Objective To investigate characteristics of TCM syndromes of pulmonary tuberculosis,and to explore new methods for its treatment. Methods TCM syndrome scale was designed to investigate and summarize the characteristic of the syndrome, the syndrome of the general information, and the main clinical symptoms of 516 pulmonary tuberculosis patients. Results The between-group comparison of distribution of TCM syndromes in patients with pulmonary tuberculosis showed statistical difference (P＜0.05) . The occurrence rate of TCM syndromes in the 516 pulmonary tuberculosis patients were listed in descending order as follows:syndrome of both Qi and yin deficiency complicated with stasis ＞ syndrome of lung yin deficiency complicated with stasis＞syndrome of both Qi and yin deficiency＞syndrome of yin deficiency with various with age (P＜0.05) . Patients with blood stasis syndrome occupied 66.15% of the total number in the youth group; Patients with blood stasis syndrome occupied 78.03% of the total number in the middle-aged group;distribution of TCM syndromes was statistically different with the initial treatment and re-treatment (P＜0.05) .Patients with the blood stasis syndrome occupied 72.73% of the total number in the initial group, patients with effulgent fire ＞ lung yin deficiency syndrome.① The distribution of TCM syndromes was statistically various with age (P＜0.05) . Patients with blood stasis syndrome occupied 66.15％ of the total number in the youth group; Patients with blood stasis syndrome occupied 78.03％ of the total number in the middle-aged group; Patients with blood stasis syndrome occupied 78.22％ of the total number in the old-aged group. ② The distribution of TCM syndromes was statistically different with the initial treatment and re-treatment (P＜0.05) . Patients with the blood stasis syndrome occupied 72.73％ of the total number in the initial group, patients with the blood stasis syndrome occupied 75.61％ of the total number in the re-treatment group.③ The distribution of TCM syndromes was statistically different with the main symptoms (P＜ 0.05 ) . Conclusion All 516 cases of pulmonary tuberculosis had Yin deficiency. There were 380 patients had the stasis, occupying 73.64%.Therefore, the methods of nourishing yin and removing blood stasis should be used to treat patients with pulmonary tuberculosis.

Biological, psychological and sociological model of medicine substantializes the old model lacking the social humane attributes. The new medical model makes people take medical anthropology into research and highly evaluate traditional medical system. Cultural anthropology of traditional Chinese medicine (TCM) is part of medical anthropology with three major characteristics: wide research scope, specificity, and integration. It has developed its own research methods, such as field investigation, comprehensive inspection and comparison study. Cultural anthropology provides an efficient research method for TCM, and its application would further develop TCM theory and form comprehensive evaluation on TCM effects.

Effect of clinical intervention on human body is multistage and multifaceted, involving physiology, psychology, social function and the surrounding resources, etc. Therefore, the range of clinical outcome assessment includes patient, his or her family and care giver. The evaluation of clinical intervention mainly focuses on its effectiveness, safety and health economics. Effects of clinical interventions are measured by comparisons of the outcome of intervention and control groups. Different effect measures come from different comparisons.

Abstract: There are two stages for selecting the clinical intervention outcome variables. One is crude collection and the other is precise collection. The selection methods include brainstorming method, Delphi method, Gordon method, systematic review, systematic analysis method, mathematic model method and so on. Each method has some advantages or disadvantages. When selecting the clinical intervention outcome variables, researchers should make sure the research aim, the representative and the sensitivity of the variables, and select all kinds of recommended methods comprehensively, then decide which method should be used.

BACKGROUND: Gentamicin bead chain is an effective drug delivery system for treatment of osteomyelitis, but it cannot be degraded, need to be removed by second operation, and can breed pathogens. As a result, biodegradable drug delivery systems become a hotspot. Nano-hydroxyapatite/poly(β-hydroxybutyrate-co-β-hydroxyvalerate)-polyethylene glycol-gentamicin (nano-HA/PHBV-PEG-GM-DDS) is considered to be a good choice for the current predicament. OBJECTIVE: To evaluate the acute or chronic toxic reactions of the whole body and local tissues, intracutaneous stimulation, cytotoxicity and hemolytic reactions after bone remodeling and implantation of nano-HA/PHBV-PEG-GM-DDS, thus providing a new kind of material for treating osteomyelitis. METHODS: Plastic nano-HA/PHBV-PEG-GM-DDS was prepared using plastic fibrin glue as microsphere scaffold and nano-HA as the core carrier of GM that was coated with PHBV and PEG. The acute, subacute/chronic toxicity, implantation, hemolysis, cytotoxicity and intracutaneous stimulation tests were performed according to the evaluated criteria of medical implanted materials as wel as biological and animal trials recommended in GB/T16886.1-1997. RESULTS AND CONCLUSION: The plastic nano-HA/PHBV-PEG-GM-DDS was nontoxic and caused no apparent changes in liver and kidney function and serum biochemical indexes. Pathological examination showed that the implanted material was covered with tissues, and inflammation changes accorded with the general regularity of inflammatory outcomes. After implantation, the nano-HA/PHBV-PEG-GM-DDS was biodegraded and replaced by osseous tissues. The hemolytic rate of the material extract to the composite diffusion solution was 1.2%, which was below the standard criteria (5%). Human bone marrow cells cultured in vitro with the plastic nano-HA/PHBV-PEG-GM-DDS grew normally with good morphology. There was no stimulation reaction according to the criteria after the diffusion solution was subcutaneously injected into the back of the animal. These findings indicate that the plastic nano-HA/PHBV-PEG-GM-DDS for treating osteomyelitis possesses excel ent biocompatibility and security.

This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.

Objective To establish HPLC characteristic chromatogram ofKanglao Qingfei Granules.Methods HPLC analysis of samples was performed on Kromasil C18 column (4.6 mm × 250 mm, 5μm), with acetonitrile-1% glacial acetic acid as the mobile phase of gradient elution (0-50 min, 5%→15% acetonitrile;50-70 min, 15%→25% acetonitrile;70-80 min, 25%→40% acetonitrile;80-90 min, 40%→65% acetonitrile, 90-120 min, 65%→95% acetonitrile);the volume flow rate was 1.0 mL/min;detection wavelength was set at 290 nm;column temperature was 30℃. Chromatographic peaks were identified by HPLC-MS/MS method.Results The similarity degrees of 10 batches of samples were all greater than 0.995, and 13 chromatographic peaks were determined as common characteristic peaks, of which 10 peaks were confirmed in the source attribution and 8 peaks were identified in chemical component.Conclusion The established HPLC characteristic chromatogram can be used for the quality control ofKanglao Qingfei Granules.

Objective To study the scientificity and rationality in data management of the project of Chinese Chronic Disease Clinical Research System and its Achievements Application Mode;To provide evidence and reference for the improvement of follow-up work. Methods According to the relevant management regulations, guidelines, and other relevant documents of national and international clinical research data,“Questionnaire for Research Data Management Assessment of Chinese Chronic Disease Prevention” was designed. The questionnaires were used in 10 clinical topics during the on-site inspection survey, and 20 valid questionnaires were retrieved and analyzed statistically. Results 50-60 percentage of subjects in data management and statistics were performed by the third party;70 percentage of subjects were performed by their own central monitoring;50 percentage of the subjects adopted a cooperative manner with others to develop appropriate data management systems;7 centers had system and plan for data management;Data management was carried out;implementation degree of training, database, CRF tracing, and others 7 aspects was low. Conclusion Improving the quality of data management of TCM clinical research still needs to be perfected from many aspects, and quality mode of large-scale clinical trials should be improved.

Objective To optimize the extraction process of Kanglao Qingfei granules. Methods Orthogonal test design was used to study the influence of soaking time, water content, extraction time on extraction technology with bergenin's extraction rate, total polysaccharides's extraction rate and extract yield as evaluation indexes. Results The optimum extraction process conditions were as follows:the raw materials were immersed in water for 1.0 h and extracted two times under reflux, and the ratio of water volume to raw materials weight was 10 and 8 (mL/g), and extraction time was 2.5 h and 2.0 h, respectively. Conclusion The optimized extraction process was simple and stable, which can provide foundation for industrial production of Kanglao Qingfei granules.

Soladulcidine is a steroidal alkaloid abundant in Solanum dulcamara L. with antitumor and other biological activities. In this study, ten soladulcidine derivatives were synthesized through esterification at C-3-hydroxy group, modification at NH group of F ring of esterification of E ring-opening products. The in vitro antiproliferative activity of these synthesized derivatives against prostate cancer (PC-3) cell line was assessed. Within this series of compounds, compound 19 exhibited the most potent inhibitory effect against the proliferation of PC-3 cell line (IC50=4.80±.9μmol/L).