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1.
Zhongguo Zhong Yao Za Zhi ; 45(1): 1-6, 2020 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-32237404

RESUMO

The discovery of active constituents of traditional Chinese medicine(TCM) faces multiple challenges, such as limited approaches to evaluate poly-pharmacological effects, and the lack of systematic methods to identify active constituents. Aimed at these bottleneck problems in the field, the present study intensively discussed the key scientific problems in the identification of active constituents of TCM, based on scientific methodologies including systematology, information theory, and synergetics. A comprehensive strategy is herein proposed to investigate the correlations between the chemical composition and biological activities of TCM, from macro-, meso-, and micro-scales. Moreover, in this study, we systematically proposed the methodology of the multimodal identification of TCM active constituents, and thoroughly constructed its core technologies. Its technical framework is suggested to be assessed by multimodal information acquisition, centered on multisource information fusion, and focused on interaction evaluation. Furthermore, the core technologies for the multimodal identification of active constituents of TCM were developed in this study, which is according to the characteristics of the exchanges of between TCM and biological organisms, in the aspects of material, energy and information. Finally, two examples of the application of the proposed method were briefly introduced. The proposed methodology provides a novel way to solve the bottlenecks in the study of active constituents of TCM, and lays the foundation for the multimodal study of TCM.

2.
Am J Chin Med ; 47(4): 751-767, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31094214

RESUMO

To systematically evaluate the efficacy and safety of berberine for the treatment of hyperlipidemia, six electronic literature databases including SinoMed, CNKI, WanFang Data, PubMed, Embase and The Cochrane Library were searched to collect clinical randomized controlled trials (RCTs) of berberine alone or combined with statins for the treatment of hyperlipidemia from the inception to 8 March 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included RCTs. Then, meta-analysis was performed by using RevMan 5.3 software. A total of 11 RCTs involving 1386 patients were finally included. The results of meta-analysis showed that compared with the placebo group, berberine could significantly reduce the total cholesterol and low-density lipoprotein levels and elevate the high density lipoprotein level ( P<0.05 ). Compared with the simvastatin group, berberine was effective only in reducing the level of triglyceride ( MD=-0.37 , 95% CI: - 0.66, - 0.07, P=0.02 ). There, however, was no statistical significance between the BBR group and simvastatin group in the low density lipoprotein and high density lipoprotein levels. Compared with the simvastatin group, berberine plus simvastatin was more effective in reducing the level of triglyceride ( MD=-0.33 , 95% CI: - 0.46, - 0.20, P<0.00001 ) and total cholesterol ( MD=-0.36 , 95% CI: - 0.60, - 0.12, P=0.003 ). In terms of adverse reactions, the incidence of adverse reactions including transaminase elevation and muscle aches was lower in the berberine alone or combined with simvastatin group than that in the control group, while the instance of constipation was higher. This study suggests that berberine is effective for hyperlipidemia. The quality and quantity of included studies, however, were dissatisfactory, which might decrease the reliability of the results. Higher quality studies are needed to provide more high quality evidence.


Assuntos
Berberina/uso terapêutico , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hiperlipidemias/tratamento farmacológico , Fitoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Sinvastatina/uso terapêutico , Berberina/efeitos adversos , Colesterol/sangue , Bases de Dados Bibliográficas , Quimioterapia Combinada , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Hiperlipidemias/sangue , Lipoproteínas HDL/sangue , Lipoproteínas LDL/sangue , Fitoterapia/efeitos adversos , Sinvastatina/efeitos adversos , Resultado do Tratamento , Triglicerídeos/sangue
3.
Ann Transl Med ; 7(6): 122, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31032277

RESUMO

Background: To develop the clinical practice guidelines for the treatment of sepsis with traditional Chinese medicine (TCM) therapy alone or TCM combined with antibiotics. Methods: The methods and process for developing the international clinical practice guidelines were fully consulted between a group of doctors. A total of 25 experts from 14 units were involved in the development of this guideline. The major clinical questions that needed to be solved were raised first, and the best available evidence to solve them was researched. Finally, according to the principle set by the GRADE system, the available evidence was graded with levels ranging from high to low. This formed the recommendation strengths, which included strong recommendation and weak recommendation, or an expert consensus recommendation. Results: The guideline identified the terms and definition for sepsis. For example, it identified its epidemiological characters, the advantages of TCM treatment on sepsis, the diagnosis and its features, the complications, and its rehabilitation and health maintenance. The guideline has put forward 14 recommendations, among which 4 were strong recommendations and 6 were weak recommendations, in addition to 4 expert consensus recommendations. Conclusions: The methods and processes for developing international clinical practice guidelines were fully consulted under the guide of relevant laws and regulations, and relevant technical documents. Based on the best existing evidence, and combined with the characteristics of TCM and the clinical realities, we developed Clinical practice guidelines for the treatment of sepsis with TCM therapy alone or TCM combined with antibiotics, with full reference to the experts' experience and patients' preferences.

4.
Zhongguo Zhong Yao Za Zhi ; 44(23): 5017-5021, 2019 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-32237332

RESUMO

To cope with the " six major scientific problems" and the " five major technical challenges" of intelligent manufacturing and lean production of Chinese medicine( CM),we systematically proposed strategies,methods and the engineering theory of intelligent and lean manufacturing for CM by integrating the holistic view of traditional Chinese medicine and the concepts inspired from international advanced pharmaceutical technology. Moreover,the translational research of the theory and methods was successfully applied to six CMs such as Xuesaitong Injection. Several intelligent production lines were designed and built on the basis of the theory and methods,which greatly accelerated the digitalization,networking,and intelligence manufacture for CM. As a conclusion,the theory and applications provide technical demonstration for technical upgrading and high-quality development of CM industry.

5.
Zhongguo Zhong Yao Za Zhi ; 44(24): 5269-5276, 2019 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-32237367

RESUMO

According to the requirements for developing the quality control technology in Chinese medicine( CM) manufacturing process and the practical scenarios in applying a new generation of artificial intelligence to CM industry,we present a method of constructing the knowledge graph( KG) for CM manufacture to solve key problems about quality control in CM manufacturing process.Based on the above,a " pharmaceutical industry brain" model for CM manufacture has been established. Further,we propose founding the KG-based methodology for quality control in CM manufacturing process,and briefly describe the design method,system architecture and main functions of the KG system. In this work,the KG for manufacturing Shuxuening Injection( SXNI) was developed as a demonstration study. The KG version 1. 0 platform for intelligent manufacturing SXNI has been built,which could realize technology leap of the quality control system in CM manufacturing process from perceptual intelligence to cognitive intelligence.

6.
Zhongguo Zhong Yao Za Zhi ; 43(19): 3834-3840, 2018 Oct.
Artigo em Chinês | MEDLINE | ID: mdl-30453706

RESUMO

The bitter taste is one of the important properties among five flavors of Chinese materia medica (CMM), characterized by downbearing and discharging, drying dampness, and consolidating Yin. In common CMM, bitter-taste CMM accounts for a large proportion, indicating the importance of it. Through the efficacy of clearing away heat and dampness, reducing fire and removing toxin, bitter-taste CMM has achieved good results in treating diabetes in clinical application, proving their definite therapeutic effect on regulating glucose and lipid metabolism (main features of diabetes). At present, there are many reports about the chemical constituents and pharmacological effects of CMM on diabetes, but there are few reviews on the chemistry and biology of bitter-taste CMM. This study summarized the properties and compatibility characteristics of bitter-taste CMM for treating diabetes, and mainly analyzed the chemistry and biology basis of bitter-taste CMM with function of regulating glycolipid metabolism, laying foundation for further researches on properties theory of CMM.


Assuntos
Materia Medica/química , Medicina Tradicional Chinesa , Paladar , Glicolipídeos/metabolismo , Pesquisa
7.
Zhongguo Zhong Yao Za Zhi ; 43(1): 1-7, 2018 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-29552804

RESUMO

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine.


Assuntos
Medicina Baseada em Evidências , Medicina Tradicional Chinesa , Pesquisa Biomédica , Humanos , Metanálise como Assunto , Controle de Qualidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisão Sistemática como Assunto
8.
Zhongguo Zhong Yao Za Zhi ; 43(24): 4741-4745, 2018 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-30717512

RESUMO

To evaluate the clinical application of clinical practice guideline on traditional Chinese medicine therapy alone or combined with antibiotics for pelvic inflammatory disease and provide reference for the revision of the Guideline. Questionnaire research was conducted from applicability and application evaluation. A total of 1 311 copies of valid questionnaires were obtained, including 717 questionnaires on applicability evaluation and 594 questionnaires on application evaluation. There were 83 items from 4 aspects in the applicability questionnaire. In statistical agreement rates of those items to reflect the application status of the Guideline, the rates of 8 items were all more than 95% except for rates of "content integrity", "comparison with the diagnosis and treatment scheme of his/her unit (individual)" and "economy of clinical application", 94.70%, 93.86% and 93.17% respectively. In statistical agreement rates of those items to reflect the quality of the Guideline, the rates of 3 items were all more than 97%, except the rate of "whether syndrome classification is reasonable" item was 95.26%. Among the items that reflect the local purchase difficulty and price evaluation of Chinese patent medicine recommended in the Guideline, most clinicians thought the prices were modest. There were 56 items from 6 aspects in the application evaluation questionnaire. In statistical agreement rates of those items to reflect the application rationality of the Guideline, the rates of 3 items were all more than 96%, except rate of "whether syndrome classification is reasonable" item was 91.58%. In statistical agreement rates of those items to reflect the clinical application effect of the recommended regimen in the Guideline, the traditional application of traditional Chinese medicine decoction had generally better application effect, whereas Chinese patent medicines were less effective. In statistical agreement rates of those items to reflect the overall evaluation of clinical application, the rates of "overall effect" and "overall safety" were all more than 96%, except the rates of "overall economy" item was 92.42%. It indicates that the overall effect of this Guideline is relatively well. It is suggested to improve the classification of syndrome differentiation and increase the species of Chinese medicine decoction and Chinese patent medicines, and to standardize the duration and course of medication. The next revised work should not only uptake the experiences of prominent TCM doctors and all kinds of research achievements, but also regularly update and strengthen the publicity of the Guideline.


Assuntos
Medicina Tradicional Chinesa , Doença Inflamatória Pélvica , Antibacterianos , Feminino , Humanos , Masculino , Medicamentos sem Prescrição , Guias de Prática Clínica como Assunto , Inquéritos e Questionários
9.
Zhongguo Zhong Yao Za Zhi ; 43(24): 4746-4752, 2018 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-30717513

RESUMO

A questionnaire survey of 1 000 clinicians having experience in treating uncomplicated lower urinary tract infections from different levels of hospitals was conducted to mainly evaluate the applicability and effectiveness of clinical application of clinical practice guideline on traditional Chinese medicine therapy alone or combined with antibiotics for uncomplicated lower urinary tract infection(hereinafter referred to as Guideline). The research was conducted with the three-level quality control strictly throughout the process, and the data was real and reliable. The survey's results showed that: most clinicians considered that the Guideline had good clinical applicability. The availability and price of the recommended medicine were moderate. Traditional Chinese medicine had obvious features and advantages in treating lower urinary tract infection for it could reduce the usage of antibiotics and shorten the course of antibiotic application. In the recommendation section, clinicians proposed increasing medication guidance, updating the Guideline timely, as well as increasing treating methods and techniques, strengthen propaganda and promotion, and improve the use of evidence-based methods. In the evaluation of effectiveness, the majority of clinicians agreed that the definition in both traditional Chinese medicine (TCM) and Western medicine and differential diagnosis in the Guideline were accurately described and the basic principle of treatment as well as the treating method of TCM were recommended appropriately. The TCM formulas and Chinese patent medicine had good effect. Some clinicians suggested refining the syndrome differentiation of stranguria. Some clinicians considered that the formulas and herbs recommended in Guideline didn't have obvious effect and some had doubts about the manipulation of fumigation and washing in the part of other methods recommended in Guideline. Moreover, specification and procedure of manipulation of fumigation and washing using herbs and the acupuncture included in characteristic TCM therapy treating uncomplicated lower urinary tract infection remained to be developed.


Assuntos
Medicamentos de Ervas Chinesas , Infecções Urinárias , Terapia por Acupuntura , Antibacterianos , Diagnóstico Diferencial , Humanos , Medicina Tradicional Chinesa
10.
Zhongguo Zhong Yao Za Zhi ; 43(24): 4753-4758, 2018 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-30717514

RESUMO

Questionnaires and case investigation methods were taken in this paper, taking the clinical practice guideline on traditional Chinese medicine therapy alone or combined with antibiotics for upper respiratory tract infection in children published by the Chinese Medicine Association as the research object. Doctors from 187 hospitals in 29 regions across the country were invited to evaluate the applicability of the Guideline and clinical application effects, so as to collect the opinions on revising the Guideline. Clinicians about 508 accepted the applicability survey of the Guideline, and considered that the structure and content of the Guideline were reasonable, with the proportions being as high as 98.23% and 98.03%, respectively. In the content of syndrome differentiation-based treatment, the factors with higher rationality included therapeutic principle and method (99.41%), diagnosis elements (98.82%), and syndrome differentiation classification (98.03%); while the factors with lower rationality included the rehabilitation and health preserving (97.05%) and complication prevention (97.24%). 98.03% of the clinicians considered theat the Guideline was to be fully applicable and basically applicable, and 1.97% of the clinicians considered it to be applicable after revision. By observing 491 cases, the Guide was applied for evaluation and analysis. The factors with higher compliance included diagnosis of Western medicine disease (100%) and the diagnosis of TCM disease (99.18%); while the factors with lower compliance included the treatment measures, with a compliance rate of 77.18% and 83.05% respectively for simple preparations and other treatment method. The safety and economy of the Guideline were good, 97.35%, 93.89%, respectively. The comprehensive evaluation was good, and 99.41% of the respondents were willing to follow the treatment schemes recommended in the Guideline, suitable for clinical application. The opinions on revision were mainly focused on dialectical treatment, complication prevention and rehabilitation. It indicates that only by actively and extensively soliciting opinions to revise the Guideline, can we improve the quality of the Guideline for clinical practice, so as to raise the level of clinical efficacy.


Assuntos
Medicina Tradicional Chinesa , Infecções Respiratórias , Antibacterianos , Criança , Humanos , Infecções Respiratórias/tratamento farmacológico , Inquéritos e Questionários , Resultado do Tratamento
11.
Zhongguo Zhong Yao Za Zhi ; 43(24): 4759-4764, 2018 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-30717515

RESUMO

To clarify the clinical application of the group standard (T/CACM 1035-2017) of the Chinese Society of Traditional Chinese Medicine (TCM), the clinical practice guideline on traditional chinese medicine therapy alone or combined with community acquired pneumonia, and to understand the clinical applicability of the Guideline. The clinical workers trained in terms of the Guideline in hospitals at all levels in China were selected as the research objects. A total of 494 questionnaires on application evaluation and 511 questionnaires on applicability evaluation were collected to construct the database of the post-effect evaluation of the Guideline. Excel software was used for statistical analysis. The overall evaluation of the Guideline was 92.31%, 91.06%, 87.45% respectively in efficacy, safety and economy. The Guideline was well used in clinical application, and 99.41% of the patients were willing to follow the recommended scheme. The agreed ratio in rationality evaluation was 97.98%, 92.37%, 94.53% and 92.71% in treatment rules, syndrome differentiation and classification, prevention of complications, and rehabilitation method. The effective rate of the prescriptions recommended in the Guideline was all above 65%. More than 80% of the prescriptions were Tanreqing Injection, Yinqiao Powder, Qingjin Huatan Decoction, Maxing Shigan Decoction, Shengmai San and Shashen Maidong Decoction. Adverse reactions, unknown active components and economy of Chinese patent medicines were the important factors affecting drug use and efficacy, providing a clinical basis for updating and revising the standard.


Assuntos
Infecções Comunitárias Adquiridas , Medicamentos de Ervas Chinesas , Pneumonia , Antibacterianos , China , Infecções Comunitárias Adquiridas/tratamento farmacológico , Humanos , Medicina Tradicional Chinesa
12.
Zhongguo Zhong Yao Za Zhi ; 43(24): 4765-4770, 2018 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-30717516

RESUMO

The purpose of this study is to analyze the obstructive factors of clinical practice guideline on traditional Chinese medicine therapy alone or combined with antibiotics for acute pharyngitis, and summarize the revision suggestions for follow-up revision and promotion. Clinical physicians from 181 hospitals in 27 regions of China were selected to complete the online questionnaire survey for statistical analysis of obstructive factors. We collected 501 copies of the applicability evaluation questionnaire and 503 copies of the application evaluation questionnaire. The obstructive factors mainly focused on limitation of the Guideline, inconvenience of access, particularity of primary medical structure and uneven distribution of surveyed subjects. As for amendments, it was suggested to improve the syndrome differentiation, indications, prescriptions, and add characteristic TCM therapies in Chinese medicine; it was suggested to clarify the time to use antibiotics in Western medicine. According to the results of this study, the relevant contents of the Guideline should be further improved so as to be better applied in clinical practice.


Assuntos
Faringite , Antibacterianos , China , Medicamentos de Ervas Chinesas , Humanos , Medicina Tradicional Chinesa , Faringite/tratamento farmacológico
13.
Zhongguo Zhong Yao Za Zhi ; 43(24): 4771-4775, 2018 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-30717517

RESUMO

The purpose of this article is to evaluate the clinical effect of clinical practice guideline on traditional Chinese medicine therapy alone or combined with antibiotics for acute tonsillitis. The applicability and application of the Guideline were evaluated based on the clinicians by using the electronic questionnaire. Questionnaires about 538 on application evaluation and 502 questionnaires on applicability evaluation were completed from April 28 to July 9, 2018. The subjects in the questionnaires include the clinicians with junior title, intermediate title, and senior title that have used this Guideline. The descriptive statistical analysis of the collected questionnaire was carried out. In the applicability evaluation, according to the classification of professional titles, the application rate was highest in intermediate title clinicians (26.77%), followed by junior (23.98%) and deputy senior (19.33%) professional title clinicians. In the quality evaluation, the rationality of application scope (98.61%) and the terminology accuracy (98.81%) scores were higher, and the rationality of differentiation and classification (96.05%) was the lowest. The applicability evaluation suggested that clinicians believed this Guideline had high safety (98.42%), reasonable content (98.03%), significant effect (99.6%), reduced use of antibiotics in Western medicine (93.89%), and a high applicability ratio (96.44%). In the application evaluation, Department of lung disease showed the highest application rate (44.24%); rationality of the Guideline was more than 97% in treatment rules and prophylaxis except the syndrome differentiation (92.75%); a high ratio of clinicians believed the recommended scheme was good: curative effect 97.4%, safety 97.59%, and economy 93.87%. The study shows that the clinical practice guideline on traditional Chinese medicine therapy alone or combined with antibiotics for acute tonsillitis is of good quality, high clinical use and good effect. It can be used as a standardized treatment scheme for acute tonsillitis in traditional Chinese medicine. But there are some unsuitable contents and need to be further improved. The Guideline should strengthen the revision on differentiation of symptoms and signs as well as prophylaxis.


Assuntos
Medicina Tradicional Chinesa , Tonsilite , Antibacterianos , Humanos , Guias de Prática Clínica como Assunto , Inquéritos e Questionários , Síndrome , Tonsilite/tratamento farmacológico
14.
Zhongguo Zhong Yao Za Zhi ; 43(24): 4776-4781, 2018 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-30717518

RESUMO

To investigate the clinical application of clinical practice guideline on traditional Chinese medicine therapy alone or combined with antibiotics for sepsis, in order to promote the follow-up revision and further promotion of the Guidelines. Copies of 500 application evaluation questionnaire and 500 copies of applicability evaluation questionnaire were given to the clinicians who had used this Guideline in China, both in a form of registered questionnaire, and a database was established by Excel 2016 for descriptive statistical analysis. Copies of 211 application evaluation questionnaire and 211 copies of applicability evaluation questionnaire were collected. We can conclude from the survey that we should adjust the whole content and structure on the basis of better evaluation of the present recommendation scheme, update the prescription selection and clinical evidence of the recommendation scheme, and put forward the improvement measures for the hindrance factors in the application of the Guideline. Furthermore, in order to promote the Guideline more clearly, we should strengthen the doctor-patient education, improve guidance quality and increase the publicity, providing basis for the implementation and promotion strategies of the Guideline.


Assuntos
Antibacterianos/uso terapêutico , Medicina Tradicional Chinesa , Sepse , China , Humanos , Sepse/tratamento farmacológico , Inquéritos e Questionários
15.
Zhongguo Zhong Yao Za Zhi ; 43(24): 4782-4785, 2018 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-30717519

RESUMO

Clinical practice guideline on traditional Chinese medicine therapy alone or combined with antibiotics for sepsis is strictly in accordance with the latest diagnostic criteria for sepsis (sepsis-3) for the treatment of septic patients at different stages through syndrome differentiation. At present, the abuse of antibiotics and the prevalence of drug-resistant bacteria are very serious, without effective solutions. Thus, this is the first time to focus on traditional Chinese medicine combined with antibiotics to treat sepsis, in order to minimize the incidence of drug-resistant bacteria. This Guideline tends to systematically analyze the sepsis period, septic shock period as well as different clinical symptoms and traditional Chinese medicine measures for organ dysfunction in the sepsis process. By analyzing and interpreting the Guideline systematically, the clinicians could understand its purpose, significance and core ideas more thoroughly, and grasp the recommended specific interventions as well as their advantages and disadvantages, hoping to better implement the Guideline, provide guidance to clinicians and standardize the treatment of sepsis by traditional Chinese medicine.


Assuntos
Antibacterianos/uso terapêutico , Sepse , Humanos , Medicina Tradicional Chinesa , Sepse/tratamento farmacológico
16.
Zhongguo Zhong Yao Za Zhi ; 42(21): 4049-4053, 2017 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-29271138

RESUMO

On October 18th, 2017, a research article named "Aristolochic acids and their derivatives are widely implicated in liver cancers in Taiwan and throughout Asia" was published on Science Translational Medicine. This article pointed out that herbs containing aristolochic acids could cause liver cancer by inducing the specific "aristolochic acids mutational signature". The public was also suggested to avoid the intake of herbs containing aristolochic acids. Since 2000, CFDA has gradually abolished the medicinal standards for herbs containing aristolochic acids such as caulis aristolochiae manshuriensis, aristolochia heterophylla and radix aristolochiae. Related drugs have been strengthened supervision since then. Chinese Pharmacopoeia has also removed the records of a series of related herbs. State Administration of Traditional Chinese Medicine held a conference on the "toxicity" of aristolochic acids as soon as the article was published. After a discussion of the studies on the toxicity of aristolochic acids, experts attending the meeting discovered several problems, including the unclearness of exposure history, tumor-producing dose and latent period, the absence of some key factors such as hepatitis B, the small sample size, miscellaneous factors, incomplete evidence chains, the missing of analyses between data with huge differences, the insufficiency of fundamental research arguments, etc. In order to understand the toxicity of aristolochic acids and the carcinogenic risks, as well as guide clinical safe medication, the experts suggested that:①Complete the systematical evaluation of aristolochic acids carcinogenicity as soon as possible. Scientifically elucidate the relationship between aristolochic acids and the genesis of liver cancer. ②Establish medication risk warnings of aristolochic acids and strengthen the supervision. ③Make an in-depth study of the toxicity of traditional Chinese medicine. Find out the adverse effects of all traditional Chinese medicine step by step.


Assuntos
Aristolochia/toxicidade , Ácidos Aristolóquicos/toxicidade , Medicamentos de Ervas Chinesas/toxicidade , Neoplasias Hepáticas/induzido quimicamente , Medicamentos de Ervas Chinesas/normas , Humanos , Medicina Tradicional Chinesa , Raízes de Plantas
17.
Zhongguo Zhong Yao Za Zhi ; 42(21): 4054-4058, 2017 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-29271139

RESUMO

Traditional Chinese medicine (TCM) prescription is the main therapies for disease prevention and treatment in Chinese medicine. Following the guidance of the theory of TCM and developing drug by composing prescriptions of TCM materials and pieces, it is a traditional application mode of TCM, and still widely used in clinic. TCM prescription has theoretical advantages and rich clinical application experience in dealing with multi-factor complex diseases, but scientific research is relatively weak. The lack of scientific cognition of the effective substances and mechanism of Chinese medicine leads to insufficient understanding of the efficacy regularity, which affects the stability of effect and hinders the improvement of quality of Chinese medicinal products. Component-based Chinese medicine (CCM) is an innovation based on inheritance, which breaks through the tradition of experience-based prescription and realize the transformation of compatibility from herbal pieces to components. CCM is an important achievement during the research process of modernization of Chinese medicine. Under the support of three national "973" projects, in order to reveal the scientific connotation of the prescription compatibility theory and develop innovative Chinese drugs, we have launched theoretical innovation and technological innovation around the "two relatively clear", and opened up the research field of CCM. CCM is an innovation based on inheritance, breaking through the tradition of experience based prescription, and realizing the transformation from compatibility of herbal pieces to component compatibility, which is an important achievement of the modernization of traditional Chinese medicine. In the past more than 10 years, with the deepening of research and the expansion of application, the theory and methods of CCM and efficacy-oriented compatibility have been continuously improved. The value of CCM is not only in developing new drug, more important is to build a communication bridge between traditional Chinese medicine and modern science and construct the system of key technologies which meet the need of innovation and development of TCM. This paper focused on the research progress, related concepts and technology development of CCM, as well as its application prospect in the theory research of Chinese medicine, development of innovative Chinese drugs, secondary development of Chinese patent medicine and upgrading of pharmaceutical technology.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa/tendências , Prescrições
18.
Zhongguo Zhong Yao Za Zhi ; 42(1): 1-5, 2017 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-28945017

RESUMO

The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated.


Assuntos
Indústria Farmacêutica , Medicina Tradicional Chinesa/normas , Controle de Qualidade , Medicamentos de Ervas Chinesas/normas
19.
Zhongguo Zhong Yao Za Zhi ; 42(1): 6-9, 2017 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-28945018

RESUMO

Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.


Assuntos
Medicina Tradicional Chinesa/normas , Vigilância de Produtos Comercializados , China , Consenso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/normas , Humanos , Injeções , Controle de Qualidade
20.
J Chromatogr B Analyt Technol Biomed Life Sci ; 1065-1066: 70-78, 2017 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-28946128

RESUMO

Paeonol, an active constituent in the root bark of Paeonia suffruticosa Andrews, is used to treat inflammation, headache and other diseases in clinic. Though the data on pharmacological researches of paeonol abounds, its metabolic profile is not so clear. It is essential to systematically characterize the in vivo metabolites in order to better understand its mechanism of action. In this study, ultra performance liquid chromatography coupled with electrospray ionization quadrupole time-of-flight tandem mass spectrometry (UPLC-ESI-Q/TOF-MS) with an integrative strategy was developed for analysis of paeonol metabolites. As a result, based on seven reference substances isolated or synthesized, twenty-five metabolites were detected and identified in urine, feces, bile and plasma of rats after oral administration of paeonol. To the best of our knowledge, 14 of these metabolites have not been reported previously. In addition, the dominating metabolic fates were oxidation, demethylation, hydrogenation, glucuronic acid and sulfate conjugations, and hydrogenation of paeonol was reported for the first time. This research provides scientific and reliable support for full understanding of the metabolic profiling of paeonol.


Assuntos
Acetofenonas/análise , Acetofenonas/química , Cromatografia Líquida de Alta Pressão/métodos , Espectrometria de Massas por Ionização por Electrospray/métodos , Espectrometria de Massas em Tandem/métodos , Acetofenonas/metabolismo , Animais , Bile/química , Fezes/química , Masculino , Ratos , Ratos Sprague-Dawley
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