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Objective To explore the potential adverse reactions of acalabrutinib by mining and analyzing the pharmacovigilance signal of acalabrutinib, to provide a reference for clinically safe and rational drug use. Methods Data related to acalabrutinib in the FAERS database were searched, and pharmacovigilance signals were obtained using the disproportionality measurement. Results A total of 3, 155 reports of adverse events with acalabrutinib as the primary suspected drug were extracted, and 73 warning signals were detected involving 15 system organ classifications, 36 of which were not included in the drug instructions of acalabrutinib. The strong signals of acalabrutinib were mainly concentrated in various inflammatory and bleeding, anemia, contusion, atrial fibrillation, and so on. The largest number of system organ classification signals were focused on the blood and lymphatic system disorders, investigations, infections, and so on. In addition, the drug may cause tachycardia, brittle nails, and other warning signs. Through further analysis of gender-related adverse events, there were a total of 49 high-risk signals with gender differences found. Herein, male patients should pay attention to adverse reactions in bleeding, heart, urinary system, hypertension, and so on; meanwhile, female patients should be alert to adverse reactions in liver function, skin inflammation, and so on. Conclusion A total of 36 drug warning signs that are not mentioned in the instructions for acalabrutinib are mined using FAERS, and blood, infection, and cardiac toxicity require special attention. Thus, these signals should be detected promptly for effective prevention in clinical medication to reduce the risk of medication use for patients.
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Objective To perform a network meta-analysis (NMA) for the efficacy of 11 drugs in preventing chronic peripheral neuropathy induced by platinum and taxane (PTIPN). Methods PubMed, Cochrane library, Embase, CNKI, WanFang database and VIP database were searched up to February 2021 for relevant randomized controlled trials (RCTs) addressing the drugs to prevent PTIPN. After extracting relevant data, Stata 14.0 and ADDIS 1.16.6 softwares were used for statistical analysis. Results A total of 70 studies involving 6201 patients were included. The results of network Meta-analysis showed that amifostine, ganglioside, Huangqi Guizhi Wuwu decoction (HQGZT), vitamin E, calcium and magnesium infusion and omega-3 fatty acids were superior to placebo or blank groups in reducing the incidence of overall or severe PTIPN. The rank probability plot and the SUCRA calculation results suggested that amifostine, HQGZT and omega-3 fatty acids were in first order. The differences between the 11 drugs and placebo or blank groups were not statistically significant, except for amifostine which was reported to aggravate the adverse reactions of nausea and vomiting and hypotension in patients. Conclusion HQGZT, Ganglioside, Vitamin E, omega-3 fatty acids, calcium and magnesium infusion and glutathione can reduce the occurrence of PTIPN, and HQGZT has the highest efficiency.
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[Objective] The present study was to evaluate the association of serum total cholesterol level and prognosis in patients with acute left heart failure and associated mechanisms.[Methods] Sixty-eight patients due to acute episode of left heart failure prospectively enrolled,and baseline data and biochemical parameters were collected.After discharge,patients were follow-up for 1 month and they were divided into two groups (with and without cardiovascular events).Differences between groups were evaluated and the association of serum total cholesterol level and cardiovascular events were analyzed by logistic regression analysis.[Results] The mean age was 57.3 ± 12.6 years old and 52 cases were male patients accounting for 76.5 ％.Among these patients,46 had a diagnosis of coronary heart disease (67.6 ％),10 rheumatic heart disease (14.7 ％),12 dilated cardiomyopathy (17.7％),38hypertension (55.9％) and 24 diabetes mellitus (35.3％).After 1 month's follow up,39 patients (57.4％) had experienced cardiovascular events,36 cases were re-hospitalized,and 3 died from heart failure.Compared to those with cardiovascular events,event free individuals were younger and were less likely smokers (P ＜ 0.05).In addition,event free group had lower serum levels of N-terminal pro-BNP and C-reactive protein (P ＜ 0.05) while serum levels of total cholesterol and albumin were significantly higher (P ＜ 0.05).There was no significant difference in medication between these two groups.After adjusted for age,gender,smoking,systolic blood pressure,serum albumin level,diabetes,hypertension and medications,increased total cholesterol level was independently associated with better prognosis with odds ratio of 0.91 (95 ％ confidence interval 0.80-0.96).Further adjusted for C-reactive protein,the association was attenuated to non-significance,with odds ratio of 0.97 (95 ％ confidence interval 0.87-1.09).[Conclusion] Adequate serum total cholesterol level was beneficial for improving short-term cardiovascular outcomes in patients with left heart failure and the potential mechanisms might be related to cholesterol effects on improving nutritional status and anti-inflammation.
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<p><b>OBJECTIVE</b>To evaluate the long-term clinical outcomes of fractional flow reserve (FFR)-guided versus intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) for intermediate coronary lesions.</p><p><b>METHODS</b>A total of 226 patients with 293 intermediate coronary artery lesions (stenosis of 40%-70%) confirmed by coronary angiography were randomized into 3 groups to undergo PCI for a minimal lumen cross sectional area (MLA)<4 mm(2) (IVUS group, 98 lesions) or for a FFR<0.80 (FFR group, 101 lesions), or to receive standard medical treatment (medication group, 94 lesions). The primary outcome was major adverse cardiac events including death, myocardial infarction, and ischemia-driven target vessel revascularization at 1 year after the index procedure.</p><p><b>RESULTS</b>The baseline percent diameter stenosis and lesion length were similar between the 3 groups, but more patients in IVUS group than in FFR group received PCI (P<0.001). No significant difference was found in the incidence of major adverse cardiac events between the 3 groups (P=0.182).</p><p><b>CONCLUSION</b>Both FFR- and IVUS-guided PCI strategy for intermediate coronary artery disease are associated with favorable outcomes, but IVUS-guided PCI based on the single index of MLA can increase the rate of revascularization therapy.</p>