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1.
Zhongguo Zhong Yao Za Zhi ; 46(12): 3150-3155, 2021 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-34467707

RESUMO

In recent years, only a small number of new Chinese medicines have been approved for marketing, which has embodied the bottleneck in the development of the Chinese medicine industry. To tackle this problem, the National Medical Products Administration has issued a series of regulations and technical requirements. In the context of new regulations, this study deeply explored the research and development strategies of new Chinese medicines under the guidance of the new classification of drug registration, and discussed the key technical issues in the research and development.


Assuntos
Medicamentos de Ervas Chinesas , Preparações Farmacêuticas , China , Medicina Tradicional Chinesa , Pesquisa
2.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1681-1685, 2021 Apr.
Artigo em Chinês | MEDLINE | ID: mdl-33982468

RESUMO

Collecting and summarizing human use experience(HUE) data, forming high-quality data and evidences that can be used for evaluation are the key links of HUE research on traditional Chinese medicine(TCM). The collection, collation and summary of human experience data were discussed in this paper. It is pointed out that the collection of HUE should be focus on the source of prescription of new traditional Chinese medicines, and be summarized based on dialectical thinking, experience in medication, characte-ristics of prescription and clinical application. The collected contents include prescription, process, clinical location and applicable population, efficacy data and safety data, etc. The methods include interview, clinical data summary and data mining. When the data formed based on HUE information is used as drug registration information, it is necessary to ensure that the data source is legal and compliant, and the ownership of intellectual property is clear.Data sources should meet the requirements of medical ethics. To avoid conflict of interest, data analysis should be conducted by an independent third party. It is necessary to develop the quality control measures of HUE data to ensure the data traceability, integrity, consistency and accuracy, and avoid data bias.The data of HUE should include the key data such as accurate clinical location and applicable population, recognized clinical efficacy and safety.After the formation of HUE, the statistical analysis plan of empirical data of human use should be formulated. Through strict data processing, statistical analysis and clinical interpretation, HUE can be produced for evaluation.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Coleta de Dados , Humanos , Prescrições , Controle de Qualidade
3.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1686-1690, 2021 Apr.
Artigo em Chinês | MEDLINE | ID: mdl-33982469

RESUMO

This article proposes that the research and development of new Chinese medicines should be based on the clinical values of traditional Chinese medicine(TCM), and expounds the multiple clinical values of new Chinese medicines such as therapeutic effects, adjuvant treatment effects, improvement of disease symptoms, improvement of quality of life, prevention of diseases, etc., so as to broaden the clinical indications of new Chinese medicines. It is pointed out that the clinical value of TCM determines the clinical efficacy evaluation method of new Chinese medicines, so as to construct a clinical evaluation system of new Chinese medicines with the characteristics of TCM. It is proposed that the clinical value of new Chinese medicines should be found under the guidance of TCM theo-ry and clinical practice, and the theoretical innovation of TCM should be emphasized. There is no difference in the clinical value of drugs, and the key is to meet the clinical needs of patients. The research and development of new Chinese medicines ignores the theoretical guidance of Chinese medicine, and relying solely on animal experiment data may lead to failure of clinical trials. Different from the individualized treatment of TCM clinical syndrome differentiation, summarizing the core pathogenesis of TCM is the basis for the development of new Chinese medicines. It is necessary to summarize the pathogenesis of the disease under the guidance of TCM theory and encourage the application of modern medical methods to clarify the diagnosis of the disease. In view of the characteristics of new Chinese medicine research and development, it is proposed that the supporting role of human experience should be emphasized, and the technical points of clinical trials of new syndrome-type Chinese medicines should be explained.The use of objective indicators for syndrome evaluation, the selection of appropriate scales, and the formulation of reasonable treatment courses are advocated. During the research and development of new Chinese medicines, it is not only necessary to pay attention to modern medical safety indicators, but also to observe the evolution of TCM syndromes and specific TCM symptoms.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Qualidade de Vida , Pesquisa , Síndrome
4.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1691-1695, 2021 Apr.
Artigo em Chinês | MEDLINE | ID: mdl-33982470

RESUMO

The relevant laws and regulations of drug clinical trials were introduced in this paper. It is pointed out that with drug re-gulatory laws and technological advances, clinical trials have become an important link in the development of new drugs of traditional Chinese medicines(TCM). Clinical trials of new drugs of TCM must comply with the requirement of "Good Clinical Practice for Trial on Medicinal Products". In view of the particularities of clinical trials of new drugs of TCM, China has established an ethical review system for clinical research in TCM and carried out ethical review and certification of TCM research. In order to guide the development of clinical trials of new drugs of TCM, relevant departments have promulgated a series of guidelines for clinical trials of it, and established a new review system and technical requirements for clinical trials. Since 1983, the "national clinical pharmacology base" has been established. At present, there are 96 drug clinical trial institutions and 32 phase I clinical research wards in TCM hospitals, which can meet the development of clinical trials of new drugs of TCM. In the long-term practice, the technical team has continued to grow and develop, the research experience and technical strength have been significantly improved, and a large number of experts have become the backbone of clinical research in Chinese medicine. It is pointed out that we should attach importance to risk and benefit assessment, human experience, select scientific, objective and appropriate effectiveness indexes, evaluate the efficacy of TCM syndromes, and encourage the use of electronic methods in clinical research of new drugs of TCM. Based on the analysis of clinical trials of TCM in recent five years, it is pointed out that the active degree of clinical trials of new drugs of TCM is not high, the innovation ability of it is insufficient and the ability and enthusiasm of all aspects need to be improved. It is of great significance to carry out clinical trials of new traditional Chinese medicines to upgrade the TCM industry and produce high-level evidence-based medicine evidences. The high quality development of TCM can be promoted by strengthening clinical trials of new drugs of TCM.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , China , Medicina Baseada em Evidências , Humanos , Síndrome
5.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1696-1700, 2021 Apr.
Artigo em Chinês | MEDLINE | ID: mdl-33982471

RESUMO

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Assuntos
Pesquisa Biomédica , Medicamentos de Ervas Chinesas , Preparações Farmacêuticas , Ensaios Clínicos como Assunto , Consenso , Revisão Ética , Humanos , Medicina Tradicional Chinesa , Estudos Multicêntricos como Assunto
6.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1701-1705, 2021 Apr.
Artigo em Chinês | MEDLINE | ID: mdl-33982472

RESUMO

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , China , Ensaios Clínicos como Assunto , Consenso , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Controle de Qualidade
7.
J Ethnopharmacol ; 274: 114073, 2021 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-33794335

RESUMO

ETHNOPHARMACOLOGICAL RELEVANCE: The incidence and mortality rates of hepatocellular carcinoma are very high all over the world, which seriously threatens human life and health. Aidi injection as a Chinese medicine preparation has a positive curative effect on hepatocellular carcinoma, but its mechanism remains unclear. AIM OF THE STUDY: The purpose of this study is to evaluate the anti-hepatocellular carcinoma effects of Aidi injection and explore its mechanism of action vitro and vivo. MATERIALS AND METHODS: The main components of Aidi injection were determined by LC-MS/MS. The effects of Aidi injection on the viability of HepG2 and PLC/PRF/5 cells were detected via CCK-8 analysis and Calcein AM/PI staining. DAPI staining and flow cytometry were applied to analyze the apoptosis-induced effects of Aidi injection on hepatocellular carcinoma cells (HCCs). The growth inhibition of Aidi injection on hepatocellular carcinoma was observed in nude mice bearing PLC/PRF/5 cells. The related signal transduction and apoptosis pathways were investigated through assays for JC-1 mitochondrial membrane potential (MMP), RNA-seq, KEGG, PPI and WB. RESULTS: There were 12 main chemical components contained in Aidi injection, viz. cantharidin, syringin, calycosin-7-o-ß-Dglucoside, isozinpidine, ginsenosides Rd, Rc, Rb1, Re, and Rg1, astragalosides II and IV, and eleutheroside E. Aidi injection significantly inhibited the proliferation of HepG2 and PLC/PLF/5 cells with IC50 of 20.66 mg/ml and 27.5 mg/ml at 48h, respectively, increased the proportion of dead cells, induced cell apoptosis, suppressed the tumor growth of nude mice bearing PLC/PLF/5 cells, reduced MMP, activated PI3K/Akt and MAPK signal transduction pathways, down-regulated the expression of p-PI3K and Bcl-xL, and up-regulated the expression of p-JNK, p-p38 and Bim. CONCLUSION: Aidi injection inhibits the growth of liver cancer probably through regulating PI3K/Akt and MAPK signal transduction pathways, inducing MMP collapse to activate the mitochondrial apoptosis pathway, and then eliciting apoptosis of HCCs.

8.
Zhongguo Zhong Yao Za Zhi ; 45(16): 4004-4008, 2020 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-32893601

RESUMO

In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China's drug regulatory agency, and put forward relevant suggestions. Although China's drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.


Assuntos
Medicamentos de Ervas Chinesas , Preparações Farmacêuticas , China , Legislação de Medicamentos , Medicina Tradicional Chinesa
9.
Zhongguo Zhong Yao Za Zhi ; 45(16): 4009-4016, 2020 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-32893602

RESUMO

The research and development progress and all relevant technical requirements about new Chinese medicines since the release of Provisions for Drug Registration(2007 Version) were reviewed and summarized in this paper. To promote the healthy deve-lopment of regulatory agencies and the traditional Chinese medicine industry, the author conducted a comprehensive analysis on the advantages and disadvantages of the current technical requirements for new Chinese medicines and some typical cases in technical review, and put forward some constructive suggestions on the philosophies of traditional Chinese medicine review and the resolution of some technical disputes.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Pesquisa
10.
Chin J Integr Med ; 26(9): 648-655, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32676976

RESUMO

OBJECTIVES: To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients. METHODS: A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed. RESULTS: An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048). CONCLUSIONS: Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Interferon-alfa/administração & dosagem , Lopinavir/administração & dosagem , Pneumonia Viral/tratamento farmacológico , Síndrome Respiratória Aguda Grave/tratamento farmacológico , Administração por Inalação , Adulto , COVID-19 , China , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/mortalidade , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Seguimentos , Humanos , Medicina Integrativa , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/mortalidade , Medição de Risco , Síndrome Respiratória Aguda Grave/diagnóstico , Síndrome Respiratória Aguda Grave/mortalidade , Índice de Gravidade de Doença , Taxa de Sobrevida
11.
Zhongguo Zhong Yao Za Zhi ; 45(13): 2993-3000, 2020 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-32726003

RESUMO

To scientifically evaluate the intervention effect of Chinese medicine preventive administration(combined use of Huo-xiang Zhengqi Oral Liquid and Jinhao Jiere Granules) on community population in the case of coronavirus disease 2019(COVID-19), a large cohort, prospective, randomized, and parallel-controlled clinical study was conducted. Total 22 065 subjects were included and randomly divided into 2 groups. The non-intervention group was given health guidance only, while the traditional Chinese medicine(TCM) intervention group was given two coordinated TCM in addition to health guidance. The medical instructions were as follows. Huoxiang Zhengqi Oral Liquid: oral before meals, 10 mL/time, 2 times/day, a course of 5 days. Jinhao Jiere Granules: dissolve in boiling water and take after meals, 8 g/time, 2 times/day, a course of 5 days, followed up for 14 days, respectively. The study found that with the intake of medication, the incidence rate of TCM intervention group was basically maintained at a low and continuous stable level(0.01%-0.02%), while the non-intervention group showed an overall trend of continuous growth(0.02%-0.18%) from 3 to 14 days. No suspected or confirmed COVID-19 case occurred in either group. There were 2 cases of colds in the TCM intervention group and 26 cases in the non-intervention group. The incidence of colds in the TCM intervention group was significantly lower(P<0.05) than that in the non-intervention group. In the population of 16-60 years old, the incidence rate of non-intervention and intervention groups were 0.01% and 0.25%, respectively. The difference of colds incidence between the two groups was statistically significant(P<0.05). In the population older than 60 years old, they were 0.04% and 0.21%, respectively. The incidence of colds in the non-intervention group was higher than that in the intervention group, but not reaching statistical difference. The protection rate of TCM for the whole population was 91.8%, especially for the population of age 16-60(95.0%). It was suggested that TCM intervention(combined use of Huoxiang Zhengqi Oral Liquid and Jinhao Jiere Granules) could effectively protect community residents against respiratory diseases, such as colds, which was worthy of promotion in the community. In addition, in terms of safety, the incidence of adverse events and adverse reactions in the TCM intervention group was relatively low, which was basically consistent with the drug instructions.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Medicamentos de Ervas Chinesas , Pandemias , Pneumonia Viral , Adolescente , Adulto , COVID-19 , Infecções por Coronavirus/tratamento farmacológico , Humanos , Medicina Tradicional Chinesa , Pessoa de Meia-Idade , Pneumonia Viral/tratamento farmacológico , Estudos Prospectivos , SARS-CoV-2 , Adulto Jovem
12.
Zhongguo Zhong Yao Za Zhi ; 42(5): 844-847, 2017 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-28994523

RESUMO

In view of the industry lacking of sufficient analyses on the bases of project establishment about the new drugs of traditional Chinese medicine(TCM) during their applying for the clinical research, from the perspective of clinical evaluation, this paper reviewed and analyzed the present situation and development paths of new drugs of TCM in recent years. Through the analyses of the rationality of formulations, human use experiences and clinical studies, the paper puts forward the countermeasures to solve these difficulties during the technical evaluation of new drugs of TCM in order to improve the new drugs' clinical research.


Assuntos
Pesquisa Biomédica/tendências , Medicamentos de Ervas Chinesas/farmacologia , Medicina Tradicional Chinesa , Indústria Farmacêutica , Humanos
13.
Curr Vasc Pharmacol ; 13(4): 492-503, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25360840

RESUMO

OBJECTIVE: To reveal the cutoff point and influencing factors in the dynamic change in phenotypic group in patients with stable angina pectoris (SAP) after Xinxuekang capsule treatment. METHODS: Five hundred and seventy-six SAP patients were randomly assigned to receive Xinxuekang (XXK) capsules or Compound Danshen (CDS) tablets for 8 weeks. Global similarity degree analysis and nonlinear mixed effects modeling (NONMEM) were employed to reveal the cutoff points and influencing factors in dynamic changes in the SAP phenotypic group. The phenotypic group was defined as the six phenotypes in SAP, including angina, choking sensation in the chest, palpitations, dark purple lips, ecchymosis on the tongue, and fine-choppy pulse, which were quantitatively evaluated on Days 0, 14, 28, 42, and 56. RESULTS: Variation in the six individual phenotypes and distribution of the SAP phenotypic profile were similar between the two experimental groups, but cutoff points for changes in the SAP phenotypic group were 7.28 and 10.73 weeks in XXK and CDS groups, respectively. Degree of severity of SAP as well as study site significantly affected the tendency for change in the SAP Xueyu Zheng in both XXK and CDS treatment groups. Different Chinese patent drugs affected the tendency for change in phenotypic group in patients with SAP. XXK was superior to CDS in controlling a clinical phenotypic group. CONCLUSION: Based on global similarity degree analysis and NONMEM, the cutoff point and influencing factors in phenomic variation of SAP may be determined, to improve the development and modification of treatment regimens.


Assuntos
Angina Estável/diagnóstico , Angina Estável/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa/métodos , Adulto , Idoso , Cápsulas , Interpretação Estatística de Dados , Método Duplo-Cego , Medicamentos de Ervas Chinesas/administração & dosagem , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento
14.
Fitoterapia ; 93: 31-8, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24369311

RESUMO

Chemical investigation of Vitex negundo seeds afforded four new lignans, including a phenylindene-type lignan, vitexdoin F (1), and three phenylnaphthalene-type lignans, vitexdoins G, H and I (2-4). Their structures were elucidated by detailed spectroscopic analyses on the basis of NMR, IR, and MS data. All compounds were evaluated for their anti-inflammatory and anti-osteoporotic activities, employing RAW264.7 macrophages, osteoblast-like UMR106 and osteoclastic cells, respectively. Compound 1 showed significant inhibition on the nitric oxide (NO) production (IC50 4.17 µg/mL) due to its down-regulation of the inducible nitric oxide synthase (iNOS) protein expression in LPS-stimulated RAW264.7 cells, which also exhibited potent stimulatory effects on the proliferation and ALP (alkaline phosphatase) activity of UMR106 cells, and significantly up-regulated the OPG/RANKL protein ratio.


Assuntos
Anti-Inflamatórios/isolamento & purificação , Artrite Reumatoide/tratamento farmacológico , Conservadores da Densidade Óssea/isolamento & purificação , Lignanas/farmacologia , Vitex/química , Animais , Animais Recém-Nascidos , Anti-Inflamatórios/química , Conservadores da Densidade Óssea/química , Linhagem Celular , Avaliação Pré-Clínica de Medicamentos , Lignanas/química , Lignanas/isolamento & purificação , Lignanas/uso terapêutico , Fitoterapia , Extratos Vegetais/química , Extratos Vegetais/farmacologia , Extratos Vegetais/uso terapêutico , Plantas Medicinais/química , Ratos , Ratos Wistar , Sementes/química
15.
PLoS One ; 7(9): e46574, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23029551

RESUMO

Polydatin is one of main compounds in Polygonum cuspidatum, a plant with both medicinal and nutritional value. The possible hepatoprotective effects of polydatin on acute liver injury mice induced by carbon tetrachloride (CCl(4)) and the mechanisms involved were investigated. Intraperitoneal injection of CCl(4) (50 µl/kg) resulted in a significant increase in the levels of serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and hepatic malondialdehyde (MDA), also a marked enhancement in the expression of hepatic tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1ß), cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS) and nuclearfactor-kappa B (NF-κB). On the other hand, decreased glutathione (GSH) content and activities of glutathione transferase (GST), superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GPx) were observed following CCl(4) exposure. Nevertheless, all of these phenotypes were evidently reversed by preadministration of polydatin for 5 continuous days. The mRNA and protein expression levels of hepatic growth factor-beta1 (TGF-ß(1)) were enhanced further by polydatin. These results suggest that polydatin protects mice against CCl(4)-induced liver injury through antioxidant stress and antiinflammatory effects. Polydatin may be an effective hepatoprotective agent and a promising candidate for the treatment of oxidative stress- and inflammation-related diseases.


Assuntos
Anti-Inflamatórios/farmacologia , Antioxidantes/farmacologia , Doença Hepática Induzida por Substâncias e Drogas/tratamento farmacológico , Medicamentos de Ervas Chinesas/farmacologia , Fallopia japonica/química , Glucosídeos/farmacologia , Estilbenos/farmacologia , Alanina Transaminase/sangue , Animais , Anti-Inflamatórios/uso terapêutico , Antioxidantes/uso terapêutico , Aspartato Aminotransferases/sangue , Tetracloreto de Carbono , Catalase/metabolismo , Doença Hepática Induzida por Substâncias e Drogas/sangue , Doença Hepática Induzida por Substâncias e Drogas/patologia , Medicamentos de Ervas Chinesas/uso terapêutico , Expressão Gênica , Glucosídeos/uso terapêutico , Glutationa/metabolismo , Glutationa Peroxidase/metabolismo , Glutationa Transferase/metabolismo , Mediadores da Inflamação/metabolismo , Fígado/efeitos dos fármacos , Fígado/enzimologia , Fígado/metabolismo , Masculino , Camundongos , Camundongos Endogâmicos ICR , NF-kappa B/metabolismo , Estresse Oxidativo/efeitos dos fármacos , Estilbenos/uso terapêutico , Superóxido Dismutase/metabolismo , Fator de Crescimento Transformador beta1/genética , Fator de Crescimento Transformador beta1/metabolismo , Regulação para Cima
16.
PLoS One ; 6(9): e25142, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21980387

RESUMO

BACKGROUND: Folic acid is widely used to lower homocysteine concentrations and prevent adverse cardiovascular outcomes. However, the effect of folic acid on cardiovascular events is not clear at the present time. We carried out a comprehensive systematic review and meta-analysis to assess the effects of folic acid supplementation on cardiovascular outcomes. METHODOLOGY AND PRINCIPAL FINDINGS: We systematically searched Medline, EmBase, the Cochrane Central Register of Controlled Trials, reference lists of articles, and proceedings of major meetings for relevant literature. We included randomized placebo-controlled trials that reported on the effects of folic acid on cardiovascular events compared to placebo. Of 1594 identified studies, we included 16 trials reporting data on 44841 patients. These studies reported 8238 major cardiovascular events, 2001 strokes, 2917 myocardial infarctions, and 6314 deaths. Folic acid supplementation as compared to placebo had no effect on major cardiovascular events (RR, 0.98; 95% CI, 0.93-1.04), stroke (RR, 0.89; 95% CI,0.78-1.01), myocardial infarction (RR, 1.00; 95% CI, 0.93-1.07), or deaths from any cause (RR, 1.00;95% CI, 0.96-1.05). Moreover, folic acid as compared to placebo also had no effect on the following secondary outcomes: risk of revascularization (RR, 1.05; 95%CI, 0.95-1.16), acute coronary syndrome (RR, 1.06; 95%CI, 0.97-1.15), cancer (RR, 1.08; 95%CI, 0.98-1.21), vascular death (RR, 0.94; 95%CI,0.88-1.02), or non-vascular death (RR, 1.06; 95%CI, 0.97-1.15). CONCLUSION/SIGNIFICANCE: Folic acid supplementation does not effect on the incidence of major cardiovascular events, stroke, myocardial infarction or all cause mortality.


Assuntos
Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Ácido Fólico/uso terapêutico , Suplementos Nutricionais , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
Zhongguo Zhong Xi Yi Jie He Za Zhi ; 29(11): 1035-9, 2009 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-20329620

RESUMO

FDA approved the first botanical drug of non-simplex ingredient on 31st Oct 2006. The new drug's trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U.S, which attracts other countries and regions' attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to promote domestic new drug investigation.


Assuntos
Bioestatística , Preparações Farmacêuticas , Preparações de Plantas , Aprovação de Drogas , Projetos de Pesquisa/estatística & dados numéricos , Estados Unidos , United States Food and Drug Administration/estatística & dados numéricos
20.
Zhongguo Zhong Yao Za Zhi ; 31(10): 804-6, 2006 May.
Artigo em Chinês | MEDLINE | ID: mdl-17048659

RESUMO

OBJECTIVE: To develop a quantitative method for determination of the total organic acids and salicyclic acid in the extract of Radix Isatidis. METHOD: The total organic acids were determined by acid-base titration and the salicylic acid was determined by HPLC. RESULT: It was shown that contents of total organic acids and salicylic acid in the extract of Radix Isatidis were 13.0% and 0.22%, respectively. CONCLUSION: The method can control the quality of this extract effectively and accurately.


Assuntos
Ácidos Carboxílicos/análise , Medicamentos de Ervas Chinesas/química , Isatis/química , Plantas Medicinais/química , Ácido Salicílico/análise , Cromatografia Líquida de Alta Pressão/métodos , Medicamentos de Ervas Chinesas/isolamento & purificação , Raízes de Plantas/química , Controle de Qualidade , Tecnologia Farmacêutica
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