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.

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.

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.

Objective To evaluate the effects of low blood sugar production index (LGI) combined with low blood sugar production burden (LGL) dietary intervention on blood glucose, oxidative stress and anthropometric indicators in type 2 diabetes mellitus. Methods A total of 150 cases of type 2 diabetes were randomly divided into two groups,maintain the original treatment plan of two groups,75 patients in the control group were given traditional food interchange method for dietary intervention;the experimental group of 75 patients, provide food education based on LGI+LGI food exchange method , the time period of 3 months. Fasting blood glucose (FPG)、2h postprandial blood glucose (2hPG), Glycated hemoglobin (HbAlc), Superoxide dismutase (SOD), Malondialdehyde (MDA), Vitamin C, Vitamin E, Body Mass Index (BMI), Waist circumference (WC) Upper arm muscle circumference (AMC), Triceps skin fold thickness (TSF) were observed before and after the intervention. Results There were no significant differences in blood glucose, oxidative stress and anthropometry between the two groups (P>0.05). After intervention, in the control group: FPG, 2hPG, HbAlc, SOD, MDA, Vitamin C, Vitamin E, BMI, WC, AMC, TSF were (10.27 ± 2.67) mmol/L, (11.51 ± 2.54) mmol/L, (8.78 ± 1.95)%, (322.73 ± 51.97) kU/L, (5.80 ± 1.76)μmol/L, (40.78±4.86)μmol/L, (19.33±4.79)μmol/L, (23.94±3.18) kg/m2, (89.57±10.23) cm, (24.10± 3.01) cm, (18.38 ± 3.79)mm respectively. In the experimental group: they were (8.76 ± 2.77) mmol/L, (10.63 ± 1.76) mmol/L, (7.96 ± 1.86)%, (357.29 ± 60.04) kU/L, (5.26 ± 1.33)μmol/L, (44.01 ± 7.06)μmol/L, (21.58 ± 5.25) μmol/L, (22.93 ± 2.75) kg/m2, (86.05 ± 10.79) cm, (22.75 ± 2.86) cm, (16.98 ± 4.48) mm respectively. There was significant difference between the two groups after intervention (t=2.049-3.769, all P < 0.05). In the experimental group, the improvement of blood sugar, oxidative stress and anthropometry was better than that of the control group (P < 0.05). Conclusions LGI combined with LGL diet intervention is better than the traditional method of food interchange, the blood glucose, oxidative stress and anthropometric indicators have improved, which can improve treatment efficacy in type 2 diabetes and easy for home self-management.

The association between atrial natriuretic peptide (ANP) polymorphism and coronary heart disease (CHD) was studied in Chinese population. The genotypes of ANP T2238C and ANP C-664G were detected by polymerase chain reaction and restriction fragment length polymorphism (PCR-RFLP) methods in 158 consecutive CHD patients and 165 controls. It was found that the distribution of A2A2 genotype in CHD group was significantly higher than that in control group (P<0.05). Stepwise Logistic regression analysis revealed that male, smoking, history of hypertension, history of diabetes, family history of hypertension, high level of serum cholesterol, and ANP T2238C polymorphism were the possible risk factors in patients with CHD (P<0.05). However, there was no significant difference between the patients with CHD and the control group in the distribution of ANP C-664G polymorphism (P>0.05). The results suggest that A2A2 T2238C genotype could be one of the risk factors for CHD (P<0.05, OR: 1.80, 95 % CI: 1.03-3.15).

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 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 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.

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.

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.