after study treatment (one month, three months) by an assessor masked to the trial group assignment. The primary outcome was the severity of PTSD assessed by the Clinician Administered PTSD Scale (CAPS). We used mixed linear regression models for statistical comparisons. ResultsThirty-eight patients (65.8% females) were randomly assigned to 110% HF rTMS (n = 18, 31.3 ± 10.0 years, 13 females) or 70% LF rTMS (n = 20, 33.5 ± 11.1 years, 12 females). From baseline to three months, mean CAPS scores decreased by 51% in the 110% HF rTMS group (from 83.7 ± 14.4 to 41.8 ± 31.9) and by 36.9% in the 70% LF rTMS group (from 81.8 ± 15.6 to 51.6 ± 23.7), but with no significant difference in improvement (time by treatment interaction −3.61 [95% confidence interval (CI), −9.70 to 2.47]; p = 0.24; effect size 0.53). One serious adverse event occurred during the study (psychogenic nonepileptic seizure). ConclusionWe found no evidence of difference in clinical improvement or remission rates between the 110% HF and 70% LF stimulation. These findings may reflect the importance of exposure procedure and that larger number of participants is needed.

Efficacy and safety profile of 2-year netakimab treatment in patients with moderate-to-severe plaque psoriasis in terms of the randomized double-blind placebo-controlled BCD-085-7/PLANETA clinical trial

Background. Netakimab, a recombinant humanized monoclonal antibody, specifically binding to IL-17 blocks its activity resulting in plaque psoriasis signs decrease. The results of the first year of BCD-085-7/PLANETA study showed high efficacy and a favorable safety profile in the treatment of patients with moderate-to-severe psoriasis.&#x0D; Aims. Efficacy and safety assessments of netakimab through 2 years of treatment in patients with moderate-to-severe psoriasis.&#x0D; Materials and methods. BCD-085-7/PLANETA study is ongoing Randomized, Double-blind, Placebo-Controlled Phase III clinical study. In the study, 213 patients with moderate-to-severe plaque psoriasis were randomly assigned to one of three study groups. In the first two groups of patients, after weekly drug administration, received netakimab at a dose of 120 mg every two or four weeks. In the third group the patients received placebo. During 12-week double-blind study period the efficacy were evaluated based on the proportion of patients achieved PASI 75. After that all patients were switched to netakimab (once in 4 weeks). Patients who failed to achieve PASI 75 at Week 52 were withdrawn from the study. The open period lasts about 3 years. Herein we focus on the results of 2-year netakimab treatment (120 mg, weekly for 3 weeks, then once in 4 weeks), the recommended per label dose. Taking into account the epidemiological situation (COVID-19) and results limitation due to missing visits, additionally to the efficacy analysis in patients received, at least, one dose of netakimab, analysis in those of them who had relevant data on each visit per Protocol was conducted (ITT and PP populations).&#x0D; Results. At Year 1, PASI 75/90/100 responses were achieved in 88,7/74,5/56,6% patients, respectively (ITT-population) and in 100/85/66% patients, respectively (ITT-population). In 2 year, 69,3/58,0/40,6% sustained their responses in ITT-population and 93,2/78,2/53,1% in PP-population. Through 2 years, the high quality of life sustained among patients. The safety profile remained favorable and immunogenicity was low.&#x0D; Conclusions. Treatment with netakimab at a dose of 120 mg every 4 weeks results in high rates of sustained clinical response and quality life improvement in patients with moderate-to-severe plaque psoriasis with remains of a favorable safety profile.

Comparison of the Clinical and Laboratory Findings and Outcomes of Hospitalized COVID-19 Patients Who Were Either Fully Vaccinated with Coronavac or Not: An Analytical, Cross Sectional Study.

COVID-19 vaccines are highly protective against severe disease; however, vaccine breakthrough infections resulting in hospitalization may still occur in a small percentage of vaccinated individuals. We investigated whether the clinical and microbiological features and outcomes were different between hospitalized COVID-19 patients who were either fully vaccinated with Coronovac or not. All hospitalized COVID-19 patients who had at least one dose of Coronavac were included in the study. The oldest unvaccinated patients with comorbidities, who were hospitalized during the same period, were chosen as controls. All epidemiologic, clinical and laboratory data of the patients were recorded and compared between the fully vaccinated and unvaccinated individuals. There were 69 and 217 patients who had been either fully vaccinated with Coronavac or not, respectively. All breakthrough infections occurred in the first 3 months of vaccination. Fully vaccinated patients were older and had more comorbidities than unvaccinated patients. There were minor differences between the groups in symptoms, physical and laboratory findings, anti-spike IgG positivity rate and level, the severity of COVID-19, complications, and clinical improvement rate. The mortality rate of fully vaccinated patients was higher than the mortality rate in unvaccinated patients in univariate analysis, which was attributed to the fact that vaccinated patients were older and had more comorbidities. The severity and clinical outcomes of hospitalized patients with breakthrough COVID-19 after Coronavac vaccination were similar to those of unvaccinated patients. Our findings suggest that the immune response elicited by Coronovac could be insufficient to prevent COVID-19-related severe disease and death within 3 months of vaccination among elderly people with comorbidities.

Role of Neutrophil-Lymphocyte Ratio and Mean Platelet Volume in the Outcome of Atherosclerotic Peripheral Vascular Disease Interventions

Purpose: Classically, neutrophils have been neglected in the pathophysiology of atherosclerosis. However, recent studies have highlighted their role. Similarly, the role of platelets in peripheral artery disease (PAD) has become evident now. The significance of neutrophil-lymphocyte ratio (NLR) and mean platelet volume (MPV) has been independently studied and found that elevated values are associated with poor outcomes of atherosclerotic peripheral vascular disease interventions. However, the measure of association of NLR and MPV to the outcomes of intervention has not been studied. Hence, this study was undertaken to examine the measure of association of NLR and MPV to the outcomes of atherosclerotic peripheral vascular disease interventions. Methodology: This is a prospective study conducted between January 1, 2020, and September 30, 2021, with 6 months of follow-up. Patients aged 21 years or more, diagnosed to have atherosclerotic peripheral vascular disease, and undergoing interventions (endovascular and open procedure) are included in the study. Patients &lt;21 years, not willing for any intervention, and with acute presentations were excluded. The primary endpoint assessed is graft patency at 6 months, and the secondary endpoints assessed are clinical improvement (which is a combined measure of change in ankle–brachial index, Rutherford grade, and ulcer status) at 1 and 6 months, redo procedure, and amputations within the follow-up period. Results: From January 2020 to September 2021, a total of 156 patients with atherosclerotic peripheral vascular disease fulfilled the inclusion and exclusion criteria. We observed that in 109 (69.9%) patients who had completed 6-month follow-up, 91 (83.5%) patients had graft patency and 18 (16.5%) patients had occluded graft. Independent receiver operating characteristic curve analysis of MPV and NLR showed that lower mean NLR and MPV values (cutoff taken as 10.15 for MPV) are associated with increased graft patency at 6 months than higher mean NLR and MPV values (NLR, P &lt; 0.001; MPV, P = 0.024). Discriminant analysis model developed with MPV and NLR as the set of predictors showed that NLR and MPV together are good predictors of graft patency at 6 months (Wilk's lambda: χ2 = 45.54, P &lt; 0.001). However, logistic regression analysis has shown that, in comparison to NLR, MPV is not a strong predictor of graft patency. Lower mean NLR value was associated with lower amputation rate (P &lt; 0.001), lower mortality rate (P &lt; 0.001), and higher clinical improvement rate at 1st month (P &lt; 0.001) and at 6 months (P &lt; 0.001) than patients with higher mean NLR. However, there was no statistically significant difference between two groups in predicting chance of redo procedure (P = 0.424). There was no statistically significant difference between the mean MPV values among patients who underwent amputation (P = 0.864), died (P = 0.640), or had redo procedure (P = 0.883), except for clinical improvement outcome where lower mean MPV value was associated with higher rate of clinical improvement at 1st month (P &lt; 0.001) and 6 months (P &lt; 0.001) than higher mean MPV value. Conclusion: In patients with atherosclerotic peripheral vascular disease, NLR value is a better predictor of outcomes after intervention than MPV, and lower mean NLR values are associated with increased rate of graft patency, clinical improvement, fewer amputations, and deaths.

Clinical efficacy and safety of lymphocyte apheresis combined with plasma exchange in the treatment of patients with hepatitis B virus-related liver failure at the ascending stage

To analyze and summarize the clinical efficacy and safety of lymphocyte apheresis combined with plasma exchange in the treatment of patients with hepatitis B virus-related liver failure at the ascending stage. A observational study was conducted. A total of 69 hepatitis B virus-related liver failure at the ascending stage patients who were hospitalized at Affiliated Guangzhou Eighth People's Hospital of Guangzhou Medical University from January 2016 to December 2020 were enrolled in this study. The patients were grouped according to their condition and wishes, including 38 patients treated with conservative medical treatment (control group) and 31 patients treated with lymphocyte apheresis combined with plasma exchange based on comprehensive medical treatment (study group). Clinical data were compared between the two groups 1-4 weeks after treatment, including dynamic changes of total bilirubin (TBil), international normalized ratio (INR), alanine aminotransferase (ALT), model for end-stage liver disease (MELD) score, and the rate of clinical improvement at 4 weeks after treatment. In addition, the adverse effects and dynamic changes of white blood cell count (WBC), lymphocyte count (LYM), platelet count (PLT), and hemoglobin (Hb) within 4 weeks after treatment were compared between the two groups. Both groups showed significant improvement in clinical parameters after 1-4 weeks of initiation of therapy. The improvement of TBil, INR and MELD score at 1-4 weeks after treatment were significantly better in the treatment group than those in the control group [TBil (μmol/L): 248 (117, 335) vs. 398 (328, 464) at 1 week, 173 (116, 278) vs. 326 (184, 476) at 2 weeks, 107 (84, 235) vs. 355 (129, 467) at 3 weeks, 70 (61, 172) vs. 290 (82, 534) at 4 weeks; INR: 1.72±0.70 vs. 2.13±0.69 at 1 week, 1.67±0.61 vs. 2.28±1.35 at 2 weeks, 1.65±0.75 vs. 2.15±0.92 at 3 weeks, 1.61±0.93 vs. 2.19±1.17 at 4 weeks; MELD score: 18.35±5.32 vs. 23.38±4.56 at 1 week, 16.47±5.16 vs. 23.71±7.94 at 2 weeks, 16.30±5.75 vs. 22.64±6.99 at 3 weeks, 14.63±6.76 vs. 20.97±8.19 at 4 weeks], with significant differences (all P < 0.05). In addition, ALT levels at 1 week and 2 weeks after treatment in the study group were significantly lower than those in the control group [U/L: 128 (93, 206) vs. 240 (167, 436) at 1 week, 64 (42, 110) vs. 85 (69, 143) at 2 weeks, both P < 0.05]. The rate of clinical improvement at 4 weeks after treatment in the study group was 54.84% (17/31), which was significantly higher than that in the control group [28.95% (11/38)], with statistically significant difference (P < 0.05). There was no significant difference in the rate of new infection between the study group and the control group [22.58% (7/31) vs. 34.21% (13/38), P > 0.05]. Additionally, expect that the PLT level at 1 week after treatment in the study group was significantly lower than that in the control group (×109/L: 101±42 vs. 128±59, P < 0.01), there was no significant difference in WBC, LYM or Hb at different time points after treatment between the two groups. Clinical efficacy of lymphocyte apheresis combined with plasma exchange based on comprehensive medical treatment in the treatment of patients with hepatitis B virus-related liver failure at the ascending stage is superior to conservative medical treatment alone, which can improve clinical improvement rate and recovery rate of liver function with high safety.

Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis

Objective: To evaluate the efficacy and safety of selective genicular artery embolization for the treatment of the knee pain secondary to osteoarthritis. Methods: From October 2020 to July 2021, 17 patients (23 knees) aged (68±7) years with moderate to severe knee pain secondary to knee osteoarthritis were prospectively included in the General Hospital of Ningxia Medical University. There were 6 males and 11 females included in this research. Patients were assessed with knee pain, stiffness, and function with the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, using the Kellgren-Lawrence (K-L) grading to evaluate the severity of KOA, and using the Magnetic Resonance Knee Osteoarthritis Score (MOAKS) to evaluate the MR imaging characteristics of the affected knee. Selective genicular artery embolization (GAE) was performed in all patients. The patients were followed up for 6 months after the procedure. Patients were assessed with the VAS score and WOMAC scale at 1 d, 1 week and 1, 3 and 6 months after the procedure to evaluate the clinical outcomes, including the improvement of knee joint pain, stiffness and function, as well as the occurrence of adverse reactions. Results: Three to seven genicular artery branches were superselected and embolized in 23 knees, and 4 to 7 genicular artery branches were embolized in 7 patients with K-L grade 4. The clinical improvement was 95.6% (22/23) at 1 month, 86.9% (20/23) at 3 months, and 91.3% (21/23) at 6 months. Twenty-three knees completed the 6-month follow-up, and the VAS score, WOMAC pain score, and total WOMAC score at 1, 3, and 6 months after surgery were (2.5±1.3), (3.4±2.4), and (19.7±9.8) points, (3.0±1.8), (4.5±3.4), and (22.3±11.3) points, (2.8±1.5), (4.1±3.0), and (20.5±11.0) points, which were lower than the (6.6±0.9), (11.4±2.6) and (47.0±12.0) points at baseline (all P<0.001). During the follow-up period, 7 patients had adverse reactions: 3 cases had skin ecchymosis in the femoral artery puncture area, 4 cases had knee joint stiffness and pain within 1 day after operation, which were relieved spontaneously in 1 week, 6 patients had joint clicking during extension and flexion activities after operation, of which 3 cases subsided spontaneously within 3 months after operation. None of the patients had major procedure-related adverse events. Conclusion: GAE has a high clinical improvement rate and a low incidence of adverse reactions in the treatment of the pain secondary to knee osteoarthritis, which provides a new treatment option for patients who fail to respond to conservative treatment.

Efficacy and safety of CD24Fc in hospitalised patients with COVID-19: a randomised, double-blind, placebo-controlled, phase 3 study

BackgroundNon-antiviral therapeutic options are required for the treatment of hospitalised patients with COVID-19. CD24Fc is an immunomodulator with potential to reduce the exaggerated inflammatory response to tissue injuries. We aimed to evaluate the safety and efficacy of CD24Fc in hospitalised adults with COVID-19 receiving oxygen support.MethodsWe conducted a randomised, double-blind, placebo-controlled, phase 3 study at nine medical centres in the USA. Hospitalised patients (age ≥18 years) with confirmed SARS-CoV-2 infection who were receiving oxygen support and standard of care were randomly assigned (1:1) by site-stratified block randomisation to receive a single intravenous infusion of CD24Fc 480 mg or placebo. The study funder, investigators, and patients were masked to treatment group assignment. The primary endpoint was time to clinical improvement over 28 days, defined as time that elapsed between a baseline National Institute of Allergy and Infectious Diseases ordinal scale score of 2–4 and reaching a score of 5 or higher or hospital discharge. The prespecified primary interim analysis was done when 146 participants reached the time to clinical improvement endpoint. Efficacy was assessed in the intention-to-treat population. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT04317040.FindingsBetween April 24 and Sept 22, 2020, 243 hospitalised patients were assessed for eligibility and 234 were enrolled and randomly assigned to receive CD24Fc (n=116) or placebo (n=118). The prespecified interim analysis was done when 146 participants reached the time to clinical improvement endpoint among 197 randomised participants. In the interim analysis, the 28-day clinical improvement rate was 82% (81 of 99) for CD24Fc versus 66% (65 of 98) for placebo; median time to clinical improvement was 6·0 days (95% CI 5·0–8·0) in the CD24Fc group versus 10·0 days (7·0–15·0) in the placebo group (hazard ratio [HR] 1·61, 95% CI 1·16–2·23; log-rank p=0·0028, which crossed the prespecified efficacy boundary [α=0·0147]). 37 participants were randomly assigned after the interim analysis data cutoff date; among the 234 randomised participants, median time to clinical improvement was 6·0 days (95% CI 5·0–9·0) in the CD24Fc group versus 10·5 days (7·0–15·0) in the placebo group (HR 1·40, 95% CI 1·02–1·92; log-rank p=0·037). The proportion of participants with disease progression within 28 days was 19% (22 of 116) in the CD24Fc group versus 31% (36 of 118) in the placebo group (HR 0·56, 95% CI 0·33–0·95; unadjusted p=0·031). The incidences of adverse events and serious adverse events were similar in both groups. No treatment-related adverse events were observed.InterpretationCD24Fc is generally well tolerated and accelerates clinical improvement of hospitalised patients with COVID-19 who are receiving oxygen support. These data suggest that targeting inflammation in response to tissue injuries might provide a therapeutic option for patients hospitalised with COVID-19.FundingMerck & Co, National Cancer Institute, OncoImmune.

Use of remdesivir in patients with COVID-19: a systematic review and meta-analysis.

ABSTRACTObjective:Studies in the literature regarding the use of remdesivir to treat COVID-19 patients have shown conflicting results. This study sought to answer questions related to the use of remdesivir for the treatment of patients hospitalized with moderate to severe COVID-19. Methods:This was a systematic review and meta-analysis including phase 3 randomized clinical trials (RCTs) and observational cohort studies selected from various databases, comparing patients hospitalized with moderate to severe COVID-19 receiving remdesivir and controls. Results:A total of 207 studies were retrieved, 9 of which met the eligibility criteria and were included in the study. The meta-analysis using RCTs alone showed no statistically significant differences regarding mortality or use of mechanical ventilation/extracorporeal membrane oxygenation between remdesivir and control groups, and the quality of evidence was moderate and low, respectively. The use of remdesivir increased the recovery rate by 6% (95% CI, 3-9); p = 0.004) and the clinical improvement rate by 7% (95% CI, 1-14); p = 0.02). Additionally, no significant differences in mortality were found between remdesivir and control groups when the meta-analysis used observational cohort studies alone (risk difference = −0.01 (95% CI, −0.02 to 0.01; p = 0.32), the quality of evidence being moderate, and the risk of adverse events was 4% ([95% CI, −0.08 to 0.01]; p = 0.09). Conclusions:The use of remdesivir for the treatment of patients with moderate to severe COVID-19 had no significant impact on clinically important outcomes.

Stereotactic Radiosurgery for Glomus Jugulare Tumors: Systematic Review and Meta-Analysis

Glomus jugulare tumors (GJTs) are benign paragangliomas of the jugular foramen. Traditional management of these tumors involves surgical resection; however, considering the proximity of these tumors to important neurovasculature, stereotactic radiosurgery (SRS) may be an appropriate noninvasive treatment to consider. The aim of this meta-analysis was to evaluate SRS as a treatment option for GJTs. An online search using PubMed, Web of Science, Scopus, and Cochrane databases was performed in March 2019 for articles on radiosurgery treatment of GJTs. The screening process followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The final analysis comprised 23 studies including 460 patients. Average rates of tinnitus, hearing loss, and lower cranial nerve deficit as presenting symptoms were 56% (95% confidence interval [CI], 46%-66%), 56% (95% CI, 44%-68%), and 42% (95% CI, 31%-54%), respectively. Overall clinical status improvement rate after treatment was 47% (95% CI, 37%-57%). Rates of tinnitus, hearing loss, and lower cranial nerve improvement after treatment were 54% (95% CI, 44%-63%), 28% (95% CI, 19%-40%), and 22% (95% CI, 11%-39%), respectively. The mean follow-up time across studies was 47 months (range, 4-268 months). The aggregate tumor control rate at the time of follow-up was 95% (95% CI, 93%-97%). The tumor control rate of 95% and 47% symptomatic improvement suggest that SRS may be a suitable treatment modality for these hypervascular skull base tumors. Future studies are warranted to further evaluate the potential role of SRS in management of GJTs.

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial

Purpose: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). Methods: The STELLA SUPERA (STEnting Long de L’Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2–6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. Results: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. Conclusion: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Impact of language proficiency on mental health service use, treatment and outcomes: "Lost in Translation"

BackgroundMastery of a language is bound to place of origin; low language proficiency is thus related to migration and cultural differences, all of which influence access to mental health care, treatment and outcomes. Switzerland, being multilingual, allows the disentangling of language proficiency from migration and, to some extent, culture. This study uses propensity score matching to explore how language proficiency relates to help-seeking behaviour, service use, treatment and outcomes in patients with mental health disorders. MethodsWe used the first admission of patients admitted to and discharged from an academic psychiatric hospital in Switzerland between January 1st, 2013 and December 31st, 2019, with an observation period of one-year post-discharge (until December 31st, 2020). We paired 2101 patients with low language proficiency to 2101 language proficient patients, balancing baseline sociodemographic and clinical characteristics using propensity score matching. ResultsPatients with low language proficiency had a higher probability of compulsory admission (OR: 1.79, 99%CI: 1.60–2.02); which remained after adjustment for confounders (OR: 1.51; 99%CI: 1.21–1.89). Whilst in treatment, they had higher rates of compulsory medication (OR: 1.73, 99%CI: 1.16–2.59) and seclusion/restraint (OR: 1.87, 99%CI: 1.25–2.79). Furthermore, patients initially admitted voluntarily had a higher probability of being compulsorily retained (OR: 1.74, 99%CI: 1.24–2.46). Both groups showed similar clinical improvement rates and service use parameters. ConclusionsOur results demonstrate that low language proficiency constitutes a risk factor for coercive measures throughout hospitalisation. The results demonstrate the need for an increase in language sensitivity in psychiatric care.