Mild Adverse Reactions Research Articles

Comparison of the efficacy of Aeromonas veronii ΔhisJ vaccine in Carassius auratus via different immunization routes.

Aeromonas veronii is a significant pathogen to various aquatic life. Infections in fish can lead to high mortality rates, causing substantial economic losses in aquaculture. Vaccination is proposed as a substitute for antibiotics in aquaculture to decrease disease-related mortality and morbidity. Our study previously constructed a hisJ-deleted strain of A. veronii, which provided protective effect to Loach. To further assess the vaccine's applicability, this study evaluated its genetic stability and safety, and the immune protective effects in Carassius auratus through four distinct administration routes: intraperitoneal injection, intramuscular injection, oral administration, and immersion, to determine the efficacy of these administration routes. The results showed that the vaccine remained genetically stable after 45 generations. Immunization via these administration routes was safe for Carassius auratus, with intraperitoneal and intramuscular injections causing stronger adverse reactions. Immersion immunization resulted in mild adverse reactions, and no significant adverse reactions were observed following oral immunization. Immunizing Carassius auratus at safe concentrations via these routes enhanced the phagocytic activity in serum, increased the levels of non-specific immune-related enzymes (ACP, AKP, C3, C4, LZM, SOD, and IgM), and improved specific serum antibody levels. It also elevated levels of cytokines related to inflammatory responses (IL-1β, IL-10, TNF-α, TGF-β) in organ tissues (liver, spleen, kidney, mid-post intestine, and gills). The survival rates of Carassius auratus were measured after challenging with the virulent strain A. veronii TH0426, resulting in the relative survival rates of 64% for Intraperitoneal vaccine group, 56% for Intramuscular vaccine group, 52% for oral vaccine group, and 48% for immersion vaccine group. Analysis of bacterial load in the liver, spleen, and kidney post-challenge showed a decreasing trend in the control group, indicating that the vaccine strain ΔhisJ could gradually restrict the rapid proliferation of bacteria in these tissues, thereby providing a certain level of immune protection against A. veronii. In brief, the vaccine strain ΔhisJ can serve as a safe live attenuated vaccine for Carassius auratus, and this study lays the foundation for the development of live attenuated vaccines against Aeromonas veronii.

Efficacy and safety of adjuvant topical application of botanicals in the treatment of melasma: A systematic review and meta-analysis

ObjectiveTo systematically evaluate the efficacy and safety of topical application of botanical (TAB) adjuvants in the treatment of melasma and provide evidence-based medical evidence for their clinical application. MethodsMedline, Web of Science, EMBASE, Cochrane Library, CNKI, VIP, Wanfang Data, and SinoMed, databases were searched to identify all randomized controlled clinical trials on TAB adjuvant treatment for melasma from inception to May 2023. The primary outcomes included clinical efficacy, adverse effects, recurrence rate, and melanin index. Subgroup analyses were performed using the Melasma Area Severity Index (MASI) scores. ResultsThis study included 16 randomized trials with 1386 participants. Eligible trials demonstrated that topical phytomedicine adjuvant treatment for melasma increased clinical effectiveness (RR = 1.14, 95% CI (1.10, 1.19), P ＜0.00001), decreased recurrence rate (RR = 0.28, 95% CI (0.13, 0.59), P = 0.0009), and decreased melanin index (MI) (MD = −22.2,95% CI (−31.79, −12.61), P < 0.00001). In addition, subgroup analysis showed that topical phytomedicines reduced MASI scores (I2 = 0%, MDI = −0.95, 95% CI (−1.23,0.67), P < 0.00001), but when scored as the rate of decrease in MASI, topical phytomedicines had high MASI scores (I2 = 15%, MD = 0.3, 95% CI (0, 0.59), P = 0.05), indicating a slower rate of melasma mitigation when botanicals were applied topically. Although burning pain, redness and other mild adverse reactions may occur during the treatment period, they can be recovered on their own, and there is no statistical significance in the comparison of the two groups (RR = 0.95, 95% CI (0.42, 2.51), P = 0.91). ConclusionTAB for melasma has a clear adjuvant clinical efficacy, a low recurrence rate, and does not cause serious adverse effects. An appropriate administration method may achieve better efficacy; however, this requires further verification.

A113 COVID-19 VACCINATIONS IN IBD PATIENTS: PATIENT KNOWLEDGE AND PERCEPTIONS

Abstract Background The IBD population has historically suffered from a below average uptake of vaccinations which raises concern for COVID-19 vaccine acceptance in this population. Patients report IBD-specific reasons for COVID-19 vaccine hesitancy including fear of vaccine-related IBD flare up, a desire for IBD-specific data regarding COVID-19 vaccine safety and efficacy, and worry about current drugs affecting vaccine efficacy. Additionally, IBD patients tend to report greater fear of COVID-19, concern about the impact of their medications on COVID-19 disease, and overall need for COVID-19 information. Aims To explore patients’ education, knowledge, and perceptions of COVID-19 vaccination with the aim of lowering COVID-19 vaccine hesitancy, improving knowledge of COVID-19 vaccines, and identifying outstanding barriers to COVID-19 vaccination uptake. Methods Study participants are patients diagnosed with IBD recruited from the Adult IBD Clinic at McMaster University Medical Centre between June 2022 and May 2023. Quantitative questionnaires were distributed to participants following receipt of informed consent at routine clinics and were offered in paper format. To describe the study population, the following descriptive statistics were performed: means and standard deviation for continuous variables, distributions (n, %) for dichotomous and categorical variables. Results In total, 236 participants were surveyed. The sample is predominantly female (61%) and most participants are diagnosed with Crohn’s disease (63.9%). The vast majority of patients have received at minimum 1 dose of a COVID-19 vaccine (92.1%). Reported reasons for vaccination included COVID-19 vaccine being available free of cost (52.3%), recommendation from a healthcare professional (51.9%), and feeling as though the benefit of the vaccine outweighs the risks (51.6%). Most patients reported having heard of negative vaccine experiences online (75.8%) including mild (27.6%) and severe (30.8%) adverse reactions. Despite this, participants viewed vaccines as effective (83%), protective towards the individual (75.5%), and safe (68.1%). Healthcare providers were regarded as a very significant influence in terms of COVID-19 vaccine information (65.6%) and were overwhelmingly viewed as a more reliable source than mass media (91.3%). Participants did not perceive an increased risk of COVID-19 infection, COVID-19 related serious illness, or COVID-19 vaccine related adverse effects due to their IBD or IBD treatments. Participants also did not show reluctance to vaccinate due to their IBD or IBD treatments. Conclusions The present study provides insight into the perceptions and knowledge of Canadian IBD patients as it relates to COVID-19 vaccines. Importantly, the results highlight the crucial role of the healthcare provider on vaccination uptake and acceptance. Funding Agencies None

Evaluation of the efficacy and safety of intravenous infusion of ferric derisomaltose in the treatment of iron deficiency anemia: a single-center retrospective analysis

Objective: To investigate the clinical efficacy and safety of ferric derisomaltose injection versus iron sucrose injection in the treatment of iron deficiency anemia (IDA) . Methods: A total of 120 patients with iron deficiency anemia admitted from June 2021 to March 2023 were given intravenous iron supplementation with ferric derisomaltose to assess the efficacy and safety of hemoglobin (HGB) elevation before and after treatment. Simultaneously, the clinical effects of iron supplementation with iron sucrose were compared to those of inpatient patients during the same period. Results: Baseline values were comparable in both groups. Within 12 weeks of treatment, the elevated HGB level in the ferric derisomaltose group was higher than that of the iron sucrose group, with a statistical difference at all time points, and the proportion of HGB increased over 20 g/L in the patients treated for 4 weeks was higher (98.7%, 75.9% ). During the treatment with ferric derisomaltose and iron sucrose, the proportion of mild adverse reactions in the ferric derisomaltose group was slightly lower than that of the iron sucrose group, and neither group experienced any serious adverse reactions. The patients responded well to the infusion treatment, with no reports of pain or pigmentation at the injection site. Conclusion: The treatment of IDA patients with ferric derisomaltose has a satisfactory curative effect, with the advantages of rapidity, accuracy, and safety. Therefore, it is worthy of widespread clinical use.

Efficacy and safety of rituximab in multiple sclerosis and neuromyelitis optica spectrum disorder

In Thailand, resource limitations lead many multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) patients to use off-label immunosuppressants. This study assesses the efficacy and safety of rituximab (RTX) with a CD19-based reinfusion regimen among Thai MS and NMOSD patients. A retrospective review of patients at the Faculty of Medicine Siriraj Hospital from January 1994 to April 2023 was conducted. The primary outcome assessed was the change in annualized relapse rate (ARR) for patients using RTX for over a year. Secondary outcomes included changes in the Expanded Disability Status Scale (EDSS) scores, time to the first relapse after RTX initiation for patients using RTX for over a year, and an evaluation of the safety of RTX. The study encompassed 36 MS and 39 NMOSD patients. A majority of patients (91.7% of MS and 79.5% of NMOSD) experienced no relapses during a median follow-up of 30 months (Interquartile range [IQR] 20–46) and 31 months (IQR 23–41), respectively. The median ARR significantly decreased in both MS (from 0.77 [IQR 0.42–1.83] to 0 [IQR 0–0], p < 0.001) and NMOSD (from 0.92 [IQR 0.68–1.78] to 0 [IQR 0–0.17], p < 0.001) patients after switching to RTX, with no difference between those following a fixed 6-month time point regimen and a CD19-based reinfusion regimen. Median EDSS scores improved significantly at the last follow-up visit in both groups. The mean time to the first subsequent relapse was 8.3 ± 3.0 months in MS and 6.8 ± 1.7 months in NMOSD. Mild adverse drug reactions occurred in 44% of patients. RTX effectively prevents relapses in Thai MS and NMOSD patients, with no observed serious adverse drug reactions.

Effectiveness of perindopril/amlodipine fixed-dose combination in the treatment of hypertension: a systematic review.

Background: Uncontrolled blood pressure is a major risk factor for cardiovascular diseases. Fixed-dose combination (FDC) therapy offers a promising approach to addressing this challenge by providing a convenient single-tablet solution that enhances the effectiveness of blood pressure control. In our systematic review, we assess the effectiveness of perindopril/amlodipine FDC in managing blood pressure. Methods: We conducted a comprehensive search across four primary electronic databases, namely, PubMed, Virtual Health Library (VHL), Global Health Library (GHL), and Google Scholar, as of 8 February 2022. Additionally, we performed a manual search to find relevant articles. The quality of the selected articles was evaluated using the Study Quality Assessment Tools (SQAT) checklist from the National Institute of Health and the ROB2 tool from Cochrane. Results: Our systematic review included 17 eligible articles. The findings show that the use of perindopril/amlodipine FDC significantly lowers blood pressure and enhances the quality of blood pressure control. Compared to the comparison group, the perindopril/amlodipine combination tablet resulted in a higher rate of blood pressure response and normalization. Importantly, perindopril/amlodipine FDC contributes to improved patient adherence with minimal side effects. However, studies conducted to date have not provided assessments of the cost-effectiveness of perindopril/amlodipine FDC. Conclusion: In summary, our analysis confirms the effectiveness of perindopril/amlodipine FDC in lowering blood pressure, with combination therapy outperforming monotherapy and placebo. Although mild adverse reactions were observed in a small subset of participants, cost-effectiveness assessments for this treatment remain lacking in the literature.

The second-line treatment of hepatocellular carcinoma with CalliSpheres drug-eluting bead transarterial chemoembolization combined with regorafenib: A safety and efficacy analysis.

This study aimed to investigate the efficacy and safety of CalliSpheres drug-eluting beads transarterial chemoembolization (DEB-TACE) combined with regorafenib in the second-line treatment of unresectable hepatocellular carcinoma. A retrospective analysis was made of 34 patients with unresectable hepatocellular carcinoma (HCC) that had progressed after first-line treatment in Linyi Tumor Hospital from October 2019 to June 2021. These patients were divided into observation group (n = 15) and control group (n = 19) based on their treatment plans, who were respectively treated with regorafenib alone and regorafenib combined with DEB-TACE. The objective response rate (ORR) and the disease control rate (DCR) were evaluated by the modified Response Evaluation Criteria in Solid Tumors (mRECIST), and the progression-free survival (PFS) and the overall survival (OS) were calculated; the factors influencing PFS and OS of patients were analyzed by the Cox proportional hazards model; and the adverse reactions to the treatments were observed and recorded. After 2months of treatment, the ORR and the DCR of the observation group were 73.3% (11/15) and 86.7% (13/15) respectively, both higher than 10.5% (2/19) and 47.4% (9/19) of the control group. Their differences are statistically significant (P < 0.05). There were no statistically significant differences in the incidences of regorafenib-related adverse reactions including hand-foot skin reactions, fatigue, hypertension, diarrhea, and proteinuria between the two groups (P > 0.05). In the observation group, the main adverse reactions to DEB-TACE such as fever, pain, nausea, and vomiting were relieved after symptomatic treatment, and no serious complications such as ectopic embolization of CalliSpheres drug-eluting beads occurred. As of July 31, 2022, the median follow-up time was 12.5months, and the average was (14.00 ± 5.69) months. The median PFS was 9months in the observation group, and 6months in the control group, presenting a statistically significant difference (P < 0.05), and the median OS was 18months in the observation group, and 12months in the control group, also presenting a statistically significant difference (P < 0.05). The results of monofactor prognostic analysis showed that Child grade, AFP level, and treatment method had an influence on the PFS and the OS of liver cancer patients receiving regorafenib second-line treatment (P < 0.05), and the results of multifactor prognostic analysis showed that child grade and treatment method independently influenced the PFS of patients, while treatment method independently influenced the OS of patients (P < 0.05). DEB-TACE combined with regorafenib is safe and feasible in the treatment of unresectable HCC, with good efficacy and mild adverse reactions.

Real-world effectiveness of erenumab in Japanese patients with migraine

BackgroundReal-world evidence of erenumab effectiveness in migraine patients in Asia with various comorbidities and multiple previous medication failures is still limited. MethodsA 6-month single-center cohort study of 45 patients with episodic or chronic migraine (CM) treated with erenumab was conducted. In the cohort, 60.0% were switching from other calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs), and 66.7% had ≥4 prophylaxis failures. The change in monthly migraine days (MMDs) from baseline and percentages of responders after treatment were calculated. Weekly migraine days (WMDs) were obtained at baseline and at months 1, 2 and 3 and were compared between weeks 2 and 4. ResultsIn total, 36%, 47%, and 63% of patients had a ≥30% response at 1, 3, and 6 months, respectively. The cumulative percentage of patients achieving a ≥30% response over 6 months was 85%. Early responders (average ≥ 30% response at 1–3 months) accounted for 37.8%, 55.6%, and 25.9% of the total, CGRP mAb-naïve, and CGRP mAb-switching groups, respectively. Late responders (average < 30% response at 1–3 months and average ≥ 30% response at 4–6 months) accounted for 46.4%, 37.5%, and 58.8% of nonearly responders in the total, CGRP mAb-naïve, and CGRP mAb-switching groups, respectively. Mild adverse reactions were observed in 5 patients (11.1%). Wearing-off, defined as an increase in the number of WMDs ≥2 between week 2 and week 4, was observed in 2.4–12.5% at months 1–3. ConclusionErenumab was effective in migraine patients. At least 4–6 months may be preferable for efficacy evaluation in patients switching to erenumab from other CGRP mAbs.

P1061 TEV-48574, an anti-TL1A antibody in development for use in IBD, is safe and well tolerated following 16 weeks of subcutaneous treatment in adults with severe uncontrolled T2-low/non T2 asthma

Abstract Background TEV-48574 is a human antibody that targets tumor necrosis factor (TNF)-like ligand 1A, also known as TNF superfamily member 15 (TNFSF15). It is in clinical development as a potential treatment for ulcerative colitis (UC) and Crohn’s disease (CD). TL1A signalling is believed to amplify immune-mediated inflammation in asthma and inflammatory bowel disease (IBD); thus, targeting TL1A may mitigate over-activation of immune responses. A proof-of-concept phase 2A study evaluated safety, tolerability and efficacy of TEV-48574 as treatment for adults with severe uncontrolled asthma (Clinicaltrials.gov NCT04545385). Although the study terminated (after meeting pre-specified criteria for futility at a preplanned interim analysis) the drug demonstrated favourable safety, tolerability and immunogenicity data, supporting the potential use of anti-TL1A treatment in patients with UC and CD. Methods TEV-48574 was administered as a loading dose followed by 7 maintenance doses given subcutaneously (sc) every 2 weeks for 16 weeks in adult patients (n = 65) with severe T2-low asthma with no/low inflammation at baseline. The primary efficacy endpoint was reduction in patients who experience loss of asthma control (LoAC). Patients were monitored for LoAC at bi-weekly visits and daily by use of a handheld spirometer/e-diary. Safety was assessed throughout the study. Results Of 65 randomized patients, 64 received at least one dose of study drug and were included in the safety analysis (33 active drug; 31 placebo). There were no severe AEs, treatment related SAEs, deaths, or withdrawals due to adverse events, and no medical device-related issues. There were no clinically meaningful changes in lab parameters, vital signs or ECGs. Furthermore, there was no evidence of immune suppression, opportunistic infections, or malignancies. Mild treatment-related adverse reactions occurred in both treatment groups (erythema and pruritus in two placebo patients; erythema in one TEV-48574 treated patient). Mild injection site reactions occurred more frequently (not statistically different) in the TEV-48574 group. Treatment-emergent anti-drug antibodies were reported in patients taking TEV-48574 (3 patients; 9.09%), with no anaphylactic or severe systemic reactions. Conclusion Overall, TEV-48574 administered every 2 weeks over 16 weeks demonstrated a favourable safety and tolerability profile with no emerging safety signals or evidence of immunosuppression. This is consistent with TL1A being an amplifier of inflammation. Treatment with TEV-48574 may dampen excessive inflammation without inducing a state of immunodeficiency in patients with conditions such as UC or CD, supporting further development in these indications.

Efficacy and safety of Yangxue Qingnao Granules in treatment of migraine: A systematic review and meta-analysis.

Yangxue Qingnao Granules (YXQN) is a Chinese patent medicine that has been commonly used in the clinical treatment of migraine. To assess the efficacy and safety of YXQN alone for the treatment of migraine. We searched 10 databases to identify relevant randomized controlled trials (RCTs) published before September 2022. Two review authors independently searched and screened the literature, extracted the data, and assessed the methodological quality of the studies using criteria from ROB 2.0, and analyzed the data using Review Manager 5.4 software. A total of 12 RCTs including 767 participants with migraine met the selection criteria. We divided these studies into comparisons of YXQN with placebo, routine treatment drugs, and other Chinese patent medicines. The meta-analysis showed the following: (1) Efficacy: The YXQN group outperformed the placebo group [relative risk (RR) = 0.29, 95% confidence interval (95%CI): 0.15-0.43, P < 0.00001], routine treatment group (RR = 0.18, 95%CI: 0.09-0.27, P < 0.0001), and Chinese patent medicine group (RR = 0.27, 95%CI: 0.13-0.41, P < 0.001); (2) frequency of headache: There was a significant difference between YXQN vs placebo [mean difference (MD) = -1.25, 95%CI: -1.60 to -0.90, P < 0.00001], routine treatment drugs (MD = -0.85, 95%CI: -1.15 to -0.56, P < 0.00001), and Chinese patent medicine (MD = -0.91, 95%CI: -1.35 to -0.46, P < 0.0001); (3) headache duration: We found great heterogeneity between studies, with no differences between YXQN and placebo (MD = -0.61, 95%CI: -1.53 to -0.31, P = 0.19) and routine treatment drugs (MD = -0.22, 95%CI: -0.89 to 0.46, P < 0.53). YXQN was more effective than other Chinese patent medicines in reducing headache duration (MD = -1.24, 95%CI: -1.70 to -0.77, P < 0.00001); and (4) headache severity: There was no significant difference between YXQN vs placebo (MD = -1.67, 95%CI: -3.52 to 0.19, P = 0.08), routine treatment drugs (MD = -0.53, 95%CI: -2.02 to 0.96, P = 0.68), and other Chinese patent medicines (MD = -0.49, 95%CI: -2.83 to 1.85, P = 0.68). Mild gastrointestinal adverse reactions were reported in three cases. This study revealed that YXQN is effective and safe for treatment of migraine.

Safety and efficacy of COVID-19 vaccine immunization during pregnancy in 1024 pregnant women infected with the SARS-CoV-2 Omicron virus in Shanghai, China.

Large sample of pregnant women vaccinated with COVID-19 vaccine has not been carried out in China. The objective of this study was to evaluate the safety and effectiveness of COVID-19 inactivated vaccine in pregnant women infected with the SARS-CoV-2 Omicron variant. A total of 1,024 pregnant women and 120 newborns were enrolled in this study. 707 pregnant women received one to three doses of the inactivated COVID-19 vaccine, and 317 unvaccinated patients served as the control group. A comparison was made between their clinical and laboratory data at different stages of pregnancy. The incidence rate of patients infected with Omicron variant in the first, the second, and the third trimesters of pregnancy was 27.5%, 27.0%, and 45.5% in patients during, respectively. The corresponding length of hospital stay was 8.7 ± 3.3 days, 9.5 ± 3.3 days, and 11 ± 4.3 days, respectively. The hospitalization time of pregnant women who received 3 doses of vaccine was (8.8 ± 3.3) days, which was significantly shorter than that of non-vaccinated women (11.0 ± 3.9) days. (P<0.0001). The positive rate of SARS-CoV-2 IgG in patients in the early stage of pregnancy was 28.8%, while that in patients in the late stage of pregnancy was 10.3%. However, three-doses of vaccination significantly increased the SARS-CoV-2 IgG positive rate to 49.5%. The hospitalization time of SARS-CoV-2 IgG-positive patients was shorter than that of negative patients (9.9 ± 3.5 days), which was 7.4 ± 2.0 days. 12.2% of vaccinated women experienced mild adverse reactions, manifested as fatigue (10.6%) and loss of appetite (1.6%). The vaccination of mother did not affect her choice of future delivery mode and the Apgar score of their newborn. All newborns tested negative for SARS-CoV-2 nucleic acid, as well as for IgG and IgM antibodies. Women in the third trimester of pregnancy are highly susceptible to infection with the Omicron strain. The vaccination of pregnant women with COVID-19 vaccine can accelerate the process of eliminating SARS-CoV-2 virus, and is considered safe for newborns. The recommended vaccination includes three doses.

Transcolonoscopic spraying formalin solution for hemorrhagic radiation proctitis: a retrospective analysis.

Radiation proctitis is a common complication that occurs as a result of radiation therapy used to treat pelvic malignancies. The most common and bothersome symptom resulting from radiation proctitis is rectal bleeding, which can be persistent or recurrent. This study aimed to review our experience and evaluate the efficacy and safety of transcolonoscopic spraying of formalin solution in patients with hemorrhagic radiation proctitis. A total of 37 patients with hemorrhagic radiation proctitis, aged between 48 and 79 years (mean age 62.56 ± 8.48 years), were divided into three cohorts based on the severity of radiation injury. Under direct endoscopic vision, a 4% formalin solution was applied directly to the rectal hemorrhagic mucosa. The patients were followed for a period of over 6 months after receiving treatment, during which the therapeutic effectiveness and occurrence of complications were observed. The study resulted in an overall response rate of 89.2% among all patients. The response rates for patients with grades 1-3 were 100, 100, and 66.7%, respectively. Notably, the rate of response among patients with grade 3 radiation injury was significantly lower compared to those with grades 1-2 (p = 0.009). Mild adverse reactions, such as anal pain and tenesmus, were reported in a small number of patients but could be alleviated without any intervention. The endoscopic application of formalin solution for the treatment of hemorrhagic radiation proctitis has shown a significant effect, particularly in patients with grades 1-2 radiation injury. The observed effect is superior to that observed in patients with grade 3 radiation injury.

Incidence of side effects of antituberculosis drugs and their related factors in northern Iran: a retrospective cohort study.

Antituberculosis drugs may cause mild, moderate or severe adverse drug reactions (ADR) leading to poor compliance. Description of the pattern of ADR and their related factors can help tuberculosis (TB) control program as part of the WHO programs. This study aims to investigate the incidence of ADR and associated factors among TB patients in northern Iran. This is a retrospective cohort study. The required information, including year of diagnosis, age, gender, residence area, nationality, HIV co-morbidity, history of anti TB treatment and ADR, was obtained from the Deputy of Health, Mazandaran University of Medical Sciences, Iran. All data were analyzed using SPSS version 21 software. Out of 3903 TB patients, 136 (3.5%) experienced major ADR. The incidence of ADR for men and women as well as for those with and without previous treatment history were 3.9% vs. 3.3% and 5.3% vs. 3.4%, respectively (p>0.05). Multiple logistic regression models showed a higher chance of ADR among those aged over 59 compared with those aged under 29 (OR=2.63, 95% confidence interval: 1.54-4.49). Age over 59 can be considered a risk factor for ADR with anti-TB drug administration.

Advancing Patient Blood Management: Evaluation of Ferric Derisomaltose in a Tertiary Hospital

ABSTRACT Background and Objectives: One of the aims of patient blood management (PBM) programs is to improve patient outcomes by managing anemia and avoiding unnecessary blood transfusions. Ferric derisomaltose (FDI) is a treatment that allows for the injection of high doses of iron in a shorter time, which makes it a promising approach for correcting iron-deficiency anemia (IDA) more efficiently. This study aimed to assess the safety, effectiveness, and cost implications of FDI in a PBM program and its impact on transfusion requirements. Methods: A retrospective analysis was conducted on electronic medical records of adult patients diagnosed with IDA who received FDI as part of a PBM strategy in a tertiary hospital from November 2019 to June 2021. Descriptive statistics summarized patient characteristics and outcomes. Changes in hemoglobin (Hb) levels were evaluated using a paired t-test. Cost analysis included direct and indirect expenses associated with FDI administration compared to alternative treatments. Results: Out of the initially enrolled 110 patients, 67 were included in the analysis. A mean increase in Hb levels of 2.7 ± 1.9 g/dL was observed as early as 4 days post-FDI administration. The majority of patients (94.0%) tolerated FDI well, with only a few experiencing mild adverse reactions. Following FDI administration, blood transfusion was avoided by 88% of patients. Cost analysis revealed that while FDI demonstrated higher direct costs compared to alternative treatments, its potential for lower total costs became apparent when considering both direct and indirect expenses. Conclusions: FDI demonstrated promising results in rapidly correcting IDA within a PBM program. It reduced the need for blood transfusions, with the treatment being well-tolerated by patients. The inclusion of FDI administration in PBM programs offers a convenient, efficient, and potentially cost-effective approach to managing IDA.

Development of Pharmacovigilance System in India and Paradigm of Pharmacovigilance Research: An Overview.

The drugs are projected to cure, prevent and treat diseases; however, there are also chances of mild or severe adverse drug reactions (ADRs) in the patients. Pharmacovigilance (PV) enhances the approach to safe medicines and healthcare, but integration into public healthcare remains a challenge in many countries. The Pharmacovigilance Programme of India (PvPI) is a nationwide programme launched by the Ministry of Health and Family Welfare (MoHFW), Government of India, on 14 July 2010. It is currently run by the Indian Pharmacopoeia Commission (IPC). Presently, 567 ADR Monitoring Centres (AMC) are functioning under PvPI across India. The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), and the Ministry of Health, Family & Welfare (MoHFW) Government of India is the National Regulatory Authority (NRA) of India. This review aims to trace the development of PV in India and its status among the top ADR reporting countries, with a focus on the current status of the studied ADR in different regions in India. Among the top 20 countries enthusiastic about sending ICSR per million population between 2015 and 2020, India shares 2% of the total ICSRs in VigiBase. India is now being recognized as a hub of global clinical trials and clinical research studies. Hence, it is the need of the hour in India to have a dynamic PV network system with an efficient and prudent operation method. Nevertheless, in India, PV programs are at an early stage on par with other countries, and only because of underreporting of ADRs. However, in the future, PvPI may appear as a big dashboard for ADR reporting culture in India as it continuously works hard to improve patients and drug safety.

Intravenous iron for critically ill children. Comparison of three dose regimens.

Anemia is extremely common among patients admitted to pediatric intensive care. Alternative treatments to transfusions such as intravenous iron must be considered. There are no published data for a prospective intravenous (IV) iron study focused in the critically ill children. The objective is to examine the safety and efficacy of intravenous iron sucrose infusion to manage anemia in pediatric critical care. A secondary objective is to examine the effect of different dose regimens of iron sucrose (3, 5, and 7mg/kg dose). Prospective investigation of intravenous iron sucrose utilization at a tertiary pediatric intensive care unit between October 2017 and November 2022. In all 115 patients received a total of 616 infusions of IV iron. Transferrin saturation index (TSI) was the most common altered iron deficiency biomarker (91.8%). After IV iron treatment, hemoglobin showed a significant increase within a 30-day follow-up (9.2 vs. 11.6g/dL, p<.001). There was also a significant improvement in TSI and serum iron (p<.001). Iron deficit replacement was higher in the 7mg/kg dose group (94%) compared to 85.9% in the 5mg/kg regimen and 77.5% in the lower dose group (p=.008), requiring less doses and a shorter time. Very few mild adverse reactions were reported (1.3% of infusions), with no differences between groups. The most frequent adverse effect was gastrointestinal in three cases. There were no anaphylaxis-like or other serious/life-threatening adverse effects. This is the first study to evaluate intravenous iron therapy in pediatric critical care, providing preliminary evidence of safety and efficacy of IV iron sucrose. The 7mg/kg dose regimen showed higher iron deficit replacement in a shorter time, which could be beneficial in critically ill children.

Tocilizumab treatment in neuromyelitis optica spectrum disorders: Updated meta-analysis of efficacy and safety

This systematic review and meta-analysis summarize the efficacy and safety of Tocilizumab (TCZ) in treating NMOSD and investigates the factors that affect its efficacy. TCZ is the first monoclonal antibody against the IL-6 receptor for treating NMOSD, and its efficacy and safety vary in different studies. We collected English-language research literature until January 1, 2023, by searching databases such as PubMed, MEDLINE, Embase, Cochrane Library, and clinicaltrials.gov, and identified 9 studies involving 153 patients (139 female and 14 male) that met our inclusion criteria. In these studies, the average ARR ratio and EDSS score reduction values in the TCZ treatment group were -1.34 (95 % CI, -1.60 to -1.09) and -0.81 (95 % CI, -1.04 to -0.58), respectively. Based on the data we have collected, compared to the AQP4-IgG negative NMOSD patients, TCZ demonstrates a more pronounced effectiveness in AQP4-IgG positive NMOSD patients. The study also found that the effectiveness of TCZ in reducing NMOSD patients' ARR ratio was related to gender, race, and TCZ dosage, while the effectiveness of reducing EDSS score was not related to these factors. Among the 153 patients receiving TCZ treatment, 101 (66 %) experienced mild adverse reactions, and one patient experienced a severe adverse reaction (facial cellulitis). The comprehensive data indicate that TCZ treatment can reduce the frequency of NMOSD relapses, improve patients' neurological function, and have good safety. The effectiveness of TCZ in reducing NMOSD patients' ARR ratio is related to multiple factors.

The Role of Vitamin A, Vitamin C and Vitamin E for Chemoprevention of Oral Leukoplakia

Introduction: Oral leukoplakia is a prevalent oral mucosal lesion known to undergo malignant transformation, posing a significant public health concern worldwide, primarily attributable to tobacco use. This study aims to investigate the potential preventive effects of vitamins A, C, and E on oral leukoplakia. We conducted a cross-sectional study at the Department of Oral &amp; Maxillofacial Surgery, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh, over a one-year period from March 2017 to March 2018. Methods: Study Population: We enrolled a total of 43 patients diagnosed with oral leukoplakia attending the Outpatient Department (OPD) of the Oral &amp; Maxillofacial Surgery Department. Data Collection: Patients were assessed at 6, 12, and 24-week intervals, during which data were collected using standardized data sheets. Lesion size was measured in square centimeters, and lesion color was recorded through photography. Adverse drug reactions were monitored based on patient complaints during follow-up. Histopathological Evaluation: Histopathological evaluations were performed both before the study and at the conclusion of the study to assess any changes in tissue characteristics. Outcome Variables: The primary outcome variables of interest were clinical response, histopathological findings, and complications associated with the treatment. Results: The study population had a mean age of 44.95±10.42 years, with an age range from 22 to 60 years. The male-to-female ratio was 1.3:1. The average duration of the lesions was 14.81±4.82 months, with a range of 6 to 24 months. Lesions were most commonly located in the right buccal mucosa (41.9%), followed by the left buccal mucosa (27.4%). The mean initial lesion size was 4.08±1.95 cm², ranging from 1 to 8 cm². After 24 weeks, 11.63% of patients showed complete improvement. All patients initially presented with white lesions, with a reduction to 97.7% after 6 weeks, 88.4% after 12 weeks, and 69.8% after 24 weeks. Mild adverse drug reactions were reported in 11.7% of patients after 6 weeks and 2.3% after 12 and 24 weeks. Complete remission was observed in 11.6% of patients, and moderate improvement (41–90%) in 37.3%. Notably, one-third of patients experienced a significant color change in their lesions, and adverse drug reactions decreased during subsequent follow-up. Conclusion: This cross-sectional study indicates potential benefits of Vitamin A, Vitamin C, and Vitamin E in mitigating oral leukoplakia symptoms, such as reduced lesion size and color improvement, with fewer adverse reactions observed. However, larger, controlled trials are necessary to establish the definitive efficacy of this vitamin combination. Update Dent. Coll. j: 2023; 13(2): 23-29

The Application of Superior Laryngeal Nerve Block for Non-Cough Laryngeal Hypersensitivity.

To investigate the effect of superior laryngeal nerve (SLN) block in patients with non-cough complaints relating to laryngeal who have failed conventional medical therapy. Retrospective chart review of 46 patients who underwent SLN block for non-cough indications between July 2019 and March 2022 was performed. Demographics, comorbidities, and patient-reported outcomes were collected. The primary diagnoses for this group included: odynophagia, throat pain, cervicalgia, muscle tension dysphonia, globus sensation, hyoid bone syndrome, and Eagle syndrome. The cohort underwent an average of 1.24 bilateral injections (range 0-7) and 0.87 unilateral injections (range 0-4). About 35 of 46 patients reported an average of 51.0% improvement in their symptoms, with the treatment effect lasting 7.60 weeks on average. On subgroup analysis, the patients with spasmodic dysphonia, odynophagia, and hyoid bone syndrome had the best percent improvement on average (75%-77.5%). Patients with globus sensation had the lowest percent improvement on average in response to this therapy, reporting only about 25%. Five patients experienced a mild adverse reaction immediately following injection which resolved spontaneously. The use of in-office SLN block for non-cough disorders involving the larynx requires further study with larger sample sizes to better delineate the efficacy of these applications. 4 Laryngoscope, 134:1765-1768, 2024.

Humoral and Cellular Immunogenicity of 3 Doses of BNT162b2 in Children With Kidney Diseases

Patients with severe kidney diseases are at risk of complications from COVID-19; however, little is known about the effectiveness of COVID-19 vaccines in children and adolescents with kidney diseases. We investigated the immunogenicity and safety of an accelerated 3-dose primary series of COVID-19 vaccination among 59 pediatric patients with chronic kidney disease (CKD) (mean age 12.9 years; 30 male) with or without immunosuppression, dialysis, or kidney transplant. Dosage was 0.1 ml BNT162b2 to those aged 5 to 11 years, and 0.3 ml BNT162b2 to those aged 11 to 18 years. Three doses of either vaccine type elicited significant antibody responses that included spike receptor-binding domain (S-RBD) IgG (90.5%-93.8% seropositive) and surrogate virus neutralization (geometric mean sVNT% level, 78.6%-79.3%). There were notable T cell responses. Weaker neutralization responses were observed among those on immunosuppression, especially those receiving higher number of immunosuppressants or on mycophenolate mofetil. Neutralization was reduced against Omicron BA.1 compared to wild type (WT, i.e., ancestral) (post-dose 3 sVNT% level; 82.7% vs. 27.4%; P< 0.0001). However, the T cell response against Omicron BA.1 was preserved, which likely confers protection against severe COVID-19. Infected patients exhibited hybrid immunity after vaccination, as evidenced by the higher Omicron BA.1 neutralization response among these infected patients who received 2 doses compared with those who were uninfected. Generally mild or moderate adverse reactions following vaccines were reported. An accelerated 3-dose primary series with BNT162b2 is immunogenic and safe in young children and adolescents with kidney diseases.