Latest ArticlesThere has been much uncertainty existing in the pharmacological treatment of cardiac arrhythmias. Ivabradine is a novel drug with potential anti-arrhythmic benefits in addition to its ability of reducing heart rate without affecting hemodynamics. However, it is not currently approved for the treatment of arrhythmias other than sinus arrhythmias because of its potential arrhythmogenic risk. This review summarizes the evidence from basic and clinical studies regarding the use of ivabradine in sinus, atrial, junctional, and ventricular arrhythmias. Whether its benefits outweigh the risks for other types of arrhythmias except sinus arrhythmias is inconclusive and needs further proofs from additional studies.
Peptide drugs are a class of medical products that are important and special. However, compared with common small-molecule chemical drugs, the technical guidelines for peptide chemical drugs from regulatory agencies and international organizations are needing improvement. In this paper, we discuss some specific technical requirements for the quality research of peptide chemical generic drugs by analyzing some case studies. It is suggested that different analytical methods of orthogonal principles should be applied combined with the characteristics of the drug to explain the consistency between generic drugs and reference listed drugs, as well as the rationality of impurities control strategy, which will promote the improvement of the study and the possibility of approval.
Triptolide is an epoxy diterpene lactone extracted from the root of Tripterygium wilfordii Hook f. It has been proved to have a variety of pharmacological activities such as anti-inflammatory, anti-virus, immune regulation, and anti-fertility. In recent years, triptolide was reported great potential in anti-tumor effect. Triptolide has significant inhibitory effects on wide range of tumor cell lines. The mechanism of actionincludes inhibiting tumor cell proliferation and migration, inducing tumor cell apoptosis, inducing tumor cell autophagy, and inducing tumor cell cycle arrest. However, its disadvantages limit its clinical application, such as poor water solubility, low bioavailability, strong toxicity and side effects. At present, nano preparations, such as lipid nanoparticles, polylactic acid nanoparticles, polymer micelles and exosomes, could deliver drugs to tumor sites, thus could improve drug efficacy and reduce toxicity, exhibiting good prospects of application. This paper summarizes the research on the antitumor effect, the mechanism, and the antitumor application of triptolide in recent years, in order to guide the further development and application of triptolide and its preparations in antitumor effect.
To observe the protective effect of 6-O-methyl-catalpol on fructose-induced NAFLD in mice and its mechanism.
The mice were randomly divided into the control group and fructose-fed groups. After 4 weeks, the fructose-fed mice were further divided to 4 subgroups: model group, silybin group (35 mg·kg-1), 6-O-methyl-catalpol (30 mg·kg-1) group, and 6-O-methyl-catalpol (60 mg·kg-1) group. The drugs were administered by gavage qd for a period of 4 weeks. At the end of the treatment, the levels of ALT, AST, TC, TG, GLU, insulin and leptin were determined. The histopathological changes of liver were evaluated using HE staining. The fatty acid synthetase (FAS) and acetyl CoA carboxylase (ACC) protein expression in liver were measured using Western blot.
Compare with the model group, the elevated levels of AST, ALT, TC, TG, insulin, leptin and HOMA-IR significantly decreased in 6-O-methyl-catalpol groups (P<0.01). HE staining showed that the degree of hepatic steatosis was obviously ameliorated in 6-O-methyl-catalpol treatment groups. The protein expression levels of ACC and FAS were also significantly down-regulated in high 6-O-methyl-catalpol group (P<0.01).
6-O-methyl-catalpol exerts protective effect against NAFLD, which may be related to the improvement of insulin sensitivity and lipid metabolism.
The aim of the article is to analyze the current research progress of COVID-19 vaccines in China and abroad based on patent data, and to make statistics on the main types and hot technologies, so as to provide reasonable suggestions for future vaccine research and development. Innojoy patent search engine and Baiten patent network were used to retrieve and analyze the patent data, and technology prediction was made according to the concept model of technology prediction. At present, the research hotspots of COVID-19 vaccines are mainly distributed in the technical fields related to the use of antigens, antibodies, peptides and genetic engineering. The research on COVID-19 vaccines in China mostly focuses on recombinant protein/epitope/polypeptide/subunit vaccines and nucleic acid vaccines, and the technical hotspots focus on antigen improvement techniques. The current research in the field of COVID-19 vaccines in the world and in China has made some progress, making the patent market active. The COVID-19 vaccine-related market and technical structure tend to enter a more developed stage.
This study proposes a neural network-based technology opportunity analysis of patent data.
First, based on learning of the content characteristics of the data by deep learning algorithm, the extraction keyword model was formed. Content similarity between keywords was calculated based on the contents. Second, patent technology network was built based on the keywords. The link prediction algorithm was used to calculate the topology features of the network, including similarity features based on local information, random walk and path. Finally, the three types of network topology features and content features were input to the BP neural network model to predict potential technology opportunities.
The field of biological nanomedicine was selected as the empirical field. The top 10 technological opportunities with the highest probability score in the patented technology network were identified in the field of biomedicine.
The results were analyzed and evaluated through the literature retrospective method, and the latest literature found the research results on these technical opportunities, but they have not successfully applied for patents.
To explore the safety and efficacy of Inetetamab combined with Pyrotinib in the treatment of HER2-positive breast cancer.
A case of patient was reported with right breast invasive ductal carcinoma with multiple systemic metastases. The patients were found progressing after 3 cycles of docetaxel+Capecitabine+Trastuzumab regimen as the first line therapy for Trastuzumab primary resistance. Second-line therapy combined inetetamab with pyrotinib (inetetamab 8 mg·kg-1 for the first time, followed by 6 mg·kg-1, q3w+pyrotinib 400 mg·d-1, qd+vinorelbine 35 mg day 1, day 8 q3w) for 18 cycles.
The patients achieved partial response (PR) at the first evaluation. During the 18 cycles of treatment, the efficacy was evaluated as continuous PR. The current progress free survival (PFS) was more than 16 months. No grade III or above adverse reactions occurred during the treatment, and the patients were well tolerated.
The combination of inetetamab with pyrotinib is effective and safe in the treatment of metastatic HER2-positive breast cancer.
In recent years, with the continuous innovation and transformation of the pharmaceutical industry, high-quality and efficient clinical trials have become one of the most important demands of the pharmaceutical industry at present. The drug clinical trial business is complicated and data volume is huge, putting forward higher requirements for drug supervision. Therefore, innovative regulatory methods and intelligent transformation are extremely in need. In order to meet various development requirements in the era of COVID-19, after years of exploration and practice, our province has started the construction of the supervision information system of drug clinical trial institutions in Hebei province, established a vertical supervision system from top to bottom, and realized the whole-process reengineering of the supervision of clinical trial institutions by means of information technology. We initiated the remote supervision mode of drug clinical trial institutions and explored the "on-site inspection-remote inspection" hybrid supervision and inspection mode. With the assistance of this system, the risk in the clinical trial process reduced, the personnel gathering under the COVID-19 epidemic reduced, while the efficiency of supervision and inspection is improved, the listing process of new and good drugs is accelerated, makingpeople easily access to good drugs as soon as possible.
To explore the construction of clinical trial information management system and its practice in the process management of traditional Chinese medicine clinical trials, so as to improve the management efficiency of drug clinical trials.
In cooperation with Tianjin Abensu Science and Technology Co., Ltd., an information management platform for clinical trial institutions was constructed in the Affiliated Hospital of Chengdu University of traditional Chinese medicine. Through the intranet system, the hospital's original closed systems such as HIS, LIS and RIS were connected. After encrypted transmission, it completed data exchange and docking with the information system running on the internet. The electronic informatization of user management, project management, subject information management, process information management and experimental drug management of clinical trial realized. The security, stability and efficiency of the involved data were analyzed.
The system realized the safety, stability and smooth flow of data in the process of clinical trial management, and greatly improved the efficiency of traditional Chinese medicine (TCM) clinical trial project management.
The introduction of information management system and its integration with internal systems like HIS and LIS is the road which must be taken to realize the modern management of TCM clinical trial institutions, and it is one of the most important ways to practice the innovation of TCM.
Dictamni cortex is the dried root bark of the Dictamnus L. in the Rutaceae family. It contains alkaloids, limonoids, phenylpropanoids, flavonoids, et al. Based on summarization of its chemical components, pharmacological effects and toxicity, and according to the concept of traditional Chinese medicine quality marker (Q-marker), the Q-markers of Dictamni cortex were predicted from the aspects of genetic relationship and measurability of components, traditional efficacy, traditional property, different producing areas and collecting periods, and component contents under different ultraviolet radiation intensities. γ-fagarine, limonin, dictamnine, obacunone and fraxinellone can be used as Q-markers of Dictamni cortex, which provide a scientific reference for the establishment of quality standards.
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