ABSTRACT
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").
ABSTRACT
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
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
To analyze the study advance of Cichorium intybus, a kind of medicinal food, this study systematically retrieved Chinese and English literatures of C.intybus-related studies based on CNKI and the Web of Science database platforms by literature metrological research method and CiteSpace 5.5.R2 software, and visualized the literatures. A total of 1 247 Chinese literatures and 1 488 English literatures were included. Author analysis showed that HAN Yongfen in Guizhou Grass Industry Research Institute and W VAN DEN ENDE in Belgium Catholic University of Leuven had the most publications in Chinese and English C.intybus literatures respectively. ZHANG Bing's team was the core study team of C. intybus in China. Beijing University of Chinese Medicine and Belgium Catholic University of Leuven had the largest number of Chinese and English Cichorium literatures. There was a few cooperation between Chinese study institutions and close cooperation between foreign research institutions. Keywords analysis showed that C.intybus studies mainly focused on breeding and growth performance, composition analysis and content determination, nutritional value and medicinal value, in which C.intybus composition and its role in reducing uric acid were the hotspots of current studies. This study found that C.intybus has a high economic value and medicinal value, and its food nutrition and medicinal activity will be the main directions of future studies.
Subject(s)
Cichorium intybus , Beijing , China , Databases, Factual , SoftwareABSTRACT
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
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
The outbreak of coronavirus disease 2019(COVID-19) seriously endangers people's health. Traditional Chinese medicine(TCM) has been recommended for the treatment of COVID-19 in Novel Coronavirus Pneumonia Prevention and Control Strategy, which have made outstanding contributions to the prevention and control of the epidemic. The wide application of Chinese medicine asked the pharmacists and doctors, nurses, and medical technicians in Wuhan and around the country to stand on the front line of COVID-19 treatment, and provide pharmaceutical care services, which has effectively guaranteed the safety and rational use of Chinese medicine. This article will introduce the TCM cognition of the COVID-19, analyze the clinical application of Chinese medicine and the entry point of pharmaceutical care, and clarify that clinical Chinese pharmacists can participate in making medication therapy plan, medication reconciliation, and prescription review, promoting rational drug use, pharmaceutical monitoring, and drug risk management. The participation of clinical Chinese pharmacists in the prevention and treatment of COVID-19 is conducive to improving the level of rational use of TCM, by ensuring the effectiveness, and safety.
Subject(s)
Humans , Betacoronavirus , COVID-19 , China , Coronavirus Infections/drug therapy , Medicine, Chinese Traditional , Pandemics , Pharmaceutical Services/organization & administration , Pneumonia, Viral/drug therapy , SARS-CoV-2 , COVID-19 Drug TreatmentABSTRACT
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
Skin itching is a subjective sensation that causes the desire to scratch. It is one of the most common clinical symptoms at department of dermatology, even the only complaint of dermatological patients, which seriously affects the quality life of patients. Therefore, based on the software of traditional Chinese medicine inheritance auxiliary platform, association rules and complex system entropy clustering were adopted to collect and analyze Zhang Bing's prescriptions for skin itching, and get the drug use frequency and the relationship between drugs. Based on that, we could conclude the experience for skin itching. A total of 147 prescriptions were collected, 20 drugs with a frequency of 34 or more and 20 high-frequency drug combinations were analyzed, and 14 core combinations and 7 new prescriptions were excavated. The high-frequency drugs included Kochiae Fructus, Dictamni Cortex, Mori Cortex. The high-frequency drug combinations included "Kochiae Fructus-Dictamni Cortex" "Angelicae Dahuricae Radix-Chuanxiong Rhizoma" "Paeoniae Radix Rubra-Paeoniae Radix Alba", and the core combinations included "Schizonepetae Herba-Saposhnikoviae Radix-Cinnamomi Ramulus" "Arctii Fructus-Cicadae Periostracum-Houttuyniae Herba" "Ghrysanthemi Indici Flos-Kochiae Fructus-Dictamni Cortex", and new formulations include "Schizonepetae Herba, Saposhnikoviae Radix, Cinnamomi Ramulus, Clematidis Radix et Rhizoma, Tribuli Fructus, Dictamni Cortex", "Phellodendri Chinensis Coritex, Lonicerae Japonicae Flos, Atractylodis Rhizoma, Ghrysanthemi Indici Flos, Kochiae Fructus, Dictamni Cortex" "Arctii Fructus, Cicadae Periostracum, Houttuyniae Herba, Trichosanthis Fructus". The result of this research shows that Professor Zhang Bing's experience in the treatment of skin itching is mainly to dispelling wind and arresting itching, clearing heat and drying dampness.
Subject(s)
Humans , Data Mining , Drug Combinations , Drugs, Chinese Herbal , Therapeutic Uses , Medicine, Chinese Traditional , Pruritus , Drug Therapy , SoftwareABSTRACT
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
The application of Aconitum herbs in the treatment of Bi syndrome has a long history and exact effects.By taking Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Preparata(Fuzi) as example, this study was aimed to mine the prescription rules of Aconitum herbs in the treatment of Bi syndrome, and provide thoughts and bases for modern clinical medication. 1 106 prescriptions were obtained in more than 20 classic books including medical, pharmacy, and synthesized books from Eastern Han dynasty to Qing dynasty. Based on the methods of frequency statistics, percentile statistics and Apriori algorithm of association rules, the characteristics of syndrome classification, dosage and compatibility of Aconitum herbs in the treatment of Bi syndrome were analyzed. The data-mining results indicated that 60.76% prescriptions contained Fuzi, which was obviously higher than Chuanwu or Caowu, and 17.63% contained two or more kinds of Aconitum herbs. 70.34% prescriptions were used mainly to treat Bi syndrome with wind-cold-wetness, others were for the syndrome with the deficiency of liver and kidney, blockage of phlegm and blood stasis, and wind-heat-wetness Bi. In the prescriptions with definite dose, 80% dosage of Fuzi was in the range from 0.29-2.14 g·d⁻¹, while the dosage of Chuanwu and Caowu was from 0.14-1.01g·d⁻¹, which was also affected by patterns, formulations and processing. The dose of Aconitum herbs was highest in the Bi syndrome with wind-cold-wetness, and its dose in the decoction and vinum was significantly higher than that in the pills and powders. The processed products were used in 93.11% prescriptions, and their dosage was higher than the raw ones. In the clinical treatment of Bi syndrome, Chuanwu and Caowu were often used with Saposhnikoviae Radix(Fangfeng), Liquiritiae Radix et Rhizoma(Gancao), Myrrha(Moyao) and Ephedrae Herba(Mahuang), while Fuzi was often used with Cinnamomi Cortex(Rougui), Achyranthis Bidentatae Radix(Niuxi), Fangfeng and Chuanxiong Rhizoma(Chuanxiong), which can both expel wind-dampness and relieve pain. All in all, Aconitum herbs are widely used in the treatment of Bi syndrome, which can relieve arthralgia and pain.
Subject(s)
Humans , Aconitum , Chemistry , Arthralgia , Drug Therapy , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Pain Management , Rhizome , ChemistryABSTRACT
Based on the relation of efficacy and toxicity, this study mined the dosage rules and characteristics of Aconitum herbs in oral prescriptions from 48 traditional ancient books from Eastern Han dynasty to Qing dynasty, to provide the basis for strengthening the clinical risk pharmacovigilance. In the 48 traditional ancient books, 4 521 prescriptions with clear daily oral dosage were included to establish a database. SPSS 20.0 software was used for statistics and analysis of the daily dosage characteristics with different kinds of herbs, indications, dose forms, processing, use in special population, and other aspects. The results showed that 67% prescriptions contained Aconitum carmichaeli(Fuzi), and 90% of them was less than 14.87 g·d⁻¹; The dosage of A. carmichaeli(Chuanwu) and A. kusnezoffii(Caowu) were less than 3.14 g·d⁻¹. In the prescriptions for treating typhoid, epidemic, edema and phlegm, the dosage of Aconitum was larger. There dosage in the decoction and vinum was significantly higher than that in the pill and powder. With the dynastic evolution, the dosage of Aconitum herbal medicines prescriptions and the application percentage of superposition drug also had decreased. For the special populations that with different metabolism process, such as old people, children, pregnant and lactating women, the application of Aconitum was not only with relatively small ratio, but also with lower dose. Therefore, based on the data-mining of ancient books, the dosage of Aconitum should not exceed the limit prescribed by the current China Pharmacopoeia, and also should be strictly controlled by considering various factors, which will ensure the balance of efficacy and toxicity.
Subject(s)
Humans , Aconitum , Chemistry , Toxicity , China , Data Mining , Dose-Response Relationship, Drug , Drugs, Chinese Herbal , Toxicity , Medicine, Chinese TraditionalABSTRACT
Sixty SD male rats were randomly divided into normal group, model group, benzbromarone group(20 mg•kg⁻¹•d⁻¹), chicory extract high dose, middle dose and low dose groups (5, 7.5, 10 g•kg⁻¹•d⁻¹). The rats in normal group were given with water, and the rats in other groups were given with 10% fructose solution to establish hyperuricemia models. All the rats were sacrificed on the 42th day. Then their serum uric acid(SUA), serum creatinine(CRE), urea nitrogen(BUN) and urinary uric acid(UUA) levels were detected to calculate the clearance rate of uric acid in kidney(CUA). Meanwhile, the protein and gene expression levels of renal glucose transporter family member 9(Glut9) were detected by immunohistochemical and Real-time quantitative reverse transcription-polymerase chain reaction(RT-qPCR) methods. The effects of Chinese herb chicory extract on expression of renal Glut9 and decreasing uric acid were explored in this study, and the results showed that chicory extract could reduce SUA level in rats with hyperuricemia, increase renal CUA, decrease the protein expression of renal Glut9, inhibit uric acid re-absorption in kidney, and thus promote renal uric acid excretion.
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Toxicity of traditional Chinese medicine(TCM) is the core of pharmacovigilance of Chinese medicine, whose initiation, development and practice revolves around the toxicity of TCM. Toxicity of TCM has rich meanings, and are influenced by three factors: drug composition, clinical use and patient constitution. With the increasingly deep understanding of toxicity of TCM, the cognition of clinicians is more objective, and the application, prevention and rescue are more complete. Therefore, based on the analysis of large numbers of ancient books, we put forward the whole pharmacovigilance theoretical frame that is formed by cognition, application, prevention and rescue of drug toxicity, which comprehensively reflects the academic Characteristics of safety medication in TCM.
ABSTRACT
Chinese patent medicines for orthopedics are among the hotspot and difficulty in the rational medication of traditional Chinese medicine (TCM), because they mostly contain toxic medicinal herbs and oriented to special patients. According to the hospital pharmacy practices and the therapeutic theories of TCM, this paper focused on a novel model of rational drug use of Chinese patent medicine for orthopedics based on the principles of ″syndrome-dosage-toxicity differentiation″. We also proposed relevant specifications for guiding their clinical use. Firstly, we proposed a list of the primary clinical application characteristics for rational drug use of orthopedic TCMs, including the syndromes of patient, the dosage of medicine and the toxic ingredients in medicine. Secondly, a database was established for recording the package inserts of all of the 81 orthopedic patent medicines in our hospital, and 2 000 retrospective recipes were analyzed for looking for the high-frequency medicines and common irrational factors. Then clinical case reports involving the adverse reactions and side effects of related drugs were searched from CNKI, VIP and WanFang databases. Then the key information for rational application of each medicine was extracted from these resources and some survey questionnaires. Finally, we established a guide named instructions for clinical use of orthopedic Chinese patient medicines (ICUOCPM) after the discusstion with experts. According to the effect after the practice in hospital for 2 months, the proposed principles of ″syndrome-dosage-toxicity differentiation″ in this paper were believed to be the core elements and the most important clinical monitoring points in TCM for orthopedic patents. It would provide innovative ideas, theoretical guarantee and data support for the development of TCM clinical pharmacy.