ABSTRACT
Objective: To sort out the knowledge structure and summarize the current development in the fields related, by summarizing the research on commonly used acupoints by moxibustion for the treatment of lumbar disc herniation, LDH.Methods: Citespace software was used to create the atlas of acupoints commonly used by moxibustion for the treatment of lumbar disc herniation and the atlas was analyzed. The data obtained was used to data back to the literature and summarize its development of the field. Results: In the field of moxibustion treatment of lumbar disc herniation, traditional acupoints, have been studied mostly. With the deepening of the research, some new ideas and methods have been gradually formed, such as heat sensitive points and heat sensitive moxibustion. Conclusion: The research on moxibustion treating LDH common acupoints scattered. It is hoped that the cooperation between scholars and research groups in this field will be made, laying a solid foundation for the future research.
ABSTRACT
Objective: To analyze the status and existing problems of the diagnostic criteria of qi and yin deficiencysyndrome by applying the knowledge mapping method. Methods: In the China Knowledge Network Database (CNKI), wesearched the relevant journal articles on the diagnostic criteria of qi and yin deficiency syndrome, exported andtransformed the literature data, and used CiteSpace software to draw co-occurrence map of authors, institutions and keywords of research on the diagnosis criteria of qi and yin deficiency syndrome for analysis.Results:A total of 378research papers were included, and the main researchers and teams represented by Li Jiansheng were found.The research institute was mainly the Institute of Geriatrics of Henan University of Traditional Chinese Medicine.Diabetes was the most concerned research direction in this field.Conclusion:Although the research on the diagnostic criteria of qi and yin deficiency syndrome is currently facing great difficulties, the research institutions in this field have cooperat extensively.The wisdom collision brought by such cooperation foundation will provide solutions to these problems, an the output of excellent results was expected.Based on diabetes, IGA nephropathy, coronary heart disease, and clinic research as the method, the relevant research is the main direction, which will be the main trend of the research on t diagnostic criteria of qi and yin deficiency syndrome.
ABSTRACT
This paper used the co-word analysis function of CiteSpace V to take the visualization analysis of related articles,research history,status quo and tendency of diagnostic criteria research of syndrome of yin deficiency of liver and kidney.China National Knowledge Infrastructure (CNKI) was used as the data source.A total of 99 papers related to diagnostic criteria research of syndrome of yin deficiency of liver and kidney were retrieved.And then,the data files were imported into CiteSpace V.The co-word and visualization analysis of authors,institutions and keywords were conducted.With the visualization analysis,the research found 389 main researchers and 4 stable research teams of diagnostic criteria research of syndrome of yin deficiency of liver and kidney.Traditional Chinese medicine (TCM) clinical basic medical institute and affiliated hospitals of universities of Chinese medicine and each region of the Chinese medicine hospital are the main institutions of this field.Cluster analysis of keywords showed that main research directions in this field contain the establishment of TCM diagnostic criteria of syndrome of yin deficiency of liver and kidney,syndrome differentiation of TCM,syndrome factors and correlational study.Diseases which attract more attentions are IgA nephropathy,hypertension,cirrhosis,chronic hepatitis B,and etc.The research result not only visually understands the research history,status quo and main research direction of this field,but also forecasts the development tendency of this field.
ABSTRACT
<p><b>OBJECTIVE</b>To analyze the researches of acupuncture and moxibustion for lumbar disc herniation (LDH) in recent 15 years and summarize the research direction and collect the knowledge structure.</p><p><b>METHODS</b>The relevant literature on acupuncture and moxibustion for the treatment of LDH was retrieved from CNKI. After Refworks format reversion, the CiteSpace software was used to create the reproductive map of the authors, research institutions and keywords in the literature on acupuncture and moxibustion for LDH.</p><p><b>RESULTS</b>In the map, 701 authors were included and 11 authors of them had published ≥ 3 papers; 740 institutions were included and 20 institutions of them had published ≥ 3 papers; 149 keywords were included and 13 keywords of them had appeared ≥ 20 times.</p><p><b>CONCLUSIONS</b>In a study of acupuncture and moxibustion for LDH, it is required to specify the nomenclature, strengthen the cooperation among institutions, promote the communication among authors and construct the treatment system, moreover, to deepen the study on the therapeutic methods, in which the researches have been conducted, and to explore a new therapeutic approach on the basis of the original therapeutic methods.</p>
ABSTRACT
Abstract: Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D Program", we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.
ABSTRACT
Conducting quality monitoring to multi-center clinical research is an effective measure of quality control.This study explored the optimization of some key links of quality monitoring of TCM clinical research,i.e.optimization of CRA appointment,optimization of monitoring preparation,optimization of monitoring items,and optimization of monitoring feedback.For monitoring items,this study emphasized on research progress,protocol compliance,original data conservation,medication management,validity,CRF fill-in,informed consent singing and acquisition,EDC,traceability of lab examination,(severe) adverse event reporting in detail,thus providing the theoretical support for quality monitoring improvement of TCM clinical research.
ABSTRACT
TCM clinical research covers different design types on basis of objective of the study. For exploratory research of TCM, cross-sectional study and descriptive research (e.g. case report and case analysis) is suitable. For hypothesis-testing research, RCT design is commonly adopted. RCT is most commonly used in activity or prevention therapy research, when using randomized cross-over design, the influence of sequence effects should be considered, and double-blind method is the best choice. Cohort study includes various intervention measures, as it doesn’t involve randomized allocation and blinding. Case-control study is widely applicable, but it may bring about bias. Cross-sectional study is much used in syndrome investigation of TCM clinical research. Descriptive research is available for summarization of TCM clinical experience and TCM exploratory research. Third party-central randomization system is recommended, as the randomization is not easy to be damaged. Randomization concealment should also be attached importance to. When blinding is impossible, blindness testing could reduce measurement bias, positive control should be supported high-level evidence. Placebo application could improve the level of evidence-based medicine.
ABSTRACT
TCM clinical investigators should attach importance to buildup of research basis in order to ensure the feasibility and normalization of clinical regimen,definite curative effect of treatment regimen and enhance consistency among different researchers and repeatability of clinical regimen.Syndrome,therapeutic method and prescription should be consistent,the addition or subtraction of the medicinal or the dosage should be reasonable.Reduce the use of rare or invaluable medicinal to avoid the restrictions of herb resource,drug cost and animal protection.When transforming decoction to capsule,granule,dripping pill and compound granule,the preliminary test in clinic to recur the curative effect of the decoction is necessary.The application of a single medicinal,the single target area of a medicinal or active ingredient of a single medicinal in a prescription should be based on the preliminary work experience.Meanwhile the county-level producing area of the processed medicinal should be explicit,in order to ensure the quality and efficacy of the processed medicinal.This article also discussed the key point of treatment regimen optimization of acupuncture and massage.
ABSTRACT
The principle of TCM diagnosis standard is communicational convenience, and the international universal standard recommended by WHO should also be paid attention to. When there’s no corresponding standard, inferior standard is available, but self made standard is generally not accepted. It’s suggested to apply the same standard for one program. The standards include international standard, regional standard, domestic standard, industrial standard, provincial standard and enterprise standard, the hierarchies and levels of these standards reduce successively. It’s thought that medical standard consists of international standard (issued by WHO or set by international academic conference), domestic standard (set by government authorities, national academic organization and conference), diagnosis standard set by provincial academic organization and textbook standard by universities and colleges. A lot of literature network database, as well as ICD-10, therapy guide, professional periodicals, professional society website, and books could be used for searching. TCM clinical trials also cover syndrome diagnosis standard. The conclusion standard and exclusion standard setting and influence of improper standard setting is also discussed in this article.
ABSTRACT
Optimization of Traditional Chinese Medicine (TCM) clinical trials as philosophy, process and method, is extremely necessary and can be applied in different levels. Optimization of TCM clinical trials should follow some principles and procedures, and be executed in two ways. Optimization of treatment plan should be supported by the research basis and literature experience, and be perfected by research group and experts argumentation. Optimization of design plan is modified and accomplished by expert discussion and repeated consulting multi-disciplinary experts. Specific research objective, exact target population definition, proper design plan selection, valid calculation of sample size, precise and appropriate main outcome measures, data management system, medical ethics and statistical analysis are the focuses.
ABSTRACT
Statistical analysis plan (SAP) is an important guidance document in clinical research which is intended to be a comprehensive and detailed description of the methods and presentation of data analyses proposed for a clinical research. The analysis plan will be completed after finalising the protocol and should be finalised before treatment unblinding, to provide full details, even to the extent of including templates of tables, listings and figures to be presented in the statistical report. Any changes between the methods in the protocol and analysis plan will be explained in the analysis plan. In order to improve the quality of TCM clinical research, it is need to optimize the SAP. Considerations in optimizing the SAP include: determine the analysis sets and analysis variables, select analysis methods and statistical software.
ABSTRACT
TCM clinical research should attach importance on ethical issues,as it takes the human for the research subjects and the clinical research activities definitely involve the benefits and risks to the subjects.Ethics optimization on the basis of safety and scientificity is necessary.This study explores the optimization of some key links of ethics of TCM clinical research,i.e.optimization of ethics committee membership,optimization of ethical review of study protocol,optimization of informed consent process,and optimization of protection and compensation of the subject,thus providing the theoretical support for ethics improvement of TCM clinical research.
ABSTRACT
Start with common problems in the quality control process of TCM clinical research,we summarize the problems in protocol execution,CRF fill-in,ICF signature,medication management,EDC management,lab examination and AE report; meanwhile we analyze the reasons and put forward the countermeasures for the optimization of TCM quality control.
ABSTRACT
Sample size design is to determine the minimum number of observed cases in the case of ensuring the reliability of research conclusions.The reliability of sample size estimation mainly related to the reliability of the basis of sample size calculation.Some things are essential,such as the emphasis on pre-test quality,extensive collection of relevant literature and research materials and accurate analysis.Estimation of sample size is first to determine the value of ?,?,or 1-? and effect indicators and their types,the effect indicators predictive value of each comparison group,the emphasis on sources and requirements of the effect indicators predictive value(the basis of calculation),besides,should pay close attention to study design and comparison of types,each group allocation ratio,the expected rate of lost to follow,the level of expected treatment compliance,the choice of some main effect indicators in outcome evaluation.An introduction and explaining with examples to estimation method and estimation of sample size formula,such as design of randomized controlled trials,cohort studies and case-control study commonly used in the clinical validation study of TCM,and study design commonly used in the clinical exploratory study of TCM,case analysis and so on.
ABSTRACT
BACKGROUND: The onset of vascular dementia (VD) is closely related to brain ischemic-hypoxia. Previous research has proved that behavioral disturbance can be obviously attenuated by xingnao qizhi capsule in VD rats; however, it remains unclear whether the improvement of VD is due to the protection on ischemic cells.OBJECTIVE: Pheochromocytoma PC12 cells were cultured in vitro and exposed to Na2S2O4 to induce hypoxia injury. Then serum pharmacological technique was used to investigate the protection of xingnao qizhi drug serum on hypoxia-injured PC12 cells.DESIGN: Randomized controlled study.SETTING: School of Traditional Chinese Medicine of Hebei Medical College.PARTICIPANTS: This study was conduced at the Experimental Animal Laboratory and Cell Culture Laboratory, School of Traditional Chinese Medicine of Hebei Medical College, between June and December 2003.Forty SD rats were randomized into 5 groups, namely serum control group (n=12) and xingnao qizhi serum 25.42, 12.71, 6.35 and 3.18 g/kg groups (n=7). PC12 cell line was purchased form the Cell Center of Chinese Academy of Medical Sciences.serum 25.42, 12.71, 6.35 and 3.18 g/kg groups were exposed through gastric lavage to xingnao qizhi of corresponding dosages (composed of wolfberwhile normal saline was given by gastric lavage to rats in control group in dosage of 10 mL/kg, twice a day at an interval of 12 hours for 3 consecutive days. One hour after the last administration, femoral blood samples were collected when rats were deeply anaesthetized and serum was sepainto 6 groups. Cells in control group were cultured with control serum while in experimental model groups cells were exposed to Na2S2O4 to induce hypoxia injury 1 hour later. Cells in Xingnao Qizhi 25.42, 12.71,6.35 and 3.18 g/kg groups were cultured in 5% drug serum with corresponding dosage of xingnao qizhi drug for 1 hour before being exposed to changes of PC12 cells in the six groups were observed under reversal microscope after exposure to Na2S2O4 for 16 hours; the inhibition rate of lactate dehydrogenase production and PC12 cell injury (MTT method) was calculated for assessing cell activity.nase production and PC12 cell injury.of xingnao qizhi displayed better refraction, with fewer cell fragments that tion: It was 81.6%, 69.6%, 54.4% and 27.8% in xingnao qizhi 25.42,PC12 cell injury: It was 82.9%, 75.6%, 65.9% and 53.7% in Xingnao Qizhi 25.42, 12.71, 6.35 and 3.18 g/kg groups, respectively.CONCLUSION: xingnao qizhi drug serum can markedly attenuate hypoxia injury of PC12 cells in dose-dependant manner, which is presented by strengthened cell activity and decreased lactate dehydrogenase activity.
ABSTRACT
<p><b>OBJECTIVE</b>To observe the effect of Zhitiaokang capsule (ZTK) on serum insulin-like growth factor-2 (IGF-2) in patients with hyperlipidemia (HLP).</p><p><b>METHODS</b>Patients with HLP were randomly divided into the treated group (n = 124) and the control group (n = 62), they were treated by ZTK and Zhibituo tablet respectively for 8 weeks as one therapeutic course. The changes of blood lipids and serum IGF-2 before and after treatment were observed.</p><p><b>RESULTS</b>ZTK could significantly reduce blood lipids and increase serum content of IGF-2.</p><p><b>CONCLUSION</b>ZTK could improve the insulin resistant status and inhibit the development of hyperlipidemia in patients by means of raising serum content of IGF-2 and suppressing vascular endothelial cell apoptosis.</p>
Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Capsules , Drugs, Chinese Herbal , Therapeutic Uses , Hyperlipidemias , Blood , Drug Therapy , Hypolipidemic Agents , Therapeutic Uses , Insulin-Like Growth Factor II , Phytotherapy , Proteins , MetabolismABSTRACT
AIM: To observe pathomorphological changes in cerebral cortex and hippocampus in the mouse with synthetic vascular dementia. METHODS: The synthetic vascular dementia model was produced in the mouse. Animals were killed 7 d, 15 d, and 30 d after the operation, brain tissues were removed and embedded in paraffin. Section of 8?m thickness were stained with hematoxylin-eosin(HE) and Nissl methods, and observed with light microscope. RESULTS: The cerebral cortex in the mouse became thinner on the seventh day, karyopyknosis in partial nervous cells was formed, the number of local neurons was reduced, sieve structure was observed, and glial cells proliferated, with the similar results 15 d and 30 d after operation. Model mouses hippocampal cells in CA 1 area were reduced and almost disappeared 30 d after operation. At the same time, glial cells were abundantly proliferated, tubercles were formed. Cells in CA 2, CA 3 area were also reduced and hippocampal sclerosis occurred. CONCLUSION: Delayed necrosis of hippocampal pyramidal cells may be the pathological basis of ischemia cerebral vascular dementia.