ObjectiveTo systematically review the renal adverse reactions of tyrosine kinase inhibitors (TKI). MethodsPubMed, EMbase, Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) on the incidence of renal adverse reactions of TKI from inception to March 30, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.4 software. ResultsA total of 19 RCTs involving 10 141 patients were included. The results of meta-analysis showed that compared with placebo or blank control, gefitinib, ranvartinib, cabotinib, vandetanib, pazopanib, arotinib, apatinib, and acitinib could lead to an increased risk of proteinuria events, while sildenib did not increase the risk of proteinuria in patients. Anlotinib could increase the risk of hematuria. Vandetanil increased the risk of acute kidney injury. Gefitinib, ranvartinib and apatinib could increase the risk of grade 3-4 renal adverse reactions. ConclusionCurrent evidence shows that TKI drugs may cause renal damage in patients, and proteinuria is the most common. Vandetanil can cause acute kidney injury, gefitinib, ranvartinib and apatinib are more nephrotoxic. The renal adverse reactions of neratinib, ibutinib and sildenib are relatively few.
ObjectiveTo investigate the risk of myocarditis caused by immune checkpoint inhibitors (ICI). MethodsThe adverse reaction (ADR) reports on myocarditis caused by atelizumab, duvalizumab, pabolizumab, and navulizumab were downloaded from the FDA Adverse Event Reporting System (FAERS) from January 1, 2014 to September 30, 2022. The relevant analysis was conducted on the gender, age, medication dosage, and occurrence time of ICI related myocarditis patients. ResultsA total of 1 892 reports of myocarditis induced by ICI were included. The proportion of myocarditis caused by ICI was higher in males than in females (1.9∶1). The incidence of myocarditis in patients with basic diseases such as diabetes and heart disease, and in the age group 65-75 was relatively high. The incidence of myocarditis caused by navulizumab was high within 30 days with the use of conventional doses, and that of the other three drugs were high within 31 to 90 days. And the incidence of myocarditis is higher when used in combination than when used alone. ConclusionDifferent varieties of ICI can lead to the occurrence of myocarditis, and male, elderly, underlying diseases, and combination therapy may be risk factors for myocarditis caused by ICI.
Objective To evaluate the efficacy and safety of rifaximin in the treatment of irritable bowel syndrome (IBS). Methods The computer system was used to retrieve PubMed, Embase, Web of Science, Cochrane Library, SinoMed, China National Knowledge Infrastructure, Wanfang and Chongqing VIP databases, and the randomized controlled trials of rifaximin for IBS published before November 30, 2022 were retrieved. The data were meta-analysed using RevMan 5.1 and Stata 12.0 softwares. Results Finally, 8 studies including 5176 patients were included. Meta-analysis results showed that the overall effective rate [relative risk (RR)=1.40, 95% confidence interval (CI) (1.21, 1.62), P<0.00001], abdominal pain relief rate [RR=1.21, 95%CI (1.12, 1.32), P<0.00001], abdominal distension relief rate [RR=1.28, 95%CI (1.15, 1.41), P<0.00001], and stool character improvement rate [RR=1.20, 95%CI (1.10, 1.32), P<0.0001] of rifaximin in the treatment of IBS were better than those of the control group. There was no significant difference in the incidence of adverse reactions (P>0.05). Conclusion Rifaximin can effectively improve the abdominal pain, abdominal distension and stool characteristics of IBS patients, and it is safe and reliable.
Objective Lacosamide (LCM), a newly approved third-generation antiepileptic drug, is still considered a novel therapy. Recommendations for adjunctive LCM treatment in pediatric epilepsy are limited, and factors influencing its efficacy remain unclear. Therefore, the therapeutic effects of LCM in children require further large-scale investigation. To evaluate the real-world efficacy, safety, and tolerability of LCM in a pediatric population with broad-spectrum epilepsy through a prospective study. Methods This prospective observational cohort study enrolled children aged 4–18 years with epilepsy who visited Qingdao University Affiliated Women and Children’s Hospital between January 2021 and January 2024. Participants included those with focal, generalized, unknown-onset epilepsy, and complex syndromes such as Lennox-Gastaut syndrome (LGS), febrile infection-related epilepsy syndrome (FIRES), and infantile spasms. Baseline seizure frequency and clinical characteristics were recorded prior to initiating LCM. LCM was administered at the starting dose recommended by the package insert and titrated to a maintenance dose based on efficacy and tolerability. Follow-up assessments occurred at weeks 12, 24, and 36, evaluating seizure frequency, concomitant antiepileptic drug use, and adverse events. The primary outcomes were treatment response (≥50% reduction in seizure frequency) and seizure-free rate, while secondary outcomes included incidence of adverse events and drug retention rate. Data were analyzed using self-controlled comparisons, and logistic regression was applied to explore clinical factors affecting efficacy. Results The overall retention rates at weeks 12, 24, and 36 following LCM adjunctive therapy were 98.0%, 97.0%, and 95.0%, respectively. Corresponding response rates were 79.2%, 78.8%, and 75.5%, and seizure-free rates were 54.5%, 56.6%, and 57.1%. Statistically significant differences (P<0.05) between responders and non-responders were observed in baseline seizure frequency, seizure duration, number of concomitant antiepileptic drugs, presence of developmental delay/intellectual disability, and normality of cranial MRI findings. Logistic regression indicated that the number of concomitant antiepileptic drugs and normal cranial MRI findings were independent factors influencing LCM efficacy. Adverse events included dizziness, somnolence, blurred vision, irritability, and headache, with an overall incidence of 6.9%. Conclusion Adjunctive LCM treatment in children aged 4~18 years demonstrates high efficacy and seizure-free rates, mild adverse effects, and favorable retention. LCM appears particularly effective in patients with normal cranial MRI findings and limited concomitant antiepileptic drug use (≤2 drugs).