To evaluate the development of health outcomes assessment instruments in Chinese medicine.

To investigate the scientificity of patient-reported outcome (PRO) scale for myasthenia gravis (MG), which was used to evaluate the clinical effects of traditional Chinese and Western medicine treatment on MG patients. Psychometric performance of the MG-PRO scale was also expected to be evaluated in this study.

[Objective] To establish the scale of the quality of life for patients with ankylosing spondylitis. [Methods] Initial scale including 58 items was proposed by the research staff. After the preliminary test was performed, 37 items were selected and a confirmed scale of the quality of life for ankylosing spondylitis ( SQOL-AS) was obtained. The feasibility, reliability, validity and sensitivity of SQOL-AS were analyzed. [Results] Statistics showed that SQOL-AS had a good feasibility, reliability, validity and sensitivity. [Conclusion] SQOL-AS can be used to evaluate the quality of life for patients with ankylosing spondylitis.

BACKGROUND:Tissue engineered skin has been used to repair defect skin, but it is not as good as to completely replace permanent skin. OBJECTIVE: To explore the biological characteristics and clinical application of various types of tissue engineered skin. METHODS: Pubmed data (1990-01/2005-12) was retrieved by computer with the key words of "tissue-engineered skin". CNKI database (2002-01/2007-12) was retrieved with the same key words. RESULTS AND CONCLUSION: Totally 226 literatures were primarily selected. After reading titles and Abstracts, studies addressing irrelative objective or repetitive content were excluded, and 11 literatures were included. The aim of skin tissue engineering is to create skin substitute that close to human.skin in histology and functional characteristics. There were many mature tissue engineered skin in clinic, and various artificial skins were developed. Their structure was similar to human, but only had skin barrier function and lack of skin appendages, so they did not have complete skin function, and did not reach skin reestablishment. Ideal skin substitute should process cuticular layer and dermial layer. The dermial layer can reach rapid vascularization and nerve redistribution, can promote physiological wound repair. The cuticular layer can rapidly obtain full barrier and protection function, which can be fully integration with wound surface. A good dermial carrier has good histocompatibility, and a certain physical and chemical properties, such as strength, scratchability, elasticity, gas permeation, water vapor permeability. These can provide a good adherence between dermis and wound surface, offer an ideal fiber stent for cell growth, and finally promote autologous skin growth. Tissue engineered skin has good prospect, but there are many problems that should be solved in biocompatibility and skin function reestablishment.

Objective To make a Meta-analysis of the effectiveness and safety of Shenling Baizhu Powder (SBP) for the treatment of ulcerative colitis(UC),thus to provide evidence for the clinical treatment of ulcerative colitis.Methods Randomized controlled trials (RCTs) of SBP combined with western medicine vs western medicine in treating ulcerative colitis were included.The quality of RCTs was assessed by the Cochrane scale.A Meta-analysis was performed for the clinical efficacy,improvement of disease activity index (DAI) levels of the included trials.Results A total of 19 RCTs were included,involving 1498 cases.The results of Metaanalysis showed that compared with the western medicine group,the combined risk ratio(RR) of clinical efficacy in the SBP combined group was 1.55,95％ confidence interval (CI) being (1.39,1.72).The subgroup analysis based on control medicine showed that the combined RR of combined use of sulfasalazine or mesalazine/Olsalazine was 1.46,1.59 [95％CI (1.19,1.77) vs 95％CI (1.40,1.80)].The subgroup analysis based on different treatment courses showed that the combined RR of 1-30 days,31-60 days,61-90 days was 1.42,1.69,1.47 [95％CI (1.18,1.70) vs 95％CI (1.44,1.97) vs 95％CI (1.15,1.88)] respectively.The differences were significant (P ＜ 0.05).(2) The differences of the two groups on the improvement of DAI and inflammatory factors levels of interlekin-17(IL-17),IL-23,tumor necrosis factor alpha(TNF-α),C-reactive protein(CRP) were statistically significant(P ＜ 0.05).(3)The sensitivity analysis of the primary outcomes showed a higher homogeneity in the literatures and the funnel plot analysis showed no evidence of publication bias.Conclusion Compared with western medicine,SBP combined with western medicine has better clinical efficacy for the treatment of UC,and the combined use of mesalazine/Olsalazine medicated for 30-60 days is more effective on improving DAI and inflammatory factors levels.However,for the low quality of the included literatures and insufficient experimental design,the conclusion needs more evidence from large sample-size randomized double-blind controlled trials.

To explore the major risk factors for hepatitis B (HBV) in Shanghai Jinshan district.A one-to-two matched case control study was performed among the residents of Shanghai Jinshan district in 2010.The data were analyzed by single factor and multivariate analysis performed with SAS 9.13.Single factor analysis showed that the risk factors for hepatitis B were family member with hepatitis B,no vaccination history of hepatitis B virus vaccine and oral treatment.Muhivariable analysis showed that family member with hepatitis B (OR =1.91),no vaccination history of HBV vaccine (OR =0.49) and oral treatment (OR =2.06) were independent risk factors for HBV infection in Shanghai Jinshan district.Strengthening health education for HBV prevention,modifying unhealthy living habits and standardizing the treatment of oral diseases are important measures for lowering infectious rate of HBV.

Objective To develop a scale for evaluating the curative effect of traditional Chinese medicine (TCM) for liver disease under the guidance of the theory of TCM, and to improve the TCM efficacy evaluation standard system for liver disease. Methods According to the TCM theory, the concept model of the liver disease-specific scale was built in combination with the international connotation of QOL and patient-reported outcomes ( PRO). A primary clinical scale was established after item pool screening, field test, culture adaptation and clinical pre-survey by the research staff. Finally, 200 questionnaires were distributed and 198 questionnaires were reclaimed. Statistical analysis was conducted to choose the items. Results All the selected items were analyzed by the different statistical methods, including significance grading, discrete tendency ( coefficient of variation ) method, stepwise regression analysis, discriminatory analysis, Cronbach’s al pha, and principal component analysis and factor analysis. A self-reported subjective scale and a perceived objective scale were developed, including 17 self-reported subjective items and 13 objective items. Conclusion According to the TCM theory and the international connotation of QOL, the scale of assessing curative effect of TCM for liver disease is practical and repeatable. It will be worthy of further evaluation and promotion to clinical application.

Objective To analyze the clinical features of 35 patients with myasthenia gravis (MG) associated with other autoimmune diseases (ADMG). Methods One hundred seventy MG patients were divided into 2 groups. One group included MG patients with autoimmune diseases ( n=35), and the other included MG patients without auto?immune diseases (NADMG, n=135). Clinical features such as gender, age of onset, types of MG, myasthenic crisis, thy?mus abnormalities, different therapies, ocular MG progressing to general MG, and relapse of MG within one year were compared between ADMG and NADMG. Results 85.7%ADMG patients were female which was higher compared with NADMG (P< 0.001); median age of onset was 40 years old (23~45 years old) in ADMG group which was younger than NADMG group. Ocular MG and thymic hyperplasia were more frequent in ADMG group than in NADMG group (45.7%vs. 24.4%, P=0.013;14.3%vs. 1.5%,P=0.001,respectively). Other clinical features such as myasthenic crisis, thymoma, different therapies, ocular MG progressing to general MG, and relapse of MG within one year were not signifi?cantly different between the two groups. In multivariate analysis, female (OR=4.76, 95% CI:1.64-13.77; P= 0.004), age of onset (OR=0.96, 95%CI:0.92-0.99;P=0.019), ocular MG (OR=3.10, 95%CI:1.30-7.41;P=0.011) and thy? mic hyperplasia(OR=16.26, 95%CI:2.22-119.11;P=0.006) were significantly different between the two groups. Con?clusions ADMG is more common in female patients with ocular MG and thymic hyperplasia.

BACKGROUND: Hypoxic training in combined with exercise training can increase the hypoxia levels of the body to mobilize the potentials of the body, resist to and actively adapt physiological responses resulted from hypoxia, so as to improve athletic performance.OBJECTIVE: To summarize the influence of hypoxic training on skeletal muscle structure and function, to provide a theoretical basis and guidance for hypoxic training.METHODS: Using "hypoxic training, skeletal muscle, function, structure" in English as the search terms, PubMed database was ratrieved from 1990 to March 2009; Using "hypoxic training, skeletal muscle, function and structure" in Chinese as the search terms,CNKI database was searched from 2000 to May 2009. Literatures are limited to English and Chinese languages. The content related to the effect of hypoxic training on skeletal muscle structure and function was selected, and repetitive researches were eliminated.RESULTS AND CONCLUSION: Totally 144 literatures were obtained from computer screening, and then analyzed according to the inclusion and exclusion criteria. Hypoxic training could avoid the disadvantages caused by conventional altitude training, the hypoxia environment is regulated according to the body's ability to adapt hypoxia, the normal training is ensured, so that skeletal muscle obtains beneficial physiological adaptation. Compared with pure hypoxia stimulation, different forms of hypoxia and different training methods may integrate into different modes of hypoxic training, which makes skeletal muscle function and structure more complex. The combination form of hypoxia and training is the main factor of the effect of hypoxia training on skeletal muscle function and structure. Different objects of experiments and test methods are likely to interfere with the conclusions, which also affect the mechanism of the role of hypoxic training on skeletal muscle.

The development of health-related quality of life (HRQL) instrument in traditional Chinese medicine (TCM) is increasing rapidly in China, but few studies focus on their necessity. This study explores the necessity of the development of TCM instruments from both theoretical and practice perspectives, and aims to explain whether the adoption of the cross-medical style is valid. Through theoretical analysis, both TCM and Western medicine instruments show the same objectives, whereas TCM instruments are more suitable for the Chinese social behavior, customs and expectations. In practical analysis, 47 TCM instruments were identified, among which 17 had 18 corresponding Western medical instruments. In the domains layer, except for physiological, psychological and social factors, TCM instruments focus more on the harmony between body and spirit, humanity and nature or human and society and the constitution, etc. In the facts layer, TCM instruments focus on the emotions, initiative social intercourse, TCM symptoms, diet, sleep, taste, feces and urine, etc. In addition, significant differences existed in the methods of information selection. There is no need to modify cross-medical style research except when TCM characteristic terms exist, but attention must be paid to the influence of culture in different areas. Therefore, the TCM instruments can resolve the limitations of the application of Western medical instruments to the Chinese setting, while also having remarkable abilities of information coverage and detection. Both forms of instruments have the capacity and requirement to inter-communicate with each other in order to serve the whole Chinese cultural system. Generally speaking, there is no need to modify the instruments in cross-medical style research. But this point requires further demonstration in the rigorous designed clinical trials.