Rate Of Adverse Reactions Research Articles

Synergistic effects of neuroprotective drugs with intravenous recombinant tissue plasminogen activator in acute ischemic stroke: A Bayesian network meta-analysis.

Neuroprotective drugs as adjunctive therapy for adults with acute ischemic stroke (AIS) remains contentious. This study summarizes the latest evidence regarding the benefits of neuroprotective agents combined with intravenous recombinant tissue plasminogen activator (rt-PA) intravenous thrombolysis. This study conducted a structured search of PubMed, the Cochrane Library, EMBASE, Wanfang Data, and CNKI databases from their inception to March 2024. Grey literature was also searched. The outcomes included efficacy (National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score) and safety (rate of adverse reactions). A total of 70 randomized controlled trials were selected for this network meta-analysis (NMA), encompassing 4,140 patients with AIS treated using different neuroprotective agents plus RT-PA, while 4,012 patients with AIS were in control groups. The top three treatments for NIHSS scores at the 2-week follow-up were Edaravone Dexborneo with 0.9 mg/kg rt-PA, Edaravone with 0.9 mg/kg rt-PA, and HUK with 0.9 mg/kg rt-PA. HUK with 0.9 mg/kg rt-PA, Dl-3n-butylphthalide with 0.9 mg/kg rt-PA, and Edaravone Dexborneo with 0.9 mg/kg rt-PA were ranked the top three for BI scores at the 2-week follow-up. The top three treatments with the lowest adverse effect rates were 0.6 mg/kg rt-PA, HUK with 0.9 mg/kg rt-PA, and Edaravone Dexborneo with 0.9 mg/kg rt-PA due to their excellent safety profiles. Compared to rt-PA alone, the combination treatments of Edaravone+rt-PA, Edaravone Dexborneol+rt-PA, HUK+rt-PA, Dl-3n-butylphthalide+rt-PA, and Ganglioside GM1+rt-PA have shown superior efficacy. This NMA suggest that combination therapies of neuroprotective agents and rt-PA can offer better outcomes for patients with AIS. The results support the potential integration of these combination therapies into standard AIS treatment, aiming for improved patient outcomes and personalized therapeutic approaches.

Effect of comprehensive management combined with cognitive intervention on patient cooperation and complications during digestive endoscopy

BACKGROUND As lifestyles continue to change worldwide, the incidence of digestive tract carcinoma has gradually increased. Digestive endoscopy is an important tool that can assist in the diagnosis, treatment, and surgical intervention for this disease. However, the examination process is affected by many factors, and patient cooperation is often poor, which can increase the risk of complications. AIM To explore the effects of integrated management and cognitive intervention on cooperation and complications in patients undergoing endoscopy for early gastrointestinal neoplasms. METHODS A total of 354 patients with early stage gastrointestinal cancer who underwent digestive endoscopy procedures between January and December 2023 at our hospital were divided into observation and control groups (177 patients in each group) in a randomized controlled blind trial. The control group received routine interventions, while the observation group received comprehensive integrated management combined with cognitive interventions. We compared the changes in adverse mood, discomfort, examination time, cooperation with the examination, and complications before and after the intervention between the two groups. RESULTS The self-rated anxiety and depression scale scores were lower in the observation group than in the control group (P < 0.05). The visual analog scale scores for discomfort during intubation and examination were also lower in the observation group than in the control group (P < 0.05). Furthermore, the examination time was shorter in the observation group than in the control group (P < 0.05), and the degree of cooperation (94.35%) was higher in the observation group than in the control group (84.75%; P < 0.05). Lastly, the incidence rates of gastrointestinal adverse reactions (10.17% vs 20.34%), choking agitation (14.69% vs 24.86%), abdominal pain (8.47% vs 18.08%), and muscle tension (5.08% vs 14.12%) were all lower in the observation group than in the control group (P < 0.05). CONCLUSION Integrated management and cognitive intervention in early gastrointestinal neoplasm endoscopy alleviate mood, reduce discomfort, shorten examinations, improve cooperation, and reduce complications.

Clinical study of different interventional treatments for primary hepatocellular carcinoma based on propensity-score matching

BACKGROUND Transcatheter arterial chemoembolization (TACE) is the main treatment for patients with primary hepatocellular carcinoma (PHC) who miss the opportunity to undergo surgery. Conventional TACE (c-TACE) uses iodized oil as an embolic agent, which is easily washed by blood and affects its efficacy. Drug-eluting bead TACE (DEB-TACE) can sustainably release chemotherapeutic drugs and has a long embolization time. However, the clinical characteristics of patients before the two types of interventional therapies may differ, possibly affecting the conclusion. Only a few studies have compared these two interventions using propensity-score matching (PSM). AIM To analyze the clinical effects of DEB-TACE and c-TACE on patients with PHC based on PSM. METHODS Patients with PHC admitted to Dangyang People’s Hospital (March 2020 to March 2024) were retrospectively enrolled and categorized into groups A (DEB-TACE, n = 125) and B (c-TACE, n = 106). Sex, age, Child-Pugh grade, tumor-node-metastasis stage, and Eastern Cooperative Oncology Group score were selected for 1:1 PSM. Eighty-six patients each were included post-matching. Clinical efficacy, liver function indices (aspartate aminotransferase, alanine aminotransferase, total bilirubin, and albumin), tumor serum markers, and adverse reactions were compared between the groups. RESULTS The objective response and disease control rates were significantly higher in group A (80.23% and 97.67%, respectively) than in group B (60.47% and 87.21%, respectively) (P < 0.05). Post-treatment levels of aspartate aminotransferase, alanine aminotransferase, and total bilirubin were lower in group A than in group B (P < 0.05), whereas post-treatment levels of albumin in group A were comparable to those in group B (P > 0.05). Post-treatment levels of tumor serum markers were significantly lower in group A than in group B (P < 0.05). Patients in groups A and B had mild-to-moderate fever and vomiting symptoms, which improved with conservative treatment. The total incidence of adverse reactions was significantly higher in group B (22.09%) than in group A (6.97%) (P < 0.05). CONCLUSION DEB-TACE has obvious therapeutic effects on patients with PHC. It can improve liver function indices and tumor markers of patients without increasing the rate of liver toxicity or adverse reactions.

Intraoperative Application of Ultrasonic Energy to Bioabsorbable Craniosynostosis Fixation Devices and Adverse Tissue Reaction. Is There a Correlation?

Bioabsorbable internal fixation is a well-accepted modality that is especially suitable for application in craniosynostosis. When first introduced, high rates of adverse tissue reactions were observed that have since been ameliorated with more biocompatible polymer formulations. However, the phenomenon has not entirely disappeared, and such reactions remain vexing. It has been suggested that intraoperative use of ultrasonic activation to heat and remodel 50:50 poly(D-lactide-co-L-lactide) fixation devices could potentiate an adverse tissue response following craniosynostosis procedures. The evidence for this was examined based on a clinical literature search, as well as a review of bioabsorbable polymer science principles, to see whether there is a theoretical basis to explain how such a relationship might be possible. Although a trend was evident suggestive of such an association, unequivocal evidence was not found. Also, no obvious potential mechanism that could explain such an association, should it exist, was apparent. The methodological approach used in this analysis and the information presented can help provide a foundation for future analyses of this nature.

The predictive value of CK-MB on the curative effect of urokinase combined with LMWH calcium in AMI.

This study investigates the predictive value of CK-MB in treating acute myocardial infarction (AMI) with urokinase combined with low molecular weight heparin (LMWH) calcium. AMI patients treated at our hospital from April 2020 to August 2022 were included in this prospective, multi-center cohort study. Patients were randomly assigned to a urokinase group or a combined treatment group (urokinase plus LMWH). CK-MB levels were measured using ELISA, and adverse reactions were recorded. The accuracy of CK-MB as a predictor was evaluated via ROC curve analysis and AUC. Before treatment, CK-MB levels were similar in both groups (p > 0.05). Post-treatment, levels were significantly lower in the combined group (p < 0.05). The combined group had a higher proportion of mild CK-MB elevation and lower moderate/severe elevations (p < 0.05). Adverse reaction rates were similar (p > 0.05). The combined treatment group showed higher effectiveness (p < 0.05), with better sensitivity (94%) and specificity (82%) than the urokinase group (sensitivity 89%, specificity 78%). CK-MB is a valuable predictor for evaluating the efficacy of urokinase plus LMWH in AMI treatment, offering advantages in reducing CK-MB levels and improving outcomes.

Factors inducing cutaneous adverse reactions in cancer patients treated with PD-1 and PD-L1 inhibitors: a machine-learning algorithm approach

Background Immune checkpoint inhibitors (ICIs) show promise in cancer treatment but can lead to immune-related adverse events (irAEs), notably affecting the skin. Understanding the factors behind these skin reactions is crucial for effective management during treatment. Hence, the aim of this study was to uncover associations between patient characteristics and cutaneous adverse reactions among cancer patients undergoing ICI treatment. Methods The study involved 209 cancer patients receiving ICIs. Statistical methods, including the chi-square test, Fisher’s exact test, and multivariable logistic regression, were employed to analyze variables such as hypertension, antihistamine use, cancer metastasis, diabetes, and opioid usage. Additionally, machine learning techniques, including logistic regression, elastic net, random forest, and support vector machines (SVM), were utilized to develop predictive models anticipating skin-related adverse events. Results Results highlighted significant associations between specific patient attributes and the incidence of skin reactions post-ICI treatment. Notably, patients using antihistamines or with cancer metastasis exhibited higher rates of skin adverse reactions, while those with diabetes or using opioids displayed lower incidence rates. Robust performance in forecasting these adverse events was observed, particularly in the predictive models employing logistic regression and elastic net. Conclusions This pioneering study contributes crucial insights into predictive modeling for ICI-induced skin reactions, emphasizing the importance of personalized treatment strategies. By identifying risk factors and utilizing tailored predictive models, healthcare providers can proactively manage adverse events, optimizing the benefits of ICIs while mitigating potential side effects.

Impact of Antibiotic on Efficacy and Adverse Reactions of Chemoimmunotherapy in Non‐small Cell Lung Cancer Patients: A Retrospective Cohort Study

ABSTRACTBackgroundThis study aimed to evaluate the impact of antibiotic exposure on efficacy and adverse reactions in non‐small cell lung cancer (NSCLC) patients receiving chemoimmunotherapy, and to explore any specific associations on the basis of antibiotic class.MethodsA retrospective study was conducted on NSCLC patients who received chemoimmunotherapy in two Shandong hospitals between January 2018 and October 2023. The association between antibiotic exposure and progression‐free survival (PFS), overall survival (OS), objective response rate (ORR) and incidence of immune related adverse reactions (irAE) of patients were evaluated.ResultsOf the 316 patients, 134 (42.41%) received antibiotics (ATB group), and 182 (57.59%) did not (N‐ATB group). There was no significant difference in PFS (aHR = 1.009, 95% CI: 0.770–1.323; p = 0.946) or OS (aHR = 1.420, 95% CI: 0.986–2.047; p = 0.060) between ATB and N‐ATB groups. The impact on efficacy was related to the type of antibiotic. β‐Lactams (aHR = 1.737, 95% CI: 1.148–2.629; p = 0.009), in particular β‐lactam/β‐lactamase inhibitor combinations (BLBLIs) (aHR = 1.885, 95% CI: 1.207–2.944, p = 0.005) were associated with poorer OS. However, quinolones (aHR = 1.192, 95% CI: 0.861–1.650; p = 0.291) were not associated with OS. The incidence of irAEs was not significantly different between ATB and N‐ATB groups (p = 0.073), but was higher with BLBLIs (p = 0.013).ConclusionsIn NSCLC patients receiving chemoimmunotherapy, no significant difference was observed in efficacy and incidence of irAEs between the ATB and the n‐ATB groups. In antibiotic class analysis, β‐lactams and specifically BLBLIs were observed to be associated with worse OS.

Clinical efficacy and outcomes of calcitriol combined with bisphosphonates in the treatment of postmenopausal osteoporosis: A quasi-experimental study.

A quasi-experimental study was conducted to investigate the clinical efficacy and outcomes of calcitriol combined with bisphosphonates in the treatment of postmenopausal osteoporosis (OP). A total of 152 patients with postmenopausal OP from March 2019 to June 2021 were enrolled. The patients who received calcitriol treatment were adopted as the control group, and the patients treated with calcitriol combined with bisphosphonates were considered as the intervention group. The treatment effects of patients were compared, and the pain degree of the joints of the patients was evaluated by Visual Analogue Scale/Score (VAS), the Barthel Index score was used to evaluate the daily living ability of patients, the hand and Oswestry Disability Index (ODI) were used to evaluate the dysfunction before and after treatment, and the bone metabolism indexes, immune cytokines and bone mineral density were detected before and after treatment, and the incidence of adverse reactions was calculated. Regarding the therapeutic effects, the intervention group indicated an effective rate of 96.05% while the effective rate was 84.21% in the control group. The total effective rate of treatment in the intervention group was higher than the control group. The VAS, ODI scores, and bone metabolism indexes of the intervention group were significantly lower than the control group at 1, 2, and 3 months after treatment. The Barthel Index scores and bone mineral density of the intervention group were higher than the control group at 1, 2, and 3 months after treatment. The improvement of immune cytokines in the intervention group was significantly better than the control group (P < .05). One patient in the intervention group developed dizziness and 1 patient developed chills, with an adverse reaction rate of 2.63%, while in the control group, 2 patients had fever, and 2 patients developed chills, with an adverse reaction rate of 5.26% (P > .05). Calcitriol combined with bisphosphonates has a significant clinical effect in the treatment of postmenopausal OP, which can significantly relieve bone pain in postmenopausal OP patients, enhance abnormal bone metabolism and immune function, and promote bone mineral density and daily living ability.

Correlation Analysis of Serum 25-Hydroxyvitamin D Levels With Immune Function and Calcium-Phosphate Metabolism in Patients With Bronchial Asthma Treated With Combination Therapy

It was to investigate the clinical efficacy of the combination therapy of fluticasone propionate inhalation aerosol and vitamin D (VD) in pediatric bronchial asthma (BA) and analyze the correlation between serum 25-(OH)-D3 levels and immune function, as well as calcium-phosphorus metabolism. A total of 110 patients with BA were recruited. Regarding treatment plan, patients were randomly rolled into a single-drug treatment group (SDT, treated with fluticasone propionate inhalation aerosol alone) and a dual-drug treatment group (TDT, treated with the combination of fluticasone propionate inhalation aerosol and VD). The changes in serum 25-(OH)-D3 levels, immunoglobulins, T lymphocyte subsets, and inflammatory cytokine levels in children with BA under different treatment modalities were compared. Clinical symptom disappearance, asthma control, and quality of life (QoL) were assessed, and the total effective rate and adverse reactions (ARs) were compared. A control group consisting of 60 healthy children who underwent concurrent physical examinations was included. The differences in serum 25-(OH)-D3 levels, immunoglobulins, and T lymphocyte subset levels between children with BA and healthy controls were compared, and their correlations were analyzed. The TDT group showed a drastic reduction in the disappearance time of lung wheezing and dyspnea relative to the SDT group. Furthermore, the TDT group exhibited notable improvements in lung function parameters, including forced vital capacity (FVC), forced expiratory volume at one second (FEV1), FEV1/FVC, and peak expiratory flow (PEF). Blood gas analysis revealed a great decrease in PaCO2 and an increase in PaO2. The Childhood Asthma Control Test (C-ACT) scores for asthma control and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores for QoL showed marked increases in the TDT group. Moreover, the TDT group demonstrated notable increases in serum 25-(OH)-D3 levels, immunoglobulins (IgA, IgG, and IgM), T lymphocyte subsets (CD4+ and CD8+), as well as blood calcium and phosphorus levels. Additionally, the TDT group exhibited a prominent increase in the anti-inflammatory cytokine interleukin (IL)-10 level and a drastic decrease in the pro-inflammatory cytokines IL-6 and tumor necrosis factor alpha (TNF-α) levels (all P&lt;0.05). The total effective rates of treatment in the SDT group and TDT group were 83.64 % and 96.36 %, respectively, with AR rates of 16.36 % and 7.27 %. The TDT group exhibited a superior total effective rate and an inferior incidence of ARs to the SDT group (both P&lt;0.05). Additionally, in contrast to the control group, the BA group showed notable decreases in serum 25-(OH)-D3 levels, immunoglobulins (IgA, IgG, and IgM), T lymphocyte subsets (CD4+, CD8+, and CD4+/CD8+), as well as blood calcium and phosphorus levels (all P&lt;0.05). Prior to treatment, there was a positive correlation between serum 25-(OH)-D3 levels and immunoglobulins (IgA, IgG, and IgM), T lymphocyte subsets (CD4+ and CD8+), as well as blood calcium and phosphorus levels in children with BA (P&lt;0.05). In patients with BA, combined treatment with inhaled fluticasone propionate aerosol and VD may have a regulatory effect on serum 25-hydroxyVD levels, immune function, and calcium-phosphate metabolism. The correlation between serum 25-(OH)-D3 levels and immune function, as well as calcium-phosphate metabolism, suggested that VD may play a crucial role in the immune regulation and calcium-phosphate metabolism of BA.

Clinical Impact of High-dose Esomeprazole-amoxicillin Dual Therapy as Rescue Treatment for Helicobacter pylori Infection: A Prospective, Multicenter, Randomized Trial.

This study aimed to compare the effectiveness and safety of high-dose dual therapy (HDDT) using esomeprazole and amoxicillin to furazolidone-based quadruple therapy (FBQT) in treating nonresponsive patients with Helicobacter pylori (H. pylori) infection. A total of 209 patients with H. pylori infection, who had previously received ineffective treatment and visited an outpatient clinic, were randomly assigned to either the HDDT or FBQT groups. All patients underwent a 14-day treatment regimen, and the success rates of H. pylori eradication and safety of the treatment regimens were assessed 4 weeks posttreatment. Following the 14-day treatment period, the intention-to-treat (ITT) analysis revealed eradication rates of 93.6% for HDDT and 86.9% for FBQT. In the per-protocol (PP) analysis, eradication rates were 94.5% for HDDT and 88.7% for FBQT. No significant difference in eradication rates was observed between the two groups. HDDT exhibited significantly lower rates of adverse reactions (9.1% in ITT and 9.2% in PP) compared with FBQT (58.6% in ITT and 59.8% in PP). Multivariate analysis identified interval time, alkaline phosphatase, and serum creatinine level as factors influencing the eradication rate. The area under the receiver operating curve of the interval time between the FBQT group and the HDDT group and the success of H. pylori eradication were 0.622 and 0.578, respectively. The optimal salvage treatment intervals were determined as 6 months for FBQT and 1 year for HDDT. HDDT using high-dose esomeprazole and amoxicillin demonstrated efficacy in treating H. pylori infection, with the added benefits of reduced side effects and improved medication compliance compared with FBQT. HDDT can be considered a rescue treatment option when other methods fail, with treatment intervals optimized accordingly.

Effectiveness and Safety of Low-flow Sevoflurane Combined with Remifentanil on Anaesthesia of Patients Undergoing Gynaecological Laparoscopic Surgery

Objective: To evaluate the advantages of sevoflurane (low-flow) + remifentanil for patients undergoing gynaecological laparoscopic surgery. Methods: 300 patients admitted for gynaecological laparoscopic surgery between July 2020 and July 2023 were selected and divided equally by random number table, 150 cases were counted in the observation group, and sevoflurane (low-flow) + remifentanil was chosen for maintenance anaesthesia; 150 cases were counted in the reference group, and anaesthesia was maintained only with remifentanil. The anaesthesia indexes, haemodynamics, stress reaction indexes, and adverse reaction rate of the two groups were compared. Results: The anaesthesia indexes of the observation group were better than those of the reference group (P &lt; 0.05). Before 5 min of anaesthesia (T1), there was no difference between the haemodynamics and stress reaction indexes of the two groups (P &gt; 0.05). After 30 min of pneumoperitoneum (T2) and immediately after the end of surgery (T3), the hemodynamic and stress indicators of the observation group were lower than those of the reference group (P &lt; 0.05). The adverse reaction rate of the observation group was lower than that of the reference group (P &lt; 0.05). Conclusion: Sevoflurane (low-flow) + remifentanil can improve the anaesthesia indexes of gynecological laparoscopic surgery patients, stabilize intraoperative haemodynamics, reduce the stress reaction, and the safety of medication is high.

The Impact of Statin Intensity on the Early Progression of Cardiac Allograft Vasculopathy.

Limited research has compared the relative risks and benefits different statins have after heart transplantation (HT). We hypothesize that higher statin intensity is associated with a smaller degree of allograft intimal thickening on intravascular ultrasound (IVUS) at 1-year post-HT. Allograft intima-media thickness (IMT) on the first annual IVUS was retrospectively compared in patients initiated on a low-intensity statin (pravastatin 20mg daily) versus moderate-intensity statin (atorvastatin 20mg daily) post-HT. A total of 172 adult patients were included (2018-2022, n = 86 in each group). At 1 year, the maximal IMT was lower in the moderate-intensity statin group, but the difference did not reach statistical significance. The LDL levels at 1 year trended lower with moderate-intensity statin therapy, while the rates of adverse reactions were not statistically different. A multivariate analysis of the logistic regression model showed moderate statin intensity at 12 months was protective, while donor-specific antibodies developed within the first-year posttransplant were associated with IMT≥0.5mm on the first annual IVUS. This study found that using moderate-intensity statin to prevent the early progression was as safe and possibly more effective than low-intensity statin therapy for the prevention of early cardiac allograft vasculopathy.

Safety of immunotherapy with Alternaria alternata glutaraldehyde-polymerized allergen extract in adults and children.

Allergies to fungi, such as Alternaria alternata, are significant contributors to respiratory conditions like asthma and rhinitis. Immunotherapy with native A. alternata extracts often results in high rates of adverse reactions. This study evaluates the safety of immunotherapy using glutaraldehyde-polymerized A. alternata extracts in both pediatric and adult populations. This observational real-world study involved 738 patients (435 children and 303 adults) monosensitized to A. alternata or polysensitized together to other allergens. Patients received personalized immunotherapy containing polymerized A. alternata extract, either alone or in combination with other polymerized allergens. The concentration of each polymerized allergen in the therapeutic vaccine was 10,000 TU/mL. Side reactions were classified and recorded based on immediate and delayed onset, and their severity was graded according to the EAACI guidelines. All side reactions were expected and related to the intrinsic properties of allergens. The number of injections administered was 7392, with 4137 to children and 3255 to adults. Thirteen relevant local reactions (0.24% in children, 0.09% in adults) and seven systemic reactions (0.09% overall) were observed. Systemic reactions included mild to moderate symptoms, such as mild bronchospasm and rhinitis. Severe reactions were not reported. Immunotherapy with glutaraldehyde-polymerized A. alternata, alone or in combination with other polymerized allergens, is safe and well-tolerated in both children and adults. The polymerized extracts allow for higher concentrations and faster administration schedules, providing an effective treatment option for patients with fungal allergies, including those polysensitized to multiple allergens.

Efficacy and safety of Chinese herbal medicines combined with biomedicine in the treatment of idiopathic membranous nephropathy: a systematic review and network meta-analysis.

Chinese herbal medicines have been extensively used to treat idiopathic membranous nephropathy (IMN). However, their efficacy and safety remain uncertain. Therefore, this study employed a network meta-analysis to evaluate the efficacy and safety of various Chinese herbal medicines in combination with biomedicines for treating IMN. A comprehensive literature search was performed across several databases, including PubMed, EMBASE, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), WanFang Data, VIP Database, and Chinese Biomedical Literature Database (CBM), to identify randomized controlled trials (RCTs) concerning the treatment of IMN using a combination of Chinese herbal medicines and biomedicine, up to 31 May 2024. Two researchers independently conducted the literature screening and data extraction. The quality of the included studies was assessed using the Cochrane quality review manual, and Stata 14.2 software was employed for network meta-analysis. A total of 31 RCTs involving 2195 IMN patients and 15 different Chinese herbal medicines were analyzed. The network meta-analysis revealed that QQC + BM (84.7%) was the most effective in reducing 24-hour urinary protein. For improving serum albumin, HZC + BM (86%) was the most effective. LGT + BM (77.2%) was the best for enhancing serum creatinine levels. MXC + BM demonstrated the highest effectiveness in lowering total cholesterol (89%) and triglycerides (97%). Lastly, WZC + BM (90.8%) was the most effective in reducing the incidence of adverse reactions. BM. The current evidence suggests that integrating Chinese herbal medicines with biomedicine may provide significant benefits in treating IMN. Specifically, QQC + BM appears to be the most effective in reducing 24-hour urinary protein, HZC + BM seems to excel in improving serum albumin levels, MXC + BM is noted for its effectiveness in lowering triglycerides and total cholesterol, LGT + BM is optimal for reducing serum creatinine, and WZC + BM shows the lowest rate of adverse reactions. Nevertheless, due to limitations in the quantity and quality of the included studies, further validation of these conclusions is necessary. [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024561028], identifier [CRD42024561028].

Surveillance for adverse events following immunization in Hebei Province, China, 2018-2020

ABSTRACT The aim of this study was to analyze the incidence and characteristics of adverse events following immunization (AEFI) with post-licensure vaccines used in Hebei province from 2018 to 2020 and to evaluate the safety of vaccines. All information of AEFI was gained from national adverse event following immunization surveillance system (NAEFISS) in Hebei Province from 2018 to 2020. Descriptive epidemiology method was used to analyze the data about AEFI in Hebei province. Reporting rates of AEFI were calculated by sex, age, city, categories of AEFI, severity of AEFI, reaction categories, etc. A total of 35,999 AEFI were reported through NAEFISS, and the average annual rate was 47.64/100,000 doses. The reporting rates of common adverse reactions and rare adverse reactions were 46.37/100,000 doses and 1.05/100,000 doses. The male-to-female ratio was 1.26:1. Most of the AEFI were concentrated in the ≤1 year age group and were reported in the second quarter and third quarter. The majority of AEFI were reported to be recovered or improved, and about 62% of the AEFI occurred within 24 hours after vaccination. Vaccines associated with the highest reporting rate of AEFI were diphtheria, tetanus and acellular pertussis combined vaccine (DTaP, 170.45/100,000 doses). The reporting rate of allergic rash was found to be the highest in the adverse reactions (0.29/100,000 doses). The majority of AEFI cases were common adverse reactions, while serious rare adverse reactions caused by vaccines were extremely uncommon, and all vaccines used in Hebei Province were safe.

Clinical evaluation of sintilimab in conjunction with bevacizumab for advanced colorectal cancer with microsatellite stable-type after failure of first-line therapy.

At present, immune checkpoint inhibitors (ICIs) remain the 1st-line therapy method for patients suffering from high microsatellite instability /deficient mismatch repair metastatic colorectal cancer (mCRC). However, ICI treatments demonstrate minimal therapeutic efficacy against microsatellite stable (MSS)/proficient mismatch repair (pMMR) CRC. This is mainly because this type of tumor is a "cold tumor" with almost no lymphocyte infiltration. Anti-angiogenic drugs have been found to improve the immune microenvironment by promoting many immune cells to enter the immune microenvironment, thereby exerting anti-tumor effects. To investigate the effects of ICIs combined with bevacizumab monoclonal antibody on tumor immune cells in MSS/pMMR advanced CRC patients with first-line treatment failure. A total of 110 MSS/pMMR patients with advanced CRC after first-line treatment failure in the Affiliated Hospital of Qinghai University were enrolled for a randomized controlled trial. In short, patients in the experimental group (n = 60) were given sintilimab plus bevacizumab for 4 cycles, and those in the control group (n = 50) patients were treated with FOLFIRI combined with bevacizumab for 4 cycles. The expression levels of cluster of differentiation (CD) 8 (+) T cells, tumor-associated macrophages (TAMs), and cancer-associated fibroblasts (CAFs) were comprehensively evaluated to assess the effects of sintilimab combined with bevacizumab on MSS/pMMR advanced CRC sufferers following failure of 1st-line therapy. The positive expression rates of CD8 (+) T lymphocytes (30% vs 50%), TAMs (23.30% vs 60%), and CAFs (23.30% vs 50%) before and after treatment in both groups exhibited statistical significance (P < 0.05). Additionally, the therapeutic effects of both groups (partial remission: 26.67% vs 10%; objective response rate: 26.70% vs 10%) were significantly different (P < 0.05). Although the experimental group showed a higher progression-free survival, median progression-free survival, and disease control rate than the control group, the difference was not statistically significant. Moreover, no significant difference in the occurrence rate of drug-related adverse reactions after treatment between the two groups was found (P > 0.05). ICIs in combination with bevacizumab can not only improve the patient's prognosis but also yield safe and controllable adverse drug reactions in patients suffering from MSS/pMMR advanced CRC after failure to a 1st-line therapy.

Clinical features and effects of cyclosporine in the treatment of psoriasis: a systemic review and meta-analysis.

To systematically evaluate clinical features and effects of cyclosporine in the treatment of psoriasis. Databases including Web of Science, PubMed, The Cochrane Library, Embase, CNKI, Wan Fang, and VIP were electronically searched for studies on the use of cyclosporine in the treatment of psoriasis, from inception to March 2024. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. A meta-analysis was then performed. A total of 12 randomised controlled trial (RCT) studies were included. Compared with the control group, there were statistically significant differences in the effective rate, recurrence rate, erythema regression time, pustular resolution time, fever resolution time, and Psoriasis Area Severity Index (PASI) score of cyclosporine in the treatment of psoriasis. Moreover, the sub-group analysis showed that the effective rate of patients aged less than 40 years was significantly higher than that of the control group and the recurrence rate was significantly lower than that of the control group. The effective rate of psoriasis patients without nail lesions was significantly higher than that of control group. The effective rate of cyclosporin was significantly higher than that of dexamethasone acetate. There was no significant change in pooled sensitivity and specificity after each study was excluded one by one, indicating the stability of the meta-analysis. Cyclosporine had a high effective rate and low recurrence rate in the treatment of psoriasis, but it still had similar rate of adverse reactions compared to other drugs. This study systematically evaluated the effect of cyclosporine in the treatment of psoriasis and provided reference for clinical practice.

Efficacy and safety of traditional Chinese medicine for the treatment of epilepsy by wind quenching and phlegm resolving: A systematic review and meta-analysis.

Using wind-quenching and phlegm-resolving (WQPR) therapy for epilepsy has yielded beneficial results in various clinical studies. However, a comprehensive analysis of the WQPR approach to epilepsy has not yet conducted to date. This study aimed to evaluate the effectiveness and safety of the WQPR method in traditional Chinese medicine (TCM) for epilepsy. Eight databases, including The Cochrane Library, Web of Science, PubMed, Embase, Chinese Biomedical Database, Chinese National Knowledge Infrastructure, Chinese Science and Technology Periodical Database (VIP), and WanFang Database, were comprehensively searched to include randomized controlled trials (RCTs) investigating the WQPR approach in epilepsy. Quality was evaluated by the Cochrane Handbook for Systematic Reviews of Interventions, and meta-analysis was conducted using the RevMan 5.4 and Stata 14.0 software. For the outcome indicators with the number of studies ≥ 10, funnel chart and Egger test were used to evaluate the bias, and the evidence quality was evaluated according to GRADEpro system. We included 19 randomized controlled trials with 1475 participants. Compared to the control group, the WQPR approach showed clinical efficacy for epilepsy (odds ratio = 3.23, 95% confidence interval [CI] [2.19, 4.77], Z = 5.90, P < .00001), reduced seizure frequency (standardized mean differences = -1.24, 95% CI [-1.62, -0.85], Z = 6.26, P < .00001), shortened seizure duration (standardized mean differences = -2.07, 95% CI [-2.99, -1.14], Z = 4.39, P < .0001), improved patient's quality of life (mean difference = 2.60, 95% CI [2.16, 3.03], Z = 11.62, P < .00001), and ameliorated TCM syndromes (mean difference = -4.37, 95% CI [-6.19, -2.56], Z = 4.72, P < .00001). The reduced rate of adverse reactions (odds ratio = 0.56, 95% CI [0.37, 0.85], Z = 2.71, P = .007). WQPR therapy appears to be an effective and safe approach for treating epilepsy, increasing clinical efficacy, reducing seizures' frequency and duration, improving patients' quality of life, ameliorating TCM syndromes, and reducing adverse reaction rates.

Therapeutic drug monitoring and safety of voriconazole in patients with liver dysfunction.

This study aims to describe the distribution characteristics of voriconazole (VRC) plasma trough concentrations (Ctrough) in patients with liver dysfunction, identify factors influencing VRC Ctrough, and provide recommendations for the use of VRC in this population. We retrospectively collected medical records of hospitalized patients with liver dysfunction who used VRC and underwent therapeutic drug monitoring (TDM) at the First Hospital of Changsha. The severity of liver dysfunction was assessed by the Child-Pugh (CP) score. Multiple linear regression was employed to explore factors affecting VRC Ctrough in these patients. A total of 147 Ctrough from 102 patients with liver dysfunction were analyzed. Patients were categorized into a control group (n = 40), CP-A (n = 39), CP-B (n = 11), and CP-C group (n = 12). The initial probability of target attainment of Ctrough was 70.6%, with 6.9% of patients obtaining subtherapeutic Ctrough and 22.5% obtaining supertherapeutic Ctrough. The initial Ctrough in CP-A and B were 5.05 (0.64-9.57) mg/L and 5.37 (0.26-10.01) mg/L, respectively, significantly higher than the control group (P = 0.021 and P = 0.010). The proportion of VRC Ctrough of >5.5 mg/L in CP-A and B was 33.3% and 45.5%, respectively. Multiple linear regression analysis revealed that factors such as age ≥70 years, CP class, C-reactive protein (CRP), and direct bilirubin were significantly related to the initial VRC Ctrough. Among all measurements, patients with severe inflammation (CRP >100 mg/L), aged ≥70 years, and albumin levels of <30 or <25 g/L had significantly higher VRC Ctrough. The treatment success rate of VRC was 69.6% (71 of 102), and the rate of VRC-related adverse drug reactions was 29.4% (30 of 102). The recommended half-maintenance dose may lead to elevated VRC Ctrough in patients with CP-A and CP-B. TDM is essential for patients with advanced age, severe infections, or hypoalbuminemia to prevent excessive VRC trough levels.

The role of trimethoprim/sulfamethoxazole in preventing opportunistic infections in systemic lupus erythematosus patients receiving low-level immunosuppressive treatment: an open-label, randomized, controlled trial

Objective: Systemic lupus erythematosus (SLE) patients receiving immunosuppressive therapy are at risk for opportunistic infections (OIs), particularly Pneumocystis pneumonia (PCP). This study aimed to evaluate the effectiveness of trimethoprim/sulfamethoxazole (TMP/SMX) as primary prophylaxis against OIs and its adverse effects in SLE patients receiving low-level immunosuppressive treatment in a real-world setting. Methods: This open-label randomized controlled trial enrolled SLE patients receiving low-level immunosuppressive treatment at Ramathibodi Hospital between May 2021 and December 2022. Patient demographics and relevant clinical data were collected. Participants were randomized 1:1 to receive TMP/SMX or no prophylaxis, with dose adjustments according to renal function. The incidences of TMP/SMX-sensitive OIs and adverse events were monitored for 12 months post-enrollment. Results: The trial was terminated early due to a high rate of adverse drug reactions (ADRs) associated with TMP/SMX. In total, 138 SLE patients receiving low-level immunosuppressive treatment were enrolled. Most patients (98.4%) were in disease remission. No TMP/SMX-sensitive OIs were observed in either group during the 12-month follow-up period. Among individuals receiving TMP/SMX, 10/70 (14.3%) developed ADRs. Of these 10 patients, eight experienced grade 1 ADRs, and two had grade 3 ADRs; all declined to resume prophylaxis. There were no deaths in the study. Conclusions: During the 12-month follow-up period, no TMP/SMX-sensitive OIs occurred in SLE patients receiving low-level immunosuppressive therapy, suggesting that primary prophylaxis with TMP/SMX may not significantly benefit this population. The high rate of ADRs observed underscores the need for clinicians to carefully consider the risks and benefits of TMP/SMX prophylaxis in these patients.