Latest ArticlesTo mine the security alert signals of risk signals of adverse drug events (ADEs) associated with post-marketing use of avacopan based on the FDA Adverse Event Reporting System (FAERS) database. The findings are intended to provide a reference for clinical safety in medication practices.
The study collected ADE reports related to Apixaban from the FAERS database for the period of Q4 2021 to Q2 2024. Potential safety signals associated with Apixaban were identified using various methodologies, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS). Weber distribution test was used to determine the occurrence rule of ADE. The reporting odds ratio was used to estimate the relative risk of arvaracopam ADE in different genders.
A total of 6 519 ADE reports involving 2 730 patients with avacopan as the primary suspected drug were collected, and 75 avacopan ADE signals were mined involving 15 systems. ADE occurs mostly within 30 days after administration of avacopan. Consistent with the description in the package insert, ADEs of hepatobiliary system, infection and infection system were commonly observed. In addition, ADEs such as epistaxis, pulmonary hemorrhage, pharyngeal swelling and deep vein thrombosis were not included in the package insert. The analysis of gender differences in the risk signals associated with arvalacopam revealed that female patients were more susceptible to conditions such as jaundice, pulmonary vasculitis, esophageal candidiasis, cheilitis, Escherichia coli urinary tract infection, etc. In contrast, male patients were more likely to have dental hypersensitivity, pulmonary hemorrhage, elevated serum ferritin, and cardiac pacemaker implantation.
In the real-world application of avacopan, it is essential to focus on the ADE related to the hepatobiliary system, respiratory system, thoracic and mediastinal systems, as well as infectious conditions. Additionally, appropriate strategies should be implemented based on gender differences to mitigate the occurrence of ADEs.
To analyze the characteristics and patterns of myocarditis associated with immune checkpoint inhibitors (ICIs) in China, providing a reference for rational clinical drug dosing.
Authors conducted a comprehensive search of CNKI, Wanfang, VIP, as well as PubMed and Web of Science to collect case reports of myocarditis caused by ICIs in China (up to June 2024). Data were extracted and analyzed accordingly.
A total of 143 cases in 132 literatures were includedin this study. The median age of patients was 66 years old, and the primary disease was lung cancer in the majority (28.67%). The onset time of myocarditis was 83.92% within 90 days of the first medication, with the median time of 24 days. The first symptoms of myocarditis were mainly chest tightness, shortness of breath, palpitation (59.44%) and fatigue (37.76%). Manifestations of myocarditis related cardiovascular adverse events were tachyarrhythmia (35.66%), bradyarrhythmia (19.58%), heart failure (12.59%), acute coronary syndrome (4.90%) and cardiogenic shock (4.90%). 15 (10.49%) patients died of myocarditis.
Myocarditis caused by ICIs in China mainly occurs in the early stage of immunotherapy, with the first symptoms mainly chest tightness, shortness of breath, palpitations and fatigue. During ICIs dosing, monitoring should be strengthened to identify myocarditis related cardiovascular events in time to ensure the safety of drug dosing.
The medication timing is an important factor affecting the clinical efficacy of drugs. Selecting the right medication timing is the key to ensure the full play of drug efficacy, as well as standardized and precise medication practices in clinical settings. Although some scholars have carried out relevant clinical studies on the medication timing, there remains a lack of systematic review and summary of its important research significance and key points of scheme design. This paper systematically discusses the concept of medication timing, research significance, understanding of traditional Chinese medicine, types of research design and key methodological points, aiming to clarify the design ideas for clinical research on medication timing, and focus on analyzing the similarities and differences, as well as key design points of different types of clinical studies. This article provides methodological guidance for timely and precise medication in clinical practice and effectively promotes the standardization and accuracy of clinical drug use.
An HPLC-MS/MS method was established for the simultaneous determination of 15 components [betaine, agaritol, bergamolide, 2-(2-phenylidene) chromone, dehydrodiisoeugenol, D-(-)-quinic acid, gallic acid, protocatechuic acid, hydroxysafflor yellow A, rutin, isoquercetin, ellagic acid, luteolin and apigenin] in Qingxin Chenxiang Bawei powder (pills). The quantitative method, combined with chemometrics and entropy weight-grey correlation degree method to analyze the comprehensive quality, provides a reference for the quality control and evaluation of this preparation.
The analysis was conducted using a Shim-pack GIST-HP C18 chromatographic column, with the mobile phase consisting of methanol (A) and a 0,1% formic acid aqueous solution (B). A gradient elution was employed at a column temperature of 35 ℃, with an injection column of 3 μL. Weisenxin platform was used for cluster analysis (CA), SIMCA 14.1 software was used for principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA), and the compounds with variable important in projection (VIP) value greater than 1.0 were used as the criterion to screen quality differences. The entropy weight-correlation degree method was used to analyze the comprehensive quality.
The linear relationship of the 15 components was good in their respective ranges, and the linear correlation r was greater than or equal 0.999 0. Precision RSD were all lower than 3.00%. The stability and repeatability were good, RSD lower than 5.00%; The average recoveries were 93.62%~105.10%, and RSD was 1.18%~4.37%. CA and PCA analysis classified 14 batches of Qingxin Chenxiang Bawei powder (pills) into 2 categories: manufacturers D (D1~D4) were grouped into one group, manufacturers A and M (A1~A4, M1~M6) were grouped into one group. Six difference markers were screened in OPLS-DA mode, which were D-(-)-quinic acid, agaritol, 2-(2-phenylethyl) chromone, dehydrodiisoeugenol, bergamolactone and quercetin, respectively. A2 has the best comprehensive quality.
The established HPLC-MS/MS method for the simultaneous determination of 15 components in Qingxin Chenxiang Bawei powder (pill) can be used for the comprehensive quality study of Qingxin Chenxiang Bawei powder (pill) combined with chemometrics and entropy weight correlation degree method.
Obeticholic acid, a chenodeoxycholic acid derivative among human primary bile acids, acts as an agonist for the farnesoid X receptor. This article introduces a process for the preparation of obeticholic acid and discusses the status of related patent applications concerning its crystalline form. By combining the context of the key patent technology and summarizing related aspects of technology evolution and efficacy relationships, this article aims to provide beneficial references for fair patent placement, patent mining, prevention of patent infringement for imitation businesses, as well as the guidance on technological development and the strategic intellectual property considerations for domestic pharmaceutical businesses.
To systematically evaluate the efficacy and safety of ferrous succinate tablets in the treatment of iron deficiency anemia during pregnancy.
Retrieved from PubMed, Embase, Cochrane Library, CNKI, Wanfang, randomized controlled trials (RCTs) about ferrous succinate versus polysaccharide iron complex capsules and ferrous sulfate tablets in the treatment of anemia during pregnancy and different dosage forms of ferrous succinate tablets for the treatment of iron-deficiency anemia in pregnancy were collected from January 2016 to April 2024. Meta-analysis was performed using RevMan 5.3 and Stata 17.0 software.
A total of 47 RCTs were retrieved with 6 655 patients. Results of meta-analysis showed that ferrous succinate tablets were significantly better than ferrous sulfate tablets in terms of overall efficacy [OR=4.65, 95%CI (3.68,5.88), P<0.000 01] and incidence of adverse reactions (P<0.05). There was no statistical significance in total response rate [OR=1.47，95％CI (0.45，4.79)，P=0.52] and specific adverse effect rates (P>0.05) between ferrous succinate tablets and polysaccharide iron complex capsules. The overall effectiveness and total incidence of adverse drug reactions in ferrous succinate sustained-release tablets were significantly better than that of ferrous succinate film-coated tablets.
The efficacy and safety of ferrous succinate tablets in treating iron deficiency anemia in pregnancy are both good.
With the expiration of the patent of denosumab (Prolia®/Xgeva®) and its marketing in China, the number of denosumab biosimilars developed by domestic biological enterprises according to the path of biosimilars is gradually increasing. This paper reviews the domestic and foreign registration and research status of the original drug and biosimilars, clarifies the challenges and technical requirements in the similarity evaluation of denosumab, analyzes and discusses the common problems in the pharmaceutical evaluation of denosumab biosimilars in combination with the review practice, in order to provide a basis for the pharmaceutical development and evaluation of denosumab biosimilars.
Allergic diseases are recognized by the World Health Organization (WHO) as a major health problem in the world. At present, allergen products have been widely used in the treatment of various allergic diseases at home and abroad. Allergen therapy is currently the only therapy that can regulate the immune system in patients with allergic rhinitis. However, high quality allergen products are related to the effectiveness of the products. In view of the important clinical value of allergen products, combined with the status quo of listed allergen products and registered allergen products, this paper briefly introduces the registration management classification of allergen products in China and the United States and the technical requirements for the registration of such products in China.
Glucagon like peptide 1 (GLP-1) can inhibit the elevation of glucagon, inhibit gastric acid secretion, and slow down gastrointestinal peristalsis. However, the plasma half-life of GLP-1 is only a few minutes to a few hours. Frequent and high-dose administration are required to achieve therapeutic effects which will increase the risk of adverse effects. Therefore, long acting is an important research interest for GLP-1 drugs. Fatty acid chain modification is the widely used long-acting strategy for GLP-1 drugs due to its advantages of definite modification sites, low heterogeneity of modified products, low loss of biological activity, and low toxic effects. To provide references for the CMC research and evaluation of fatty acid chain-modified GLP-1 drugs and other fatty acid chain-modified peptide drugs, this article shares the experience accumulated in the evaluation of fatty acid chain-modified drugs and proposes the evaluation considerations for recombinant fatty acid chain-modified GLP-1 drugs from the perspectives of raw materials for production, production processes, quality control, and stability research.
The rapid development of cell and gene therapy products carries the high expectations of industry, patients, and healthcare workers, and also poses a considerable challenge to drug regulatory authorities. In order to promote the development and marketing of these products with great therapeutic potential, the US and European drug regulatory authorities have adopted measures to adjust organizational structures, improve regulations and guidelines, and develop targeted accelerated procedures for cell and gene therapy products. China's regulatory policy for cell and gene therapy products is also constantly improving. By summarizing and analyzing the accelerated assessment and approval policies of the US and European drug regulatory agencies for cell and gene therapy products, this paper aims to provide reference for the optimization of the accelerated assessment and approval policies for these classes of products in China.
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
