[A study of scale response for Health Scale of Traditional Chinese Medicine].

Objective: To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM).

Methods: A cross-sectional investigation was carried out among 28 hospital staff members by using 151 scale descriptors. This investigation involved all the descriptors from the initial version of HSTCM.

[Reliability and validity of Health Scale of Traditional Chinese Medicine].

Objective: To test the reliability and validity of Health Scale of Traditional Chinese Medicine (HSTCM) by means of questionnaires.

Methods: A cross-sectional survey was conducted at Liwan Community of Guangzhou, Old People's Home in Guangzhou and Outpatient Department of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 652 Chinese individuals (over 18 years old) were assessed with the 88-item version of HSTCM and World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF), which were randomly delivered to them.

[Establishment and initial evaluation of health scale of traditional Chinese medicine].

Viewing from some TCM concepts and basic characteristics of health, assimilating the operationalization concerning thinking and procedure of modern scientific research, the pilot form of Health Scale of TCM--initial health scale of TCM (iHSTCM) based upon TCM theory was developed. From November 2002 to January 2003, the domain, facets and items of HSTCM were finally established by analyzing the data from a survey of 652 persons in Guangzhou City using iHSTCM. In conclusion, the HSTCM has its theoretical ratio-nality and is applicable.

[Exploration on health concept of TCM and the operationalization of its measurement].

Viewing from the concept of health and several basic characteristics of health outlook of traditional Chinese medicine (TCM), assimilating the thinking and procedure of modern scientific research concerning operationalization, in this paper, the TCM concept of health and its measurement operationalization as well as their relevant things were expounded. And the frame, related domain, indexes and items of health assessment scale based upon TCM theory were tried to be established using opertionalization method.

[Exploration on establishment and application of soft index survey tools in TCM study].

This paper discussed the concept, categorizations, methods and basic principles for establishing of soft index survey tools (SIST) in clinical medicinal field, pointed out the relation between the connatural theoretical and practical mode of TCM and the establishment of SIST having TCM characteristics, and elaborated several key points which should be paid attention to in the establishment of SIST. It was pointed out that there was broad space for application of SIST in TCM study.

[Application of non-randomized study in the field of traditional Chinese medicine or integrated traditional Chinese and Western medicine].

Non-randomized studies (NRS) have gradually attracted people's attention in the field of clinical medicine. In this paper, the importance of NRS was emphasized on the viewpoints of the coherence of scientific research, the limitation of randomized control trials (RCTs), the immanent characteristics of TCM clinical practice and the actual requirement of complex intervention in clinical practice. And two main points in evaluation and implementation of NRS differed to those in RCTs were put forward, i.

[How to analyze and interpret the effective values in clinical trials].

The analysis of the effective value obtained in clinical trails should take account of both sides of its size and precision, for its interpretation, the general principles of: accuracy, explicitness and quantification should be complied. Criteria such as relative risk (RR), relative risk reducing rate (RRR), absolute risk reducing rate (ARR) and number needed to treat (NNT) an important clinical event, etc. are commonly used in the primary outcomes interpretation, while the methods to express the effective size and precision of surrogate outcomes and intermediary outcomes are needed to be further studied.

[Surrogate outcomes, intermediary outcomes and their application in TCM clinical efficacy evaluation].

In this paper, the concepts of surrogate outcomes and intermediary outcomes, their correlation with the primary outcome, how to select surrogate outcomes and intermediary outcomes and the particular requirements for using surrogate outcomes in assessing TCM clinical efficacy were discussed and described. It is difficult to evaluate clinical efficacy objectively and thoroughly by means of a single surrogate outcome for reason of the global characteristics of TCM, therefore, to rationally select such intermediary outcomes as important clinical symptoms, combination of several syndromes, patients' subject feeling, patients' satisfaction for treatment and quality of life, should be beneficial for objectively evaluating the efficacy of TCM intervention approaches.

[Exploration on the basic framework of standard for macrocosmic diagnosis of syndrome].

Starting from the thinking characteristics of TCM in the holistic approach of syndrome and process of syndrome differentiation, the problems in the criteria of syndrome diagnosis was analyzed, combining with the outcome of investigation on macrocosmic diagnosis of syndrome carried on twice by expert group nationwide in China, a concept for designing basic framework of standard for macrocosmic diagnosis of syndrome was advocated in this study. In order to recognize and master fully the standard, the following items would be the contents of the framework: give a standardized term of each syndrome; the basic clinical features of a syndrome; the qualitative parameters which could be used to distinguish the nature of a syndrome, and indexes to be used to judge the affected location of a syndrome during identifying process for a syndrome; the order of pertinent indexes with their given score, and the threshold for quantitative diagnosis. It is considered that the above framework defined the sufficient criteria which is constructed on the bases of the approaches with integrated qualitative and quantitative methods.

[General contemplation on causality in appraising clinical efficacy of traditional Chinese medicine].

This paper briefly introduced the general principles for causality in scientific researches and clinical studies, addressed the importance of population-based approaches in it, and also reviewed the developing course and presented the elementary requirements of randomized controlled trials (RCTs). The author identified with views that as compared with the research design of other types, RCTs is the most authentic one in the aspect of causality of efficacy and intervention. It is stressed that a causal inference for the efficacy assessment of traditional Chinese medicine (TCM) must meet the nomothetic criteria.

[Preliminary study on outcome assessment system of treatment of stroke].

Objective: In order to scientifically reflect the real efficacy of TCM treatment and to preliminarily establish a definitely valid and reliable assessment system of stroke treatment, with multi-dimensional outcome assessment indexes, including efficacy evaluation system of conventional western medicine, syndrome evaluation criteria in TCM and quality of life assessment system.

Methods: An integrative approach of cross-sectional survey and prospective follow-up was adopted. Two hundred and forty-five case-episodes of stroke patients were assessed by determining such parameters as nerve functional deficit scale, grading of total status of living ability, activity of daily living (ADL), TCM stroke criteria of diagnosing-treatment, TCM syndrome related symptoms/signs, Health Survey Questionnaire (Short form 36, SF-36), and index of quality of life (QOL), and their construction and relation were analyzed by such methods as multivariate relation, partial relation, linear regression, factor analysis, Cronbach's alpha coefficients, and the responsiveness estimation.

[Effect of bushen yizhi recipe on neurotransmitter release in A beta segment neurotoxin induced NG108-15 cellular model of Alzheimer disease].

Objective: To observe the effect of Bushen Yizhi Recipe (BSYZR) on neurotransmitter release in A beta segment neurotoxin induced NG108-15 cellular model of Alzheimer disease (AD).

Methods: The levels of choline acetyltransferase (ChAT) activity, synapsin and functional synapse formation rate in the cellular model treated with BSYZR containing serum were determined by Western blot analysis, immunoradiometric assay and electrophysiologic technique.

Results: BSYZR containing serum treatment could cause increase of ChAT activity and synapsin level in model cells, as compared with those in normal control model cells treated with non-drug containing serum, it also could regulate the release capacity of transmitter and raise the functional synapse formation.

[Effects of D-galactose combined with lesions of nucleus basalis of Meynert on hippocampal long-term potentiation and synaptic morphology].

Aim: To study the changes of synaptic plasticity in rat model with Alzheimer disease (AD).

Methods: AD rat model was conducted by D-galactose intraperitoneal injection combined with lesions of nucleus basalis of Meynert (nbM). Behavioral performance, LTP in dentate gyrus and synaptic morphology in hippocampal CA1 were observed.