Some conclusions drawn from explanatory randomized controlled trial (ERCT) lack practical value in application under real-world clinical settings, and there are also some limitations on the generalization of pragmatic randomized controlled trial (PRCT) results. In some countries, real-world studies (RWSs) have been conducted to explore the effectiveness and safety of clinical interventions or postmarketing drugs, which is a new tendency in clinical researches. By reviewing some RWSs carried out in Western countries, we sum up the basic characteristics of the research design, and discuss the differences and connections between PRCT and RWS. The design ideas of RWS are different from PRCT. Researchers in RWS tend to perform long-term evaluation based on large quantities of subjects and quite large sample and focus on outcome measures which are clinically meaningful. Strict control on data collection, management and analysis are very important to RWS and PRCT. Owing to the complexity of clinical interventions and evaluation, PRCT is not completely suitable for clinical researches in traditional Chinese medicine (TCM). It is an inevitable tendency to apply RWS in clinical trials of TCM. We can explore the efficacy of TCM interventions through PRCT, and better understand the effectiveness through RWS. RWS will become a powerful approach to TCM clinical trials and postmarketing evaluation of Chinese medicines.

For a long time, in the field of medical research, due to lack of proper methods, research decision-making process has not made the most of human experience, recommendations and different opinions, viewpoints, and expositions related to subjective interpretation. At present, this problem in the course of the standardized clinical research on traditional Chinese medicine is particularly prominent and needs to be solved urgently. Consensus methods can be used for studying different perspectives within the group and get different levels of "consent" in order to achieve "consensus", especially in the formation of a consensus of experts, which are widely used now. Consensus methods include three frequently used methods such as Delphi method, nominal group technique and consensus development conference. The research team of WHO Western Pacific Regional Primary Osteoporosis Clinical Practice Guideline of Traditional Medicine completed the preparation of good practice points in the first draft after three expert consensus meetings by using consensus development conference method. This article discusses the application of consensus development conference method in the developing process of clinical practice guidelines of traditional medicine.

It is not finally concluded how to standardize the use of qualitative research in the world. Qualitative researchers disagree with each other about this issue. As we know, there have been a large number of articles written in different ways about qualitative research due to the "flexibility", one of its features. Qualitative research is quite different from quantitative research which is easy to control its quality and quality assessment. A series of criteria has been set up for quantitative research. However qualitative research needs to be improved in these aspects, in which qualitative interviews are mostly used at home and abroad at present. Hence, it becomes an important and urgent issue for qualitative researchers to standardly control and assess the quality of qualitative interview.

Qualitative interview can collect data independently and can help modify and explain data when being combined with the quantitative research. The authors of this article introduced some kinds of qualitative interviews and their application in clinical research of traditional Chinese medicine (TCM). It emphasized some aspects of qualitative interview including the origin and definition, classification, basic standards, sampling, data analysis and report writing, quality evaluation and application for TCM clinical research.

The paper aims to explore basic steps, regulation and data analysis methods of semi-structured and in-depth interview studies of clinical research in traditional Chinese medicine (TCM), and to provide some helpful information obtained from the examples for decision making in TCM research field. A pilot study was made with eight interviewees and, based on which, a formal one with twelve interviewees was done in this study. All the recordings were transcribed into verbal manuscripts, categorized into different archives and labeled by letter from A to T. Grounded theory for analyzing qualitative data was used in this study, and cross-case analysis was also made on the basis of case-by-case analysis results. Nine theories with central categories were constructed by three coding procedures from grounded theory. Three kinds of relationships, three types of optimized attitude, and three concerns were obtained from the example study. Nine analyzing conceptual graphs and nine theories related to optimization of TCM clinical research program were established finally. The researchers of large national studies were included as interviewees in the study. A comprehensive and critical data analysis from twelve interviewees for in-depth interview was conducted in accordance with current international qualitative research, and a response theory model focused on optimization of TCM clinical research program was established. The study laid the foundation for using semi-structured and in-depth interview for TCM clinical research.

Objective: To study the mechanism of effect of total flavone of rhizoma drynariae in groups with different dosage on osteoblasts cultured in vitro. Methods: To culture osteoblasts with UMA-106-01 osteoblast strain and to observe the activity of ALP and the endosmosis of 3H-TdR. Results: The total flavone of rhizoma drynariae increased the activity of ALP in cells cultured with UMR-106-01 strain. The ALP activities correspondingly changed in the 24h, 48h and 72h, which related to dosage effect and time effect. Among them, the activity in the 48h is the most ideal one. And the amount of endosmosis of the total flavone of rhizoma drynariae to 3H-TdR increased more remarkably in the 48h than that in the 24h and it also related to the time effect. Conclusion: The total flavone of rhizoma drynariae can promote the differentiation and multiplication of osteoblasts.

Objective To study the drug-time process of aurantiin in Rhizoma Drymariae in vivo.Methods By the optimization of the chromatographic condition,a reversed-phase HPLC was established to measure the content of aurantiin in the serum and the tissues of rats.Results After administration of total flavones of Rhizoma Drymariae to the rats by gavage,aurantiin started to be absorbed in 30 minutes and arrived at the peak in 90 minutes.The blood drug concentration decreased evidently 4 hours after gavage and maintained at a certain level in 8 hours.The drug concentration was highest in the stomach and bowels,but decreased quickly.The concentration in the liver,lungs and kidney came next and can be determined in the muscles and fat;however,it was very low or zero in the brain.Conclusion This method is convenient,sensitive,rapid and without the interference of other impurities.It is suitable for the determination of aurantiin content in the serum and tissues of rats.Administering total flavones of Rhizoma Drymariae to the rats by gavage,aurantiin is absorbed slowly and maintains for a long time and subsides slowly in the blood.

Objective Study the common symptoms of sub-healthy people. Methods Study the 59 symptoms of the 1 828 cases of sub-healthy people that the study of DME Research on TCM Syndrome of Sub-health State had collected. Select the symptoms by analysis of percentage, mean, correlation and discriminance. Finally, find out the symptomatic characters of the sub-healthy people by the data mining method of decision tree. Result There were 26 variables selected from the 56 symptoms. The result of decision tree showed that low quality of sleep, fatigue, dry in throat, acid and distend in eyes, ache, emptiness in heart had greater relations with sub-health. Conclusion Low quality of sleep, fatigue, dry in throat, acid and distend in eyes, ache, emptiness in heart are the symptoms that have greater relations with sub-health.

Objective To evaluate reliability and validity to perfect the syndrome questionnaire of osteoporosis. Methods The reliability was evaluated with Cronbach alpha and Guttman Split-half, the construct and content validity of the questionnaire was evaluated with factor analysis. Results The Cronbach alpha is from 0.365 4 to 0.852 5. The Guttman Split-half is from 0.542 9 to 0.746 5. The factor analysis had extracted 12 common factors which initial eigenvalues bigger than one. The Cumulative Proportion is 66.24%. The factors cover all the main facets of the questionnaire. Conclusion The questionnaire has its reliability and validity, and should be revised and perfected in future study.

Objective To investigate whether antenatal administration of dexamethasone would provide protection against cerebral hypoxic ischemic damage in asphyxiated fetal rats. Methods Fifty seven fetal rats of twenty day gestational age were randomly divided into five groups: sham operation (normal control, n =11), asphyxiated control (group E, n =10), and group D 1?D 2?D 3 of different timings of intravenous dexamethasone treatment (1 mg/kg) in pregnant SD rats ( n =15, 12, and 9 respectively). The times assigned for dexamethasone injection were thirty minutes before clamping, the time aroung clamping and the beginning of reperfusion respectively. Intra and extra cellular concentrations of calcium, sodium and potassium in fetal rat brains were measured in each group after thirty minutes of reperfusion. Results (1)Intracellular free calcium concentrations of fetal rat brains in group E,D 1, D 2 and D 3 were 552?94, 438?105, 445?57, and 456?110 nmol/L respectively, and all significantly higher than that in the normal control 315?87 nmol/L ( P