Latest ArticlesTo improve the relatively backward condition and level of clinical trial institutions in Northwest China by relying on advanced clinical research management concepts and adopting information technology, and explore solutions for the uneven development of clinical trial institutions in China.
Based on the daily work requirements and management experience of the clinical trial institution in the First Affiliated Hospital of Xi'an Jiaotong University, we developed the Clinical Trial Institution Management System (CTIMS) meeting the regulatory requirements in the new period and provided solutions for the improvement of research ability and management level of clinical trial institutions in Northwest China.
By using the CTIMS, the clinical trial institutions in Northwest China can obtain standardized, digital, and intelligent clinical trial management methods, so that they can enter the "fast lane" of clinical research and achieve the goal of narrowing the capacity gap with clinical trial institutions in developed areas.
Through the application of the CTIMS, the clinical research capacity, management efficiency and level of clinical trial institutions, as well as the relatively backward situation of clinical trial development in Northwest China will be improved.
Charged aerosol detector (CAD) is a new universal liquid chromatography detector rapidly developed in recent years. It has the advantages of high sensitivity, broad linear range, the signal response consistency independent of chemical structures, as well as the feature of simple operation. It is especially suitable for detecting substances without ultraviolet absorption. This paper briefly summarizes the working principle and detection characteristics of CAD detector and its application in the analysis fields of traditional Chinese medicine and natural products, chemical drugs, sugars, biochemical drugs, pharmaceutic adjuvant and surfactants, so as to provide reference for its better application in the liquid chromatographic analysis.
Natural medicines are becoming more and more popular in clinical applications because of their remarkable efficacy with few side effects. Natural pharmaceutical compounds have been shown to be effective against many human diseases, especially cancer. Sulforaphane (1-isothiocyanate-4-(methylsulfonyl) butane) is a natural drug, which widely exists in cruciferous plants and is abundant in broccoli, Chinese kale, broccoli and other vegetables. There is growing evidence that sulforaphane is effective in the prevention and treatment of various cancers, including prostate, breast, colon, skin, bladder and oral cancers. In addition, researchers have found that sulforaphane is highly effective in fighting neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease and multiple sclerosis. Moreover, sulforaphane has great potential in preventing oxidative stress, anti-inflammation and anti-fatigue. In this paper, the biological activity and mechanism of sulforaphane are reviewed, and the bioavailability and toxicity of sulforaphane are discussed.
To systematically evaluate the efficacy and safety of ginkgo biloba preparation combined with western medicines in the treatment of depression.
Randomized controlled trials (RCTs) were electronically retrieved from CNKI, Wanfang Data, VIP, CBM, Pubmed and Cochrane Library according to the preset inclusion criteria and exclusion criteria. A total of 242 articles were retrieved. Through reading topics, abstracts, and full texts, 12 articles that met the inclusion and exclusion criteria were finally included for the analysis. The data extraction and Meta-analysis were conducted by using RevMan 5.3 software.
The clinical efficacy of ginkgo biloba preparation combined with western medicines in the treatment of depression was superior to the western medicine routine treatment group, OR=2.48, 95%CI (1.77, 3.45), P<0.000 01. At the same time, the combined application of Ginkgo biloba extract could reduce the HAMD scale score and improve depressive symptoms, MD=-3.22, 95%CI (-4.25, -2.19), P<0.000 01.
Compared with the western medicine routine treatment group, the ginkgo biloba preparation treatment can improve depressive symptoms, lower the HAMD score, and reduce the adverse reactions of western medicines.
To analyze the characteristics of perampanel-related treatment emergent adverse events (TEAEs), providing references for clinical rational drug use.
The literatures about TEAEs caused by perampanel were retrieved from databases like CNKI, Wanfang, VIP, PubMed, ScienceDirect and Web of Science. The cases were divided into treatment group and overdose group according to the drug dose.
A total of 20 literatures including 25 cases were reported, with 14 cases in the treatment group and 11 cases in the overdose group. Most TEAEs occurred within 60 days after drug administration in the treatment group (8 cases, 32.00%), mainly involving TEAEs in mental system (7 cases, 28.00%) and nervous system (3 cases, 12.00%). The TEAEs occurred in the treatment group were relieved after withdrawal and/or symptomatic treatment. All TEAEs mainly occurred in nervous system (9 cases, 36.00%) and the mental system (5 cases, 20.00%) on the day of medication in the overdose group, among which 9 cases were completely improved, and 2 cases had sequelae after treatment.
TEAEs caused by perampanel should be paid attention to, and medication education should be strengthened to avoid the occurrence of serious TEAEs and ensure the safety of clinical medication.
Direct data capture (DDC) by means of digital health technology (DHT) has been played a significant role in the evaluation of clinical benefits in either traditional centralized clinical trials or novel decentralized clinical trials of medicinal products. As a part of e-source data, a trial execution with the regulatory compliance of the DHT is one of the challenges in clinical data flow managements. In the views of developmental trends in GCP and global regulatory and supervisory requirements, DHT applications in clinical trials should meet the validation standards of an e-clinical system, conforming to the ALCOA principle regarding the trial data flow managements with roles and qualifications of relevant stakeholders, such as sponsors, investigators and subjects. In the standpoints of project management views, this paper discusses how the DHT application is complied with regulations, rational monitoring and supervisions on the DHT data flow, and responsibilities of relevant stakeholders, ensuring the approvability of clinical outcomes on DHT-based clinical data by regulatory authorities.
To sort out the previous on-site inspection of clinical trial data by the Center for Food and Drug Inspection (CFDI) of National Medical Products Administration (NMPA), to analyze and discuss the concerns and requirements of common problems in on-site inspection of drug clinical trial data after the implementation of the 2020 Good Clinic Practice (GCP), and to provide reference for the implementation and management of clinical trials.
We collected unqualified situation of the on-site verification of hospital's acceptance of CFDI data since July 22, 2015. A total of 21 items of clinical trials were included, among which 135 items were unqualified. For the common problems in the past non-conformities, the concerns and requirements of the 2020 version of GCP and on-site inspection were analyzed.
The previous unqualified items mainly focused on process records, as well as inspection and inspection of data traceability, program execution, safety event records, management and records of investigational drugs, biological sample circulation management, and the integrity of related data chains. The 2020 GCP and on-site verification points were quite different from the previous requirements regarding common problems in on-site verification of clinical trial data.
Under this new situation, it is necessary to change the previous concepts and rules, and carry out drug clinical trials according to the concerns and requirements of the 2020 version of GCP and the data on-site verification of drug clinical trials.
Camptothecin is a kind of quinoline alkaloid and is also a natural topoisomerase I inhibitor isolated from Camptotheca involucrata. After complexing with topoisomerase I-DNA, camptothecin prevents DNA replication and RNA synthesis, indicating an anti-tumor effect. Clinical studies have shown that camptothecin and its derivatives have good antitumor activity. However, the high toxicity and low bioavailability limited its clinical application. Novel drug delivery systems can make up the defects through enhancing the drug stability, bioavailability and targeting ability to improve the anti-tumor effect, which can help reduce the toxicity, and solve the problems of camptothecins to a certain extent. This paper analyzes and summarizes the research progress of camptothecin-based antitumor drug delivery systems in recent published literatures, in order to provide theoretical guidance and suggestion for the development of new preparations of camptothecins that meet the needs of clinical applications.
To investigate whether licorice extracts (LE) combined with iron death inducer Erastin can induce iron death of colorectal cancer cell DLD1 through dipeptidyl peptidase-4 (DPP4).
DLD1 cells were randomly divided into control group, L-LE group (50 μg·mL-1 LE), H-LE group (100 μg·mL-1 LE), H-LE+Erastin group (100 μg·mL-1 LE+30 nmol·L-1 Erastin) and H-LE+Erastin+Sita (DPP4 inhibitor) group (100 μg·mL-1 LE+30 nmol·L-1 Erastin+31.25 μg·mL-1 Sita), with drug interventions for 24 h. Cell cloning assay and Edu-594 cell proliferation test were conducted to determine the cloning and proliferation abilities of the cells. ELISA assay was used to detect the Fe2+ content and DPP4 activity. Flow cytometry was used to detect reactive oxygen species(ROS) content. Western blotting was used to detect the expression of solute carrier family 7 member 11(SLC7A11) and arachidonate lipoxygenase 3(ALOXE3) proteins.
Compared with control group, the cell cloning number decreased while the ROS content increased in L-LE group, H-LE group and H-LE+Erastin group (P<0.05 or P<0.01); and the proliferation ability and Fe2+ content decreased, DPP4 activity and ALOXE3 protein expression increased, SLC7A11 protein expression decreased in H-LE and H-LE+Erastin groups (P<0.05 or P<0.01). Compared with H-LE+Erastin group, the addition of Sita significantly increased cell cloning, proliferation and SLC7A11 protein expression, while significantly decreased Fe2+ content, DPP4 activity, ROS content and ALOXE3 protein expression (P<0.01).
LE combined with Erastin can induce iron death of colorectal cancer (CRC) cell through DPP4.
Insulin degludec and insulin detemir are the third generation of insulin analogues that are chemically modified on long chain aliphatic acid. It is necessary to establish a specific and sensitive liquid chromatography-tandem mass spectrometry method for the determination of amino acid sequences of chemically modified insulin analogues.
The separation was achieved by an ACQUITY UPLC peptide BEH C18 column (100 mm×2.1 mm, 1.7 μm,300 Å) with a mobile phase of 0.1% FA/H2O as Solvent A and 0.1% FA/acetonitrile as Solvent B in a gradient mode. The flow rate was set at 0.3 mL·min-1. MSE was used as the detection mode of mass spectrometry, and the collision energy was 30~40 eV.
The coverage rate of insulin degludec and insulin detemir sequences was good as expected, and the fragment ion y1& was detected by chemical modification. RSD% of ionic strength of medium and high strength ions was within 15%. Both insulin sequences can be effectively distinguished it from other unmodified ones.
A liquid mass spectrometry method for amino acid sequences of adipose-side chain modified insulin analogs with good repeatability, specificity and durability was established, providing reference for the research method of sequence structure of this kind of products.
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