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1.
Article in Chinese | WPRIM | ID: wpr-879120

ABSTRACT

Post-marketing evaluation of traditional Chinese medicine(TCM) is an important research stage in the life cycle of a drug, and the add-on-design is a common method for its post-marketing evaluation. This article introduces the basic concept of add-on-design, and points out that it is suitable for use based on the principles of medical ethics when the standard treatment should not be interrupted. The post-marketing evaluation of TCM should be carried out based on human experience and in compliance with regulations and ethics. The clinical values of TCM, such as the therapeutic effect for disease, improvement of disease symptoms, improvement in quality of life, as well as the synergism and toxicity attenuation of combined use of TCM and chemical drugs, should be fully reflected through the clinical trials designed with add-on-design. The key points of add-on-design are accurate clinical positioning, scientific estimation of sample size, and rigorous standard treatment. Standard treatment should be a recognized one, consistent and stable; appropriate and recognized efficacy indicators and targeted safety indicators should be selected; the design and operation of clinical research scheme should meet the requirements of randomization and blind method, with special emphasis on the production of qualified placebo. The add-on-design has the advantages that the rights and interests of the subjects are adequately protected. Besides, the research conclusions are easily put into clinical application. But there are also many difficulties, such as the influence of confounding bias, the "ceiling" effect of clinical efficacy, and the difficulty of interpretation of adverse events. Therefore, a rigorous research quality assu-rance system should be established, and the quality control of evaluation consistency of researchers should be emphasized to ensure strict quality control in the research process.


Subject(s)
Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Quality Control , Quality of Life
2.
Article in Chinese | WPRIM | ID: wpr-879080

ABSTRACT

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.


Subject(s)
China , Drugs, Chinese Herbal , Evidence-Based Medicine , Humans , Medicine, Chinese Traditional , Syndrome
3.
Article in Chinese | WPRIM | ID: wpr-879079

ABSTRACT

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.


Subject(s)
Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality of Life , Research , Syndrome
4.
Article in Chinese | WPRIM | ID: wpr-879078

ABSTRACT

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.


Subject(s)
Data Collection , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Prescriptions , Quality Control
5.
Chinese Medical Journal ; (24): 757-763, 2012.
Article in English | WPRIM | ID: wpr-262530

ABSTRACT

<p><b>BACKGROUND</b>Gastric cancer (GC) is one of the most common types of cancer in the world. A change in the metabolism of lipids in tumor cells could lead to the pathogenesis of cancer. In this study, we investigated fatty acid and fatty acid amide metabolic perturbations associated with GC morbidity.</p><p><b>METHODS</b>Gas chromatography/mass spectrometry (GC/MS) was utilized to analyze fatty acids (FAs) and fatty acid amides (FAAs) of GC tissues and matched normal mucosae from 30 GC patients. Acquired lipid data was analyzed using non parametric Wilcoxon rank sum test to find the differential biomarkers for GC and diagnostic models for GC were established by using orthogonal partial least squares discriminant analysis (OPLS-DA).</p><p><b>RESULTS</b>A total of 13 FAs and 4 FAAs were detected using GC/MS and 5 differential FAs as well as oleamide were identified with significant difference (P<0.05). The OPLS-DA model generated from lipid profile showed adequate discrimination of GC tissues from normal mucosae while the OPLS-DA model failed to separate GC specimens of different TNM stages. A total of 8 variables were obtained for their most contribution in the discriminating model (Variable importance in the projection (VIP) value>1.0), five of which were detected with significant difference (P<0.05).</p><p><b>CONCLUSIONS</b>FA and FAA metabolic profiles have great potential in detecting GC and helping understand perturbations of lipid metabolism associated with GC morbidity.</p>


Subject(s)
Amides , Metabolism , Fatty Acids , Metabolism , Female , Gas Chromatography-Mass Spectrometry , Humans , In Vitro Techniques , Male , Metabolic Diseases , Stomach Neoplasms , Metabolism , Pathology
6.
Article in Chinese | WPRIM | ID: wpr-321602

ABSTRACT

<p><b>OBJECTIVE</b>To investigate the nutritional status, and provide evidence for nutritional treatment option.</p><p><b>METHODS</b>A total of 452 patients with gastrointestinal cancer were selected, including 156 gastric cancer,117 colon cancer, and 180 rectal cancer. The nutritional risk screening 2002(NRS2002) was applied to grade the nutritional risk. A multi-frequency bioelectrical impedance analysis was used to measure the patients' body composition. Albumin (Alb), prealbumin(PA), transferring(Tf), retinol binding protein(RBP), red blood cell(RBC), hemoglobin (Hb), haematocrit(Hct) were measured after fasting.</p><p><b>RESULTS</b>The rate of patients with NRS2002 score more than 3 was 70.5%(110/156) for gastric cancer, 53.8%(63/117) for colon cancer, and 46.7%(86/180) for rectal cancer. The score for impaired nutritional status more than 1 for gastric cancer was higher than that for colorectal cancer(P<0.05), while patients with disease score more than 2 was less for gastric cancer(P<0.05). Body mass index(BMI), obesity degree, fat content, fat percentage, and arm circumference were lower in gastric cancer patients as compared to colorectal cancer patients(P<0.05); but protein percentage, muscle percentage, ratio of muscles of arm, and cell mass percentage were higher in gastric cancer patients(P<0.05). The proportions of patients with low Alb, PA, Tf, BC, Hb, Hct were higher for gastric cancer and colon cancer(P<0.05).</p><p><b>CONCLUSION</b>Patients with gastric cancer are prone to fat loss and therefore have a higher nutritional risk and malnutrition than those with colorectal cancer. Combination of body composition analysis and laboratory examination may achieve comprehensive evaluation of the nutritional status of patients, and provide the evidence of nutritional therapy by being combined with NRS2002 score.</p>


Subject(s)
Female , Gastrointestinal Neoplasms , Humans , Male , Middle Aged , Nutrition Assessment , Nutritional Status , Risk Factors
7.
Chinese Medical Journal ; (24): 326-331, 2010.
Article in English | WPRIM | ID: wpr-314590

ABSTRACT

<p><b>BACKGROUND</b>Techniques for the fast and accurate detection of bacterial infection are critical for early diagnosis, prevention and treatment of bacterial translocation in clinical severe acute pancreatitis (SAP). In this study, the availability of a real-time PCR method in detection of bacterial colonization in SAP rat models was investigated.</p><p><b>METHODS</b>Samples of blood, mesenteric lymph nodes (MLN), pancreas and liver from 24 specific pathogen-free rats (8 in a control group, 16 in a SAP group) were detected for bacterial infection rates both by agar plate culture and a real-time PCR method, and the results were made contrast.</p><p><b>RESULTS</b>Bacterial infection rates of the blood, MLN, pancreas and liver in the SAP group and the control group by the two different methods were almost the same, which were 5/16, 12/16, 15/16, 12/16 in the SAP group compared with 0/8, 1/8, 0/8, 0/8 in the control group by agar plate culture, while 5/16, 10/16, 13/16, 12/16 and 0/8, 1/8, 0/8, 0/8 respectively by a real-time PCR method. Bacterial number was estimated by real-time PCR, which showed that in the same mass of tissues, the pancreas contained more bacteria than the other three kinds of organs in SAP rats (P < 0.01), that may be due to the edema, necrosis and hemorrhage existing in the pancreas, making it easier for bacteria to invade and breed.</p><p><b>CONCLUSION</b>Fast and accurate detection of bacterial translocation in SAP rat models could be carried out by a real-time PCR procedure.</p>


Subject(s)
Acute Disease , Animals , Bacterial Translocation , Genetics , DNA, Ribosomal , Genetics , Female , Male , Pancreatitis , Microbiology , Polymerase Chain Reaction , Methods , Rats
8.
Article in Chinese | WPRIM | ID: wpr-242699

ABSTRACT

<p><b>OBJECTIVE</b>To study the effect of betaine on the formation of atherosclerotic plaque in apolipoprotein E (ApoE)-deficient mice and explore its anti-inflammatory mechanism.</p><p><b>METHODS</b>Seven-week-old ApoE-deficient mice (C57BL/6J background) were divided into four groups randomly based on body weight: model group and three betaine groups. Wild-type mice with the same age and genetic background were used as control group. The control group and model group were fed AIN-93G diet. Three betaine groups were fed AIN-93G diet supplemented with 1, 2, 4 g betaine/100 g diet, respectively. Serum tumor necrosis factor-alpha (TNF-alpha), monocyte chemoattractant protein-1, lipid levels and methylation status of TNF-alpha promotor in aorta were determined at 0, 7 and 14 weeks. The percentage of aorta sinus plaque to lumen area was measured at 14-week.</p><p><b>RESULTS</b>The percentage of aorta sinus plaque to lumen area of 1% and 2% betaine groups were (11.43+/-2.65)% and (12.09+/-3.07)%, respectively, which were 41% and 33% smaller than that of the model group (t=3.117, 3.010, respectively, and P<0.01). Serum TNF-alpha level of three betaine groups were (56.33+/-3.86), (63.04+/-4.67) and (65.52+/-3.97) pg/ml, respectively, which were lower than that of the model group (79.40+/-4.68) pg/ml (t=9.270, 6.571 and 5.576, respectively, P<0.001), but there was no significant difference in the methylation status of TNF-alpha promotor among all five groups.</p><p><b>CONCLUSION</b>Betaine could inhibit the development of atherosclerosis via anti-inflammation.</p>


Subject(s)
Animals , Apolipoproteins E , Genetics , Atherosclerosis , Blood , Drug Therapy , Betaine , Pharmacology , Therapeutic Uses , Chemokine CCL2 , Metabolism , Dietary Supplements , Disease Models, Animal , Male , Mice , Mice, Inbred C57BL , Tumor Necrosis Factor-alpha , Metabolism
9.
Article in Chinese | WPRIM | ID: wpr-358113

ABSTRACT

<p><b>OBJECTIVE</b>To investigate the direct electrochemical behaviors of matrine (MT), oxymatrine (OMT), sophoridine (SR) and oxysophoridine (OSR) at a glassy carbon electrode in a physiological medium, and to determine the contents of commercial MT and SR pharmaceutical products were determined.</p><p><b>METHOD</b>Their electrochemical behaviors and contents in 0.15 mol x L(-1) NaCl aqueous solutions were obtained by cyclic voltammetry (CV) and square wave voltammetry (SWV) methods.</p><p><b>RESULT</b>The electrochemical experimental results show that the two totally irreversible oxidation peaks for both MT and SR were observed, which potential values are 0.81 V and 0.92 V, and the electrode reaction processes were diffusion-controlled. But for both OMT and OSR, they have no oxidation peaks observed in the same condition as well. The linear range of the concentration of MT and SR and the contents in their products were obtained by SWV.</p><p><b>CONCLUSION</b>The research results can be applied in determination of the contents of commercial MT and SR pharmaceutical products.</p>


Subject(s)
Alkaloids , Chemistry , Carbon , Electrochemistry , Methods , Electrodes , Oxidation-Reduction , Plants, Medicinal , Chemistry , Quinolizines , Chemistry , Reproducibility of Results , Sophora , Chemistry
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