ArchiveChinese medicine has rich theoretical and practical experience in the treatment of blood stasis and the application of blood-activating and stasis-removing drugs. The widespread use of contemporary blood-activating and blood-stasis treatment methods has made an important contribution to the prevention and treatment of major diseases. However, the clinical application of blood-activating and stasis-transforming Chinese patent medicines still suffers from unclear application indications, efficacy, action characteristics, safety information, dose and course of treatment, etc. Safety issues such as bleeding caused by irrational use of drugs have been a concern in the industry. To provide traditional Chinese medicine practitioners, Western medicine practitioners, general practitioners and clinical pharmacists with general principles for the scientific, rational and standardized use of blood-activating and blood-stasis-removing proprietary Chinese medicines. This guideline writing group follows the evidence-based principles and makes reference to the current high-quality clinical evidence to develop the "Guidelines for Rational Use of Proprietary Chinese Medicines for Promoting Blood circulation and Removing Blood Stasis". The upper part contains 8 varieties of blood-activating and stasis-transforming Chinese patent medicines and 16 recommendations, involving gynecology, orthopedics, surgery, otorhinolaryngology, dermatology and ophthalmology.
Chinese medicine has rich theoretical and practical experience in the treatment of blood stasis and the application of blood-activating and stasis-removing drugs. The widespread use of contemporary blood-activating and blood-stasis treatment methods has made an important contribution to the prevention and treatment of major diseases. However, the clinical application of blood-activating and stasis-transforming Chinese patent medicines still suffers from unclear application indications, efficacy, action characteristics, safety information, dose and course of treatment, etc. Safety issues such as bleeding caused by irrational use of drugs have been a concern in the industry. To provide traditional Chinese medicine practitioners, Western medicine practitioners, general practitioners and clinical pharmacists with general principles for the scientific, rational and standardized use of blood-activating and blood-stasis-removing proprietary Chinese medicines. This guideline writing group follows the evidence-based principles and makes reference to the current high-quality clinical evidence to develop the "Guidelines for Rational Use of Proprietary Chinese Medicines for Promoting Blood circulation and Removing Blood Stasis". The next part contains 18 varieties of blood-activating and stasis-transforming Chinese patent medicines and 26 recommendations, involving mainly cardiovascular and cerebrovascular diseases.
To provide recommendations for clinicians on rational use of Chinese patent medicine for treatment of heart failure, the study was conducted by systematically collecting and analyzing clinical randomized controlled trials (RCTs). Based on three international electronic databases (PubMed, Embase and Cochrane library) and three Chinese literature databases (Chinese Journal Full Text Database, Wanfang Medical Database and Chinese Science and Technology Journal Database (Weipu)), all relevant RCTs from the beginning of the establishment of each database to July 1, 2022 were included, a total of 83 proprietary Chinese medicines were retrieved, and finally 15 proprietary Chinese medicines were chosen to be recommended for treatment of heart failure, including 7 injections and 8 oral proprietary Chinese medicines. The basic information, sample size, intervention and outcome indicators of the 15 proprietary Chinese medicines were compared and analyzed, and the quality of evidence for the efficacy of the included proprietary Chinese medicines was evaluated using the GRADE classification method to assess their efficacy and safety on heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) and acute heart failure (AHF). Combined with the evidence-based medicine approach, a comprehensive evaluation of 15 proprietary Chinese medicines currently in use and with sufficient evidence for the treatment of heart failure were conducted, with the intention to provide some basis for clinicians to use proprietary Chinese medicines rationally.
To assess the current situation of rational use of proprietary Chinese medicines in emergency department.
Subject search was carried out by using "rational drug use" OR "prescription analysis" OR "prescription review" AND "Chinese patent medicine" OR "traditional Chinese medicine injection" OR "injection" AND "emergency" in CNKI database, and all literatures from the establishment of the database to August 1, 2022 were sorted by literature source, publication year, author and institution. The literature was classified by region, age distribution of the study population, and irrational drug use, and bibliometrics was used to evaluate the rational use of proprietary Chinese medicines in emergency department.
A total of 121 literature published in 65 journals were included. The research on the rational use of proprietary Chinese medicines in emergency department was on the rise, and researchers in East China were relatively more concerned about the rational use of proprietary Chinese medicines in emergency department. The total number of prescriptions in the included literature was 1 160 273, including 15 815 irrational prescriptions. Among them, non-conformant prescriptions, inappropriate prescriptions and extraordinary prescriptions accounted for 21.16%, 57.53% and 10.79%, respectively. The total number of emergency prescriptions of proprietary Chinese medicines for children (or infants) was 32 179, and the number of unreasonable prescriptions was 2 211. Among them, non-conformant prescriptions, inappropriate prescriptions and extraordinary prescriptions accounted for 16.46%, 30.48% and 50.57%, respectively. The irrational drug use in children mainly involved heat-clearing and expectorant Chinese patent medicines, and the irrational drug use was mainly off-label. The elderly in the emergency department mainly used proprietary Chinese medicines for promoting blood circulation and removing blood stasis, and the irrational drug use mainly involved repeated administration and inappropriate combination medication. The adverse reactions of proprietary Chinese medicines mainly involved skin tissue and digestive system symptoms, and related irrational drug use conditions included unsuitable combination medication, repeated medication, and unsuitable injection vehicles (or unsuitable route of administration or dosage form).
The number of studies on the rational use of proprietary Chinese medicines in the emergency department is limited and the quality is not high. In the future, it is urgent to formulate guidelines for the clinical use of proprietary Chinese medicines that are more suitable for emergency department, optimize the evaluation criteria, and lay the foundation for effectively promoting the rational and standardized application of proprietary Chinese medicines in the emergency department.
To discuss the problem and current situation of the use of Chinese patent medicine based on literature of prescription analysis and prescription review in the past four years.
Literature of prescription analysis and prescription review from January 2019 to July 2022 was obtained by searching the CNKI, Wanfang and VIP databases. After two times of screening, the proportion of irrational use of Chinese patent medicine in the selected literature, the irrational use of Chinese patent medicine in different regions, hospitals, and that of medicines with different efficacies, and the influencing factors of irrational use of Chinese patent medicine were analyzed.
A total of 66 articles were included. The overall irrational rate of Chinese patent medicine prescription was 4.91%. Among them, Hainan, Xinjiang, and Shanghai had the highest proportion of irrational use, which were 22.08%, 18.03% and 11.98%, respectively, while the proportions of irrational use of Chinese medicine in other regions were less than 10%. Irrational prescription in tertiary hospitals was the lowest, accounting for 4.36%, in secondary hospitals for 7.99%, and in primary community hospitals for 12.55%. Irrational use of drugs for oncology accounted for 10.94%, rehabilitation 10.55%, cardiovascular 7.09%, gynecology 5.30%, and irrational drug use in other departments was less than 5%. Among the Chinese patent medicines with various effects, the proportion of irrational use of medicines for promoting blood circulation and removing blood stasis was the highest, which was 18.85%. Irrational use of Chinese patent medicine for regulating qi and relieving pain accounted for 10.38%, while the irrational use of other types of Chinese patent medicine accounted for less than 10%. Improper usage and dosage, inappropriate drug selection and inappropriate indications were the most common problems in the use of proprietary Chinese patent medicines, with a cumulative proportion of more than 60%.
The problem of irrational use of Chinese patent medicine shows an inversely proportional relationship with the hospital grade. Chinese patent medicine for activating blood circulation and removing blood stasis has the highest frequency of irrational use. Usage and dosage, selection of drugs, and indications may be the main factors affecting the rational use of Chinese patent medicines. The rational use of Chinese patent medicine still needs to receive more attention from medical institutions and clinicians at all levels, and corresponding guidelines and norms are needed for standardized drug use.
To explore the main active components, potential targets and mechanisms of Polygonatum in the treatment of Alzheimer's disease (AD) by using network pharmacological techniques and methods.
The active components of Polygonatum were screened in TCMSP. AD-related targets were retrieved from GeneCards database, TTD database and DrugBank database. Cytoscape 3.7.2 software was used to establish the "yellow essence-component-target" network, which was imported into STRING database to obtain the target PPI network. Key genes were screened using "CytoHubba" function, and GO biological process and KEGG pathway enrichment analysis were performed.
β-Sitosterol, baicalin, diosgenin and other active components in Polygonatum may exert an effect of prevention and treatment of AD through AKT1, CASP3, TP53, VEGFA, HIF1, mTOR and other key gene targets to regulate neurodegenerative pathways, including various diseases, PI3K-Akt signaling pathway, MAPK signaling pathway, and apoptosis signaling pathway.
Polygonatum may regulate and integrate multi-components, multi-targets and multi-pathways to achieve prevention and treatment of AD.
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.
The situation of new drug approval by the State Drug Administration (NMPA) from 2016 to 2020 was systematically analyzed and compared with that by the Food and Drug Admin-istration (FDA) of the United States in the same period, the trend of drug R&D in China in the past five years was analyzed, and the trend of new drug R&D and approval in China from 2016 to 2020 were summarized. Combined with China's drug administrative supervision and management regulations, the status and role of China in global drug R&D were analyzed. It was found that a total of 956 new drug applications (NDA) were approved by NMPA from 2016 to 2020, including 471 for chemicals, 235 for traditional Chinese medicine, and 250 for biopharmaceuticals. The number of new drugs approved by NMPA continued to increase in the 5 years. Compared with the application and approval of FDA, the number of drugs de-clared in China was larger, but the proportion of approval was smaller, the number of first-class innovative drugs was smaller, the main indications for approved listed drugs were anti-tumor, digestive system and anti-infection, and the R&D of drugs for rare diseases and orphans were insufficient. The number of approved new drugs in China was increasing year by year, but the proportion of local original research and new drugs was relatively small, basic research and transformation research was weak, and the R&D of new target molecular drugs was not enough.
The article was to carry out visualized analysis of Chinese and English literatures of regulatory science, and compare the current research status and hot spots around the world. Using "regulatory science" as the search term, Chinese literature was searched in CNKI, Wanfang and VIP from January 1, 2016 to December 26, 2021. English literature was searched in the Web of Science core collection and PubMed from January 1, 2001 to December 26, 2021. After excluding duplicate or irrelevant literature, the VOSviewer 1.6.17 was used for social network analysis and time series, including countries, organizations, authors and keywords. A total of 264 Chinese and 3 307 English literatures were included in the analysis. The research hotspots of Chinese literature were drugs, medical devices and discipline construction. While the research hotspots of English literature were biomarkers, nano medicine and other specific technologies. China's regulatory science has preliminarily established the framework and system of drug regulatory scientific research by carrying out the first batch of key projects and collaboration with universities. With the further deepening of research in the future, China will be completely in line with the world's level in this area.
To 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.
Huangqi (Astragali Radix) is the dry root of Mongol Milkvetch (Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao) and Membranous Milkvetch (Astragalus membranaceus (Fisch.) Bge.), which is a major medicinal material in Gansu Province. It mainly contains Astragali Radix polysaccharides, flavonoids, saponins, alkaloids, amino acids, trace elements, organic acids and other chemical components. The pharmacological effects of Huangqi mainly focus on improving immunity, anti-oxidation, anti-tumor, protecting cardiovascular, promoting body metabolism, lowering blood sugar, diuresis and decreasing swelling. Based on literature retrieval, the distribution of resources, chemical components and pharmacological effects of Astragalus are reviewed and summarized. The quality markers (Q-Marker) of Astragali Radix are predicted based on traditional medicinal properties, efficacy, chemical components and different compatibility. The chemical components of Astragali Radix polysaccharide, ononin, calycosin, formononetin, astragaloside Ⅰ, astragaloside Ⅱ, and astragaloside Ⅳ were predicted by the analysis, providing a scientific basis for the quality control of Astragali Radix.
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 study the pharmacokinetics of metformin hydrochloride tablets (manufactured by Beijing Zhongxin Pharmaceutical Co., Ltd.) and the reference preparation metformin hydrochloride tablets (trade name: Glycoran®, manufactured by Nippon Shinyaku Co., Ltd., Japan) in healthy subjects after single-dose administration under postprandial state, evaluate their bioequivalence, and observe the safety.
Thirty-six healthy subjects were randomly divided into two groups, 18 in each group. After having high-fat meal, the subjects took the test or reference preparations. Blood samples were collected at 0 h (after meal and before administration) and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12 and 24 h after administration. Plasma levels of metformin were measured. The trial consisted of two periods of cross administration and 7-day washout period. PhoenixTM WinNonlin® 8.1 software was used to estimate the non-compartmental pharmacokinetic parameters, and SAS9.4 software was used for statistical description and bioequivalence analysis. If the 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters (Cmax, AUC0-T, AUC0-∞) of T/R were within 80.00%~125.00% equivalent interval, it was safely proved that the two preparations were bioequivalent.
One out of 36 subjects dropped-out due to adverse events. The main pharmacokinetic parameters of the test and reference preparations were as follows: Cmax were (418.42±94.72) and (399.52±79.49) ng·mL-1, AUC0-t were (3 402.04±803.32) and (3 219.06±704.13) ng·h·mL-1; AUC0-∞ (3 458.50±815.42) and (3 276.11±715.12) ng·h·mL-1. The geometric mean ratios of Cmax, AUC0-t, AUC0-∝, and their 90% confidence intervals were 103.11% (98.69%~107.72%), 104.73 (100.11%~109.57%), and 104.63% (100.03%~109.44%), respectively. All were within the bioequivalent range of 80.00%~125.00%. No serious adverse events and unexpected adverse events occurred during the trial.
The test preparation is bioequivalent to the reference preparation after a single-dose oral administration under postprandial condition in healthy Chinese subjects. The two preparations have good safety and tolerability.
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