Clinical Improvement Rate Research Articles

Safety and efficacy of transvenous embolization of cerebrospinal fluid-venous fistula in patients with spontaneous intracranial hypotension.

Transvenous embolization is a recent treatment strategy for cerebrospinal fluid-venous fistulas (CSFVF), which are associated with spontaneous intracranial hypotension (SIH). Participants were selected from a prospective database on patients with CSFVF that received transvenous Onyx embolization. All patients underwent a brain magnetic resonance imaging (MRI) before and after embolization with MRI follow-up performed at least 3 months after treatment. Clinical and MRI results after treatment were described. Twenty-one consecutive patients (median age 63 years, IQR = 58-71; females: 15/21 = 71.5%) with 30 CSFVF were included. Most lesions were situated between T9 and L1 (19/30 = 63%), 70% were right-sided, and 38% of the patients had multiples fistulas. Embolization was successful in all cases. The mean MRI SIH score before and after treatment was 6 (±2.5) and 1.4 (±1.6), respectively (p < 0.0001). Twenty patients (90%) experienced improvement of their initial condition, of which 67% reported complete clinical recovery. The mean HIT-6 score decreased from 67 (±15) to 38 (±9) (p < 0.0001), the mean amount of monthly headache days from 23.5 (±10) and 3.2 (±6.6) (p < 0.0001), the visual assessment scale (VAS) for headache severity from 8 (±1.9) to 1.2 (±2) (p < 0.0001), and the mean VAS for perception quality of life improved from 2.6 (±2.5) to 8.6 (±1.8) (p < 0.0001). There were no major complications. The suspected rebound headache rate after treatment was 33%. Transvenous embolization of CSFVF allowed high rates of clinical improvement with no morbidity related to the treatment.

308 Improvement in Cranial Nerve Neuropathies Following Treatment of Intracranial Aneurysms With Flow Diverters: Institutional Outcomes and Meta-analysis of Literature

INTRODUCTION: Cranial nerve (CN) neuropathies are rare presenting symptoms of intracranial aneurysms. Ophthalmological outcomes for symptomatic aneurysms treated with flow diversion are not well established. METHODS: We conducted a retrospective review of our institutional database for patients with intracranial aneurysms presenting with CN neuropathies who underwent treatment with flow diversion between 2015 and 2023. Systematic review of the literature was performed using Medline, EMBASE, Cochrane, and manual citation searches. Random effects meta-analysis was used. RESULTS: Twelve out of 136 studies were included in this meta-analysis, totaling 261 patients. The results were combined with our institutional data. The pooled rate of improvement in any CN neuropathies following flow diversion was 76% (95% CI, 67%-84%, n = 272). Patients presenting with CNII deficits were less likely to improve following treatment compared to other CN neuropathies (pooled OR [pOR] 0.32, 95% CI, 0.16-0.63, n = 224). The pooled rate of clinical improvement was 53% in CNII deficits (95% CI, 42%-65%, n = 80) and 80% in other CN deficits (95% CI, 71%-88%, n = 106). Intervention within one month of presentation was associated with improvement (pOR 6.53, 95% CI, 1.34-31.81, n = 33). Adjunctive coiling did not demonstrate effect on the improvement rate (pOR 0.38, 95% CI, 0.07-2.13, n = 31). Near total occlusion (Raymond Roy Occlusion Classification of 1 or 2, or O'Kelly-Marotta scale of C or D) was associated with symptomatic improvement (pOR 5.29, 95% CI, 1.66-16.90, n = 118), but not total occlusion (pOR 2.83, 95% CI, 0.97-8.23, n = 118). CONCLUSIONS: Flow diversion improves CN outcomes in patients with symptomatic intracranial aneurysms. These results support the theory that CN neuropathies depend more on the pulsatility of the aneurysm sac rather than mass effect. The inferior rate of improvement in CNII deficits compared to other CN symptoms may imply an additional, more irreversible mechanism contributing to CNII visual deficits.

Comparing the efficacy of vedolizumab between males and females: a post-hoc analysis of GEMINI-1 and VARSITY.

Vedolizumab is a first-line treatment option for ulcerative colitis. There are differences in incidence of ulcerative colitis between males and females, but whether sex affects treatment outcomes is less clear. We examined sex-based differences in patients with ulcerative colitis initiated on vedolizumab from two major randomized controlled trials (RCTs). We conducted a post-hoc analysis on participants with ulcerative colitis from the VARSITY and GEMINI-1 RCTs who received vedolizumab. Outcomes of interest were rates of clinical improvement, clinical remission, and endoscopic improvement at weeks 6, 14, and 52 in male and female participants, as were differences in concentrations of trough vedolizumab and C-reactive protein; 1009 persons in GEMINI-1 and VARSITY trials were included. Male and female patients had similar disease characteristics aside from males being more likely to have Mayo 3 grade endoscopic severity at baseline (62.8 vs. 48.9%, P < 0.001). At week 6, females were more likely to have endoscopic improvement (47.4 vs. 35.2%, P = 0.001) and increased vedolizumab trough levels [34.0 (23.0-44.5) vs. 28.9 (19.0-34.6), P < 0.001]. The probability of achieving clinical remission (28.9 vs. 34.5%, P = 0.057) or endoscopic improvement (35.5 vs. 39.3%, P = 0.212) at week 52 was not different between males and females. Females with ulcerative colitis treated with vedolizumab appear more likely to achieve early endoscopic improvement than males, though longer-term outcomes demonstrated no difference. Further studies are required to better understand mechanisms through which sex or sex-associated factors could influence response to therapy in ulcerative colitis.

Patients With and Without Double Crush Syndrome Achieve Similar Rates of Clinical Improvement Following Carpal Tunnel Release.

The purpose of this study is to compare outcomes of carpal tunnel release (CTR) in patients with and without double crush syndrome (DCS), defined as concurrent carpal tunnel syndrome (CTS) and cervical radiculopathy at C5-T1 on preoperative nerve conduction studies. Patients with preoperative nerve conduction studies who underwent unilateral, isolated CTR were retrospectively identified. All patients completed preoperative and 3-month postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) upper extremity (UE) and pain interference (PI), and Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaires, and responded to the anchor question: "Since your treatment, how would you rate your overall function?" (much worse, worse, slightly worse, no change, slightly improved, improved, much improved). Preoperative, postoperative, and changes in scores for UE, PI, and QuickDASH were compared, as were the anchor question responses and rates of achieving the minimal clinically important difference (MCID). Sixty-three patients with DCS and 115 patients with CTS only were included. At 3- to 4-month follow-up, absolute and change in UE, PI, and QuickDASH scores were not statistically different between patients with DCS and CTS. Rates of anchor question response and MCID achievement were comparable for patients with CTS only and DCS on each questionnaire. The MCID achievement ranged from 48.4% to 68.8% in the unmatched cohort and 48.4% to 60% in the matched group. At 3 to 4 months, patients with DCS experience similar patient-reported symptomatic and functional improvement, and achieve MCID of outcome measures at comparable rates to patients with CTS only. For patients with nerve compression at the carpal tunnel and cervical spine, CTR is a reasonable first step prior to proceeding with cervical spine decompression.

Therapeutic strategies and outcomes in neuropsychiatric systemic lupus erythematosus: an international multicentre retrospective study.

The management of neuropsychiatric systemic lupus erythematosus (NPSLE) poses considerable challenges due to limited clinical trials. Therapeutic decisions are customized based on suspected pathogenic mechanisms and symptoms severity. This study aimed to investigate therapeutic strategies and disease outcome for patients with NPSLE experiencing their first neuropsychiatric (NP) manifestation. This retrospective cohort study defined NP events according to the American College of Rheumatology case definition, categorizing them into three clusters: central/diffuse, central/focal and peripheral. Clinical judgment and a validated attribution algorithm were used for NP event attribution. Data included demographic variables, SLE disease activity index, cumulative organ damage, and NP manifestation treatments. The clinical outcome of all NP events was determined by a physician seven-point Likert scale. Predictors of clinical improvement/resolution were investigated in a multivariable logistic regression analysis. The analysis included 350 events. Immunosuppressants and corticosteroids were more frequently initiated/escalated for SLE-attributed central diffuse or focal NP manifestations. At 12 months of follow-up, 64% of patients showed a clinical improvement in NP manifestations. Focal central events and SLE-attributed manifestations correlated with higher rates of clinical improvement. Patients with NP manifestations attributed to SLE according to clinical judgment and treated with immunosuppressants had a significantly higher probability of achieving clinical response (OR 2.55, 95%CI 1.06-6.41, P = 0.04). Age at diagnosis and focal central events emerged as additional response predictors. NP manifestations attributed to SLE by clinical judgment and treated with immunosuppressants demonstrated improved 12-month outcomes. This underscores the importance of accurate attribution and timely diagnosis of NPSLE.

The safety and efficacy of Houtou Jianweiling tablet in patients with chronic non-atrophic gastritis: a double-blind, non-inferiority, randomized controlled trial.

Background: Common symptoms of Chronic Non-atrophic Gastritis (CNAG) include nausea, stomach distension, and abdominal pain. The Houtou Jianweiling Tablet (HTJWT) is a chinese patent medicine (CN1368229A) and it has been used clinically for more than 20years with proven clinical efficacy in treating CNAG, prompted us to establish the clinical efficacy and safety of HTJWT on patients with mild to moderate CNAG symptoms in Pakistani population. Methods: This phase II, double-blind, randomized, parallel-controlled trial was conducted in a single center between November 2022 and February 2023 in Pakistan. In a ratio of 1:1, total 240 CNAG patients with erosion identified by pathological biopsy and gastroscopy were randomly assigned to control (Omeprazole) group (n = 120) and the treatment (HTJWT) group (n = 120). Patients in the treatment group received orally four HTJWT (0.38g/tablet), three times a day and one placebo of Omeprazole enteric-coated tablet prior to breakfast, daily. On the other hand, patients in the control group received one Omeprazole enteric-coated tablet (20 mg/tablet) prior to breakfast and four placebo of HTJWT, thrice a day. The patients consumed the investigated drugs (i.e., treatment and control) treatment regimen was followed for a duration of 28days. The safety of the patients were evaluated through adverse events, serious adverse events and laboratory tests such as blood biochemistry, urine analysis, liver and renal function tests. Vital signs like; blood pressure, pulse rate, body temperature, respiratory rate for all the patients were recorded. The cardiac status of the patients were assessed through electrocardiogram (ECG). The primary efficacy indicators were the improvement rate of gastric distention and gastralgia as the main clinical symptoms. Secondary indicators were visual analogue score (VAS); improvement rate of secondary clinical symptoms and signs; improvement rate of total clinical signs and symptoms; the disappearance/remission rate of Gastric pain and, remission/disappearance time of gastric distension; and the negative conversion rate of Helicobacter pylori (H. pylori). The outcomes among each group were compared using the chi-square test. Results: Patients in both groups had good drug compliance (80%-120%), and there was no statistically significant difference in the patients' baseline characteristics. The clinical improvement rate was found to be 91.1% in the treatment group and 91.0% in the control group with negligible variation among the two groups (p = 0.9824; 95% confidence interval: -0.0781-0.0798). Similarly, hardly no difference was found in the negative conversion rate of H. pylori between the treatment group and the control group (i.e., 70.1% and 71.8% respectively, p = 0.8125). There were no significant differences in respiratory rate, vital signs, blood pressure, laboratory results for blood biochemistry, urine analysis, liver and renal function tests between the two groups. The ECG assessment carried out for the treatment and control group revealed no considerable difference. Margin variation in the disappearance time of gastric pain (p = 0.1860) and remission rate (p = 0.5784) between the two groups were observed. The control group exhibited a faster remission period for gastrointestinal discomfort indications as compared to treatment group (p = 0.0430). Only one patient in the control group experienced mild to moderate adverse events, namely,; epigastric pain and dyspepsia. The results were consistent with the intention-to-treat and per-protocol analysis that included patients who were 100% compliant to the assigned therapy. Conclusion: The lower limit of confidence interval (CI, 95%) for the differences in the effective rate between the treatment and the control groups was found to be -0.0781 which is greater than -0.15, hence the treatment group is non-inferior to the control group. The therapeutic dosage used in the trial and treatment period did not cause any significant adverse event, and there were no obvious changes in the ECG profile, vital signs and biochemistry of the patients. Based on the clinical efficacy evaluation and reported adverse events, it can be concluded that the HTJWT is a safe and effective traditional chinese medicine for the treatment of patients suffering from chronic non-atrophic gastritis with mild to moderate symptoms. Clinical Trial Registration: [www.clinicaltrials.gov], identifier [NCT04672018].

High rate of clinically relevant improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis.

The minimal clinically important difference (MCID) is defined as the smallest meaningful change in a health domain that a patient would identify as important. Thus, an improvement that exceeds the MCID can be used to define a successful treatment for the individual patient. To quantify the rate of clinical improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis. Patients were treated with the Global Unite total shoulder platform arthroplasty between March 2017 and February 2019 at Herlev and Gentofte Hospital, Denmark. The patients were evaluated preoperatively and 3 months, 6 months, 12 months, and 24 months postoperatively using the Western Ontario Osteoarthritis of the Shoulder index (WOOS), Oxford Shoulder Score (OSS) and Constant-Murley Score (CMS). The rate of clinically relevant improvement was defined as the proportion of patients who had an improvement 24 months postoperatively that exceeded the MCID. Based on previous literature, MCID for WOOS, OSS, and CMS were defined as 12.3, 4.3, and 12.8 respectively. Forty-nine patients with a Global Unite total shoulder platform arthroplasty were included for the final analysis. Mean age at the time of surgery was 66 years (range 49.0-79.0, SD: 8.3) and 65% were women. One patient was revised within the two years follow-up. The mean improvement from the preoperative assessment to the two-year follow-up was 46.1 points [95% confidence interval (95%CI): 39.7-53.3, P < 0.005] for WOOS, 18.2 points (95%CI: 15.5-21.0, P < 0.005) for OSS and 37.8 points (95%CI: 31.5-44.0, P < 0.005) for CMS. Two years postoperatively, 41 patients (87%) had an improvement in WOOS that exceeded the MCID, 45 patients (94%) had an improvement in OSS that exceeded the MCID, and 42 patients (88%) had an improvement in CMS that exceeded the MCID. Based on three shoulder-specific outcome measures we find that approximately 90% of patients has a clinically relevant improvement. This is a clear message when informing patients about their prognosis.

Associations of nirmatrelvir-ritonavir treatment with death and clinical improvement in hospitalized patients with COVID-19 during the Omicron wave in Beijing, China: a multicentre, retrospective cohort study

Background The effectiveness of nirmatrelvir–ritonavir has mainly been shown in non-hospitalized patients with mild-to-moderate coronavirus disease 2019 (COVID-19). The real-world effectiveness of nirmatrelvir-ritonavir urgently needs to be determined using representative in-hospital patients with COVID-19 during the Omicron wave of the pandemic. Methods We performed a multicentre, retrospective study in five Chinese PLA General Hospital medical centers in Beijing, China. Patients hospitalized with COVID-19 from 10 December 2022 to 20 February 2023 were eligible for inclusion. A 1:1 propensity score matching was performed between the nirmatrelvir-ritonavir group and the control group. Results 1010 recipients of nirmatrelvir-ritonavir and 1010 matched controls were finally analyzed after matching. Compared with matched controls, the nirmatrelvir-ritonavir group had a lower incidence rate of all-cause death (4.6/1000 vs. 6.3/1000 person-days, p = 0.013) and a higher incidence rate of clinical improvement (47.6/1000 vs. 45.8/1000 person-days, p = 0.012). Nirmatrelvir-ritonavir was associated with a 22% lower all-cause mortality and a 14% higher incidence of clinical improvement. Initiation of nirmatrelvir-ritonavir within 5 days after symptom onset was associated with a 50% lower mortality and a 26% higher clinical improvement rate. By contrast, no significant associations were identified among patients receiving nirmatrelvir-ritonavir treatment more than 5 days after symptom onset. Nirmatrelvir-ritonavir was also associated with a 50% increase in survival days and a 12% decrease in days to clinical improvement. Conclusion Among hospitalized patients with COVID-19 during the Omicron wave in Beijing, China, the early initiation of nirmatrelvir-ritonavir was associated with clinical benefits of lowering mortality and improving clinical recovery.

Transforaminal endoscopic lumbar foraminotomy for octogenarian patients.

Radiculopathy caused by lumbar foraminal stenosis in older people has become more common in the aging general population. However, patients aged ≥80 years rarely undergo conventional open surgery under general anesthesia because of the high risk of peri-operative morbidity and adverse events. Therefore, less invasive surgical alternatives are needed for older or medically handicapped patients. Transforaminal endoscopic lumbar foraminotomy (TELF) under local anesthesia may be helpful in at-risk patients, although only limited information is available regarding the clinical outcomes of this procedure in octogenarians. Therefore, this study aimed to investigate the safety and efficacy of TELF for treating radiculopathy induced by foraminal stenosis in octogenarian patients. Overall, 32 consecutive octogenarian patients with lumbar foraminal stenosis underwent TELF between January 2019 and January 2021. The inclusion criterion was unilateral radiculopathy secondary to lumbar foraminal stenosis. The pain focus was confirmed using imaging studies and selective nerve blocks. Full-scale foraminal decompression was performed using a percutaneous transforaminal endoscopic approach under local anesthesia. Surgical outcomes were assessed using the visual analog pain score, Oswestry Disability Index, and modified MacNab criteria. The pain scores and functional outcomes improved significantly during the 24-month follow-up period, and the rate of clinical improvement was 93.75% in 30 of the 32 patients. None of the patients experienced systemic complications. TELF under local anesthesia is an effective and safe treatment for foraminal stenosis in octogenarian or medically compromised patients. The mid-term follow-up did not reveal any significant progression in spinal stability. Therefore, this endoscopic procedure can be an effective alternative to aggressive surgery for managing lumbar foraminal stenosis in octogenarian patients with intractable radiculopathy.

Transforaminal Endoscopic Lumbar Lateral Recess Decompression for Octogenarian Patients.

The incidence of radiculopathy due to lumbar spinal stenosis has been on the increase in the aging population. However, patients aged ≥ 80 years hesitate to undergo conventional open surgery under general anesthesia because of the risk of postoperative morbidity and adverse events. Therefore, less invasive surgical alternatives are required for the elderly or medically handicapped patients. Transforaminal endoscopic lumbar lateral recess decompression (TELLRD) may be helpful for those patients. This study aimed to demonstrate the efficacy of TELLRD for treating radiculopathy in octogenarian patients. A total of 21 consecutive octogenarian patients with lumbar foraminal stenosis underwent TELLRD between January 2017 and January 2021. The inclusion criterion was unilateral radiculopathy, which stemmed from lumbar lateral recess stenosis. The pain source was verified using imaging studies and selective nerve blocks. Full-scale lateral canal decompression was performed using a percutaneous transforaminal endoscopic approach under local anesthesia. We found the pain scores and functional status improved significantly during the 24-month follow-up period. The clinical improvement rate was 95.24% (20 of 21 patients) with no systemic complication. In conclusion, endoscopic lateral recess decompression via the transforaminal approach is practical for octogenarian patients.

Surgical versus non-surgical treatment for carpal tunnel syndrome.

Surgical versus non-surgical treatment for carpal tunnel syndrome.

Stenotrophomonas maltophilia Infections in Haematological Malignancies and Hematopoietic Stem Cell Transplantation: A Case Series including Cefiderocol-Based Regimens.

Background and Objectives: Stenotrophomonas maltophilia is a ubiquitous, aerobic, Gram-negative bacillus causing increasing concern in patients affected by haematological malignancies. Materials and Methods: We report a case series from two centres in Northern Italy to describe the characteristics, outcome and microbiological response of S. maltophilia infections in patients with haematological malignancies and/or allogenic hematopoietic stem cell transplantation (aHSCT). Results: Ten patients were included. The median age was 67 years, and seven patients (70%) were males. The median Charlson Comorbidity Index was 6 (IQR: 4-8). The most frequent haematological comorbidities were acute myeloid leukaemia (AML; n = 3; 30%) and non-Hodgkin's lymphoma (n = 3; 30%). Three (30%) patients underwent aHSCT before infection, all for AML. All the patients had undergone a recent antibiotics course and had an indwelling central venous catheter before infection. The main clinical presentations were nosocomial pneumonia, with (2; 20%) or without (4; 40%) secondary bloodstream infection and CRBSI (3; 30%). Four patients were treated with cefiderocol in monotherapy or combinations therapy with cotrimoxazole. The rest of the patients were treated with cotrimoxazole or levofloxacin in monotherapy. Conclusions: Despite a high rate of clinical improvement (90%) after starting antimicrobial therapy, we faced high 30-day mortality (30%) and in-hospital mortality (50%) rates in a highly comorbid population.

Real-world effectiveness and safety of nirmatrelvir-ritonavir (Paxlovid)-treated for COVID-19 patients with onset of more than 5days: a retrospective cohort study.

Nirmatrelvir-ritonavir (Paxlovid) has received emergency use authorization from the US Food and Drug Administration owing to its effectiveness and safety. However, data on the effectiveness and safety of Paxlovid use in COVID-19 patients with onset of more than 5days are lacking. A real-world retrospective study was performed during the outbreak involving the SARS-CoV-2 BA.5.2 subvariant. Hospitalized COVID-19 patients (including mild, moderate, severe and critical cases) were divided into three groups: Paxlovid treatment within (Group A) or more than (Group B) 5days of COVID-19 onset and no Paxlovid treatment during more than 5days of COVID-19 onset with only basic symptomatic treatment (Group C). Endpoints were all-cause 28-day mortality, improvement in clinical classification, and a composite endpoint of disease progression, viral load and virus elimination time. Safety was assessed by comparing adverse events reported during treatment in each group. During the period, 248 hospitalized COVID-19 patients, including 55 in Group A, 170 in Group B, and 23 in Group C, were enrolled. There were no significant differences in the clinical classification improvement rate [80.0% (16/20) vs. 81.3% (52/64), p = 1.000; 60.0% (21/35) vs. 55.7% (59/106), p = 0.653, respectively] or all-cause 28-day mortality [0% (0/20) vs. 1.6% (1/64), p = 1.000; 11.4% (4/35) vs. 6.6% (7/106), p = 0.576, respectively] between Groups A and B for nonsevere and severe cases. However, the clinical classification improvement rate in Group B was markedly higher than that in Group C [81.3% (52/64) vs. 50.0% (6/12), p = 0.049] among nonsevere cases. Cycle threshold values of the N and ORF genes in Group B were significantly increased after Paxlovid treatment [31.14 (IQR 26.81-33.93) vs. 38.14 (IQR 36.92-40.00), p < 0.001; 31.33 (IQR 26.00-33.47) vs. 38.62 (IQR 35.62-40.00), p < 0.001, respectively]. No significant differences in reported adverse events of neurological disease (p = 0.571), liver injury (p = 0.960) or kidney injury (p = 0.193) between Group A and Group B were found. Paxlovid treatment within 10days of onset can shorten the disease course of COVID-19 by reducing the viral load. Paxlovid is effective and safe in treating COVID-19 with onset of more than five or even 10days when patients have a high viral load.

A Continuous Registry of Medical Record, Patient Input, and Epidemiological Data of Patients With Ulcerative Colitis: a Multicentre, Prospective, Observational Clinical Registry Study in Japan.

This registry aims to allow for a prospective non-interventional observational study of ulcerative colitis. This will facilitate monitoring of the current state of ulcerative colitis in Japan and improving the long-term disease course and adverse events associated with current treatment options. Inclusion of patients from five centres in Japan is planned. The study is expected to take place from July 15, 2020, to November 30, 2024. Background, demographics, and medical history/information will be collected from electronic medical records at enrolment. Medical information including medications, laboratory data, and disease activity will be collected automatically from electronic medical records throughout the study. Patient-reported quality of life data will be collected directly from patients via smartphone. Efficacy endpoints (clinical remission rate, clinical improvement rate, and endoscopic healing rate) and safety endpoints (incidence of adverse events and specific ulcerative colitis-related events) will be collected according to treatment administered. Treatment categories include no treatment, 5-aminosalicylic acids, corticosteroids, immunomodulators, immunosuppressants, anti-tumour necrosis alpha agents, cytapheresis, Janus kinase inhibitors, anti-integrin antibodies, and anti-interleukin-12/23 antibodies. The dataset will include cross-sectional and longitudinal data and is expected to capture the state of ulcerative colitis in Japan. Patients will be included on a large scale, and the registry will be established automatically from electronic medical records and direct patient input, facilitating the accurate recording of medical information for patients with ulcerative colitis in Japan and minimizing limitations intrinsic to databases that require manual data entry, such as the burden on participating investigators and entry of data with errors/typos.

Investigating the effect of mesenchymal stem cells on the rate of clinical and pathological improvement of asthmatic lung in mouse model

Asthma is a pulmonary disease and its pathophysiology includes inflammation, obstruction, edema of the airways, and mucus secretions in the airways. Mesenchymal stem cells (MSCs) are self-renewal that use the therapeutic potential of these cells can be applied as treatments of asthma. In this study, the effect of Mesenchyme stem cells on asthma was investigated.MSCs were administrated for asthmatic mice and then, percentage of eosinophils in blood and bronchoalveolar lavage fluid (BALF), levels of interleukine (IL)-4 and Immunoglubolin (Ig)E were measured. Also histopathological study of lung tissue was done.MSCs administration could control percentage of eosinophils in blood and BALF, levels of IgE and IL-4, eosinophilic inflammation, mucin realizing and goblet cell hyper-plasia.Administration of MSCs as treatment of asthma can be a useful and applicable therapy in control of asthma symptoms.

Improvement of restless leg syndrome in maintenance hemodialysis patients with limb ischemic preconditioning: a single-center randomized controlled clinical trial

Objective This study evaluated the efficacy and safety of limb ischemic preconditioning (LIPC) in treating restless leg syndrome (RLS) in maintenance hemodialysis (MHD) patients. Methods A total number of 45 patients participated in the study. They were randomly divided into LIPC group and control group. The LIPC was performed by inflating the limb ischemic preconditioning training device in the patient’s thigh to 200 mmHg to create transient ischemia, whereas control group inflated the device to 20 mmHg. International Restless Legs Syndrome (IRLS), Clinical Global Impression Scale (CGI-S), and Medical Outputs Study Sleep Scale were employed to evaluate LIPC effectiveness. The primary endpoint was the ‘rate of clinical improvement in RLS severity’, defined as the percentage of patients who had an IRLS score decrease of ≥5 points in each group. Results After intervention, the rate of clinical improvement in RLS severity was 56.5% in the LIPC group and 13.6% in the control group (13 (56.5) vs 3 (13.6), p = 0.003). In addition, the LIPC group’s IRLS, CGI-S scores, the sleep disturbance and somnolence scores showed a significant downward trend compared to the control group (−5.5 ± 5.3 vs − 1.0 ± 3.8, p = 0.002; −1.7 ± 1.2 vs − 0.5 ± 1.4, p = 0.003; −15.5 ± 17.8 vs 3.7 ± 12.0, p < 0.001; −9.9 ± 18.8 vs − 2.4 ± 8.6, p = 0.003). During the study, there were no serious adverse event in any of the patients. Conclusions LIPC could be employed to effectively and safely alleviate the RLS symptoms in MHD patients.

Biologic Treatment Modification Efficacy in Concurrent Inflammatory Bowel Disease and Ankylosing Spondylitis: A Retrospective Cohort Study at a Single Tertiary Center.

The link between ankylosing spondylitis (AS) and inflammatory bowel disease (IBD) is well-established, with concurrent prevalence estimates ranging from 5-10%. However, there are still significant gaps in our understanding, and a comprehensive treatment guideline for these co-diagnosed patients has yet to be established. Our objective was to explore patterns of treatment alterations following the diagnosis of AS in patients previously diagnosed with IBD, and vice versa. Additionally, we sought to determine how these modifications influence clinical outcomes in both conditions. This retrospective data-based cohort study included patients with coexisting IBD and AS that were diagnosed between the years 2009-2022 and were followed by the gastroenterology and the rheumatology units of the Sheba Medical Center, Israel. The data were extracted from the electronic health record and included demographic information, medication history, treatment modification at the time of second diagnosis, and the characteristics and activity of both IBD and AS at the index time and at the 3-month mark. The study included a total of 68 patients, with a male predominance (40 patients, 59%). The median age was 43 years (IQR 31-55) and 78% had Crohn's disease (CD). The median duration between the diagnosis of the first disease to the second one was 4 years (IQR 1-9.5). A significant proportion of patients (85%) underwent treatment modification at their second diagnosis. Out of the total cohort, 28% initiated biological therapy, 17.6% switched their biologic regimen, and 16.2% discontinued NSAIDS. Patients who underwent biologic modifications at time of the second diagnosis (the initiation/switch/augmentation of a concurrent regimen) experienced significantly higher rates of clinical improvement in either IBD or AS at the 90-day follow-up compared to patients who did not (68% vs. 32%, p = 0.004), and biologic modification was found to be an independent predictor for clinical improvement (OR 3.69, CI 1.08-12.58, p = 0.037). Our findings suggest that biologic therapy modification at the time of the second diagnosis was associated with a higher rate of improvement in AS/IBD at the 90-day follow-up.

Assessment of toxicological effects of favipiravir (T-705) on the lung tissue of rats: An experimental study.

This study aimed to present new data on the side effects of favipiravir on healthy lung tissue and the respiratory system. In the study, two different durations (5 and 10 days) were preferred to determine the effect of favipiravir treatment due to clinical improvement rates of approximately 5 and 10 days during the use of favipiravir in COVID-19 patients. In addition, after 10 days of favipiravir treatment, animals were kept for 5 days without any treatment to determine the regeneration of lung tissues. Favipiravir was administered to rats by oral gavage at a daily dose of 200 mg/kg for 5 and 10 days, as in previous studies. At the end of the experiment, the histopathological and biochemical effects of favipiravir in the lung tissue were investigated. The data obtained from the study showed that favipiravir increased oxidative stress parameters, expression of apoptotic markers, and pro-inflammatory markers in lung tissue. Since malondialdehydes is an oxidant parameter, it increased in favipiravir-administered groups; It was determined that the antioxidant parameters glutathione, superoxide dismutase, glutathione peroxidase, and catalase decreased. Other markers used in the analysis are Bcl-2, Bax, NF-κB, interleukin (IL)-6, Muc1, iNOS, P2X7R, IL-6 and caspase-3. The levels of Bax, caspase-3, NF-κB, IL-6, Muc1, and P2X7R were increased in the Fav-treated groups compared with the control. However, the levels of Bcl-2 decreased in the Fav-treated groups. The present study proves that favipiravir, widely used today, causes side effects in lung tissue.

Efficacy of polyherbal formulation along with standard care of treatment in early recovery of COVID-19 patients: a randomized placebo-controlled trial

BackgroundThe coronavirus disease-2019 (COVID-19) pandemic crisis has affected millions of people worldwide. The emergence of mutant strains one after the other, breakthrough infections post-vaccination and reinfection of the virus have made it difficult to fight the pandemic and bring an end to it. Naturally available compounds with an array of phytochemicals and potent antiviral properties can provide an alternate solution in improving innate immunity, early recovery and symptomatic cure from COVID-19.ObjectiveThe present study investigates the efficacy of a polyherbal formulation, NAOQ19, on the rate of recovery and clinical improvement among COVID-19-infected patients who were not on a ventilator or in intensive care unit.MethodsA randomized placebo-controlled study design was adopted for the study. The study enrolled 124 patients with 62 patients included in the NAOQ19 arm and other 62 patients enrolled in the placebo arm along with standard care of treatment. Key outcomes of the study included improvement from COVID-19 based on RT-PCR negative test tested on day 3, 5, 7 and 10, CRP inflammatory rate and drug safety. Data analysis included intention to treat approach. Significance was accepted with a two-sided p value < 0.05 for the outcome measures.ResultsThe results of the present study demonstrated higher proportion of patients recovering in NAOQ19 arm compared to placebo arm on day 3 (33.8% vs. 8%; p < 0.001). The mean number of days required to turn RT-PCR (Real-time reverse transcriptase-polymerase chain reaction) negative was also lower in NAOQ19 arm by a day compared to placebo arm (5.4 vs. 6.2; p = 0.022). Inflammatory marker CRP (C-reactive protein) significantly reduced in the NAOQ19 arm at exit compared to placebo arm (6.25 mg/L vs. 10.26 mg/L; p = 0.048). Liver function test and kidney function test profiles were within normal limits during exit demonstrating the drug safety.ConclusionNAOQ19 along with standard care of treatment demonstrated higher percentage of population recovering from COVID-19 in comparison with those who were on standard care of treatment.Trial registration: The trial was also registered in Clinical Trial Registry India with registration number CTRI/2021/10/037423.

Experience with and attitude toward clozapine use among patients receiving clozapine on long term and their caregivers.

Despite clozapine being the gold standard for treating patients suffering from treatment-resistant schizophrenia, the experience and attitude of patients receiving clozapine for a long duration and their caregivers have not been evaluated, especially in India and other low-middle-income countries. Also, no standardized scale has been validated for such assessment. This study aimed to evaluate the perception regarding clozapine among patients and their caregivers. We also attempted to evaluate the factor structure of the scale for such assessment. A total of 172 consenting patients who have been receiving clozapine for ≥1 year and their caregivers were evaluated on self-designed questionnaires (patient and caregiver versions containing 44 and 47 items, respectively) to assess various aspects of their experiences about clozapine use. A majority (70-80%) of patients and caregivers reported improvement in psychotic symptoms, mood symptoms, and overall functioning with starting of clozapine. However, about 40% of the patients reported cognitive side effects, and 20-25% reported disabling side effects like lethargy, forgetfulness and decreased attention, and distress related to blood testing after starting of clozapine. Factor analysis of the questionnaires yielded five- and seven-factor models for the experience and attitude of the patients and the caregivers, respectively. The positive experiences were associated clinical and functional improvement, lower disability, and improvement in functioning as well as the self-reported perceived improvement by the patient and caregiver. This study suggests that patients tend to have an overall positive experience and attitude about using clozapine. The caregivers also report the beneficial effect on the caregiving. A good level of agreement was seen between the experience of patients, caregivers, and clinician-rated improvement in the psychopathology and functioning.