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1.
Biomed Chromatogr ; 38(6): e5856, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38486344

ABSTRACT

In this study, a novel quality control strategy was proposed, aiming to establish a multivariate specification for the processing step by exploring the correlation between colors, chemical components, and hemostatic effects of the carbonized Typhae pollen (CTP) using multivariate statistical analysis. The CTP samples were stir-fried at different durations. Afterward, the colorimeter and LC-MS techniques were applied to characterize the CTP samples, followed by the determination of bleeding time and clotting time using mice to evaluate their hemostatic effect. Then, principal component analysis, hierarchical cluster analysis, and multi-block partial least squares were used for data analysis on colors, chemical components, and their correlation with the hemostatic effect. Consequently, 13 critical quality attributes (CQAs) of CTP were identified via multivariate statistical analysis-L*, a*, b*, 3,4-dihydroxybenzoic acid, 4-hydroxybenzoic acid, 3-hydroxybenzoic acid, quercetin-3-O-glucoside, azelaic acid, kaempferol-3-O-glucoside, quercetin, naringenin, kaempferol, and isorhamnetin. The multivariate specification method involving the 13 CQAs was developed and visualized in the latent variable space of the partial least squares model, indicating that the proposed method was successfully applied to assess the quality of CTP and the degree of carbonization. Most importantly, this study offers a novel insight into the control of processing for carbonized Chinese herbal medicines.


Subject(s)
Pollen , Quality Control , Typhaceae , Animals , Pollen/chemistry , Multivariate Analysis , Mice , Typhaceae/chemistry , Mass Spectrometry/methods , Chromatography, Liquid/methods , Male , Drugs, Chinese Herbal/chemistry , Drugs, Chinese Herbal/analysis , Liquid Chromatography-Mass Spectrometry
2.
Article in Chinese | WPRIM | ID: wpr-921721

ABSTRACT

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.


Subject(s)
Humans , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Prescriptions , Reproducibility of Results , Research
3.
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)
Humans , Drugs, Chinese Herbal , Marketing , Medicine, Chinese Traditional , Quality Control , Quality of Life
4.
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)
Humans , China , Drugs, Chinese Herbal , Evidence-Based Medicine , Medicine, Chinese Traditional , Syndrome
5.
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)
Humans , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Quality of Life , Research , Syndrome
6.
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)
Humans , Data Collection , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Prescriptions , Quality Control
7.
Article in Chinese | WPRIM | ID: wpr-802546

ABSTRACT

Citri Sarcodactylis Fructus, a traditional Chinese medicine with dual-purpose of drug and food, has a long history of cultivation and application, showing high medicinal, dietetic, ornamental and economic values. Many modern researches have been conducted on the extraction technology, chemical constituents, quality standards and biological activities, but the herbal textual researches were relatively insufficient. The related records of Citri Sarcodactylis Fructus in the ancient Chinese medicinal classics were ambiguous and confusing. By referring to ancient Chinese medicinal classics and modern books, the textual researches of Citri Sarcodactylis Fructus, including the names, plant morphology, origin, medicinal properties, efficiency and application were systematically reviewed and analyzed in this paper, in order to provide the basis for the confirmation of original source of Citri Sarcodactylis Fructus. The results showed that Citri Sarcodactylis Fructus was usually recorded as ‘Xiangyuan’ ‘Juyuan’ ‘Ganyuan’ ‘Xiangyuan’ ‘Foshougan’ etc. in ancient books. After the Ming and Qing dynasties, it became clear that ‘Xiangyuan’ was equivalent to ‘Juyuan’, but different from ‘Foshougan’. Therefore, these two species were recorded separately. From the ancient times to the present day, Citri Sarcodactylis Fructus was always mainly distributed in south of the Yangtze River, such as Fujian, Guangdong, Guangxi, and Jiangxi provinces. Ancient records and modern reports basically have the same understanding on properties, efficacies and indications of Citri Sarcodactylis Fructus, considering it was warm in nature with the effectiveness of soothing liver, relieving pain, eliminating dampness and resolving phlegm. ‘Baking it into powder on new tiles’ and ‘steaming’ were the traditional processing methods. The description of ‘The longer of storage period, the better of the effect’ was occasionally recorded. These results provide theoretical references for the further study, resource development and comprehensive application of Citri Sarcodactylis Fructus.

8.
Acta Pharmaceutica Sinica ; (12): 1047-2016.
Article in Chinese | WPRIM | ID: wpr-779275

ABSTRACT

Epigenetic is a hotspot of post-genomic era research, and epigenetic modification is a mechanism in the study of cardiovascular disease. Myocardial ischemia-reperfusion injury (MIRI) is one of the problems in the cardiovascular disease, and many experimental interventions are reported in the protection of the ischemic myocardium in experimental animals. However, with the exception of early reperfusion, none has been translated into clinical practice. There is an advantage of traditional Chinese medicine (TCM) in the regulation of epigenetic modification, and pathogenesis of myocardial ischemia-reperfusion injury. This review article is prepared to cover the research progress in the treatment of myocardial ischemia-reperfusion injury by TCM with a focus on epigenetic regulation. The epigenetic regulation is documented in TCM theory through a systematic review of the protecting drugs in the MIRI development guidelines.

9.
Article in Chinese | WPRIM | ID: wpr-498495

ABSTRACT

Objective To evaluate the effect of external application therapy combined with chiropractic therapy on the pediatric asthma.Methods A total of 55 patients were randomly assigned into the treatment group (28 patients) and the control group (27 patients), The treatment group was treated with external application therapy combined with chiropractic therapyin the the hottest and coldest weather of each year; while the control group was only treated with chiropractic therapy. Both groups were treated for 3 years. After the treatment, the total effective rate, the clinical control rate, and the frequency of asthma attacks were detected.Results The total effective rate was 92.9% (26/28) and the clinical control rate was 64.3% (18/28) in observation group, which were better than those of 70.4% (19/27) and 22.2% (6/27) in the control group (χ2=4.073,P=0.044, andχ2=8.823,P=0.003). After 3 years’ treatment, the asthma grading distributionin the treatment group was significantly different from the control group (χ2=10.776,P=0.005). The frequency of asthma attacks in the treatment group after the first year treatment (4.5 ± 0.5 timesvs. 5.0 ± 0.5 times,t=3.708,P<0.01) was significantly lower than that in the control group; so did the second years after treatment (3.0 ± 0.5 timesvs.4.3 ± 0.5 times,t=9.728,P<0.01), and the third years (1.5 ± 0.5 times vs. 3.0 ± 0.5 times,t=11.225,P<0.01).ConclusionsThe external application therapy combined with chiropractic therapy could prevent asthma in children patients.

10.
Article in Chinese | WPRIM | ID: wpr-307095

ABSTRACT

Coronary artery heart disease (CHD) is one of the common cardiovascular diseases in clinical. The morbidity and mortality of CHD recently continue increasing in our country, which has aroused wide attention. Many studies confirm that traditional Chinese medicine has better therapeutic effect on CHD. Guanxin Danshen formula, widely used in the treatment of CHD, consists of Salviae Miltiorrhizae Radix et Rhizoma, Notoginseng Radix et Rhizoma and volatile oil from Dalbergiae Odoriferae Lignum, and has the efficacy in promoting blood circulation to resolve stasis, regulating the circulation of Qi and alleviating pain. This review summarized the pharmacologic effects and mechanism of Guanxin Danshen formula and its effective components in the treatment of CHD to provide reference for its fundamental research and clinical application.

11.
Article in Chinese | WPRIM | ID: wpr-341794

ABSTRACT

Based on the characteristics of multicomponent of traditional Chinese medicine and drawing lessons from the concepts, methods and techniques of biopharmaceutics classification system (BCS) in chemical field, this study comes up with the science framework of biopharmaceutics classification system of Chinese materia medica (CMMBCS). Using the different comparison method of multicomponent level and the CMMBCS method of overall traditional Chinese medicine, the study constructs the method process while setting forth academic thoughts and analyzing theory. The basic role of this system is clear to reveal the interaction and the related absorption mechanism of multicomponent in traditional Chinese medicine. It also provides new ideas and methods for improving the quality of Chinese materia medica and the development of new drug research.


Subject(s)
Animals , Humans , Biopharmaceutics , China , Drugs, Chinese Herbal , Chemistry , Classification , Pharmacology , Materia Medica , Chemistry , Classification , Plants, Medicinal , Chemistry , Classification
12.
Article in Chinese | WPRIM | ID: wpr-341793

ABSTRACT

Evaluation of the permeability mainly focuses on intestinal absorption in biopharmaceutics classification system (BCS). It is more complicated that the absorption and metabolism under multicomponent environment in biopharmaceutics classification system of Chinese materia medica (CMMBCS) compared with single component environment, which needs suitable mathematical models to be described. Therefore, with full consideration of existing single component mathematical algorithm combining with the characteristics of intestinal absorption and metabolism, we explored and designed a new mathematical algorithm of intestinal absorption and metabolism of multicomponent drug. Then we put forward a new coefficient, P (influence), the relative change rate of the single component's intestinal absorption and metabolism under multicomponent environment compared with single component environment, which described the influences of intestinal absorption and metabolism of the component under multicomponent environment. Moreover, P (influence) highlights the distinctive characteristics of multicomponent drug's intestinal absorption and metabolism, and lays the foundation for the construction of CMMBCS.


Subject(s)
Humans , Algorithms , Drugs, Chinese Herbal , Chemistry , Pharmacokinetics , Intestinal Absorption , Intestines , Chemistry , Metabolism , Models, Theoretical , Solubility
13.
Article in Chinese | WPRIM | ID: wpr-341791

ABSTRACT

The study is a paticular embodiment of Chinese patent medicine based on biopharmaceutics classification system of Chinese materia medica (CMMBCS) , focusing on assessment of synchronization issues of dissolution that may affect the timing of the multicomponent absorption. The accumulative dissolution percentages of nine components in Gengen Qinlian tablets in different dissolution solvents and times were determined by HPLC. The dissolution curve was drew and its similarity was evaluated by similarity factors (f2) and cluster method. Results in this experiment showed that the components that peak 7 and peak 8 (baicalin) represented had poor similarity with the reference peak 2 (puerarin). Their similarity factors were both 43 in water dissolution media and 31 and 45 in pH 7.4 dissolution media, respectively. Components that peaks represented had better similarity with the reference peak 2 (puerarin) in other medium. It illustrated that components that peak 3,4,5,6 (berberine) represented had fully synchronous dissolution characteristics with the reference peak 2 (puerarin), components peak 1 and 9 represented had nearly fully synchronous dissolution characteristics with the reference peak 2 (puerarin), while components that peak 7 and 8 (baicalin) represented had no synchronous dissolution characteristics with the reference peak 2 (puerarin).


Subject(s)
Biopharmaceutics , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Chemistry , Classification , Hydrogen-Ion Concentration , Solubility , Tablets , Chemistry , Classification
14.
Article in Chinese | WPRIM | ID: wpr-341789

ABSTRACT

The evaluation of permeability in biopharmaceutics classification system of Chinese materia medica (CMMBCS) requires multicomponent as a whole in order to conduct research, even in the study of a specific component, should also be put in the multicomponent environment. Based on this principle, the high content components in Gegen Qinlian decoction were used as multicomponent environmental impact factors in the experiment, and the relevant parameters of intestinal permeability about puerarin were measured with using in situ single-pass intestinal perfusion model, to investigate and evaluate the intestinal permeability of puerarin with other high content components. The experimental results showed that different proportions of baicalin, glycyrrhizic acid and berberine had certain influence on intestinal permeability of puerarin, and glycyrrhizic acid could significantly inhibit the intestinal absorption of puerarin, moreover, high concentration of berberine could promote the absorption of puerarin. The research results indicated that the important research ideas of permeability evaluation in biopharmaceutics classification system of Chinese materia medica with fully considering the effects of other ingredients in multicomponent environment.


Subject(s)
Animals , Male , Rats , Berberine , Pharmacokinetics , Biopharmaceutics , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Pharmacokinetics , Flavonoids , Pharmacokinetics , Glycyrrhizic Acid , Pharmacokinetics , Intestines , Chemistry , Metabolism , Isoflavones , Pharmacokinetics , Kinetics , Materia Medica , Pharmacokinetics , Permeability , Rats, Wistar
15.
Article in Chinese | WPRIM | ID: wpr-308616

ABSTRACT

The rhizome of Alpinia officinarum is a widely used Chinese herbal medicine. The essential oil in A. officinarum rhizome is mainly composed of 1, 8-cineole and other monoterpenes, as the major bioactive ingredients. In plants, monoterpenes are synthesized through the methylerythritol phosphate (MEP) pathway in the plastids, and 1-deoxy-D-xylulose 5-phosphate reductoisomerase (DXR) is an enzyme catalyzing a committed step of the MEP pathway. In the present study, the full-length cDNA encoding DXR was cloned from the rhizome of A. officinarum, using homology-based RT-PCR and rapid amplification of cDNA ends (RACE) techniques. The new cDNA was designated as AoDXR and submitted to GenBank to be assigned with an accession number HQ874658. The full-length cDNA of AoDXR was 1 670 bp containing a 1 419 bp open reading frame encoding a polypeptide of 472 amino acids with a calculated molecular mass of 51.48 kDa and an isoelectric point of 6.15. Bioinformatic analyses revealed that AoDXR showed extensive homology with DXRs from other plant species and contained a conserved plastids transit peptide, a Pro-rich region and two highly conserved NADPH-binding motifs in its N-terminal region characterized by all plant DXRs. The phylogenetic analysis revealed that AoDXR belonged to angiosperm DXRs. The structural modeling of AoDXR showed that AoDXR had the typical V-shaped structure of DXR proteins. The tissue expression pattern analysis indicated that AoDXR expressed strongly in leaves, weak in rhizomes of A. officinarum. Exogenous methyl jasmonate (MeJA) could enhance the expression of AoDXR and the production of 1, 8-cineole in A. officinarum rhizomes. The cloning and characterization of AoDXR will be helpful to reveal the molecular regulation mechanism of monoterpene biosynthesis in A. officinarum and provides a candidate gene for metabolic engineering in improving the medicinal quality of A. officinarum rhizome.


Subject(s)
Aldose-Ketose Isomerases , Genetics , Alpinia , Chemistry , Genetics , Amino Acid Sequence , DNA, Complementary , Genetics , Gene Expression Regulation, Enzymologic , Gene Expression Regulation, Plant , Molecular Sequence Data , Monoterpenes , Metabolism , Phylogeny
16.
Article in Chinese | WPRIM | ID: wpr-285180

ABSTRACT

<p><b>OBJECTIVE</b>To compare therapeutic effects of acupuncture at Xuanzhong (GB 39) combined with Chinese herbs pyrogenic dressing therapy and common acupuncture on calcaneus spur.</p><p><b>METHODS</b>A single-blind, randomized and controlled trial was adopted. Sixty-six cases were randomly divided into an observation group (n=34) and a common acupuncture group (n=32). The observation group was treated with acupuncture at Xuanzhong (GB 39) combined with Chinese herbs pyrogenic dressing therapy and the common acupuncture group with common acupuncture, Yanglingquan (GB 34), Kunlun (BL 60) etc. selected. The markedly effective rate and the changes of heel pain scores, heel swelling scores, heel burning sensation scores, and walking function scores were compared between the two groups before and after treatment.</p><p><b>RESULTS</b>The markedly effective rate of 64.7% (22/34) in the observation group was higher than 37.5% (12/32) in the common acupuncture group (P<0.05). After treatment, all the scores in the two groups were significantly improved as compared with before treatment (all P<0.05), and the observation group was better than the common acupuncture group (all P<0.05).</p><p><b>CONCLUSION</b>The therapeutic effect of acupuncture at Xuanzhong (GB 39) combined with Chinese herbs pyrogenic dressing therapy on calcaneus spur is superior to that of common acupuncture.</p>


Subject(s)
Adult , Humans , Male , Middle Aged , Acupuncture Points , Acupuncture Therapy , Calcaneus , Combined Modality Therapy , Drugs, Chinese Herbal , Therapeutic Uses , Osteophyte , Drug Therapy , Therapeutics , Treatment Outcome
17.
Article in Chinese | WPRIM | ID: wpr-337523

ABSTRACT

Based on studying the manifestation of untranslatability of traditional Chinese medicine (TCM) technical terms, and through analysis on the enriched cultural content and special linguistic characteristics, the author summarized the factors that caused the untranslatability, and suggested some projects for compensation and reformation, including transliteration, word-formation, free translation and literal translation. Although the existence of untranslatability of TCM technical terms is affirmable, on account of the uninterrupted international cultural communications, the untranslatability of TCM terms will not be lasting invariable.


Subject(s)
Medicine, Chinese Traditional , Terminology as Topic , Translations
18.
Chinese Journal of Hematology ; (12): 15-18, 2005.
Article in Chinese | WPRIM | ID: wpr-229892

ABSTRACT

<p><b>OBJECTIVE</b>To observe the incidence of elimination delay in high dose methotrexate (HDMTX) therapy, its side effects and influence to next course of chemotherapy and analyze the relationship between the dosage, the duration of MTX infusion and the morbidity of the elimination delay.</p><p><b>METHODS</b>A total of 121 childhood acute lymphoblastic leukemia (ALL) (497 infusions of HDMTX) were analysed in this study. The elimination delay rate and the adverse effects in different dose groups (3 g/m2 vs 5 g/m2) and different infusion duration groups (7 h vs 24 h) were compared. The adverse effect evaluation was based on the World Health Organization (WHO) Toxicity Grading Criteria. The rescue dosages of calcium folinate (CF) among these groups were compared through CF/MTX index.</p><p><b>RESULTS</b>The overall morbidity of elimination delay was 12.1% with a relative risk of 30.6% for the first time. The relative risk for the second time of occurrence was increased to 45.9% (P < 0.01) and it was not significantly increased for the third time (35.3%). Children with elimination delay had lower platelet count (P < 0.01) and higher CF rescue dosage (P < 0.01), while the damage of oral mucous membrane was more severe (P < 0.05) and the next course of chemotherapy would be postponed for a median of 4 days in 3 g group. There was no significant difference in elimination delay rates between 3 g and 5 g groups (12.1% vs 12.0%, P > 0.05), and between 7 h and 24 h MTX infusion groups (13.6% vs 11.9%, P > 0.05). The only side effect occurred in 5 g group was gastrointestinal morbidity. The CF/MTX index of 5 g group without elimination delay was less than that of 3 g group (P < 0.01).</p><p><b>CONCLUSION</b>Elimination delay in HDMTX therapy accompanies the suppression of bone marrow and damage of oral mucous membrane, which need more CF rescues and will postpone the following course of chemotherapy. Elimination delay is not associated with the duration of the infusion and the dosage of MTX within the range of 3 approximately 5 g/m2 but there are individual differences.</p>


Subject(s)
Adolescent , Child , Child, Preschool , Female , Humans , Infant , Male , Young Adult , Antimetabolites, Antineoplastic , Pharmacokinetics , Therapeutic Uses , Dose-Response Relationship, Drug , Metabolic Clearance Rate , Methotrexate , Pharmacokinetics , Therapeutic Uses , Nausea , Precursor Cell Lymphoblastic Leukemia-Lymphoma , Drug Therapy , Retrospective Studies , Treatment Outcome , Vomiting
19.
Article in Chinese | WPRIM | ID: wpr-306733

ABSTRACT

<p><b>OBJECTIVE</b>To observe the effect of Xuefu Zhuyu decoction (XZD) on the chronic hepatitis B caused liver fibrosis (CHBLF) and the portal hemodynamics.</p><p><b>METHODS</b>Sixty patients with CHBLF were randomly divided into two groups, the 28 patients in the treated group were treated with oral intake of XZD and conventional liver protective treatment, the 32 patients in the control group were treated with conventional liver protective treatment alone, the therapeutic course for both groups was 3 months. Serum liver fibrosis criteria and portal dynamical criteria were observed before and after treatment.</p><p><b>RESULTS</b>Comparison of the remarkable effective rate between the two groups showed significant difference. After treatment, in the treated group, all the serum criteria for liver fibrosis (HA, PCIII, LN) and criteria for portal trunk hemodynamics, such as mean velocity and quantity of blood flow were significantly improved (P < 0.05 or P < 0.01), as compared with those in the control group, the difference was also significant (P < 0.05 or P < 0.01).</p><p><b>CONCLUSION</b>XZD has definite therapeutic effect on chronic hepatitis B caused liver fibrosis.</p>


Subject(s)
Adolescent , Adult , Female , Humans , Male , Middle Aged , Collagen Type III , Blood , Drugs, Chinese Herbal , Therapeutic Uses , Hemodynamics , Hepatitis B, Chronic , Blood , Hyaluronic Acid , Blood , Liver Cirrhosis , Blood , Drug Therapy , Phytotherapy , Portal Vein
20.
Article in Chinese | WPRIM | ID: wpr-240934

ABSTRACT

<p><b>OBJECTIVE</b>To seek effective drugs for anti-hepatitis C virus by screening 20 Chinese herbs often used for clearing heat and dissipating toxin with nude mice model of hepatitis C viral (HCV) infection.</p><p><b>METHODS</b>After the model mice had been treated with selected drug for 3 months, transmission electron microscope was used to observe whether the HCV-like particles in human fetal hepatocytes (HFH) transplanted into mice spleen still existed, and quantitative RT-PRC technique was used to detect the serum content of HCV-RNA before and after treatment.</p><p><b>RESULTS</b>(1)HCV-like particles existed in all the model mice after treatment. (2) Serum content of HCV-RNA decreased after treated with Radix Gentianae, Radix Scutellariae, Radix Sophorae tonkinensis, Fructus Gardeniae and Fructus Sophorae flavoscentis, but unchanged after treatment with other drugs.</p><p><b>CONCLUSION</b>All the 20 herbs screened has not effect in directly eradicating HCV, but Radix Gentianae, Radix Scutellariae, Radix Sophorae tonkinensis, Fructus Gardeniae and Fructus Sophorae flavoscentis could significantly inhibit the replication of HCV-RNA.</p>


Subject(s)
Animals , Female , Male , Mice , Antiviral Agents , Pharmacology , Drug Evaluation, Preclinical , Drugs, Chinese Herbal , Pharmacology , Gentiana , Chemistry , Hepacivirus , Hepatitis C , Virology , Mice, Nude , Phytotherapy , Scutellaria baicalensis , Chemistry , Sophora , Chemistry , Virus Replication
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