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1.
Medicine (Baltimore) ; 100(1): e23965, 2021 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-33429758

RESUMO

BACKGROUND: postmenopausal osteoporosis is a systemic metabolic skeletal disease associated with menopause-related estrogen withdrawal. postmenopausal osteoporosis is characterized by low bone mass, bone microstructure destruction, leading to increased bone brittleness and be prone to fracture, resulting in disability and death. At present, the commonly used drugs are estrogen, calcium, bone formation promoter and bone resorption inhibitor, and the side effects are obvious. In Traditional Chinese medicine, kidney-tonifying differentiating medicine is guided by the whole concept, Xianling Gubao capsule as the representative, the treatment of postmenopausal osteoporosis has certain therapeutic advantages, but lacks evidence-based medicine evidence. The purpose of this study is to systematically study the efficacy and safety of Xianling Gubao capsule in the treatment of postmenopausal osteoporosis. METHODS: use computer to search English databases (PubMed, Embase, Web of Science, the Cochrane Library) and Chinese databases (China Knowledge Network, Wanfang, Weipu, Chinese Biomedical Database), in addition manually search Baidu academic, Google academic, from the establishment of database to October 2020, for randomized controlled clinical study of postmenopausal osteoporosis in the Xianling Gubao capsule treatment. Two researchers independently did the data extraction and literature quality evaluation, using RevMan5.3 software to do meta-analysis of the included literature. RESULTS: this study assessed the efficacy and safety of xianling gubao capsule in the treatment of postmenopausal osteoporosis by total effective rate, bone density after treatment, blood calcium level after treatment, blood phosphorus level after treatment, pain score, quality of life and so on. CONCLUSION: this study will provide reliable evidence-based evidence for the clinical application of Xianling Gubao capsule in the treatment of postmenopausal osteoporosis. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/TP394.


Assuntos
Protocolos Clínicos , Medicamentos de Ervas Chinesas/normas , Osteoporose Pós-Menopausa/tratamento farmacológico , Densidade Óssea/efeitos dos fármacos , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto
2.
Medicine (Baltimore) ; 100(1): e24082, 2021 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-33429773

RESUMO

BACKGROUND: Diabetic foot ulcers are the most common complication among diabetic patients, which may put the patients in a great danger of amputation. Astragalus as a Chinese herbal medicine has been reported in many publications that it has an efficacy toward diabetic foot ulcers. However, the systematic review and meta-analysis of its efficacy and safety are still absent. Therefore, we aim to evaluate the effectiveness and safety of Astragalus for diabetic foot ulcers. METHODS: The following databases will be searched from January 1st, 2010 to September 2020: The Cochrane Library, Pubmed, EMBASE, Web of Science, China National Knowledge Infrastructure, and Wanfang Data. All the English and Chinese publications will be searched without any restriction of countries. Data will be extracted by 2 reviewers independently. RevMan 5.4.1. will be used to perform analysis and synthesis of data. RESULTS: This meta-analysis of randomized controlled trials will evaluate the efficacy and safety of Astragalus for diabetic foot ulcers during the past 10 years. CONCLUSION: This study will provide an evidence to judge whether Astragalus is effective and safe for diabetic patients with foot ulcers. INPLASY REGISTRATION NUMBER: Inplasy protocol 2020110059. (doi:10.37766/inplasy2020.11.00596).


Assuntos
Astrágalo (Planta) , Protocolos Clínicos , Pé Diabético/tratamento farmacológico , Medicamentos de Ervas Chinesas/normas , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto
3.
Medicine (Baltimore) ; 99(51): e23826, 2020 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-33371163

RESUMO

BACKGROUND: Sciatica is one of the common clinical diseases. Studies have proved the efficacy of Chinese patent medicine (CPM) in the treatment of sciatica, so far, there has not been a complete systematic review of its effectiveness and safety, and the comparative efficacy and safety of CPM have not been ranked. Therefore, it is necessary to evaluate the efficacy and safety of these CPM by means of systematic review and network meta-analysis (NMA), and to compare them in order. METHODS: We will search PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, VIP, CBM and other databases for RCTs of CPM in the treatment of sciatica, (database established until December 30, 2020). In addition, we will manually search the "Pharmaceutical Information", "National Essential Drug List", "Chinese Pharmacopoeia", etc. to inquire about drug instructions, and screen the market circulation and clinically commonly used CPM. We will use RevMan software, gemtc package, GeMTC software for statistical analysis, and draw the surface under cumulative ranking area (SUCRA) to predict the order of curative effect of treatment measures. RESULTS: Our study will compare and evaluate the effectiveness of CPM in the treatment of sciatica, and rank different CPM. The outcome indicators will include clinical efficacy, pain degree, lumbar spine function and adverse events. CONCLUSION: Our research will provide support for clinical practice. INPLASY REGISTRATION NUMBER: INPLASY2020110073.


Assuntos
Protocolos Clínicos , Medicamentos de Ervas Chinesas/normas , Ciática/tratamento farmacológico , Teorema de Bayes , Medicamentos de Ervas Chinesas/farmacologia , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto
4.
Medicine (Baltimore) ; 99(51): e23848, 2020 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-33371168

RESUMO

BACKGROUND: Allergic rhinitis, abbreviated AR, modern medicine considers AR to be a chronic inflammatory reactive disease of the nasal mucosa mediated by exposure to allergens such as pollen and mites immunoglobulin E. AR not only affects patients' daily life, sleep, work, and study, but also brings huge economic burden to patients and society. At present, desensitization therapy, antiallergic drugs, antihistamines, hormones, and other drugs are used to improve symptoms or immune regulation, but the clinical short-term and long-term efficacy is general, the symptoms are easy to be repeated after drug withdrawal, and the long-term toxicity and side effects of drugs are obviously insufficient. Tian moxibustion therapy has a good effect on AR. Therefore, this paper will carry out a systematic evaluation and meta-analysis of the efficacy and safety of moxibustion in the treatment of allergic rhinitis. METHODS: Eight electronic databases will be searched, including PubMed, Embase, Web of Science, Cochrane Library, the China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), Wanfang Database (WF), and Chinese Biomedical Literature Database (CBM). We will search above electronic databases from the beginning to November 2020, without any language restriction, but involving only the human subjects. Clinical efficacy, including total effective rate or cure rate, and recurrence rate will be accepted as the primary outcomes. The Rhinoconjunctivitis quality of life questionaire (RQLQ) score, symptom score (nasal congestion, snot, continuous sneezing) will be used as secondary outcomes. The Cochrane Handbook of Systematic Review (5.3.0) randomized controlled trials (RCT) risk assessment tool will be used to evaluate the risk of bias by 2 independent researchers. RESULTS: After the completion of this study, the results will be reported, so it is not possible to give accurate results at present. CONCLUSIONS: The results of this study will provide reliable evidence for the efficacy and safety of Tian moxibustion in the treatment of allergic rhinitis. ETHICS AND DISSEMINATION: This paper does not need to be approved by the Ethics Committee, because this paper is a systematic review and quality evaluation of relevant literature. The results of this study will be disseminated in the form of a paper to help better guide the clinical practice of Tian moxibustion in the treatment of allergic rhinitis. INPLASY REGISTRATION NUMBER: INPLASY2020110058.


Assuntos
Protocolos Clínicos , Medicamentos de Ervas Chinesas/normas , Moxibustão/normas , Rinite Alérgica/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Metanálise como Assunto , Moxibustão/métodos , Rinite Alérgica/fisiopatologia , Revisões Sistemáticas como Assunto
5.
PLoS One ; 15(12): e0243111, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33259548

RESUMO

Salt stress affects the metabolic homeostasis of medicinal plants. However, medicinal plants are sessile organisms that cannot escape from salt stress. They acclimatize themselves to the stress by reprogramming their metabolic pathways. Lonicerae Japonicae Flos (LJF) with strong antioxidant activity is commonly used in traditional Chinese medicine, tea, and beverage. Nevertheless, the variation of integrated metabolites in LJF under different salt stresses remains unclear. In this study, High Performance Liquid Chromatography tandem triple time-of-flight mass spectrometry (HPLC- triple TOF-MS/MS) coupled with multivariate statistical analysis was applied to comparatively investigate the metabolites changes in LJF under different salt stress (0, 100, 200, 300 mM NaCl). Total 47 differential metabolites were screened from 79 metabolites identified in LJF under different salt stress. Low salt-treated group (100 mM NaCl) appeared to be the best group in terms of relative contents (peak areas) of the wide variety in bioactive components. Additionally, the phenylpropanoid pathway, monoterpenoid biosynthesis, glycolysis, TCA cycle, and alkaloid biosynthesis were disturbed in all salt-stress LJF. The results showed that LJF metabolisms were dramatically induced under salt stress and the quality of LJF was better under low salt stress. The study provides novel insights into the quality assessment of LJF under salt stress and a beneficial framework of knowledge applied to improvement the medicinal value of LJF.


Assuntos
Lonicera/metabolismo , Extratos Vegetais/metabolismo , Plantas Medicinais/metabolismo , Cromatografia Líquida de Alta Pressão , Medicamentos de Ervas Chinesas/metabolismo , Medicamentos de Ervas Chinesas/normas , Flavonoides/biossíntese , Humanos , Hidroxibenzoatos/metabolismo , Iridoides/metabolismo , Medicina Tradicional Chinesa , Redes e Vias Metabólicas , Metaboloma , Metabolômica , Análise Multivariada , Extratos Vegetais/normas , Controle de Qualidade , Estresse Salino/fisiologia , Espectrometria de Massas em Tandem
6.
Medicine (Baltimore) ; 99(44): e22854, 2020 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-33126327

RESUMO

INTRODUCTION: Allergic rhinitis (AR) is an inflammatory disease of nasal mucosa caused by IgE mediated inflammatory mediators and various immune active cells and cytokines after exposure of specific individuals to allergens. In recent years, its prevalence rate has increased gradually. Therefore, we must pay attention to carry out early intervention. However, there are still some side effects in the current drug therapy of AR, and the recurrence of AR cannot be well controlled. Some Chinese herbs have anti-allergic, anti-inflammatory and immunomodulatory effects, and have a better effect on the nasal symptoms of perennial and persistent rhinitis. The curative effect of allergic decoction on AR has been confirmed clinically. However, due to the lack of reliable evaluation means for its safety and effectiveness, it is necessary to carry out a systematic evaluation of allergic decoction in the treatment of AR, so as to lay a foundation for further research in the future. METHODS AND ANALYSIS: The following databases will be searched from their inception to August 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WanFang, VIP medicine information, and China National Knowledge Infrastructure. Primary outcomes: nasal symptoms (sneezing, runny nose, nasal itching, and nasal congestion) and ocular symptoms (eye itching, foreign body sensation, red eyes, tearing). It can be measured by any appropriate scales or other forms of tools, such as the Total Nasal Symptom Score. Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the efficacy and safety of Guominjian for patients with AR. CONCLUSION: Through the systematic review of this study, the evidence of the treatment of AR by Guominjian has been summarized so far, so as to provide guidance for further promoting the application of Guominjian in patients with AR. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRA MEWORK (OSF) REGISTRATION NUMBER: September 12, 2020.osf.io/24w8n.(https://osf.io/24w8n).


Assuntos
Medicamentos de Ervas Chinesas/normas , Metanálise como Assunto , Rinite Alérgica/tratamento farmacológico , Protocolos Clínicos , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Revisões Sistemáticas como Assunto
7.
Medicine (Baltimore) ; 99(44): e22858, 2020 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-33126328

RESUMO

BACKGROUND: Plasma cell mastitis (PCM) is a benign suppurative disease of the breast based on the expansion of mammary ducts and infiltration of plasma cells. It is relatively rare clinically, and its main manifestations include nonperiodic breast pain, nipple discharge, areola lump, nipple depression, nipple fistula, among others. Modern medicine is mainly surgical treatment, which is easy to recur. The clinical practice shows that the overall treatment of patients with TCM syndrome differentiation using oral medicine combined with western medicine therapy, combined internal and external treatment, can significantly improve the curative effect, prevent recurrence, has a certain therapeutic advantage, but lack of evidence of evidence-based medicine. The purpose of this study is to study the efficacy and safety of oral traditional Chinese medicine (TCM) combined with western medicine therapy in the treatment of PCM. METHODS: Use computer to retrieve English databases (PubMed, Embase, Web of Science, the Cochrane Library) and Chinese databases (CNKI, Wan Fang, VIP, Chinese biomedical database), from the establishment of database to September 2020, for randomized controlled trials(RCTs) of oral TCM combined with western medicine therapy in the treatment of PCM, two researchers independently extracted the data and evaluated the quality of the included research, and meta-analysis was conducted on the included literatures using RevMan5.3 software. RESULTS: This study evaluated the efficacy and safety of oral TCM combined with western medicine therapy in the treatment of PCM from the aspects of effective rate, symptom score, recurrence rate, adverse reaction rate, and patient satisfaction. CONCLUSION: This study will provide reliable evidence-based evidence for the clinical application of oral TCM combined with western medicine therapy in the treatment of PCM. ETHICS AND DISSEMINATION: The purpose of this study is to sort out and analyze the literature. This systematic review also does not involve endangering participant rights. Ethical approval was not required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences. OSF REGISTRATION NUMBER:: doi 10.17605/OSF.IO/K9A78.


Assuntos
Medicamentos de Ervas Chinesas/normas , Mastite/etiologia , Metanálise como Assunto , Plasmócitos/efeitos dos fármacos , Protocolos Clínicos , Medicamentos de Ervas Chinesas/uso terapêutico , Feminino , Humanos , Mastite/fisiopatologia , Revisões Sistemáticas como Assunto
8.
Medicine (Baltimore) ; 99(32): e21584, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769909

RESUMO

BACKGROUND: Acute cerebral infarction (ACI) has a high incidence, recurrence rate, and mortality. Chinese herbal injections (CHIs) are widely used in the substitution therapy of ACI. Due to the lack of randomized trials comparing the efficacy of various injections directly, it is still difficult to judge the relative efficacy. Therefore, we intend to conduct a network meta-analysis to evaluate the benefit among these CHIs. METHODS: According to the retrieval strategies, randomized controlled trials (RCTs) on CHI therapies for ACI will be obtained from China National Knowledge Infrastructure, WanFang, Chinese Scientific Journals Database, PubMed, Embase and Cochrane Library, regardless of publication date or language. Studies were screened based on inclusion and exclusion criteria, and the Cochrane risk bias assessment tool will be used to evaluate the quality of the literature. The network meta-analysis will be performed in Markov Chain Monte Carlo method and carried out with Stata 14 and WinBUGS 1.4.3 software. Ultimately, the evidentiary grade for the results will be evaluated. RESULTS: This study will compare the efficacy and safety of CHIs in the treatment of ACI, and give a more reasonable choice. CONCLUSION: Our findings will provide references for future clinical decision and guidance developing.INPLASY registration number: INPLASY202060087.


Assuntos
Infarto Cerebral/tratamento farmacológico , Protocolos Clínicos , Medicamentos de Ervas Chinesas/normas , Medicamentos de Ervas Chinesas/uso terapêutico , Infarto Cerebral/fisiopatologia , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto
9.
Medicine (Baltimore) ; 99(32): e21589, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769912

RESUMO

BACKGROUND: Coronary heart disease (CHD) is the leading cause of morbidity and mortality worldwide. Guipi Decoction (GPD) is a classical traditional Chinese medication used to treat CHD. However, systematic review and meta-analysis regarding its efficacy and safety has not been systematically evaluated. The objective of this protocol is to determine the efficacy and safety of GPD in the treatment of CHD. METHODS: Randomized controlled trials evaluating the effectiveness and safety of GPD in the treatment of CHD will be retrieved from 8 electronic databases, including PubMed, EMBASE, Cochrane Library, Web of science, China National Knowledge Infrastructure Database, VIP Database, Wanfang Database and China Biology Medicine Database. Study selection, data collection, risk of bias assessment, and evaluation of the quality of evidence will be performed in order. Data will be analyzed by RevMan V.5.3.5 software. RESULTS: This study will evaluate the efficacy and safety of GPD in the treatment of CHD. CONCLUSION: This systematic review will provide evidence for determining whether or not GPD is an effective and safe intervention for CHD. PROSPERO REGISTRATION NUMBER: PROSPERO CRD 42020156420.


Assuntos
Protocolos Clínicos , Doença das Coronárias/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Medicamentos de Ervas Chinesas/normas , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Resultado do Tratamento
10.
Medicine (Baltimore) ; 99(32): e21590, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769913

RESUMO

BACKGROUND: As one of the common cardiovascular diseases, acute myocardial infarction (AMI) is characterized by a high mortality rate, frequent complications, and a serious threat to human health and quality of life. Traditional Chinese medicine injection (TCMI) has been used clinically to treat AMI; however, there is no uniform standard for clinical treatment of AMI. The purpose of this study is to evaluate the efficacy and safety of different TCMI by using systematic review and network meta-analysis. METHODS: According to the strategy, the authors will retrieve both 4 Chinese databases and 3 English databases by June 30, 2020. After a series of screening, randomized controlled trials will be included related to TCMI for AMI. Two researchers will use Aggregate Data Drug Information System and STATA 15.0 to analyze the data. Finally, the evidence grade of the results will be evaluated. RESULTS: This study will provide a reliable evidence for the selection of TCMI therapies for AMI. CONCLUSION: The results of this study will provide references for evaluating the influence of different TCMI therapies for AMI, and provide decision-making references for clinical research. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/FYGBT.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Resultado do Tratamento , Medicamentos de Ervas Chinesas/normas , Humanos , Injeções/métodos , Metanálise como Assunto , Infarto do Miocárdio , Qualidade de Vida/psicologia , Revisões Sistemáticas como Assunto
11.
Medicine (Baltimore) ; 99(32): e21619, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769923

RESUMO

BACKGROUND: Kanglaite injection is a broad-spectrum anti-tumor drug, which is extracted from the seeds of the Chinese medicinal herb Coix lacryma-jobi, and has been widely used for the treatment of gastric cancer (GC). This study aimed to systematically investigate the efficacy and safety of Kanglaite injection for the treatment of GC. METHODS: We will perform the comprehensive literature search in English and Chinese electronic database from its inception to June 2020. Two trained researchers will independently select the qualified studies for data extraction and assess the quality and risk of bias. Cochrane Risk of Bias tool will be used to assess the risk of bias of included studies. The outcomes included overall response rate, complete response rate, 3-year progression-free survival rate, 3-year overall survival rate, and different types of treatment-related adverse events. Funnel plot analysis and Egger test will be used to assess the publication bias. Finally, the quality of evidence will be assessed by the grading of recommendations assessment, development, and evaluate system . We will calculate the risk ratio as well as their 95% confidence intervals of these outcomes and pool the results using RevMan 5.4 software and STATA 16.0 software. RESULTS: The results of our research will be published in a peer-reviewed journal. CONCLUSION: The conclusion of our systematic review will provide evidence to judge whether Kanglaite injection is an effective intervention for patient with GC. OSF REGISTRATION NUMBER: 10.17605/OSF.IO/HF679.


Assuntos
Protocolos Clínicos , Medicamentos de Ervas Chinesas/uso terapêutico , Neoplasias Gástricas/tratamento farmacológico , Medicamentos de Ervas Chinesas/normas , Humanos , Metanálise como Assunto , Neoplasias Gástricas/fisiopatologia , Revisões Sistemáticas como Assunto , Resultado do Tratamento
12.
Medicine (Baltimore) ; 99(32): e21643, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769932

RESUMO

BACKGROUND: We design this study to assess the efficacy and safety of Chinese herbal compound for allergic rhinitis in children. METHODS: PubMed, EMbase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), WanFang, the Chongqing VIP Chinese Science and Technology Periodical Database, and China biomedical literature database (CBM) will be searched from the establishment of each database to July 2020. Randomized controlled trials of Chinese herbal compound for the treatment of allergic rhinitis in children will be included. Two researchers will screen the literature, extract data, and assess the risk of bias independently. Statistical analysis will be performed in RevMan 5.3. RESULTS: This study will summarize high quality evidence of randomized controlled trials on exploring the efficacy and safety of Chinese herbal compound for allergic rhinitis in children. CONCLUSIONS: The findings of study will provide scientific evidence of the efficacy and safety of Chinese herbal compound for allergic rhinitis in children for clinician and further studies. ETHICS AND DISSEMINATION: The private information from individuals will not be published. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/Q5TRZ.


Assuntos
Protocolos Clínicos , Medicamentos de Ervas Chinesas/normas , Rinite Alérgica/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Metanálise como Assunto , Pediatria/instrumentação , Pediatria/métodos , Pediatria/normas , Revisões Sistemáticas como Assunto , Resultado do Tratamento
13.
Medicine (Baltimore) ; 99(29): e21144, 2020 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-32702868

RESUMO

BACKGROUND: Hypertension becomes increasingly an alarming global health concern. There is a growing interest in treatment of traditional Chinese medicine (TCM), and tonifying kidney therapy (bushen, TKT) has been extensively used in the treatment of hypertension according to TCM theory. In this article, we outline the protocol of research projects and methods to examine comprehensively the effectiveness and safety of TKT in treating hypertensive patients. METHODS: We will collect randomized controlled trails (RCTs) that report the application of TKT for patients with hypertension from electronic databases including PubMed, EMBASE, CENTRAL, CNKI, VIP, CBM, and Wanfang database. Time of literature retrieval is set from the beginning of database construction to the end of June, 2020. Two reviewers will independently perform literature screening, data extraction, and quality assessment of included literature, and any divergences will be worked out via discussion. The primary outcomes include total efficacy rate, systolic and diastolic blood pressure change will be assessed. The secondary outcomes include clinical symptoms and adverse events will also be assessed. RevMan5.3 software will be applied to analyzing data included studies. RESULTS: This study will synthesize and analyze all collated data in order to evaluate TKT for the treatment of hypertension involves different aspects in total efficacy rate, systolic and diastolic blood pressure change, clinical symptoms, and adverse events. CONCLUSION: This study will determine the efficacy of TKT in the treatment of hypertension and recommend its clinical value based on the evaluated the effectiveness and security results. REGISTRATION NUMBER: INPLASY202050044.


Assuntos
Protocolos Clínicos , Medicamentos de Ervas Chinesas/uso terapêutico , Hipertensão/tratamento farmacológico , Resultado do Tratamento , Pressão Sanguínea/efeitos dos fármacos , Medicamentos de Ervas Chinesas/normas , Humanos , Hipertensão/fisiopatologia , Rim/efeitos dos fármacos , Rim/fisiopatologia , Medicina Tradicional Chinesa/métodos , Medicina Tradicional Chinesa/normas , Metanálise como Assunto , Revisões Sistemáticas como Assunto
14.
Pharmacol Res ; 160: 105074, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32653649

RESUMO

PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.


Assuntos
Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Medicamentos de Ervas Chinesas/normas , Medicamentos de Ervas Chinesas/uso terapêutico , Materia Medica/normas , Medicina Tradicional Chinesa/normas , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , Infecções por Coronavirus/tratamento farmacológico , Composição de Medicamentos , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Materia Medica/efeitos adversos , Materia Medica/uso terapêutico , Segurança do Paciente , Farmacopeias como Assunto , Saúde Pública , Controle de Qualidade
15.
Medicine (Baltimore) ; 99(23): e20473, 2020 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-32501994

RESUMO

BACKGROUND: In China, heat-clearing and detoxifying Chinese medicines combined with conventional therapy are commonly applied to treat the mild hand, foot, and mouth disease (HFMD). However, there is lack of solid evidence on the efficacy and safety of such therapies. METHODS: We conducted a pooled analysis with individual patient data from 5 strictly randomized controlled clinical trials to assess the efficacy and safety of this combination therapy for mild HFMD. An intention-to-treat analysis was performed. A 2-stage meta-analysis method was adopted to analyze the pooled effect size. RESULTS: In total, 947 patients were included. Compared with conventional therapy, the combination therapy significantly reduced the progression rate of HFMD from mild to severe (odds ratio [OR] 0.43, 95% confidence interval [CI]: 0.22 to 0.83, P = .01). Meanwhile, the healing time of skin rash and oral ulcer in the combination therapy group was significantly shorter than that of conventional therapy. The overall hazard ratio (HR) of healing time of the skin rash or oral ulcer was 1.22 (95%CI: 1.04 to 1.43; P = .02). However, except Jinlianqingre effervescent tablets, the combination therapy cannot shorten the time to fever resolution (HR 1.12, 95%CI: 0.97 to 1.29, P = .14). Because of the heterogeneity, Jinlianqingre effervescent tablets were analyzed separately and the HRs of the time to fever resolution and the healing time of skin rash or oral ulcer were 3.88 (95%CI: 3.19 to 4.72; P < .0001) and 3.79 (95%CI: 2.81 to 5.11; P < .0001), respectively. There were 30 adverse events reported in total; 2 cases were related to Chinese medicines. CONCLUSION: In conclusion, the heat-clearing and detoxifying Chinese medicines on top of conventional therapy can effectively reduce the progressive rate of mild HFMD and improve healing of skin and oral mucosal lesions. More studies are needed for the time to fever resolution.


Assuntos
Quimioterapia Combinada/normas , Medicamentos de Ervas Chinesas/normas , Febre/tratamento farmacológico , Doença de Mão, Pé e Boca/tratamento farmacológico , Quimioterapia Combinada/métodos , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Inativação Metabólica , Razão de Chances
16.
Yakugaku Zasshi ; 140(6): 783-788, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32475928

RESUMO

The latest edition of the Japanese Pharmacopoeia (JP) is the second supplement to the 17th edition containing 324 herbal medicines, of which 176 are crude drugs and 35 are Kampo extracts. Although 148 prescription Kampo extracts are covered by national health insurance, only 35 are listed in the latest JP. However, the sales volume of these 35 Kampo extracts accounts for more than 70% of the total sales volume of Kampo products, as Kampo formulas with higher sales volumes are preferentially listed in the JP. The JP officially defines the origin and description of the listed crude drugs and Kampo extracts and elaborates on their limited values and testing methods. As crude drugs and Kampo extracts are derived from natural products and have the characteristics of traditional medicines, some degree of variation has been experienced during their long-term use, which is one of the crucial differences from chemical drugs. The Japanese Pharmacopoeia Committee on Crude Drugs promotes standardization of the JP by reflecting the actual Japanese market situation. This review explains the characteristics of natural and traditional medicines in crude drug-related items, the JP drafting process and points to be noted, and the significance of listing in the JP.


Assuntos
Misturas Complexas/normas , Medicamentos de Ervas Chinesas/normas , Farmacopeias como Assunto/normas , Japão , Medicina Kampo
17.
Zhongguo Zhong Yao Za Zhi ; 45(6): 1350-1356, 2020 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-32281347

RESUMO

To define the composition of relevant substances in Breviscapine for Injection, in order to improve the quality control of impurity, and ensure the clinical safety. The analysis and structural identification of relevant substances in different specifications and batches of Breviscapine for Injection powders were carried out by HPLC and UPLC-QTOF-MS. Three primary relevant substances, namely 5,6,7,3',4'-pentahydroxyflavone-7-O-glucuronide(3), 3,5,6,7,4'-pentahydroxyflavone-3-O-glucuronide(4) and scutellarein(10), as well as three minor impurities, namely 6-hydroxyapigenin-6-O-glucosyl-7-O-glucuronide(1), methoxylscutellarin(6) and apigenin-7-O-glucuronide(7) were structurally identified by matching retention time, UV spectra, and mass spectra with authentic compounds and MS fragmentation rules. The main relevant substances(3) and(4) were separated and purified by semi-preparative HPLC, and their structures were further confirmed by NMR data. The study defined relevant substances of Breviscapine for Injection, and provided reference for improving the quality control level of single impurity in breviscapine preparation.


Assuntos
Apigenina/análise , Medicamentos de Ervas Chinesas/normas , Flavonoides/química , Glucuronídeos/análise , Cromatografia Líquida de Alta Pressão , Injeções , Espectroscopia de Ressonância Magnética , Espectrometria de Massas , Controle de Qualidade
18.
Zhongguo Zhong Yao Za Zhi ; 45(1): 92-97, 2020 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-32237416

RESUMO

Pyrrolizidine alkaloids(PAs) are a kind of natural toxins, which can cause severe hepatotoxicity, pulmonary toxicity, genotoxicity, neurotoxicity, embryotoxicity and even death. Therefore, international organizations and countries such as World Health Organization have paid great attention to herbal medicines and preparations containing PAs. PAs are widely distributed in Chinese herb medicines and contained in hundreds of traditional Chinese medicine preparations. The content of adonifoline, the main PAs in Senecionis Scandentis Herba, shall be less than 0.004% in herbal medicines as described in Chinese pharmacopeia. However, there is no guidance in preparations which contain Senecionis Scandentis Herba. In this study, 14 preparations were analyzed by an UPLC-MS method. Among them, 8 preparations were found to contain adonifoline much higher than the content limits of such countries as Germany, Netherlands and New Zealand. And the highest contents of adonifoline were found in Qianbai Biyan Tablets and Qianbai Biyan Capsules, which are officially recorded in Chinese Pharmacopeia. The contents of adonifoline varied in different batches of the same preparations. The highest content was 156.10 µg·g~(-1) Qianbai Biyan Tablets, whose daily intake of adonifoline was up to 1 030.26 µg according to the recommended dosage of the preparation. Our results showed the potential risk of these preparations, and the content limit of adonifoline shall be inspected Chinese medicine preparations containing Senecionis Scandentis Herba.


Assuntos
Medicamentos de Ervas Chinesas/análise , Lactonas/análise , Alcaloides de Pirrolizidina/análise , Senécio/química , Cromatografia Líquida , Medicamentos de Ervas Chinesas/normas , Medicina Tradicional Chinesa , Espectrometria de Massas em Tandem
19.
Zhongguo Zhong Yao Za Zhi ; 45(1): 119-123, 2020 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-32237420

RESUMO

Astragali Radix is commonly used as bulk medicinal materials. Chinese Pharmacopoeia contains about 150 compound preparations of Astragali Radix, but the sample preparation method under the determination of Astragali Radix content in Chinese Pharmacopoeia is tedious and time-consuming, not convenient for the test of a large number of samples. Therefore, it is of great significance to simplify the sample preparation method and improve the practicability of the method for the quality control of Astragali Radix and its preparations. In this study, ultrasonic extraction method was used instead of heated reflux extraction, and solid phase extraction method was used to enrich and prepare the samples. A set of practical quality evaluation method was established for Astragali Radix slices and standard decoction, greatly shortening the sample preparation time and improving the accuracy of the method. The results of Astragali Radix standard decoction analysis showed that the transfer rate of calycosin 7-O-ß-D-glucospyranoside,(96.5±28.7)%, had great variation, which was found to be related to the conversion of mulberry isoflavone glucoside into calycosin 7-O-ß-D-glucospyranoside during the preparation of standard decoction. The transfer rates were(59.4±14.4)% and(101.3±12.3)% for calycosin and astragaloside Ⅳ respectively, which were relatively stable. Therefore, it is suggested that Astragali Radix slices and water decoction preparations should be evaluated by using calycosin and astragaloside Ⅳ as the quality evaluation index. The results provide a scientific and practical method for quality control of Astragali Radix slices and its standard decoction, and also provide scientific evidence for quality evaluation of the preparations.


Assuntos
Astrágalo (Planta)/química , Medicamentos de Ervas Chinesas/análise , Medicamentos de Ervas Chinesas/normas , Glucosídeos/análise , Raízes de Plantas/química , Controle de Qualidade , Extração em Fase Sólida
20.
Zhongguo Zhong Yao Za Zhi ; 45(5): 961-966, 2020 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-32237468

RESUMO

Polygoni Multiflori Radix is a commonly used traditional Chinese medicine in clinical treatment and health care. However, the related liver injury has been frequently reported, which has attracted extensive attention. Fortunately, in recent years, the scholars have made substantial progress in revealing the basic properties, main causes, material basis and molecular mechanism of Polygoni Multiflori Radix related liver injury. The basic characteristics and biomarkers of its susceptible subjects have been found. It indicated that Polygoni Multiflori Radix is only at risk of liver injury for a small number of specific subjects but safe for the majority. To provide detailed guidance for the rational use of Polygoni Multiflori Radix and related preparation, we compiled this guideline based on existing research and knowledge. The guideline has been issued by the China Association of Chinese Medicine(No. T/CACM 1328-2019).


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Fallopia multiflora/química , Raízes de Plantas/química , Doença Hepática Induzida por Substâncias e Drogas , China , Medicamentos de Ervas Chinesas/normas , Humanos , Fígado/efeitos dos fármacos , Medicina Tradicional Chinesa , Guias de Prática Clínica como Assunto
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