ABSTRACT
There is still a serious challenge of the measurement of critical quality attributes (CQAs) related to clinical efficacy for Chinese materia medica manufacturing. To overcome this challenge, an integrated strategy of biosensor and ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) was proposed using Tongren niuhuang qingxin pills as a trial. Firstly, an original biosensor was created using a semiconductor chip material high electron mobility transistor (HEMT) as the transducer and the macrophage migration inhibitory factor (MIF) as the identification element. By this MIF-HEMT biosensor, the efficacy on stoke of different components from Tongren niuhuang qingxin pills was measured. It was clear that all three components of Tongren niuhuang qingxin pills had strong therapeutic effects on stroke, especially the section A, the KD of which reached to 8.722×10-10 g·mL-1. Furthermore, MIF-HEMT biosensor integrated UPLC-MS/MS was introduced to identify the efficacy CQAs of different components of Tongren niuhuang qingxin pills. As a result, 19 potential CQAs, such as albiforin, paeoniflorin, and prim-O-glucosylcimifugin, were measured as the efficacy CQAs of Tongren niuhuang qingxin pills on stroke treatment by MIF. These results provided vital measurement techniques and methodological guidance for the CQAs study of Tongren niuhuang qingxin pills intervention in MIF-induced stroke treatment. This also provided an essential guideline for the efficient utilization and quality control measurement of high-quality classical recipes.
ABSTRACT
Aiming at the hysteresis and destructiveness of off-line static detection of critical quality attribute of the moisture content of the raw material unit of the traditional Chinese medicine manufacturing process, honey-processed Tussilago farfara, honey-processed Astragalus and honey-processed Glycyrrhiza uralensis were used as the research carriers, and the drying method was used to measure the moisture content as a reference value. The moving stage was used to simulate the movement process of samples on the conveyor belt in the actual on-site production process, and near-infrared (NIR) spectra were collected, combined with machine learning, to establish NIR on-site dynamic detection model of moisture content in multi-variety honey-processed Chinese herbal slice. The results show that the second derivative method is used to preprocess the spectrum. The number of decision trees (ntree), the number of random features (max feature), and the minimum number of samples for generating leaf nodes (node size) are selected: 46, 76, and 8, respectively. The quantitative analysis model of moisture content has the best effect. The prediction coefficient of determination (the prediction coefficient of determination, R2pre) and the root mean square error of prediction (root mean square error of prediction, RMSEP) of the model were 0.903 2 and 0.330 2, respectively. The NIR quantitative model for the moisture content of multi-variety honey-processed Chinese herbal slice established in this study has good predictive performance, and can achieve rapid, accurate and non-destructive quantitative analysis of the moisture content of honey-processed Tussilago farfara, honey-processed Astragalus and honey-processed Glycyrrhiza uralensis at the same time, and provides a method for determining the moisture content of honey-processed Chinese herbal slice of the raw material unit of the traditional Chinese medicine manufacturing process.
ABSTRACT
To identify the bitter compounds of real-world Xiaoer Ganmao Oral Liquid sugar-free intermediates, an integrated strategy has been developed by using ultra-high performance liquid chromatography with linear ion trap-Orbitrap mass spectrometry (UHPLC-LTQ-Orbitrap MSn) method and BitterX database prediction. The chromatographic operating conditions were as follows, chromatographic column: Acquity UPLC BEH C18 (100 mm × 2.1 mm, 1.7 μm), mobile phase: 0.1% formic acid-water solution (A)-acetonitrile (B) with gradient elution. The data were collected in positive and negative ion modes, respectively. The accurate molecular mass and structural information of the target compounds were obtained based on quasi-molecular ions and fragmentation ions provided by high-resolution mass spectrometry. The compounds were identified by combining retention time, reference substances, reports, and other relevant data, and a total of 57 constituents including flavonoids, alkaloids, and phenylpropanoids were finally identified. Further, the BitterX database was used to predict binding probability of compounds to bitter receptors and identify potential bitter critical quality attributes, finally 33 potential bitter compounds, including kukoamine A and linarin, were predicted. This study comprehensively characterized the material basis of Xiaoer Ganmao Oral Liquid sugar-free intermediates, it provides an effective method for bitter compound screening and a reference for further improving the undesirable taste of Xiaoer Ganmao Oral Liquid.
ABSTRACT
Acute myeloid leukemia (AML) is a genetic heterogeneous disease in which primordial and juvenile myeloid cells proliferate or accumulate abnormally in bone marrow, peripheral blood and other tissues, resulting in damage to normal hematopoietic function. Studies have shown that about 30% of AML patients have FMS-like tyrosine kinase 3 (FLT3), FLT3 abnormal regulation is closely related to the occurrence and development of AML. At present, FLT3 has become an important target for developing small molecular targeted drugs. Currently, a variety of FLT3 inhibitors and FLT3 degraders have been developed targeting FLT3, and some compounds have exhibited good anti-AML activity. This article summarizes and sorts out the current mainstream drugs for AML therapeutic targeting FLT3, in order to provide a reference for the development and design of AML drugs.
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Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".
Subject(s)
Humans , China , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , Reference StandardsABSTRACT
Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.
Subject(s)
Humans , China , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , PharmacovigilanceABSTRACT
This study systematically combed and analyzed the use of such terms as "prohibition", "contraindication", and "use with caution" in ancient Chinese books on materia medica and prescriptions, Pharmacopoeia of the People's Republic of China(《中华人民共和国药典》), and teaching materials and monographs of Chinese materia medica by means of hermeneutics, commentariology, textology, and data mining, and explored the historical evolution and conceptual connotations of "prohibition", "contraindication", and "use with caution" in Chinese materia medica, so as to provide reference for standardizing their understandings and clinical reasonable medication. The "prohibition", "contraindication", and "use with caution" of Chinese materia medica were first proposed in the period of pre-Qin and Han dynasties. "Prohibition" and "contraindication" were separately developed in the Sui, Tang, and Five dynasties and Song, Jin, and Yuan dynasties and have been widely used since the Ming and Qing dynasties. The "use with caution" becomes popular rapidly in modern times and is often present in clinical medication together with "prohibition" and "contraindication". "Prohibition" basically means strictly prohibited and "contraindication" means to avoid as much as possible. The terms "prohibition", "contraindication", and "use with caution" have experienced evolution from the pre-Qin period to modern times, and they are used to describe the degree of restriction on drug use("prohibition" > " contraindication" > "use with caution").
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In view of the current controversy in the clinical evaluation of the terms of 'prohibition' 'contraindication', and 'use with caution', the present study summarized their evaluation elements to provide references for the classification of 'prohibition' 'contraindication', and 'use with caution' and clinical rational medication of drugs. Based on the ancient and modern representative traditional Chinese medicine (TCM) literature, such as the records on herbal medicines and prescriptions, medical classics, pharmacopoeia, clinical monographs, and papers, this study proposed the evaluation elements and the underlying ideas of 'prohibition' 'contraindication', and 'use with caution' around the risks and benefits of medication. The results indicate that the evaluation elements of 'prohibition' 'contraindication', and 'use with caution' include TCM property,syndrome,symptom, TCM compatibility,dosage,and treatment course. When evaluating 'prohibition' 'contraindication', and 'use with caution' of TCM under specific conditions of medication,we can determine the properties of prohibited or contraindicated drugs prior to figuring out the differences in 'prohibition' 'contraindication', and 'use with caution'. It is feasible to evaluate the clinical 'prohibition' 'contraindication', and 'use with caution' in TCM from Chinese medicine, body, and the clinical medication, which are correlated with each other in the practice implementation.
ABSTRACT
Autism spectrum disorder (ASD) is a common neurodevelopmental disorder in childhood, whereas there is no specific medicine at present. There are more and more researches on the treatment of ASD with traditional Chinese medicine(TCM) which the curative effect is reliable. The heart and spleen are the main viscera for the treatment of ASD, but there is still a lack of in-depth analysis of the mechanism of TCM. In order to explore the relationship between the core symptoms of ASD and the heart and spleen, this article specifically explores the theoretical origins of the heart and the spleen in the formation of the core symptoms of ASD, and to clarify the role of the heart and spleen in the occurrence and development of the two core symptoms of ASD from the perspective of TCM. In view of social communication and communication obstacles, the author puts forward and explains the language problems of children with ASD based on the functions of the heart and spleen, the theory of the viscera, the ascription of the meridians, and the classics. The mechanism of the heart and spleen in TCM about the failure of the spleen, the loss of the heart, and the endogenous phlegm. Aiming at the mechanism of the stereotyped symptoms of abnormal behaviors in children with ASD, this paper proposes and explains the TCM mechanism of constant deficiency of the spleen and dereliction of duty, leading to loss of mind, heart and spleen injury, and finally a series of stereotypes and strange syndromes due to lack of spirit. Through the analysis and excavation of TCM theory, it explores theoretical basis for ASD from the theory of heart and spleen, with a view to preliminarily constructing the theoretical framework of TCM syndrome differentiation and treatment of the deficiency of both the heart and spleen, and provide theoretical reference for TCM syndrome differentiation and treatment of ASD. The treatment of ASD from the differentiation of symptoms and signs of the heart and spleen is supported by a strong theoretical basis of TCM, and the rationale, law and prescriptions are complete, which may be the direction of screening effective TCM prescriptions for the treatment of ASD in the future.
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In order to solve the problems of confusion in clinical medication and imperfect instructions in Chinese patent medicines(CPMs), the Standardization Department of the China Association of Chinese Medicine and Center for Pharmacovigilance and Rational use of Chinese Medicine in Beijing University of Chinese Medicine jointly compiled the Instructions for Clinical Application of Chinese Patent Medicines(CPMs). As the interpretation and supplement of drug instruction information, it aims to guide clinical safety and rational use of CPMs. In addition, the technical specification for clinical application description of CPMs has been formulated, which covers the seven processes of "carding instructions, clinical investigation, data retrieval, data screening, evidence classification, path transformation and writing format". It will enable readers of Instructions for Clinical Application of Chinese Patent Medicines to understand the work behind the compilation.
Subject(s)
Beijing , China , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription Drugs , PharmacovigilanceABSTRACT
Objective:To analyze the research status of gouty arthritis at home and abroad in the past 15 years,and to provide reference for for further in-depth research in this field. Method:With “Gouty arthritis” as the research topic, the related papers during 2004—2019 were searched in Web of science core collection database and CNKI databases respectively. The results were statistically sorted out according to publication year,author,institution,literature source and key words,etc,and were visualized by CiteSpace software. Result:A total of 5 071 Chinese papers and 1 136 English papers were included. The amount of domestic and foreign publications continued to rise,forming a core team represented by LI Zhao-fu,XIONG Hui,SCHLESINGER NAOMI and other authors. The research hotpots focused on the pathogenesis,diagnosis methods, Chinese and Western medicine treatment,clinical observation,risk assessment and other aspects of gouty arthritis. Both of them had their own emphases. Domestic researches tended to focus on the treatment of gouty arthritis with traditional Chinese medicine,while foreign ones focused on the pathological research and clinical investigation of gouty arthritis. Conclusion:The number of researches in the field of gouty arthritis is on the rise as a whole,and there are both consistency and differences in the research content and hot topics between domestic and foreign literature. Therefore, we should strengthen cooperation and exchange between different teams and countries,so as to promote the overall development of this field.
ABSTRACT
Based on the pharmacovigilance thoughts of Chinese medicine of cognition, application, prevention and rescue of drug toxicity, to sort out the pharmacovigilance information in representative herbal works of the Ming dynasty, and to analyze the characteristics of the pharmacovigilance thoughts of the Ming dynasty, so as to provide reference for rational drug use in modern clinical practice. Taking Bencao Pinhui Jingyao, Bencao Gangmu, Paozhi Dafa, Bencao Shengya Banjie, Bencao Mengquan as the blueprints, and taking the traditional Chinese medicines in these books as the research objects, the text information was extracted from the four aspects of drug identification, drug use, drug prevention and detoxification, and the idea of pharmacovigilance was summarized. In Ming dynasty, pharmacovigilance had a systematic understanding, and cognition of drug toxicity was clear in identifying poison and correcting the mistakes of predecessors, in the aspects of using and preventing poisons, the use of poisons was prominent, the compatibility and process of poisons were emphasized, and the methods and mechanism of poison relief were clear in detoxification. Ming dynasty has initially formed the whole pharmacovigilance theoretical frame of cognition, application, prevention and rescue of drug toxicity, which has certain guiding and reference significance for modern clinical rational drug use.
ABSTRACT
Rheumatoid arthritis(RA) has a high disability rate and is highly harmful. It has a long course of treatment and is prone to adverse reactions or events(ADR/ADE). Selection of drugs in particular shall give consideration to both benefits and risk. Tripterygium Glycosides Tablets(TGT) is one of the important drugs for the treatment of RA. It has a remarkable efficacy, but a strong toxicity, which is controversial in clinical use. The study was oriented to patients, and quantitatively evaluated the efficacy and risk of TGT in treatment of RA, providing an intuitive basis for clinical safety and effective application of TGT. A multi-criteria decision-making analysis(MCDA) model of TGT was built in the treatment of RA, and then benefit and risk indicators were weighted by SWING method. Totally 53 random clinical trials(RCT) in accordance with the evaluation criteria were included by Meta-analysis method. The RCT results were merged by Meta-analysis, indicating that compared with the conventional therapy of chemical immunosuppressant(CISD), TGT could improve the curative effect whether it was used alone or in combination with CISD, but it would increase the incidence of reproductive system damage. The combined administration with CISD would also increase the incidence of liver and kidney damages. Treatment outcomes varied according to the different conditions of the combined administration with CISD. Based on MCDA model and clinical results, the benefit value, risk value and benefit-risk value of different doses, courses and combined administration of TGT in the treatment with RA were compared. The results showed that when the benefit and risk of the drug were equally important to the patient, the benefit-risk value of the single administration of TGT was 59, while that of the combined administration of TGT and CISD was 39. Therefore, the benefit-risk value of the single administration of TGT was 100% better than the combined administration. When the combined administration of TGT and CISD is unavoidable, the benefit-risk value of low-dose TGT(0.10-0.99 mg·kg~(-1)·d~(-1)) was 48, while that of high-dose TGT was 36. Therefore, low-dose TGT combined with CISD was more easily accepted by patients. The 2 to 3-month treatment course had a benefit-risk value of 40, while the long treatment course had a benefit-risk value of 38. Based on existing evidences, the single administration of TGT may be better than the combined administration with CISD. If the patients need to combine with CISD to treat RA, low dosage and 2 to 3-month course may be relatively optimal.
Subject(s)
Humans , Arthritis, Rheumatoid/drug therapy , Decision Support Techniques , Drugs, Chinese Herbal/therapeutic use , Glycosides/therapeutic use , Randomized Controlled Trials as Topic , Tablets , Tripterygium/chemistryABSTRACT
Coumarin is an important class of natural organic compounds, which widely exists in a variety of plants and microorganisms. Coumarins have many biological activities and wide clinical applications, such as anti-tumor, anti-HIV, anti-bacterial, anti-inflammatory, anti-oxidation, anti-coagulation, but they have obvious toxic effects in rodents. It was found that the toxicity of coumarins in different animals and organs was significantly different, and high dose oral administration was more likely to produce toxic reactions. Based on the research and analysis of domestic and foreign literatures in recent 60 years, this paper mainly summarized the hepatotoxicity and pulmonary toxicity induced by coumarins, and probed into their possible mechanisms. It was found that the toxicity of coumarins had metabolic differences and species differences. The liver of rats and lungs of mice were more susceptible to coumarins. Toxic reactions occurred mainly in the second metabolic pathway of coumarin metabolism in vivo. In order to put forward safety considerations and evaluate the impact of coumarin on human body, it was found that coumarin is unlikely to produce hepatotoxicity at normal exposure level. It was also suggested that species differences due to different metabolic patterns in model animals should be carefully considered when assessing coumarin toxicity, in order to provide reference for clinical research and rational use of coumarins and improve the rational use of coumarins.
Subject(s)
Animals , Humans , Mice , Rats , Coumarins/toxicity , Liver/drug effects , Lung/drug effects , Metabolic Networks and Pathways , Species Specificity , Toxicity TestsABSTRACT
Because coronavirus disease 2019(COVID-19) is highly contagious and serious, it has posed a major threat to public health worldwide. The curative effects of integrated traditional Chinese medicine and Western medicine in the treatment of COVID-19 have been widely recognized and confirmed. However, medical workers shall pay attention to drug-induced heart injury in clinical application. Based on the guideline from the Diagnosis and Treatment Plans for COVID-19(trial seventh edition), taking the recommended drugs as examples, by Western medicine, traditional Chinese medicine, Chinese herbal injection and integrated traditional Chinese and Western medicine, the study analyzed the basic characteristics of recommended drugs for cardiac injury by means of literature review and bioinformatics methods, and summarized cardiac adverse reactions, toxicity mechanisms, combined pharmacotherapy, special population and drug monitoring, focusing on the clinical manifestations, toxic components, targets and regulatory mechanisms of drug-induced cardiac injury. The findings suggested being vigilant to drug-induced cardiac injury during the treatment of COVID-19, playing the advantages of clinical pharmacists and clinical Chinese pharmacists, improving the knowledge reserve of pharmacovigilance, strengthening the prescription review, medication notification and medication monitoring, promoting rational drug use and paying attention to special populations and high-risk groups. The study aims to provide suggestions and reference for pharmacovigilance and pharmaceutical care for front-line doctors and pharmacists against COVID-19, in order to avoid the occurrence of drug-induced heart injury for patients with COVID-19.
Subject(s)
Humans , Betacoronavirus , Cardiotoxicity , Coronavirus Infections , Drug Therapy , Drugs, Chinese Herbal , Heart Injuries , Medicine, Chinese Traditional , Pandemics , Pharmacovigilance , Pneumonia, ViralABSTRACT
To investigate the pharmacodynamic effect and virulent effect of the main components of the toxic Chinese medicine Tripterygium wilfordii,such as triptolide,tripchlorolide,tripterine,demethylzeylasteral,wilfotrine and euonine,the admet SAR online assessment system was used to calculate the properties of the main components of T. wilfordii. The potential targets of the components were mined and collected through multiple databases,and the potential targets were enriched by the bioinformatics database DAVID.Cytoscape software was used to establish a " target-pathway" network and perform topology analysis on the network. The main chemical components of T. wilfordii were able to penetrate the blood-brain barrier and had intestinal permeability. A total of 65 targets were predicted,including pathways in cancer,hepatitis B,rheumatoid arthritis,and chagas disease( American trypanosomiasis),Toll-like receptor signaling pathway,apoptosis,colorectal cancer,NF-kappa B signaling pathway,etc. T. wilfordii mainly plays a role in the treatment of immune diseases and cancer by regulating inflammatory signaling pathways and cancer signaling pathways. Its action on apoptosis pathway and drug metabolism enzymes may be the mechanism of its toxicity.
Subject(s)
Humans , Computational Biology , Drugs, Chinese Herbal , Pharmacology , Inflammation , Signal Transduction , Tripterygium , ChemistryABSTRACT
Through literature review, it was found that there were many literature reports on the effect of single-herb traditional Chinese medicine for lowering uric acid in comparison with other single-herb traditional Chinese medicines. Then what is the relationship between single-herb traditional Chinese medicines for eliminating dampness and uric acid? How do they play a role in lowering uric acid? In this study, traditional Chinese medicines for eliminating dampness in the 2015 Chinese Pharmacopoeia and the innovative textbook of Clinical Chinese Pharmacy for Chinese medicine colleges and universities in the new century were selected as the research objects, and articles about the effect of single-herb traditional Chinese medicines for eliminating dampness in the treatment of hyperuricemia were searched through CNKI, WanFang and VIP. Afterwards, Excel(2016) was used to establish a database, and Excel screening tool was used to extract the classification statistics of its uric acid lowering effect, pharmacodynamic sites, uric acid lowering pathway and mechanism, so as to clarify the relationship between single-herb traditional Chinese medicines for eliminating dampness and uric acid as well as their mechanism on lowering uric acid. The results showed that there were 16 kinds of traditional Chinese medicines with uric acid lowering effect, accounting for 23.88% of the 67 kinds of traditional Chinese medicines for eliminating dampness. Other medicines with the uric acid lowering effect included traditional Chinese medicine extracts and chemical components. The main ways of reducing uric acid included: inhibiting uric acid synthesis and promoting uric acid excretion; mechanism of action was mainly regulating the two key enzymes generated by uric acid and the ion transporters excreted by uric acid. Therefore, it can be seen that this kind of traditional Chinese medicines have a clear effect in reducing uric acid, providing new ideas for drug screening, prescription compatibility and target determination for the treatment of hyperuricemia as well as a theoretical basis for the clinical treatment and research of hyperuricemia.
Subject(s)
Humans , Drugs, Chinese Herbal , Therapeutic Uses , Hyperuricemia , Drug Therapy , Medicine, Chinese Traditional , Uric Acid , MetabolismABSTRACT
Taking the Zeyao Materia Medica,Benjing Fengyuan,De Pei Materia Medica,Shiyi Materia Medica,Harmful Benefits of Materia Medica as representative works in Qing Dynasty,this paper extracts text information from four aspects: drug identification,drug use,drug prevention and detoxification,constructs a drug pharmacovigilance information table of Qing Dynasty herbal works,and summarizes the drug pharmacovigilance of Qing Dynasty. Thought,in the Qing Dynasty,there were many recordings of drug pharmacovigilance. In the aspect of drug awareness,the main representative was Shi Yi Materia Medica which added many new drugs and introduced more new uses of drugs. In addition,in the aspect of drug use and prevention,the main representatives were Zeyao Materia Medica,Benjing Fengyuan,De Pei Materia Medica,and Harmful Benefits of Materia Medica. In the aspect of taboo of disease and syndrome,attention should be paid to the integration of medicine so as to make drugs closely related to clinical use. Although there is no special introduction on detoxification,it has been introduced in various medicines in the De Pei Materia Medica,Shiyi Materia Medica,which has a relatively systematic and complete drug warning ideology system of " drug identification-use-drug prevention-detoxification".This study found that the traditional pharmacovigilance thought of Qing Dynasty had the characteristics of attaching importance to the clinical application of toxic traditional Chinese medicine and the combination of medicine,which had certain guiding significance for modern clinical medication. This paper aims to explore the traditional drug pharmacovigilance knowledge in representative works of the Qing Dynasty,analyze the characteristics of the drug pharmacovigilance thought in the Qing Dynasty,and lay a foundation for clarifying the traditional drug pharmacovigilance system.
Subject(s)
China , Drug Delivery Systems , Drugs, Chinese Herbal , Materia Medica , Medicine, Chinese Traditional , Pharmacovigilance , RecordsABSTRACT
Objective: Aconitum has a wide range of pharmacological activities, but its clinical toxic dose is close to the therapeutic dose. Puji Fang, as the greatest prescription book in China, analyzes and studied Aconitum herbal medicines prescriptions in Puji Fang used for children, and summarizes the rules and characteristics of children's medication for Aconitum Chinese medicine, so as to provide guidance for the clinical application of Aconitum herbal medicines in children. Method: Aconitum herbal medicines prescriptions in Puji Fang used for children were collected and organized to establish a prescription data sheet for Aconitum herbal medicines, for the purpose of statistics and analysis of Aconitum herbal medicines, their dosage, dosage form, indications and processed products. Result: A total of 300 children prescriptions containing Aconiti Lateralis Radix Praeparata, Aconiti Radix, Aconiti Kusnezoffii Radix, Aconitum carmichaelii and Tianxiong in Puji Fang were collected, and 64.45% of the prescriptions were based on Aconiti Lateralis Radix Praeparata. There were 13 types of diseases, mainly including severe convulsion, chronic spleen convulsion, vomiting and diarrhea. The prescriptions with a medicinal dose of Aconitum herbal medicines below 3 g accounted for 95.10% of the recorded dose. Children's Aconitum herbal medicines prescriptions were mainly for oral administration, 48.33% were pills, and the dosage of pills was higher than that of powder and decoction. There were 169 prescriptions for the use of processed products, accounting for 54.17%, 170 prescriptions with a specially administered medicine method, and those taken with "rice soup" occupied the highest proportion. Conclusion: Children's Aconitum medicines prescriptions account for a small proportion in the prescriptions of Puji Fang and a lighter dose, with differences in the dosage between different formulas. This article provides a reference for the safe and effective use of Aconitum medicines by studying the application of Aconitum medicines in children's prescriptions. It is necessary to establish a clinical warning of aconitum herbal medicines in the aspects of drug delivery based on syndrome differentiation, strict control of dosage and course of treatment, emphasis on compatibility, medication contraindications, and strengthened clinical drug monitoring.
ABSTRACT
Rheumatoid arthritis (RA) has the characteristics of long course of disease and difficulty in treatment. The conventional therapy may easily induce adverse drug reactions or events (ADR/ADE) due to the long-time medication. Thus, it should be given special attentions to treatment benefit and medication risk of RA patients. Aconitum, a kind of toxic traditional Chinese herbs, is an important complement therapy for RA, with some controversy in clinical application. Coming straight to the practical problem of combined use of traditional Chinese medicines (TCM) and Western medicines (WM), this study conducted quantitative assessment on the benefits and risks of Aconitum using combined with WM or not, which was carried out by the method of multi-criteria decision analysis model. RevMan 5.2 software was used to separately analyze the results of every index of 21 random clinical trials (RCTs) of Aconitum exclusive use in the treatment of RA, and 49 RCTs of Aconitum combined use with WM. The merged results indicated that as compared with the conventional therapy of WM, no matter the exclusive use or the combined use of Aconitum could improve the efficacy and decrease the incidence of ADR/ADEs. Based on the benefit-risk assessment decision tree of RA treatment, Hiview 3 software and Crystal Ball Monte Carlo simulation were used to calculate the benefit value, risk value and benefit-risk value of Aconitum exclusive use and the combined use of Aconitum with WM. The results showed that the combination therapy had significantly better benefits than Aconitum exclusive using, difference value was 15, (95%CI[9.72, 20.25]), but the risk of combined use was higher difference value=23, (95%CI[15.57, 30.55]). In comprehensive consideration of the benefit and risk, the total benefit-risk value of using Aconitum alone was 58, while that of the combination therapy was 55, and the probability of the former superior to the latter was 81.07%. The study showed that Aconitum was the important therapy to supply RA treatment. In clinical application, the patient's acceptability of benefit and risk need to be considered; if patients cannot bear the risk, the combination use of Aconitum and WM is not recommended.