Objective: To analyze the published domestic documents of the clinical trial for treatment of anal fissure in past 10 years, to evaluate the quality of literatures about anal fissure randomized controlled clinical trials, and to provide references of clinical studies for the treatments of anal fissure in Traditional Chinese Medicine (TCM). Methods: In term of principles of evidence-based medicine, we evaluate the published domestic literatures of the randomized controlled clinical trial for treatments of anal f issure in past 10 years. Results: We analyze 52 literatures which are in the method of randomized controlled clinical studies. 28 literatures (accounting for 53.85%) record diagnostic criteria, 38 literatures (accounting for 73.08%) make sure standards of evaluating the effect and 18 literatures (accounting for 34.62%) mention comparability between groups without describing the baseline statistics. Only 5 are marked as a funded research projects. Conclusion: in current published literatures of randomized controlled study for treatments of anal fi ssure, the problems are focused on: ① Experimental idea is unclear and design is unreasonable, ② The description of implemented process in randomized control is unspecif ic, ③ Signifi cant parameters in statistical data are missed and with less credibility, ④ Criteria of diagnosis and effi cacy are different, ⑤ Evaluation indicators are fuzzy. All above clue to the quality of clinical research needs to be improved rapidly, and standardized evaluation of eff icacy also needs to be created urgently.

The sub-health status is closely related to the functions and activities of heart in traditional Chinese medicine (TCM). The sub-health is commonly presented with a series of heart system symptoms such as palpitation, chest distress, shortness of breath, fatigue, fidgets and insomnia. It may also be accompanied with arrhythmia or blood pressure value between normal and high level. This heart system sub-health status can be transformed into re-lated heart system diseases with high possibility. This article made a review from aspects of theoretical literature, an-imal experiment, curative effect observation and clinical evaluation on the research progress of heart system sub-health status.

Neuropsychiatric systemic lupus erythematosus (NP-SLE) is more common in young woman but not yet in people over 75 years old.We report a case of NP-SLE in an old woman,who complained of tremor,hypermyotonia and gatism.The lab examinations showed strong positive (1∶3200) ANA,decreased levels of CH50,C3,C4,WBC,RBC,PLT,anti-ds-DNA(+),anti-Sm(+),SSA(+),PO(+),RO-52(+),urine blood (+) and protein (+).The proteins,MBPand IgGin CSF were increased.Head MRI scan showed many demyelination in bilateral intra ventricular and multiple patchy irregular long T1 and T2 signal under right parietal subcortical.The patient was immediately given methylprednisolone hormone therapy,combined with gamma globulin and hydroxychloroquine.After 4 days of treatment,most symptoms such as tremor and hypermyotonia disappeared.Laboratory tests showed that all immune markers changed better in three weeks.The patient was discharged in 4 weeks.it must be identified with cerebrovascular disease,Parkinson's disease and other common diseases in elderly people.It can be improved if the diagnosis and treatment of NP-SLE is immediately and the illness is well controlled.

In this paper, the Fourier transform based minimum mean square error (FT-based MMSE) method is used to calculate the regional cerebral blood volume (rCBV) in magnetic resonance (MR) perfusion imaging, and the method is improved to handle the existing noise in the imaging process. In the experiments with signal-to-noise ratio (SNR) of 50 dB, the rCBV values were compared with the results using MMSE method. The effects of different SNRs on the estimation of rCBV were analyzed. The experimental results showed that MMSE was a simple way to filter the measurement noise, and could calculate rCBV accurately. Compared with other existing methods, the present method is not sensitive to environment, and furthermore, it is suitable to deal with the perfusion images acquired from the environment with larger SNR.
Blood Volume ; Brain ; blood supply ; Fourier Analysis ; Humans ; Magnetic Resonance Angiography

Objective To explore the role of insulin-like growth factor-2/insulin-like growth factor1 receptor/insulin receptor substrate-1 (IGF2/IGF1R/IRS1) signal pathway inducing the chemoresistance of epidermal growth factor receptor 2 (ErbB2) positive breast cancer cells to Herceptin.Methods Quantitative real-time polymerase chain reaction (qRT-PCR) and Western blot assay were used to determine the expression levels of IGF2,IGF1 R,and IRS1.The direct targets of miR-126 were validated by dual-luciferase reporter gene assay.In SKBR3/pool2 cells,IGF1 R activity was reduced by an inhibitor of IGF1 R,and IRS1 was knocked-down by shRNAs.Furthermore,3-(4,5-dimenthylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium (MTS) assay was performed to evaluate the sensitivity of these treated cells to Herceptin.Results IGF2,IGF1 R,and IRS1 were significantly higher expressed in SKBR3/pool2 cell compared to that in SKBR3 cell.Western blot assay showed that IGF2/IGF1R/IRS1 was activated in SKBR3/pool2 cells.Bioinformatics analysis combined with luciferase activity suggested that miR-126 directly targeted IRS1.MTS results demonstrated that the chemosensitivity to Herceptin of SKBR3/ pool2 cells with inhibitor of IGF1R or shRNAs targeting IRS1 or overexpressing miR-126 was significantly reduced.Conclusions IGF2/IGF1R/IRS1 signal pathway confers to the chemoresistance of ErbB2 positive breast cancer cells to Herceptin.

] Objective To explore the role and mechanisms of FGF2 in chemo?resistance in breast cancer. Methods The inhibitors for different signal pathway were used to treat two drug?resistant breast cancer cell lines MCF?7/5?Fu and T47D/5?Fu established in our lab. MTS assay was used to determine chemo?sensitivity and Hoechst stain was used to measure apoptosis. Protein activation and FGF2 protein level in cell culture medium were detected by western blot and ELISA respectively. Results Akt inhibitor MK?2206 (20 nM) and mTOR inhibitor AZD8055 (2 nM) significantly reversed the chemo?resistance of MCF?7/5?Fu and T47D/5?Fu cell lines to 5?Fu and paclitaxel, but ERK1/2 inhibitor SCH772984 showed no significant effect. Compared to parent cell lines MCF?7 and T47D, p?Akt and p?S6K (represented as mTORactivity) levels were obviously up?regulated in MCF?7/5?Fu and T47D/5?Fu cell lines, and so do the FGF2 mRNA level and FGF2 protein level from culture medium. Moreover, FGFR inhibitor AZD4547 (4 nM) markedly reversed the chemo?resistance of MCF?7/5?Fu and T47D/5?Fu cell lines to 5?Fu and paclitaxel and down?regulated activation of FGFR?Akt?mTOR signal pathway. In agreement, FGF2 protein (10ng/ml) enhanced the chemo?resistance of MCF?7 and T47D cell lines to 5?Fu and paclitaxel and up?regulated activation of FGFR?Akt?mTOR signal pathway. Conclusion Activation of FGF2?FGFR?Akt?mTOR signal pathway promoted chemo?resistance of breast cancer cells.

Objective To observe the value of virtual tough tissue imaging quantification (VTIQ) in differential diagnosis of thyroid imaging reporting and data system(TI-RADS) 4 thyroid nodules.Methods A total of 185 patients with 192 TI-RADS 4 nodules were included in this study.The nodules were divided into three groups according to the maximum size as follows:Group Ⅰ,the maximum size≤0.6 cm;Group Ⅱ,0.6 cm＜ the maximum size≤ 1.0 cm;Group Ⅲ,the maximum size ＞ 1.0 cm.Shear wave velocities (SWV) of nodules were measured by means of VTIQ technique.With pathological diagnosis as the gold standard,SWV value of benign and malignant nodules were analyzed and ROC curve was drawn to assess the diagnostic efficiency.Results By the ROC curve test,at SWV cut-off values of 2.44 m/s for group Ⅰ and group Ⅱ,2.49 m/s for group Ⅲ,the sensitivity were 79.0 ％,76.0 ％,88.6％,specificity were 88.6％,89.5 ％,93.7 ％,accuracy were 83.5 ％,81.8 ％,90.1％,Youden index were 0.68,0.66,0.82,respectively.Conclusions VTIQ can reflect the hardness of TI-RADS 4 nodules,the value of the differential diagnosis of such nodules is high,convenient,noninvasive and not limited by the size of nodules.

Objective To investigate the incidence of subclinical hypothyroidism (SCH) during the third trimester of pregnancy and its effects on pregnancy outcomes and neonatal hypothyroidism.Methods A total of 10 695 women in the third trimester of pregnancy (28-42 weeks of gestation) who labored from January 1,to December 31,2012 in Changzhou Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University were enrolled.The levels of thyroid stimulating hormone (TSH),free thyroxine (FT4) and thyroid peroxidase antibody (TPOAb) of the mothers were quantified by electrochemical immunoassay.The time-resolved fluorescence immunoassay was used to detect neonatal thyroid hormone levels.Using t test or x2test,the incidence of adverse pregnancy outcomes was compared between SCH group and euthyroid group and between SCH women with positive (n=40) or negative TPOAb (n=176).Results The incidence of SCH was 2.02％ (216/10 695) and the positive rate of TPOAb in SCH women was 18.5％ (40/216).No neonatal thyroid dysfunction was found.According to the age matched,222 cases were randomly selected as controls from 7 757 euthyroid women.Compared with the controls,SCH women had a higher incidence of premature rupture of membranes [28.7％ (62/216) vs 14.9％ (33/222),x2=12.34],anemia [11.6％ (25/216) vs 4.1％ (9/222),x2=8.65],pregnancy-induced hypertension [9.7％ (21/216) vs 4.5％ (10/222),x2=4.53],premature labor [8.8％ (19/216) vs 3.6％ (8/222),x2=5.10] and intrahepatic cholestasis of pregnancy [8.3％(18/216) vs 2.3％ (5/222),x2=8.14] (all P＜0.05).The overall incidence of adverse pregnancy outcomes was also higher in SCH group than in the controls [69.4％ (150/216) vs 49.5％ (110/222),x2=17.96,P＜0.01].The incidence of fetal growth restriction and still birth in SCH mothers with positive TPOAb was higher than in those with negative TPOAb [7.5％ (3/40) vs 0.0％ (0/176),x2=13.32,P＜0.01; 2.5％ (1/40) vs 0.0％ (0/176),x2=4.40,P＜0.05],but there was no significant difference in the overall incidence of adverse pregnancy outcomes compared with TPOAb-negative mothers [65.0％ (26/40) vs 70.5％ (124/176),x2=0.46,P=0.50].Conclusions SCH diagnosed in the third trimester may lead to adverse pregnancy outcomes.Early screening for thyroid dysfunction is necessary.

This study was aimed to compare the criteria on quality of questionnaire development and psychometric property evaluation. The references listed in the ISOQOL and consequent included criteria were searched. Two reviewers independently screened papers to include articles with inclusion criteria as follows: fully evaluating the questionnaire development and/or psychometric property; published or unpublished, but not book. Two reviewers independently extracted the information which contained criteria name, types of questionnaire assessed, criteria purpose, research methods, content, evaluation method and etc. Qualitative analysis was conducted to synthesize common characteristics of criteria, and to compare what each criterion emphasized on. The results showed that 9 included criteria sharing the same purpose which evaluated the questionnaire development process and/or psychometric properties of the health related quality of life questionnaire or patient reported outcome. Experts consensus based on previous studies were the criteria development methods. The standard content included conceptual framework, targeted population, content validity, internal consistency, test-retest reliability, structure validity and responsiveness with interpretability. Assessment scoring system used in the criteria was categorized as 2- or 4-point Likert scales. Or document of evaluation evidence was required to be provided. It was concluded that nine criteria can be used to develop new questionnaires, evaluate existed/new questionnaires, or choose the right questionnaires for clinic, based on the following elements such as their research purpose, trials types, questionnaire types or questionnaire administrations.

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.